Project of GUIDELINES FOR BEST PRACTICES IN MEDICAL DEVICE ... · 56 1.1 Introduction ... 185 Medical device management requires the involvement of staff from many disciplines

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Draft for Comment Purposes (Not for Implementation)

Medical Devices Sector

SAUDI FOOD & DRUG AUTHORITY

Project of GUIDELINES FOR BEST PRACTICES IN MEDICAL

DEVICE MANAGEMENT WITHIN HEALTH FACILITIES

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Contents 52

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LIST OF ABBREVIATIONS AND ACRONYMS ................................................... 4 54

Chapter 1: Preambles 11 55

1.1 Introduction ....................................................................................................... 11 56

1.2 Health Technology Management Department .................................................. 14 57

2.1.2 Preventable medical errors 15 58

Chapter 2: Planning 17 59

2.1 Introduction 17 60

2.2 Medical Devices Planning Process 19 61

2.3 Checklist 30 62

Chapter 3: Procurement 31 63

3.1 Introduction ....................................................................................................... 31 64

3.2 Procurement Procedures ................................................................................... 33 65

3.3 Operation Costs Consideration ......................................................................... 35 66

3.4 Methods of Acquisition2 ................................................................................... 35 67

3.5 Tender Contents ................................................................................................ 36 68

3.6 Ethical Considerations ...................................................................................... 37 69

3.7 Evaluation Criteria ............................................................................................ 39 70

3.8 Compliance Checking ....................................................................................... 40 71

3.9 Contract with Supplier. ..................................................................................... 40 72

3.10 Payments Scheduling. ....................................................................................... 40 73

3.11 Storage Requirements: ...................................................................................... 40 74

3.12 Tender Award Process and Payment Processing .............................................. 40 75

3.13 Checklist ........................................................................................................... 42 76

Chapter 4: Installation & Commissioning ............................................................... 43 77

4.1 Introduction ....................................................................................................... 43 78

4.2 Delivery............................................................................................................. 44 79

4.3 Medical Device Installation & Commissioning ................................................ 45 80

4.4 Checklist ........................................................................................................... 47 81

Chapter 5: Operations 48 82

5.1 Introduction ....................................................................................................... 48 83

5.2 Operation Activities .......................................................................................... 50 84

5.3 Corrective Maintenance Management .............................................................. 52 85

5.4 Transfer and storage procedures ....................................................................... 53 86

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5.5 Reusable Medical Devices Reprocessing ......................................................... 54 87

5.6 Computerized Maintenance Management System (CMMS) ............................ 58 88

5.7 Data integrity .................................................................................................... 60 89

5.8 Considerations in selecting a new or replacement CMMS ............................... 63 90

5.9 Reporting adverse events to SFDA ................................................................... 65 91

5.10 Special requirements for specific medical devices ........................................... 69 92

5.11 Special safety requirements .............................................................................. 71 93

5.12 Inventory Accuracy ........................................................................................... 72 94

5.13 Warranty Management...................................................................................... 74 95

5.14 Disaster/Contingency Planning ......................................................................... 75 96

5.15 User Training .................................................................................................... 77 97

5.16 HTM/Clinical Engineering Training programs ................................................ 77 98

5.17 Spare Parts procurement and management ....................................................... 78 99

5.18 On Site Libraries ............................................................................................... 78 100

5.19 Workshop Space and Test Devices ................................................................... 79 101

5.20 Inter Service Coordination ................................................................................ 79 102

5.21 Checklist ........................................................................................................... 80 103

Chapter 6: Disposal & Donation 82 104

6.1 Introduction ....................................................................................................... 82 105

6.2 Checklist: .......................................................................................................... 86 106

Chapter7: Special Topics 87 107

7.1 Introduction ....................................................................................................... 87 108

7.2 Medical device Consumables, Single Use. ....................................................... 90 109

7.3 SFDA requirements with regards to reprocessing of single use devices .......... 91 110

7.4 Reuse of Reusable, Limited Use & Single Patient Use Medical Devices ........ 91 111

7.5 Reuse of Single Use Medical devices ............................................................... 91 112

7.6 Medical Device Implants .................................................................................. 93 113

7.7 Checklist ......................................................................................................... 100 114

8. References 101 115

9. Appendices 102 116

9.1 Planning: ......................................................................................................... 102 117

9.2 Procurement .................................................................................................... 129 118

9.3 Device Inventory Auditing Example .............................................................. 133 119

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LIST OF ABBREVIATIONS AND ACRONYMS 123

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AAMI American Association of Medical Instrumentation

AI Artificial Intelligence

BMET Biomedical Engineer/Technician/Technologist

CCTV Closed-Circuit Television

CE mark Conformité Européene (EU certificate of conformity)

CD Construction Documents

CM Corrective Maintenance

CMMS Computerized Maintenance Management System

CPG Clinical Practice Guidelines

CR Computed Radiography

CSSD Central Sterile Supplies Department

CT Computed Tomography

DD Design Development

DHCP Dynamic Host Configuration Protocol

ECG Electrocardiogram

ECRI Emergency Care Research Institute

EHRs Electronic Health Records

EM Equipment Management

EU European Union

FDA Food and Drug Administration

GMDN Global Medical Device Nomenclature

HR Human Resources

HTM Health Technology Management

IDFs The intermediate distribution frames

ICDs Implantable cardioverter-defibrillators

IHE Integrating the Healthcare Enterprise

IR Interventional Radiology

ISO International Organization Standards

IT Information Technology

LDAP Lightweight Directory Access Protocol

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MDEL Medical Devices Establishment Licensing

MDF Multiple Distribution Frame

MDMA Medical Device Manufacturers Association

MDNR Medical Devices National Registry

MEMDMC Medical Equipment Management Device Management Communication

MRI Magnetic Resonance Imaging

PACU Post Anesthesia Care Unit

PET Positron Emission Tomography

PPM Planned Preventive Maintenance

SAM Service Availability Mapping

SEM Small and Medium Sized Enterprises

SFDA Saudi Food and Drug Authority

SON Statement of Need

SUMD single-use medical device

UMDNS Universal Medical Device Nomenclature System

UPS Uninterruptible Power Supply

WHO World Health Organization

LIST OF DEFINITIONS 125

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Acceptance

Testing

The initial inspection performed on a piece of medical equipment prior to

it being put into service. When the device first arrives in the health-care

facility, it is checked to ensure it matches the purchase order, it is

functioning as specified, the training for users has been arranged and it is

installed correctly. If a computerized maintenance management system

(CMMS) is available, it is registered into the CMMS.

Medical Device

Accessories

Products intended specifically by its manufacturer to be used together

with a medical device to enable that medical device to achieve its intended

purpose.

Assessment

Process

Tool for determining medical device needs at the healthcare facility and

detecting the gaps in the availability of medical devices by collecting

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baseline information that can support recommendations for future

planning.

Calibration

Some medical equipment, particularly those with therapeutic energy

output (e.g. defibrillators, electrosurgical units, physical therapy

stimulators, etc.), needs to be calibrated periodically. This means that

energy levels are to be measured and if there is a discrepancy from the

indicated levels, adjustments must be made until the device functions

within specifications. Devices that take measurements (e.g.

electrocardiographs, laboratory equipment, patient scales, pulmonary

function analyzers, etc.) also require periodic calibration to ensure

accuracy compared to known standards.

Certificate of

Need (CON)

Planning tool used to support decision-makers in evaluating investments

of highly specialized and expensive medical equipment, based on

technical, epidemiological, and cost-benefit criteria in order to best

optimize resources.

Clinical

Engineer

A professional who supports and advances patient care by applying

engineering and managerial skills to healthcare technology.

Computerized

Maintenance

Management

Systems

Computer-based software system that is used to automate issues related

to technical support of medical devices and provide support to the

management of the medical device inventory, corrective maintenance,

preventive maintenance, contract management and provides a wide range

of real time data reports on different issues related to the medical device

lifecycle such as downtime, life cycle cost and inventory reports related

to device type, location or selected manufacturers.

Corrective

Maintenance

(CM)

A process used to restore the physical integrity, safety and/or performance

of a device after a failure. Corrective maintenance and unscheduled

maintenance are regarded as equivalent to the term repair. This document

uses these terms interchangeably.

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Cybersecurity

Body of technologies, processes and practices designed to protect

networks, computers, programs and data from attack, damage or

unauthorized access.

Device

Planning

Core component of hospital planning and design. Some medical devices

require special architectural, electromechanical and infrastructure design

in addition to the unique and specific utility and pre-installation

requirements.

Failure The condition of not meeting intended performance or safety

requirements, and/or a breach of physical integrity. A failure is corrected

by repair and/or calibration.

Global Medical

Devices

Nomenclature

System

(GMDNS)

List of generic names used to identify all medical devices to provide

health authorities, regulators, health care providers, manufacturers and

others with a naming system that can be used to exchange medical device

information and support patient safety.

The GMDNS is used for:

a) Data exchange between manufacturers, regulators and healthcare

authorities

b) Exchange of post-market vigilance information

c) Supporting inventory control in hospitals

d) Purchasing and supply chain management

The GMDNS is recommended by the International Medical Device

Regulators Forum (IMDRF) and is now used by over 70 national medical

device regulators to support their activity. The GMDNS is managed by

the GMDN Agency, a registered charity, which has a Board of Trustees,

which represent regulators and industry.

Healthcare

Needs

Assessment

The identification and definition of prioritized requirements regarding

medical devices.

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Health

Technology

Management

(HTM)/

Clinical

Engineering

The cost-effective and clinical effective management of all issues related

to the medical device lifecycle. This may consist of a framework of

standard policies and procedures designed to address all different

components and issues related to medical devices. The term health

technology management is used to describe the delivery structure required

to manage the medical devices within healthcare systems.

Inspection Scheduled activities necessary to ensure a piece of medical equipment is

functioning correctly. It includes both performance inspections and safety

inspections. These occur in conjunction with preventive maintenance,

corrective maintenance, or calibration but can also be completed as a

stand-alone activity scheduled at specific intervals.

Inspection and

Preventive

Maintenance

(IPM)

IPM refers to all the scheduled activity necessary to ensure a piece of

medical equipment is functioning correctly and is well maintained. IPM

therefore includes inspection and preventive maintenance (PM). This is

also referred as PPM (Planned Preventive Maintenance).

Medical Device

Any instrument, apparatus, implement, machine, appliance, implant, in

vitro reagent or calibrator, software, material or other similar or related

article:

A. Intended by the manufacturer to be used, alone or in combination,

for human beings for one or more of the specific purpose(s) of: −

Diagnosis, prevention, monitoring, treatment or alleviation of

disease, − Diagnosis, monitoring, treatment, alleviation of or

compensation for an injury or handicap, − Investigation,

replacement, modification, or support of the anatomy or of a

physiological process, − Supporting or sustaining life, − Control

of conception, − Disinfection of medical devices, − Providing

information for medical or diagnostic purposes by means of in

vitro examination of specimens derived from the human body;

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B. Which does not achieve its primary intended action in or on the

human body by pharmacological, immunological or metabolic

means, but which may be assisted in its intended function by such

means.

Medical Device

Nomenclature

Systems

Classification system to identify the type of medical devices by assigning

a code to the type of device such as CT, MRI and implantable pacemakers.

The classification system is needed for several HTM and regulatory

issues. It must be part of any CMMS coding system to be able to identify

and track certain parameters related to the different types of medical

devices managed by the CMMS.

Performance

Inspections

Activities designed to test the operating status of a medical device. Tests

compare the performance of the device to technical specifications

established by the manufacturer in their maintenance or service manual.

These inspections are not meant to extend the life of the device, but

merely to assess its current condition. Performance inspections are

sometimes referred to as ‘performance assurance inspections.’.

Preventive

Maintenance

(PM)

PM involves maintenance performed to extend the life of the device and

prevent failure. PM is usually scheduled at specific intervals and includes

specific maintenance activities such as lubrication, cleaning (e.g. filters)

or replacing parts that are expected to wear (e.g. bearings) or which have

a finite life (e.g. tubing). The procedures and intervals are usually

established by the manufacturer. In exceptional cases the user may change

the frequency to accommodate local environmental conditions.

Preventive maintenance is sometimes referred to as ‘planned

maintenance’ or ‘scheduled maintenance’. This document uses these

terms interchangeably.

Repair A process used to restore the physical integrity, safety, and/or

performance of a device after a failure. Used interchangeably with

corrective maintenance.

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Reuse Repeated use or multiple use of any medical device with reprocessing

(cleaning, disinfection or sterilization) between uses.

Safety

Inspections

Safety inspections are performed to ensure the device is electrically and

mechanically safe. These inspections may also include checks for

radiation safety or dangerous gas or chemical pollutants. When these

inspections are done, the results are compared to country or regional

standards as well as to manufacturer’s specifications. The frequency of

safety inspections may be different than planned maintenance and

performance inspections, and are usually based on regulatory

requirements.

Single Patient

Use Medical

Device

Medical devices that can be used for more than one episode of use on one

patient only. The device shall be decontaminated between each use.

Single Use

Medical Device

(SUMD)

Medical device intended for use once, on an individual patient for a single

procedure, and then should be discarded.

Unique Device

Identification

Code (UDI)

Unique device identification code using a globally accepted standard

format which consist of series of numeric or alphanumeric characters and

used as the key access to information stored in a UDI database.

Universal

Medical

Devices

Nomenclature

System

(UMDNS)

Standard, free of charge, monthly updated, international nomenclature

and computer coding system to help better manage classifying medical

device types.

UMDNS facilitates identifying, processing, filing, storing, retrieving,

transferring, and communicating data about medical devices. The

nomenclature is used in applications ranging from hospital inventory and

work-order controls to national agency medical device regulatory systems

and from e-commerce and procurement to medical device databases.

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Chapter 1: Preambles 130

1.1 Introduction 131

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1.1.1 Objective 134 135

To develop standardized national guideline for best practices in medical device 136

management throughout their life cycle within healthcare facilities. 137

Enhance the efficiency and improve the management of medical devices, their 138

operation and their rational use within healthcare facilities. 139

Minimize the risks associated with the use of medical devices. 140

Ensure the medical devices within the healthcare facility are: 141

- utilized appropriately; 142

- suitable for its intended purpose; 143

- maintained in a safe and reliable condition; 144

- operated in accordance with the manufacturer’s instruction by users and 145

professionals who have obtained and maintained the correct level of 146

knowledge and competency necessary, and disposed of appropriately at the 147

end of its useful life. 148

Periodically monitored for performance, leakage current, isolation, insulation, 149

calibration, adverse events, risks, utilization and cost 150

Perform one of the surveillance tasks that on the official order of SFDA system 151

that mentions the “SFDA shall monitor the obligation of healthcare facilities 152

with international standards of safety performance for medical devices" in 153

accordance with these guidelines for management of health technology /medical 154

devices within healthcare facilities. 155

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In accordance with these guidelines, the SFDA is working with its partners to build 157

a framework of regulatory procedures to support improving the quality of healthcare 158

in the kingdom. 159

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1.1.2 Scope 163

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This guideline will apply to any medical device used as part of the routine care of 165

patients. It will provide procedures and practices that will help ensure that a medical 166

device is managed, operated and maintained as recommended by the manufacturer 167

to ensure that its performance will be maintained throughout its lifetime. The 168

procedures will cover the medical devices life cycle as following: 169

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1. Planning phase: User requirements, safety, needs assessment, pre-installations 171

requirements; 172

2. Procurement phase: Tender process, technical specifications, life-cycle cost, 173

effective tender evaluation, pre-installation costs; 174

3. Installation phase: Pre-installation, inspection and commissioning, acceptance 175

certificate, connectivity, operating and service manuals; 176

4. Operation phase: Effective lifecycle management of medical technologies; 177

implementation of CMMS, preventive and corrective maintenance, calibration, 178

training users, transport, and storage. 179

5. Disposal phase: Justification for scrapping, safety and hygiene, removal, 180

dismantling and disinfection of medical device. 181

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1.1.3 Stakeholders within healthcare facility 183 184

Medical device management requires the involvement of staff from many disciplines 185

–technical, clinical, financial, administrative, etc. It is not just the job of managers; 186

it is the responsibility of all members of staff who deal with healthcare technology1. 187

This includes the departments of Biomedical Engineering, information technology, 188

Nursing, Medical, Finance, Projects, General maintenance, Asset management 189

…etc. 190

1 How to organize a system of healthcare technology management

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1.1.4 Background 192 193

Medical devices are for Diagnosis and Treatment. They play a crucial role in patient 194

care and treatment. Once a device is in the market, its safety and performance 195

depends on: 196

Preservation of the integrity of the device through applying proper management 197

procedures in storage, handling, transportation, delivery, installation and 198

testing. 199

Using the devices for the exact intended purpose as per the manufacturer's 200

instruction. 201

Operating them effectively and safely. 202

Device characteristics change with time, therefore, continuous monitoring for 203

safety and performance is essential to ensure that these changes don't have an 204

impact on patient safety. 205

Constant detection, investigation of unexpected incidents and possible adverse 206

events. 207

Proper preventive, corrective Maintenance, calibration and electrical safety tests 208

to preserve its specified performance. 209

Maintain proper documentation for all actions taken on the device including 210

utilization, operation and maintenance cost. 211

Decommission, disposing and replacing unsafe and obsolete items. 212

Ensuring the staff have the right skills to optimally use the medical device. 213

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Health technology management involves a cycle of activities in the life of 215

equipment, as shown in (Figure 1.1). 216

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Figure 1.1: Medical Device life cycle. 218

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1.2 Health Technology Management Department 220

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Medical devices and supplies constitute a good percentage of hospital costs. They 222

play a role in Diagnosing and treating patients in almost every department and ward 223

within a healthcare facility. Managing these sensitive and fast evolving devices 224

requires the availability of trained biomedical engineers and technicians who are 225

capable of identifying and managing risks associated with the technology used 226

within the hospital. Furthermore, most of the medical devices now share information 227

with the hospital network to create and platform for information exchange and 228

artificial intelligence. 229

In principle, no technology can be added or removed without the involvement of 230

Health Technology Management/Clinical Engineering department in the process. 231

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The recommended organizational structure of the HTM Department (sometimes called 233

Clinical Engineering or Biomedical Department) depends mainly on the size and nature 234

of services within the healthcare facility. The world health organization (WHO) 235

published "HUMAN RESOURCES FOR MEDICAL DEVICES The role of 236

biomedical engineers" as part of Medical Devices technical series to ensure access to 237

quality and safe use of medical devices. The booklet details the responsibilities of the 238

Decommissioning and Disposal

OperationInstalling &

Commissioning

Planning & Technology Assessment

procurement

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HTM/Clinical Engineering department depending on the hospital size. The following 239

shows some of the responsibilities of this department: 240

1. Planning for new technologies that includes (needs assessments, budgeting, 241

cost analysis, pre-installation requirements …etc. 242

2. Purchasing process: Oversee the procurement cycle, putting specifications, 243

tender processing, technical assessment, contracting, commissioning and 244

acceptance testing. 245

3. Preventive and corrective maintenance of medical devices (in-house) and/or 246

management of service contracts for devices categorized to be maintained by 247

service providers (support the preparation, signing and supervising the 248

implementation of contracts with manufacturers and local suppliers of medical 249

devices, spare parts, chemicals, reagents and consumables). 250

4. Administrative support: Oversee the internal and external administrative 251

communications, human resources and other administrative work related to 252

medical devices. 253

5. OEM & 3rd party Contract Management, negotiations and administration 254

6. Quality control: Monitor the quality of technical support provided to medical 255

devices, ensure safety to department staff, users and patients and monitor the 256

overall performance of the HTM Dept, adverse events reporting, managing 257

recalls on medical devices, incident reporting and investigations 258

7. Medical equipment retirement plan including decommissioning, disposing, 259

and replacing unsafe & obsolete items. In order to ensure safe, accurate, and 260

affordable technology in the hospital and to exclude obsolete, beyond repair 261

and un-economical technology in the hospital. 262

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2.1.2 Preventable medical errors 264

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Significant percentage of preventable medical errors are caused by improper use of 266

medical devices. In USA 440,000 patients are dying annually because of preventable 267

medical errors1. The figure below illustrates errors related to medical devices. In 268

another study, 59.5% of drug errors reported to USP from 570 HC facilities are due to 269

implicate use of computers2 . 270

It is the responsibility on clinical engineers when building their HTM system to have 271

amandate to enhance the safety and performance of medical devices by monitoring the 272

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performance of medical devices, detect any risk related to that devices and take all 273

measures to minimize all adverse events related to medical devices. 274

In most Middle East countries, medical errors including those adverse events related to 275

medical devices are not properly tracked. The role of HTM system and clinical 276

engineers is to be part of any available initiative for tracking medical errors and adverse 277

events related to medical devices and raise a “red flag” to hospital leaders such 278

mechanism is not available. 279

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Chapter 2: Planning 282

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2.1.1 Objective 286

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To demonstrate how to conduct the medical devices planning through providing 288

basic tools, references, and examples to do a proper planning and assessment of their 289

current situation and future needs about medical devices. 290

2.1.2 Scope 291

292

This chapter applies to any healthcare facility whose planning for medical devices 293

includes: 294

New construction 295

Renovation 296

Device installation 297

298

to come up with a list of needs of medical devices and supplies from all healthcare 299

providers departments with justifications that based on previous years utilizations, 300

future needs and other objective parameters (product or service, quality, quantity, 301

pre-installation, the condition and performance of current medical devices installed, 302

including: device failures and issues; utilization, performance, maintenance; repair 303

and calibration history). 304

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2.1.3 Ownership 306 307

The involvement of Committee with minimum members as following: 308

Healthcare provider administration. 309

Finance department. 310

Healthcare technology /Clinical engineering department. 311

End-user department. 312

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IT department. 313

Facility management department. 314

Supply chain / procurement department. 315

Project management department. 316

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2.1.4 Background 318 319

Early engagement of all stakeholders in planning the technology needs for a new 320

department or hospital is important to assure having a comprehensive view over the 321

needs to make an educated decision on the proper technologies needed. The 322

following diagram shows the steps involved in technology planning. 323

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Figure 2.1: Pre-installation and Planning Processes Work Flow. 336

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Needs of New

Medical Device

Healthcare Needs

Assessment

Occupancy

Construction

Design Data Collection and

Needs Assessment

Process

Clinical Program

Planning Process

Schematic

Design

The Required

New Clinical

Services

Device

installation

Commissioning

planning

IT

Infrastructure

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2.2 Medical Devices Planning Process 340

341

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Planning can be divided into four major phases: 343

Healthcare needs assessment. 344

Design. 345

Construction. 346

Occupancy. 347

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2.1.5 Healthcare Needs Assessment 349 350

In this section, the required data collection and analysis steps that are required for 351

specific medical devices needs assessment processes include: 352

- Health service requirements, 353

- Health service availability, 354

- Human resources Information, 355

- Budgeting 356

- Priority setting – local, regional and national 357

358

2.1.5.1 Health Service Requirements 359

360

The following should be considered to understand the overall requirements of the 361

health services in the target area: 362

a. Epidemiological needs (disease priorities). 363

b. Population issues (demography, patient rate). 364

c. Anticipated level of utilization (how many times the devices will be used, is 365

there a demand on advanced or just basic options, impact on quality of care 366

for the patient 367

d. Clinical program guidelines and protocols; national or local 368

recommendations; and internationally recognized standards on diagnosis 369

and treatment of different diseases relevant to this population. 370

371

Example: For a needs assessment for computed tomography (CT) imaging 372

services, it is important to understand the needs for CT of the target population. 373

To determine if more CT scanners are needed, the current region’s number of CT 374

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scanners per 10,000 population can be compared to the average international and 375

regional standards. The specifications for the CT scanner will also be influenced 376

by the regional disease burden, the clinical scope of the healthcare facility and the 377

availability of qualified human resources. 378

379

2.1.5.2 Health Services Availability 380

381

The following are the main types of information needed to be collected: 382

1) Healthcare provider infrastructure 383

384

- Type, size, and location of facilities, including the number and type of 385

building(s). 386

- Availability and condition of water supply, connections and installation 387

(e.g., Where does the water come from? What is the water quality?). 388

- Electrical power supply, electrical connections and installations (e.g., Is 389

an emergency generator available?). 390

- Waste disposal system (e.g., How is waste handled, segregated, and 391

disposed of?). 392

- Availability of tele-communication infrastructure. 393

- Assessment of electromagnetic compatibility (EMC). 394

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2) Medical Devices 397 398

It is very important to understand and collect all relevant information 399

associated with the current available medical devices. Normally, all 400

needed information should be available in the healthcare facility’s 401

CMMS reporting system and may include the following: 402

- Device type and available quantity. 403

- Manufacturer & model names. 404

- Average lifetime of medical devices identified by installation date. 405

- Location and distribution of medical devices identified by clinical 406

departments, building number, floor level and room number. 407

- Working condition (operational, out of order, awaiting parts, etc.). 408

- Lifecycle costs information. 409

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- Downtime information. 410

- Availability and consumption rate of spare parts. 411

- Supplier performance assessment. 412

- Any available incident reports. 413

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2.1.5.3 Human Resource (HR) Information 415

416

Following are some HR related items to consider in the needs assessment process: 417

a. Availability of clinical staff with required qualifications. For example, 418

qualified radiologists and radiographers are needed when considering the 419

need for CT and X-ray systems. 420

b. The availability of outcome based continuing medical education programs 421

(training based on manufacturer requirements) that include on the job 422

training. 423

424

2.1.5.4 Budgeting 425 426

The following financial information are necessary: 427

a. Available budget, project or annual, for medical devices. 428

b. Estimated costs of the medical devices requested by the medical staff. 429

c. Estimated life cycle costs of the needed devices, such as spare parts, 430

maintenance contracts, software licenses, other support costs, consumables, 431

chemicals, training and disinfection. 432

d. The estimated costs for any additional infrastructure. 433

e. Does the device require consumables? Is it an open or closed system? 434

f. The estimated cost of any pre-installation and training requirements. 435

436

2.1.5.5 Priority setting – local, regional and national and final needs 437

assessment recommendations 438 439

After data collection, perform a gap analysis as following: 440

- Interpretation of the collected information. 441

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- Determine what similar technology is available in the local 442

healthcare providers city (or region) and, where applicable, in 443

the entire country based on the health services demand and 444

overall population health and health delivery organization 445

circumstances of the local area. 446

- Determine the available local, national and international 447

standards. 448

- Consider the possible financial and human resource constraints, 449

as well as prioritized epidemiological requirements. 450

451

The outputs of the gap analysis is a development of a prioritized needs list. (Table 452

2.1) outlines the questions to be asked, the data required to answer those 453

questions, and the tools available to collect and evaluate the data. 454

455

There are several procedures available internationally to identify gaps in medical 456

device availability. For example, a stepwise approach to identify gaps in medical 457

devices (availability matrix and survey methodology) by the World Health 458

Organization provides lists of recommended medical devices for various health 459

screening and treatment processes. 460

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Questions Data Required Tools Results

1 What do we

want/need in

terms of

health

services?

- Population (target population,

patient’s rate, density of

population).

- Health service provider

availability

- Epidemiological data (disease

priorities…).

- “Certificate of need”

process, see Appendix A

- Clinical practice

guidelines (CPG).

- Survey questionnaires

- Standards of level of

care.

Appropriate

health

services

delivery

2 What do we

have? (Local

conditions/

Limitations).

- Health service availability.

- Lists of available medical

devices.

- Human resources availability.

- Service Availability

Mapping (SAM)

questionnaires?

- Evaluation tools?

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- infrastructure of medical devices

management ( electrical, water

gases and IT system related to

medical devices

- Inventory management

tool.

- Computerized

maintenance management

system (CMMS).

3 Which

standards/

recommende

d best

practices

exist that

could be

applied or

adapted?

- Standards/ recommendations for

health service delivery coverage.


medical devices


human resources required for

operation/maintenance/

management of medical

equipment.

- (Essential) Medical

device lists; i.e., per

facility type and

department, or per clinical

procedure.

4 Overall Gap (2 – 3): List of

General

Needs

5 What

financial /

human

resources do

we have?

(Constraints).

Budget (capital investment and

operational)

Human resources.

6 Prioritized Needs (4 – 5): Prioritized

List of Needs

Table 2.1: Sample questions to be asked, data required to answer those questions, 465

and the tools available to collect and evaluate the data. 466

467

2.1.6 Design of new departments in hospitals 468

469

Once the healthcare needs assessment is reviewed and approved, preliminary design 470

planning can begin: 471

472

Clinical Program Planning Process 473 474

Design starts with a detailed clinical program planning process. 475

a) Program planning process should describe the following: 476

- Clinical services that will be included in the proposed new or renovated 477

building(s), 478

- Each clinical program’s general requirements (e.g. number of patient, 479

exam and treatment rooms; number of operating rooms; space size needs) 480

within the constraints of the approved healthcare needs assessment (e.g. 481

24

overall building/remodel space size needs and budget estimate for the 482

project). 483

484

Note: Clinical engineering technology assessments are useful at the program 485

planning stage since generic device needs are one of several factors to be decided 486

in the program planning phase (e.g. Do we need a CT scanner in this new 487

building? Do we need basic CT scanner, intermediate, or advanced? What 488

accessories do we need to add to address the clinical needs? Do we have trained 489

staff to run the advanced options? What are the training needs? ). Clinical 490

engineers should get involved in this program planning stage in translating 491

clinical requirements and concerns into technical and facility requirements. At 492

this stage, clinical engineers can provide technology assessments for major 493

clinical systems as well as starting to develop a generic equipment list with 494

generic requirements for required major systems (e.g. Radiology systems, OR 495

rooms and lights) under consideration for each program. This is also the time to 496

discuss in general terms required utilities for the programs and medical devices 497

systems that will need to be installed or remodeled in the new building(s). Of 498

course, even at this early stage, specific national and local regulatory requirements 499

and governmental approvals need to be met and, if necessary, appropriate 500

preliminary local and national regulatory agency approvals obtained. 501

502

b) For the next step in the Program planning process, a “schematic design” plan 503

is drawn describing the program and space requirements for each department, 504

their required support services and “adjacencies” (i.e. what other services 505

need to be nearby). 506

507

Example: Once it is determined, that five operating rooms will be included in a 508

new healthcare facility building then the Post Anesthesia Care Unit (PACU) or 509

Recovery Room needs to be located adjacent and sized accordingly (e.g. 20+ 510

beds). The Central Sterilization Department also needs to be designed in 511

proximity to the operating rooms (ORs), or provisions made for the efficient 512

movement of dirty and clean/sterile instruments back and forth from the ORs to 513

that department. 514

25

515

c) The next step in the design phase is the development of detailed architectural 516

and engineering drawings, often called design development (DD) drawings. 517

The architectural and engineering teams develop detailed drawing sets 518

including the following: 519

- Patient flow 520

- Floor plans. 521

- Interior elevations. 522

- Mechanical. 523

- Electrical. 524

- Plumbing. 525

- Fire prevention. 526

- Radiation Protection 527

- Medical Gasses 528

- Reception area 529

- Nursing station 530

- Changing rooms, utilities, restrooms, storage …etc. 531

- Special power requirements (3 phase, grounding, Uninterrupted power 532

systems, backup generators, isolating service powerlines from medical 533

equipment power lines, Intensive care unit and operating room electrical 534

isolation …etc) 535

- Medical equipment loaded drawings. 536

- Tele- communication, including IT. 537

- Furnishings, finishes and other detailed drawings. 538

539

d) Simultaneously with the architectural design phase, a multidisciplinary team 540

which include clinical engineers and clinical end-users shall develop a 541

medical devices plan and incorporate the medical device plan into the 542

architectural and engineering drawings showing medical devices locations 543

and utility requirements (see: Table 9.1 of utilities). First priority, from an 544

architectural planning standpoint, are the medical device systems that are 545

fixed and therefore, require installation. 546

547

26

e) Technical requirements and selection of major system products based on the 548

program plan, technology assessment reports, standards within the healthcare 549

facility and the community, and the new facility design need to be developed. 550

551

Note: This is an iterative approach with input from the end-users and various 552

support teams, including IT, and clinical engineers. Typically, a multidisciplinary 553

formal drawing set review takes place at critical drawing development thresholds 554

such as 50% completion, and 95% completion. After 100% DD drawing 555

completion, healthcare executive leadership review and approval, funding 556

approval, regulatory review and approval; final schedules and construction 557

documents (CD) can be developed and construction contracts can be bid and let. 558

559

560

2.1.7 Construction 561

562

Once construction starts, clinical engineers need to be available to answer any 563

questions that the design and/or construction teams have regarding device 564

requirements. 565

566

Note: Change orders are expensive and need to be minimized. However, change 567

orders often need to occur to accommodate the selected technologies that may not 568

have been available or known about earlier in the new healthcare facility design 569

process. Often changes in device requirements occur due to changes in technology, 570

particularly when there is a long period of time between the design of the building 571

and construction completion. For example, a plan for installing the magnet for an 572

MRI machine needs to be in place since the magnet comes as one large piece and 573

may require demolishing some walls to be placed in its place. 574

575

2.1.8 Occupancy Planning 576 577

As construction gets well underway, it’s time to finalize occupancy and device 578

installation and commissioning planning. After finalizing the procurement phase 579

(see chapter 3, Procurement), plans and schedules need to be developed for fixed 580

device installation, fixed device moves (de-installation and re-installation), furniture 581

27

installation, and people and mobile medical device moves. Plans also need to be in 582

place so that all medical devices get tested prior to first clinical use. 583

584

The medical devices requiring contractor installation get installed after their 585

respective rooms and utilities are ready for these systems. As construction nears 586

completion, and all building, fire and utility inspections and testing are complete, 587

it’s time to continue medical devices installation and testing (some will call this 588

milestone “Beneficial Occupancy”). 589

590

In addition, with the large amount of medical devices requiring IT connectivity, 591

HTM shall coordinate with IT to install the manufacturer’s recommended IT 592

requirements. After the IT infrastructure is installed and operational, network 593

connected medical device installation and testing can be completed. 594

Clinical end-users will require training on all new medical devices. Clinical 595

engineers, along with clinical educators, both internal and supplier-provided, need 596

to assure that as many clinical staff as possible complete training on all new 597

technology prior to occupancy and first clinical use. 598

599

Note: HTM is responsible for the coordination of all medical device installation and 600

testing. 601

602

2.1.9 Consideration of Emerging Technologies on Medical Devices 603 604

Several emerging technologies will impact future improvements in medical devices. 605

For example, the increasing computerization of medical devices, and their 606

interconnectivity has created a very large impact on medical devices. This 607

integration and convergence of IT and Clinical Engineering is a recurring theme in 608

many emerging technologies. Some of the challenges created by this convergence 609

include the re-focus of Medical Devices resources (funds and staff) toward IT-610

related activities, medical device/IT security-related challenges for networked 611

connected medical devices, and the need for the education of HTM and Clinical 612

Engineering staff in IT technologies. 613

614

28

2.1.9.1 IT Security-related Challenges for Network-connected Medical 615

Devices 616 617

Connected devices and cyber security are rapidly becoming critical topics for 618

regulators as sophisticated IT technology integrates with medical devices. 619

Connected devices’ generally refer to devices wired or wirelessly connected to 620

other machines and those connected to the “Internet of Things” (IoT). 621

MD Specific Considerations: computerized medical devices can be vulnerable to 622

security breaches and potentially impacting the safety & effectiveness of the 623

device. This vulnerability escalates as medical devices are increasingly connected 624

to the internet, hospital networks, and to any other medical device. 625

626

There are numerous sources of cybersecurity risk in medical devices and 627

consideration must be given to all in order to ensure adequate protection which 628

include but are not limited to the following: 629

1. Malware infections of devices that are network connected. 630

2. Unsecured or uncontrolled password distribution. 631

3. Failure to provide adequate software security updates. 632

4. Theft or loss of networked medical device. 633

5. Unauthorized access to hospital network or devices. 634

6. Off-the-shelf software that is not designed to prevent unauthorized access. 635

7. Denial-of-service (DoS) attack renders a device inaccessible to the 636

authorized user. 637

8. Improper disposal of patient data or information. 638

9. Untested or defective software and firmware. 639

10. Misconfigured networks or poor security practices. 640

11. Saudi FDA cyber Security for Medical Devices requirements 641

642

Healthcare facilities need to take special precautions in order to safe-guard their 643

network systems to attempt to reduce/eliminate potential attacks. 644

Ongoing Healthcare Facility Processes Required Regarding Cybersecurity: 645 646

The following may be used to help mitigate cybersecurity threats: 647

648

- Improve cybersecurity awareness. 649

29

- Evaluate shared networks. 650

- Build security requirements into contracts. 651

- Follow cybersecurity hygiene regimes during medical device 652

deployment. 653

- Encourage collaboration and harmonize with network participants. 654

- Address healthcare facility IT process inconsistencies. 655

656

2.1.9.2 Education of HTM Professionals in IT-Related Skills 657 658

All HTM professionals (e.g. Clinical Engineers, BMETs) will need to obtain basic 659

and more advanced training in IT-related topics. HTM professionals are often the 660

only staff that understand a complex network-connected medical device system 661

“end-to-end”. Training will have to occur at all HTM levels. Expertise will need 662

to be developed in all areas of healthcare IT including networks, applications, 663

operating systems, tools and troubleshooting. And most importantly, the HTM 664

professional will have to learn to work closely with their peers in IT, who will 665

continue to be the experts on the infrastructure (e.g. networks and data center), 666

healthcare provider-wide IT services (e.g. LDAP, DHCP) and healthcare provider 667

-wide applications such as the EHR. 668

669

670

671

672

673

674

675

676

677

678

679

680

681

682

683

684

685

686

687

688

689

690

691

30

692

693

694

695

696

697

698

2.3 Checklist 699

700

701

No. Check list item Status Comments

Yes

No

In

pro

gre

ss

1 Availability of the needs assessment process incorporating

a Health Technology Assessment review

2 Involvement of HTM and biomedical staff in the needs

assessment

3 Availability of a medical device planning written

procedure.

4

Availability of Group/ Committee for Medical

Devices/Health Technology Planning with involvement of

all related parties in the ownership.

31

702

Chapter 3: Procurement 703

704


706

3.1.1 Objective 707 708

To get satisfactory quality, service and price within a timely delivery schedule (right 709

product or service of the right quality, right price and the right quantity, at the right place 710

and time).5 711

To have effective procurement practice that leads to safe and high quality health care. 712

Other potential benefits of good procurement will include the following: 713

- The most economically advantageous terms for the medical devices acquired – not 714

necessarily the lowest price obtained through tender, but the best deal for the 715

organization’s needs. 716

- Timely delivery. 717

- Satisfactory and well-defined terms of delivery, installation, commissioning, 718

training, payment, warranty and after-sales service. 719

- A greater interest from the suppliers in submitting offers in the future. 720

To acquire a product that is safe, improves quality of care, is cost effective within the 721

context of its application and is manageable (both support and training requirements) 722

within the institution concerned. 723

A product acquisition that fits within the strategic plan and the needs of the organization. 724

A procurement process that follows national regulatory requirements with standardized 725

structure that is transparent, auditable, effective and fair. 726

727

3.1.2 Scope 728 729

This process applies to the healthcare providers who will procure the medical devices and 730

should include the following: 731

Sourcing and solicitation of offers. 732

Evaluation of offers. 733

Review and award of contracts. 734

735

32

Contracting and all phases of contract administration until delivery of the products. 736

Requesting from suppliers that they provide accurate and transparent information in 737

terms of product support and their understanding of a healthcare facility’s needs. 738

739

3.1.3 Ownership 740

741

The mechanism for procuring medical devices should be handled by committee with 742

minimum members of: 743

Purchasing. 744

Legal. 745

Finance. 746

HTM department. 747

End-users. 748

IT. 749

750

3.1.4 Background 751

752

In order to provide safe, effective and high quality patient care, healthcare facilities need to 753

have well-defined medical device acquisition and management programs. Not all devices 754

are created equal, and not all devices are suitable for all healthcare environments. Therefore, 755

it is essential that any new acquisition be thoroughly evaluated to ensure that it is an 756

appropriate choice for a given facility and application. This includes soliciting feedback 757

from a variety of personnel, such as end users and clinical engineers. Multiple devices 758

should be reviewed and compared on predetermined key features listed in technical 759

specifications, which are created by "clinical, technical, and end-user groups" to ensure that 760

the needs of these groups are met (Willson et al.)4 761

The adoption of a value analysis based approach to procurement is also relevant and 762

addresses the need to consider the benefits to quality of care and service delivery using a 763

multidisciplinary, evidence based systematic approach. 764

765

766

767

33

3.2 Procurement Procedures 768

769

770

3.3.1 Pre-procurement Procedures 771

772

Before reaching the point of procurement, as stated in earlier chapters of this document, it 773

is important to use the planning information described in the previous chapter. 774

After that, procurement can move forward and enable a process which includes: 775

- Sourcing and solicitation of offers. 776

- Evaluation of offers. 777

- Review and award of contracts, 778

- Requesting from suppliers to provide accuracy and transparency in terms of product 779

support and understanding of a healthcare facility’s needs. 780

- Contracting and all phases of contract administration until delivery of the product. 781

Ethical and transparency principles need to be adopted in the process, all stakeholders must 782

avoid any perceived conflict of interest. Involved parties must declare any conflict of 783

interest and avoid participating in decisions related to favoring one party over the other. 784

785

Figure 3.1: Purchasing Process. 786

787

788

Tender Requirements: 789 790

Technical & Medical Evaluation Committee

HTM Department

Medical Department

Purchasing Department

Condition of Site/ Works

Planning Phase

Market Testing Pre Supplier

Survey

Supplier List

Invitation to Tender(ITT)

Tender Analyses

Supplier Award

Installation & Commissioning

34

Prepare the tender to obtain the following: 791

- Technical specifications from HTM department. 792

- Clinical application/specifications from the end users department. 793

- Pre-installation requirements from engineering (e.g. architects, physical plant). 794

- Governmental/Legal requirements and tender submission procedure from 795

logistics/procurement. 796

- Regulatory requirements (License for the distributor, Market authorization for 797

the device) 798

- Transparency and conflict of interest policy associated with the tender 799

- Tender evaluation process and important dates. 800

- Process of obtaining further information related to the tender. 801

- Pre-installation requirements request. 802

- Choose your key performance indicators that are going to be used for approving 803

payments (warranty, spare parts, time to respond to service request, required up 804

time, maximum allowed down time, delivery time, installation time, spare parts 805

requirements, length of warranty, training of user, training of biomed in 806

hospital, accessories, availability of an engineer on sight, service and operation 807

manual, preventive maintenance requirements, Electrical safety tests required, 808

Calibration tests requirements …etc) 809

- Any other requirements associated with the medical device (e.g. radiation 810

safety, chemical, medical gases, central supply and sterilization/cleaning 811

requirements). 812

3.3.2 Technical Specification Development of Tender Document, General 813

Considerations: 814

815

- Clearly identify the previously identified clinical needs for the device. 816

- Suppliers need to understand whether you need a product with simple, moderate 817

of advanced options. 818

- Establishing unbiased technical specifications for the technology requested. 819

- It is vital that a Clinical Engineer is involved in the development of the technical 820

specifications to be included in any tender for the medical device under 821

consideration. 822

- The tender evaluation will depend on the specifications, requirements and 823

performance levels, therefore, be very specific and clearly identify your needs. 824

35

- Avoid adding specifications that would exclude certain suppliers over the other 825

unless there is a clearly identified clinical need. 826

- Request device upgrade and update policy 827

- Technology evolving is fast and quick, therefore, healthcare facilities need to have a 828

mechanism to constantly develop and update technical specifications for medical 829

devices in all modalities (Radiology, different laboratory departments, Intensive care, 830

operating rooms, oncology ..etc). Such committees need to include biomedical 831

engineers, clinicians, and technologists. They need to remain up to date with the 832

developments, recalls issued, and assesments done in their areas. 833

834

3.3 Operation Costs Consideration 835

836

The full costs of ownership of the technology includes: 837

- Training (both initial and ongoing) for the operator, clinician and Biomedical engineers. 838

- Software updates. 839

- Maintenance and installation costs, which are effectively identified prior to execution 840

of any agreement. 841

- Running costs (ex: Daily expenses to operate the equipment. This might include the 842

reagent cost, detergent cost, cession cost, etc.) 843

- Preventive maintenance cost if some parts need regular repalcements 844

- Extended warranty cost 845

- Agreement that if at a later date it is necessary to move the device to another location, 846

cost of supplementary reinstallation. 847

- Any medical device that is ‘donated’ or ‘gifted’ to a healthcare facility also requires a 848

thorough life cycle costing analysis prior to acceptance even though there may be no 849

initial capital outlay for the device itself. 850

851

3.4 Methods of Acquisition2 852

853

The suppliers of medical devices to hospitals and healthcare organizations in the Kingdom of 854

Saudi Arabia is for the most part provided by local vendor representatives of the manufacturers. 855

The process of acquiring/selling medical devices follows the International standards under 856

three (3) known methods: 857

36

1) The direct purchase/sale form is used for the medical devices which are owned by the 858

hospitals in general. 859

2) Leased medical devices are owned by the vendors and installed in hospitals according 860

to agreements for the purchase of medical consumables or laboratory reagents as per 861

the consumption by the leased medical devices used/consumed for a certain period of 862

time. 863

3) The third type of acquiring medical devices is through agreements known as 864

“Guaranteed Price Per Reportable Results (GPPRR). In this kind of agreement the 865

device remains the property of the vendor and medical/laboratory consumables are 866

provided by the supplier free of charge while the hospital pays only for reportable test 867

results in compliance with the terms of the agreement. 868

869

3.5 Tender Contents 870

871

A generic template of tender should be designed and subsequently customized to incorporate 872

the specific technology/medical device core requirements. Typical tender items of a generic 873

nature include: 874

Distributor Qualification requirements (licenses, bank guarantees, previous 875

experience, SFDA establishment license, Market authorization for devices …etc) 876

General condition of the contract (sometimes referred to as Terms & Conditions). 877

Contract specification (sometimes referred to as scope of work) which will include the 878

technical specifications of the technology required. 879

Pricing schedule (this enables potential suppliers to present their pricing within a 880

standard layout enabling comparisons to be made during the evaluation process). 881

Proposal evaluation criteria and matrix 882

Tender processing time lines, and 883

Process for seeking further information (all suppliers must have access to the same 884

level of information so that no one has more advantage over the other) 885

Site visiting arrangements process (suppliers need to visit the site, ask clarification 886

questions about the clinical and technical needs, ,etc). 887

Administrative instructions (this will cover matters such as return of tender documents, 888

delivery, application procedure, closure date, mechanism of asking questions …etc.). 889

Announce the tender shall include the following: 890 891

37

- List of medical devices with quantities and specifications, 892

- Performance characteristics like accuracy… etc. 893

- Ability to upgrade medical devices if needed. 894

- Interoperability requirements 895

- Safety requirements. 896

- Regulatory requirements (SFDA establishment license (MDEL) No. for the 897

establishment, SFDA Medical Devices Market Authorizations (MDMA) No. of 898

requested devices...etc.) 899

- Warranty period required. 900

- Extended warranty 901

- Training needs. 902

- Maintenance costs. 903

- Known risks associated with the device(s). 904

- Supplier evaluation criteria. 905

- Pre-purchase questioner. 906

- Compatibility of the operating/environmental conditions of the place where the 907

device will be used. 908

- Manuals (user, operation, instructions for use (IFU), service, spare part list, lists 909

of tool and test equipment required, circuit diagram, planned preventive 910

maintenance manual and checklist as per manufacturer’s requirements). 911

- Decontamination, cleaning, disinfection and sterilization procedures, ensuring 912

the healthcare facility is able to reprocess in line with the manufacturer’s 913

instructions (e.g. by trained technicians). The infection control & CSSD team 914

and should be consulted. 915

- Disposal instructions. 916

917

3.6 Ethical Considerations 918

919

An integral component of any procurement process is a mandatory need to ensure that all 920

ethical considerations are observed. These are as follows: 921

922

• Transparency, confidentiality and fairness 923

• All suppliers should be treated fairly and evenhandedly at all stages of the 924

procurement process. 925

38

• Avoid any perceived conflict of interest between members involved in the 926

tender evaluation and the suppliers. Any such conflict of interest must be 927

declared. (Example: supplier is a relative of one of the decision makers in 928

the tender, one of the tender evaluation committee members have previously 929

benefited from the supplier or may benefit from the current tender, supplier 930

is funding a project running by one of the committee members …etc) 931

• Use of power 932

Buyers should discourage the arbitrary or unfair use of purchasing power or influence. 933

• Corruption 934

Buyers must not tolerate corruption in any form. 935

• Declaring an interest 936

All personal interests should be declared. 937

• Business gifts and hospitality 938

No prospective supplier business gifts or hospitality should be tolerated in the 939

procurement cycle. 940

• Payment terms 941

Payment terms should be objective with clear milestones. Late payments undermine an 942

organization’s credibility. 943

• Supplier relationships and competition 944

Relationships with suppliers, regardless of duration, should be managed professionally. 945

• Encouraging small businesses 946

Buyers should, wherever possible, be aware of opportunities to support the local 947

community and SMEs, whilst maximizing opportunities for global sourcing. 948

• Employment relationship 949

Employees should have legal contracts. 950

• Wages and working hours 951

Living wages are paid. 952

• Treatment of employees 953

No harsh or inhumane treatment is allowed. 954

• Health and safety 955

Working conditions are safe and hygienic. 956

• Discrimination 957

No discrimination is practiced. 958

959

39

3.7 Evaluation Criteria 960

961

Apply the predetermined evaluation criteria for all suppliers after receiving and evaluating the 962

bids by comparing the suppliers' proposals based on the below criteria (supplier competency) 963

per the following: 964

• Service support (Availability of hotline and quick response time, quick delivery of spare 965

parts). 966

• Time to deliver. 967

• Adhering to the regulatory requirements (establishment license, no issued alerts/recalls, 968

MDMA as applicable). 969

• Cost. 970

• Installation cost included or not? 971

• Freight included or not? 972

• Risk of device: 973

- Patient safety – is there a risk of patient harm with this technology? 974

- Risk and clinical effectiveness – will patient outcome be impacted negatively? 975

- Patient experience – will this be better or worse with the provision of this technology? 976

- Risk to health and safety. 977

• Accessories need. 978

• Maintenance costs. 979

• Warranty period. 980

• Cost of consumables. 981

• Lifetime cost. 982

• Meets specification requirements 983

• Meets standards 984

• Review of published hazard and recall data to identify any ongoing technology issues. 985

• Examine the evidence base (documentation, clinical trials data, etc.) for any manufacturer 986

claims cited in the submitted documentation. 987

• Consideration of the use of market trend and price benchmarking systems to identify 988

significant pricing trends and discrepancies. 989

• Supplier Capability: 990

- Staffing structure. 991

- Availability of experienced staff. 992

- Have a system to measure customer satisfaction. 993

- Experience in the industry. 994

40

- Warranty information. 995

- After sale service. 996

• Suppliers history of performance: 997

- Experience in the industry 998

- Previous experience. 999

- References and customers’ recommendations. 1000

• Clinical users evaluation. Evaluate the usability, safety and risk management. Evaluate 1001

that precautions are incorporated into the design to guard against misuse. 1002

• End user license agreements for software products. 1003

• Cybersecurity information (e.g. ability to run anti-virus software). 1004

1005

3.8 Compliance Checking 1006

1007

• Prioritize the above evaluation criteria (i.e. is this requirement specified a ‘high’, 1008

‘medium’ or ‘low’ priority) 1009

• Assign weight for all criteria 1010

• Compare and rank the suppliers responses 1011

1012

3.9 Contract with Supplier. 1013

1014

3.10 Payments Scheduling. 1015

1016

3.11 Storage Requirements: 1017

1018

See tables (9-6) and (9-7) in the appendixes for more details. 1019

1020

3.12 Tender Award Process and Payment Processing 1021

1022

A tender award is often initially provided through a letter confirming supplier status followed 1023

by the issuing of a purchase order document from the institution. This may also be 1024

supplemented for large value items with a contract document. 1025

1026

41

The following shall be considered before tender awarding or payment processing: 1027

• Any contract documentation generated should include the information and terms and 1028

conditions originally specified in the invitation to tender documentation. 1029

• Any advanced payment for a selected technology should be resisted and payment should 1030

be specifically tied to successful acceptance testing, completion of delivery, installation 1031

and all training aspects for the product. On large projects, partial payments based on 1032

objective milestone completions, may be appropriate. 1033

• Any contracts generated should be duplicated for the “Buyer” and “Supplier” and 1034

forwarded to the Supplier for signature in the first instance. Once signed off by both 1035

parties the contract will be in force. 1036

• Unsuccessful suppliers who participated in the tendering process should be entitled to a 1037

debrief including identification of the areas of weakness established during the evaluation 1038

process. 1039

• Any meetings should be held and coordinated by the Procurement Department supported 1040

by Clinical/ biomedical Engineering Department in conjunction with the End-user 1041

Medical Department also involved. 1042

• Any comparisons with other tender responses received should be avoided, as tenders will 1043

have been submitted on a confidential basis. 1044

• Any such meetings should be documented. 1045

1046

1047

1048

1049

1050

1051

1052

1053

1054

1055

42

3.13 Checklist 1056

1057

The table below represents a best practice checklist. Its purpose is to serve as a tool for 1058

evaluating procurement activities and assist in the development of process improvements. 1059


Yes

No

In

pro

gre

ss

1 Availability of purchasing committee members as

indicated in the ownership

2 Availability of written procurement procedure

3 Availability of tender format

4 Recognize method of acquisition

5 Availability of code of ethics

6 Evaluation Criteria are applied

7 Availability of acceptance process

8 Availability of purchasing committee members as

indicated in the ownership

9 Availability of written procurement procedure

10 Availability of tender format

1060

1061

1062

1063

43

1064

1065

Chapter 4: Installation & Commissioning 1066

1067


1069

4.1.1 Objective 1070 1071

• Ensure the medical device supplied matches the specification of the device indicated in 1072

the Supplier’s invitation to tender response. 1073

• Ensure the medical device is in good condition and fully functional after commissioning. 1074

1075

4.1.2 Scope 1076

1077

This process applies to the healthcare provider who will install and commission the medical 1078

devices that will include the following: 1079

1080

• Checking the supplied medical device with related manuals, catalogues, accessories & 1081

official documentation. 1082

• Ensure the medical device is in good condition and fully functional. 1083

• Checking the Calibration, performance and electrical safety tests. 1084

• Getting the related training (both user and technical). 1085

1086

4.1.3 Ownership 1087 1088

The mechanism for installation of medical devices should be handled by committee with 1089

minimum members of: 1090

• Warehouse Department. 1091

• HTM Department. 1092

• End-users Department. 1093

• Assets management. 1094

• Purchase Department. 1095

• Project management department. 1096

1097

44

1098


1100

Pre-installation Requirements, Receipt and Acceptance 1101 1102

- Following completion of the tender process, the Supplier will be responsible for 1103

the delivery of the medical device. 1104

- Prior to delivery and installation, any site preparation work shall be completed. 1105

1106

Note: Pre-installation checks should apply to all medical devices installed into a healthcare 1107

setting, whether they are leased, donated, on trial or purchased. 1108

1109

PurchasingPhysical

Check

Components

Check

Accessories

Check

Disinfection

Requirements

Availability Check

Transport&

Storage

Condition Check

Accompanied

Documents

Check

InstallationConfiguration

Check

Function &

Safety Check

Data Capturing

in Inventory

CMMS

MD label with

Control

Number

Maintenance

Schedule in

CMMS

User and

Technical

Training

Signed

Acceptance

Report

Planning

1110

Figure 4.2: Installation & Commissioning processes. 1111 1112

1113

1114

4.2 Delivery 1115

1116

The healthcare provider shall check for external damage to the package or its 1117

contents. (physical checks). 1118

The medical device delivered matches the original tender acquisition specification. 1119

The healthcare facility should ensure the medical device supplied matches the 1120

specification of the device indicated in the Supplier’s invitation to tender response. 1121

The medical device has been supplied with the appropriate original medical device 1122

manufacturer recommended accessories and consumables. 1123

45

All necessary information and documentation, including instructions for use have 1124

been provided. 1125

Ensure that manufacturers transport and storage requirements are met. Many chemical 1126

reagents lose their effectiveness because they were not transported or stored properly. 1127

4.3 Medical Device Installation & Commissioning 1128

1129

1130

• The device is configured in an appropriate manner. 1131

• Installed according to the original medical devices manufacturer's recommendations and 1132

located where required with oversight of this process by the Clinical Engineering 1133

department. 1134

• Delivery has been achieved with the technology/medical device in good condition and 1135

fully functional. 1136

• Manufacturer’s and regulatory authorities’ Health & Safety requirements during the 1137

installation process are considered and met. 1138

• The availability of disinfection and sterilization contract or competent personnel tools 1139

and spaces. 1140

• Data has been captured and stored on the organizations Computerized Maintenance 1141

Management System (CMMS) for asset tracking purposes. 1142

• Formal training needs according to the manufacturer requirements have been identified 1143

and implemented and data captured for inclusion in training databases for ongoing needs. 1144

• In the case of reusable devices, maintenance requirements have been identified and 1145

scheduled. 1146

• Information about proper storing and transporting. 1147

• Involvement of HTM and End-user departments during the installation and acceptance 1148

process. The entire process should be coordinated by clinical/ biomedical department 1149

which should liaise with other groups as required. 1150

• Report signed from the responsible clinical/biomedical engineer and end user explaining 1151

that the medical device is installed, in good condition and fully functional. 1152

• Confirmation that all documentation has been delivered including local configurations, 1153

as-built drawings, and IT information for connected devices. 1154

• A control number will be assigned and labelled, placed on the unit, along with any other 1155

appropriate labels (e.g. warrant expiration date, loaned device.) 1156

• In case the delivered medical device failed to comply with healthcare facility’s identified 1157

requirements in the tender, the Procurement Department shall be responsible for liaising 1158

46

with the medical device supplier in the event of damaged or inappropriately delivered or 1159

unrepairable medical device. 1160

1161

Note: Medical devices must not be put into use before acceptance check processes have 1162

been performed. 1163

1164

1165

1166

1167

1168

1169

1170

1171

1172

1173

1174

1175

1176

1177

1178

1179

1180

1181

1182

1183

1184

1185

1186

1187

1188

1189

1190

1191

1192

47

1193

1194

4.4 Checklist 1195

1196


evaluating procurement activities and assist in the development of process improvements. 1198


Yes

No

In

pro

gre

ss

1 HTM Supervise/ Perform the installation and

commissioning stage with the related parties

2 All testing and commissioning activities are

documented

3 All Devices have passed the relevant safety and

performance tests

4 User and service manual exist

5 Completion of pre-installation work and analysis prior

to delivery of the technology.

6 Installation and acceptance testing completion including

all necessary training.

1199

1200

1201

1202

1203

1204

48

1205

Chapter 5: Operations 1206

1207


1209

5.1.1 Objectives: 1210

1211

• Effective maintenance plans of the medical devices in order to increase the lifetime and 1212

decrease the breakdown of medical devices. 1213

• Documentation of medical device history. 1214

• Maintaining the safety and effectiveness of the medical devices. 1215

• Ensuring that the medical device’s users are trained and have the required 1216

skills/knowledge to operate the devices. 1217

• Effective reprocessing of medical devices. 1218

1219

5.1.2 Scope: 1220

1221

This chapter covers all operational activities of medical devices as follows: 1222

• Tracking the medical devices. 1223

• Maintenance of medical devices (i.e. CM, PPM). 1224

• Management of spare parts. 1225

• Calibration. 1226

• Safety inspection. 1227

• Reprocessing. 1228

• Transfer of medical devices. 1229

• Managing the field service notifications (FSNs), recalls and alerts and reporting any 1230

adverse events. 1231

5.1.3 Ownership: 1232

1233

• HTM/Clinical Engineering Department. 1234

• End-user Medical Departments. 1235

• Quality Department. 1236

• CSSD. 1237

49


1239

After the medical devices acceptance phase has been satisfactorily completed, the device can 1240

be used safely and the device is now in the operations phase. 1241

1242 Figure 1 .1: Operations processes. 1243

1244

50

1245

5.2 Operation Activities 1246

1247

The healthcare facility shall do the following: 1248

5.2.1 Create Device History Record 1249 1250

An asset management software (e.g. CMMS) shall be used to manage the medical devices. The 1251

software shall include –but not be limited to- the following information: 1252

1253

Device General Information 1254 1255

Includes: device category, device type (according to GMDN, description, model 1256

name & number, manufacturer, supplier, serial number and asset number, SFDA 1257

MDMA number, warranty period, purchasing costs, device location, assigned 1258

HTM/Clinical Engineering employee and service contract information if applicable, 1259

acceptance date, type of procurement (this could be: lease, reagent rental, deferred 1260

payment, loan, etc.), life expectancy of the medical device and risk class of device, 1261

accessories requirements if any. 1262

1263

Periodic Preventive Maintenance (PPM) 1264 1265

Includes: Frequency of periodic preventive maintenance (PPM), procedure of PPM, 1266

calibration requirements and spare parts used for PPM. 1267

1268

Test equipment required 1269 1270

The characteristics of all measuring or energy delivering devices even the best 1271

designed ones change with time. Meaning if the device is showing a reading of (10), 1272

as the device is used more frequently, the deviation from the actual value increases. 1273

Therefore, special test devices need to be used regularly by a trained biomedical 1274

engineer/technician to verify the level of deviation in the operation of the devices. All 1275

devices having a deviation higher than the acceptable range identified by the 1276

manufacturer must be removed from service and the supplier must re-calibrate them. 1277

Some of the test devices include (patient simulator, infusion pump tester, defibrillator 1278

tester, Xray KV mater, artificial lung, laser power meter, and more. 1279

51

Examples: 1280

o The anesthetic sets up the anesthesia machine for a certain gas and air 1281

percentage, certain gas volume and expects the machine to deliver the 1282

amounts indicated on the machine. The actual delivered parameters by 1283

the machine would change with time, and this requires using an 1284

artificial lung with calibrated sensors to verify that the actual delivered 1285

parameters match the machine settings. If not, the machine should be 1286

removed from service. 1287

o Kilovolt (KV) and milli-ampere-second (mAs) meters need to be 1288

frequently used on Xray machines to ensure that the dose delivered 1289

from an Xray tube matches the machine settings, if not, the machine 1290

needs to be removed from service. 1291

o All devices connected to patients must be checked for leakage current, 1292

insulation resistance, ground resistance and more electrical parameters 1293

to ensure that no excessive currents leading to possible heart failures 1294

enters into the body from that machine. 1295

1296

The supplier needs to identify the processes for: 1297

o Preventive maintenance procedures and frequency 1298

o Calibration verification procedure and frequency 1299

o Test equipment needed for functional tests for the device 1300

o Regular replacement parts needed for the machine 1301

1302

Device History 1303 1304

Includes: 1305

- PPM history: date of each PPM, PPM kits & parts used, who completed the 1306

work, and time spent performing PPM. 1307

- Corrective Maintenance (CM) history: date of failure, failure description, spare 1308

parts used, time duration of maintenance. 1309

- related FSNs/recalls 1310

- The history record of a new device shall be generated when a new device is 1311

ready for clinical operation (installed, tested, and tagged). 1312

1313

52

5.2.2 Plan for PPMs, Spare Parts Inventory and Electrical Safety Tests 1314

1315

Periodic Preventive Maintenances (PPMs) and safety tests are performed to maintain the basic 1316

safety and essential performance of medical devices according to the manufacturer 1317

requirements. In addition, performing PPM will reduce the chance of breakdown of the device 1318

which will increase the device’s utilization and reduce repair cost during the device’s life cycle. 1319

When performing PPM, the following points should be considered: 1320

1321

• The PPM frequency and procedures shall be in line with the manufacturer requirements. 1322

• The PPM frequency is usually indicated by time periods (interval-based), or as per 1323

device’s operation hours (meter-based), or both. 1324

• Only trained personnel shall perform the PPM. 1325

• For some devices, the PPM procedure requires replacing some parts or PPM kits. In this 1326

case, an adequate number of PPM kits shall be kept in stock, and periodically re-stocked, 1327

depending on the number of devices used in the facility and frequency of PPMs. 1328

1329

Note: If the PPM procedure includes using test equipment for performance or calibration 1330

checks, the test equipment shall be tested and calibrated by the manufacturer or a certified 1331

body. 1332

1333

• Before performing PPM, the device shall be clean, decontaminated (if needed), and 1334

working in a good condition. 1335

• After performing PPM, a device’s performance and function tests shall be carried out. 1336

• In all cases, this should include a safety test and safety inspection as part of the PPM. 1337

• The PPM details (date, PPM kits, etc.) shall be recorded in the device’s history in the 1338

CMMS. Data shall be filed for a minimum of five years. 1339

• All PPMs must be signed off by the end-user and clinical engineer/contractor performing 1340

the service. In addition, the device shall be tagged after PPM. The tag shall contain at 1341

least the date of last performed PPM, the due date for the next PPM, and responsible the 1342

engineer or technician. 1343

5.3 Corrective Maintenance Management 1344

1345

1346

If a device has a malfunction, the user shall do the following: 1347

• Inform the HTM/Clinical Engineering department immediately. 1348

53

1349

A work order shall be generated and contain –at least- the following information: 1350

- Device’s description and asset number. 1351

- Location of the device. 1352

- Description of the problem. 1353

- Requestor’s contact details. 1354

1355

• The work order should be assigned to the responsible clinical engineer/technician who 1356

shall have proper training, qualifications, and tools to repair the device. 1357

• After repairing the device, the assigned clinical engineer/technician shall update the work 1358

order by entering details of the used spare parts, time consumed in repairing the device, 1359

and corrective action details. Then close the work order. 1360

• All CM order must be signed off by the end-user and Clinical Engineer/Contractor 1361

performing the service and the device is working as intended by the manufacturer. 1362

• On all electrical medical devices, a test/safety Inspection shall be conducted as part of the 1363

CM. 1364

• Function and calibration tests shall be conducted after installation, any major replacement 1365

and modification. 1366

• If applicable, the device shall be calibrated after the corrective maintenance, as per 1367

manufacturer requirements. 1368

1369

Note: If the CM procedure includes using test equipment for performance or calibration 1370

checks, the test equipment shall be tested and calibrated by the manufacturer or a certified 1371

body. 1372

1373

5.4 Transfer and storage procedures 1374

1375

1376

• When transferring a device to be used in another location or department, a transfer form 1377

shall be filled. The form should contain at least the device description and asset number, 1378

present location, new location, date of transfer. 1379

• A copy of the (transfer form) must be sent to the HTM/Clinical Engineering Department 1380

to update the device’s record in order to keep track of the device for the purpose of the 1381

device’s maintenance, utilization, and future needs assessments. 1382

54

• In case the device need to disassembled and reassembled in different location, qualified 1383

engineer according to the manufacturer recommendations shall conduct this task. 1384

In case the device needs to be stored, it must be stored in accordance with the 1385

manufacturer's storage instructions such as the device’s shelf life, storage room 1386

temperature and humidity requirements ( See: tables (9.6) and (9.7) in the appendixes for 1387

more details). 1388

1389

5.5 Reusable Medical Devices Reprocessing 1390

1391

1392

5.5.1 Steps of the Reprocessing 1393 1394

1395

Pretreatment Disinfection Require

Sterilization?Sterilization

Document

Release or ReprocessEND

Function &

Safety CheckYes

Reprocess

Release

No

1396 Figure 5.2: Reprocessing steps. 1397

1398

The reprocessing process includes several steps and sub-processes. These apply depending on 1399

the risk classification of the medical device, which imply the aimed goal whether it is 1400

disinfection or sterilization. The process of reprocessing includes the following: 1401

1402

1. Pretreatment (to eliminate obvious stains): 1403

a) Collecting. 1404

b) Pre-cleaning. 1405

c) Disassemble. 1406

1407

2. Disinfection: 1408

55

Disinfection can be manual or machine accomplished (e.g. washer-disinfectors 1409

machines according to ISO 15883 standards). The process includes the following sub-1410

processes: 1411

a) Cleaning and rinsing: To eliminate the residual blood, secretion or tissue 1412

before disinfection. 1413

b) Disinfection: To eliminate bacteria, fungus and virus 1414

c) Final rinsing and drying 1415

d) Check for cleanliness and integrity 1416

e) Assembly 1417

f) Visual inspection 1418

3. Functionality check (at the end of disinfection). 1419

4. Sterilization: To eliminate prion pathogens: 1420

a) Packaging (per ISO 11607) 1421

b) Sterilization: (using one of the methods listed below based on 1422

manufacturer requirements): 1423

i. Moist heat sterilization (ISO 17665). 1424

ii. Dry heat sterilization (ISO 20857). 1425

iii. Sterilization through radiation (ISO 11137). 1426

iv. Sterilization through ethylene oxide (ISO 11135). 1427

c) Labeling: 1428

i. Device name and model. 1429

ii. Release date. 1430

iii. Devices expiration date. 1431

iv. Sterility expiration date. 1432

v. Time of use limit and the current time of use. 1433

vi. Assign a lot-number to each reprocessed medical device. 1434

5. Documentation and release or reprocess. 1435

6. Change the lot-number after each validation and any update on the process and maintain 1436

records for 5 years. 1437

7. Transport and store (Disinfected medical devices shall be stored under clean-room 1438

conditions and sterile medical devices shall be stored under the recommended 1439

conditions of the manufacturer of the packaging material. 1440

1441

5.5.2 General Consideration for Reprocessing 1442 1443

56

1. All parts and external and internal components of the medical devices shall be exposed 1444

to the effect of each process. 1445

2. Follow all manufacturer recommendations. 1446

3. Check after each step for any residual stains or degradation of the medical devices. 1447

4. Use desalinated water for rinsing. 1448

5. Maintain checklist and clear comprehendible SOPs for each process. 1449

1450

5.5.3 Risk Classification 1451 1452

Considerations for the risk classification and choosing the reprocessing method: 1453

1. Design, material, technical and functional properties of the device. 1454

2. The risk of the to-be-disinfected medical device can be defined based on: 1455

a) The expected adverse effect as a result of: 1456

i. The usage preceding the disinfection process 1457

ii. The preliminary disinfection process that preceded the main 1458

disinfection. 1459

iii. The transport and the stage of the medical devices. 1460

b) The type of usage following the reprocessing. 1461

3. The amount and typical types of pathogens expected to be on the device’s surfaces after 1462

use and their resistance to the proper disinfection process. 1463

1464

5.5.4 Risk Classes 1465

1466

1. Uncritical: 1467

Medical devices that only come into contact with intact skin. 1468

1469

2. Semi-critical: 1470

Medical devices that come into contact with mucous membranes or diseased skin. 1471

1472

a) Medical devices without reprocessing special requirements (A). 1473

b) Medical devices with more stringent reprocessing requirements (B) if: 1474

i. The judgment of the efficacy of reprocessing is not possible by simply 1475

inspection, 1476

57

ii. The fully avoidance of influential factor on the use or functional safety 1477

of the devices, as a result of reprocessing or transporting of the medical 1478

devices, is not guaranteed, or 1479

iii. The number of uses or the reprocessing-cycle are limited as per 1480

manufacturer's instructions. 1481

1482

3. Critical: 1483

Medical devices for the application of blood, blood products or other sterile drug or 1484

sterile medical devices, and medical devices which, as intended, penetrate the skin or 1485

mucous membrane and are used in contact with blood, or internal tissues or organs, 1486

including wounds 1487

1488

a) Medical devices without reprocessing special requirements (A): 1489

i. The medical device is thermostable (can be sterilized by steam 1490

sterilizer under 134 degrees C). 1491

1492

b) Medical devices with higher reprocessing requirements (B):If the device is 1493

thermostable (can be sterilized by steam sterilizer under 134 degrees C) and: 1494

i. The judgment of the efficacy of reprocessing is not possible by simply 1495

inspection, 1496

ii. The fully avoidance of influential factor on the use or functional safety 1497

of the devices, as a result of reprocessing or transporting of the medical 1498

devices, is not guaranteed, 1499

iii. The number of uses or the reprocessing-cycle are limited as per 1500

manufacturer's instruction, or 1501

1502

c) Medical devices with special high reprocessing requirements (C) if: 1503

i. The medical device is thermolabile (not to be sterilized by steam 1504

steam). 1505

1506

1507

1508

1509

1510

1511

58

5.5.5 Requirements for Each Class 1512

1513

Class Processes Requirements

Uncritical Cleaning

Semi Critical A Disinfection

Optional:

Pre-treatment

Sterilization

Manual process.

Quality Management.

SOPs and validation.

Semi Critical B Pretreatment

Disinfection

Optional:

Sterilization

Automated cleaning and disinfection.

Quality Management.


Critical A Disinfection

Sterilization

Optional:

Pre-treatment


Moist Heat Sterilization.

Quality Management.


Critical B Pretreatment

Disinfection

Sterilization

Optional:

Labeling

Evidence of accredited training.


Moist Heat Sterilization.

Quality Management.


Critical C Pretreatment

Disinfection

Sterilization

Labeling

Proper Sterilization process

Certification of the Quality Management Process

according to ISO 13485.

Risk Management according to ISO 14971


Table 5.1: Sterilization and Disinfection Risk Classes Requirements. 1514

1515

5.6 Computerized Maintenance Management System (CMMS) 1516

1517

A computerized maintenance management system (CMMS) is a software application that 1518

provides the documentation and management tools used by healthcare technology management 1519

(HTM) programs to collect, store, organize, analyze, and report medical device data for 1520

healthcare facility. 1521

Sophisticated CMMSs support medical devices throughout the entire device lifecycle; from 1522

pre-procurement, acquisition, commissioning, device inventories, corrective maintenance (CM 1523

or unplanned repair) and planned maintenance management, field safety notices/ recalls and 1524

adverse events management, to device “end-of-life” management, replacement analysis and 1525

disposal. 1526

59

1527 Figure 5.3: A comprehensive CMMS supports medical device throughout the medical 1528

device lifecycle. (Derived from Cohen and Baretich, 2017) 1529

1530 1531

Each healthcare facility shall have a CMMS for the following reasons: 1532

• Track the medical devices within its institution 1533

• Monitor the performance of medical devices during its life cycle in the healthcare 1534

facility. 1535

• Calculate the operational costs of medical devices during their life cycle in the 1536

healthcare facility. 1537

• Contract Management – management of outsourced maintenance to 1538

manufacturers/vendors or third party sources 1539

• Parts management. 1540

• Forecasting demand for future medical device acquisitions 1541

• Providing history database for all installed medical devices. 1542

• Staffing requirements to support the medical device– both directly and indirectly 1543

through external support (vendors, third party providers etc.) 1544

60

• Present the responsible engineer for each devices and trained end-users. 1545

• Document reprocessing process. 1546

1547

5.7 Data integrity 1548

1549

Without accurate and complete data, a CMMS is not going to be of much use to the HTM 1550

department. All HTM staff is responsible for assuring that the data they enter and update are 1551

complete and accurate. Incomplete and inaccurate data make it difficult to report useful 1552

information, which can lead to poor decision-making. 1553

1554

Good data quality depends on several factors, including the following: 1555

• Availability of HTM-relevant data sources: Source data needs to be available to the 1556

HTM staff. For example, medical device acquisition cost data, which should be included 1557

on every asset record, require a purchase order or invoice information in order to 1558

accurately capture the device’s price. 1559

• HTM employee accountability: Documentation quality begins at the source, the 1560

employees. CMMS training and documentation expectations and guidelines should be 1561

provided to every HTM employee. Assessment of documentation quality should be 1562

included in employee performance appraisals. 1563

• CMMS data standardization: Operation of a high-data-quality CMMS depends on 1564

multiple levels of data field standards. These include fields defined by the CMMS 1565

supplier, fields defined within the healthcare facility, and fields that use nationally or 1566

internationally published “standardized” definitions. Policies should indicate which data 1567

definitions HTM staff should use. For example, fields that indicate which department 1568

“owns” a medical device can use the organization’s own chart of accounts. Device type 1569

fields can use the Global Medical Device Nomenclature (Global Medical Device 1570

Nomenclature, 2017) or Universal Medical Device Nomenclature System (UMDNS, 1571

2017). HTM supervisory personnel or the CMMS database administrator should be 1572

responsible for managing (adding, deleting, and updating) these and other foundation data 1573

tables (e.g. department, building, medical device type, manufacturer and vendor lists). 1574

• Referential integrity: For the foundational data, both the underlying database structure 1575

and the CMMS application error-checking capability, are important to ensure high data 1576

quality. The database should include appropriate referential integrity in order to make 1577

sure that related fields do not have any “orphan” data. For example, every medical device 1578

61

record should have a manufacturer's reference, and every manufacturer reference should 1579

have a manufacturer name, address, and so on. 1580

• Field definitions: Each CMMS field should have a written definition so every HTM staff 1581

member uses the field the same way. Without field definitions, individual staff may 1582

interpret a single field in different ways. For example, for a network-connected medical 1583

device, what is the definition of the “Port” field on the IT data section of the asset record 1584

in (Figure 5.4)? Is it the physical data port where the Ethernet cable plugs into the wall 1585

or the virtual port used for HL-7 data communication with the electronic medical record?. 1586

Both “ports” are important data, but they serve different purposes. 1587

1588

1589 Figure 5.4: all fields need to be defined. For example, is the “port” field a data port in the 1590

wall or a logical port for HL-7 data or? 1591

1592

• Maintenance activity coding: Where sharing or comparison of maintenance data is 1593

desirable or required, maintenance activities must be consistently and accurately coded. 1594

Dropdown lists and other coding techniques help standardize data, although sometimes 1595

at the expense of detail. Definitions are paramount to make sure “apples to apples” 1596

comparisons can be made. For example, what does the checkbox field “PM-preventable 1597

mean” (Figure 5.5)? Does it only apply to CM workorders, or can it be used to indicate a 1598

change is needed in a PPM procedure? How will the aggregated data from this field be 1599

used? 1600

1601

1602 Figure 5.5: “PM-Preventable” is an example of a field that needs to be defined. When 1603

should technicians check this box? 1604

1605

5.7.1 Error Checking 1606

1607

Certain fields in the CMMS are always required (e.g. Asset Control Number). Other fields may 1608

be required by Healthcare Facility/HTM policy and the CMMS should allow these to be 1609

configurable (e.g. Downtime). 1610

1611

62

The CMMS should provide a robust set of configurable error checks. For example: 1612

• Data types: The CMMS should automatically ensure that each field has the appropriate 1613

data type entered (e.g., string, number, dollar amount, date). 1614

• Range constraints: Most fields have logical ranges, so constraints can be configured to 1615

make sure that data entry is stopped, or a warning issued, if a value is out of the expected 1616

range. For example, a range check for a vendor hourly rate field could be set for a 1617

minimum of $50 USD to a maximum of $999 USD per hour to catch an obviously 1618

erroneous data entry. 1619

• Date checks: Dates (and times) need to have a consistent format throughout the CMMS. 1620

Some dates (e.g., next PPM due date) must be in the future when initially entered. Most 1621

other dates should be current or in the past when entered (e.g., work order completion 1622

date). 1623

• Multiple-field error checking: Multiple-field error checking is more complex and often 1624

requires special CMMS configuration or customization. For example, suppose that 1625

downtime is a required field when an asset is a “critical system,” but optional if it is not. 1626

Multiple-field error checking would be configured so that downtime is always required 1627

on critical system repair work orders. 1628

• HTM business rules: A healthcare provider may have internal requirements that 1629

mandate certain rules in the CMMS. For example, local business rules may authorize 1630

different levels of purchasing authority for parts and services for different levels of HTM 1631

personnel, based on the cost of the order (e.g., a staff BMET is allowed to place parts 1632

orders up to $1,000 USD without additional approval, whereas a BMET supervisor is 1633

allowed to place an order up to $5,000 USD). 1634

In addition to automatic error checking, periodic audits are necessary to maintain data quality. 1635

Some data problems that require data aggregation cannot be immediately caught at data entry. 1636

1637

Example: For a specific BMET, or group of staff, an audit could recognize that an insufficient 1638

number of labor hours have been documented on work orders compared to payroll system-1639

related data (e.g., time card entries). Sampling audits by supervisors can also check for 1640

problems that are difficult to automate, such as verification that work orders are accurate and 1641

documented in sufficient detail. 1642

1643

For a CMMS to be effective it needs to be easy to use. Modern CMMSs allow the use of smart 1644

phones, tablets, and laptops. Pick lists, autocomplete text entry, voice to text, and other modern 1645

63

data entry techniques make them easier to use. Reports can be set up to run at regular intervals 1646

and dashboards can provide near-real-time feedback on ongoing activities (see: section 9.1.3). 1647

1648

5.8 Considerations in selecting a new or replacement CMMS 1649

1650

1651

Suppliers offer a wide variety of CMMS applications at a wide variety of price points. With 1652

such wide availability, it is not recommended that HTM departments try to develop their own 1653

CMMS. Modern CMMSs are complex software applications, that take a lot of time to write 1654

and can be difficult to update and maintain. Most healthcare facilities will already have some 1655

kind of CMMS in place so the rest of this section will focus on CMMS replacement selection 1656

and implementation. If there is no CMMS currently available, and there are no, or very little, 1657

funds available for a CMMS, there are low cost, or even free (with restrictions) CMMSs 1658

available, although they are not typically HTM focused (Hoppe, 2017). 1659

1660

CMMS Software Evaluation and Selection 1661

1662

The evaluation and selection process should be as follows: 1663

1. Assess your current CMMS system for its features that are working well and its 1664

deficiencies. Also, as you assess deficiencies of your current system, take into 1665

consideration that some of those deficiencies might be data related, and poor quality 1666

data are poor quality data regardless of the CMMS features. You don’t want to import 1667

bad data into your new CMMS, so a data clean-up project may also be appropriate. 1668

2. Develop a high-level list of your CMMS needs, including key required and desirable 1669

features, for a new system. 1670

3. Consider the proposed physical location of the new system (cloud-based vs local), 1671

taking into account security considerations, data ownership, hardware, support model, 1672

and cost. 1673

1674

Note: Commercial CMMS suppliers offer vendor-hosted, cloud-based CMMS software that 1675

runs from a web browser and is compatible with a variety of web-enabled devices (e.g. 1676

laptops, tablets and smart phones). 1677

1678

1679

1680

64

4. Invite vendors to provide an on-line demonstration of their software. 1681

1682

Note: To optimize everyone’s time, focus on your requirements list by providing the 1683

suppliers in advance of their demonstrations with a draft high-level list of your requirements 1684

and, if possible, a few scenarios that they can use to show how their products might meet 1685

your requirements. (e.g. demonstrate a COSR report for all imaging systems, show a 1686

dashboard of pending work for today or for this week). From these demonstrations, and the 1687

other information you gather, you can develop a more formal and final requirements 1688

document and pursue your selection process through RFI (Request for Information) and/or 1689

tender/RFP/RFQ (Request for Proposal/Quotation) processes depending on your healthcare 1690

facility’s procurement process requirements. The result should be a written response from 1691

each vendor to each of your requirements and a written pricing proposal. You may also want 1692

to prioritize each specification item (e.g. mandatory, preferred, desirable). 1693

1694

5. Review the supplier’s written responses and see which products meet which 1695

specifications—both “out of the box” and through customization. 1696

1697

Note: Pay particular attention to supplier responses that require customizations: What will 1698

the customizations cost? How long will they take to complete? Contact references and, if 1699

needed, schedule additional demonstrations. 1700

1701

6. Limit the number of suppliers to your top candidates based on pricing and features. 1702

Limit the demonstrations to exactly what you want to see so you can clearly evaluate 1703

their responses. Features can be “scored” by your evaluation team based on how well 1704

they meet your requirements. Pricing comparisons should include both initial pricing 1705

and support and licensing pricing for a period of time (e.g. 5 years, 10 years) so you 1706

can evaluate pricing based on life cycle costs. Then determine which product comes 1707

closest to meeting both feature requirements and budget. 1708

7. Once you decide on a single product, the next step is to negotiate a final price, schedule, 1709

and terms and conditions with the vendor. Get all the vendor promises in writing. Be 1710

clear about the deliverables, responsibilities, expectations, and schedules, particularly 1711

customization and data imports, which sometimes are problematic and can take a long 1712

time. Then start getting ready for the implementation-planning phase. 1713

65

1714

5.9 Reporting adverse events to SFDA 1715

1716

It is a moral responsibility for users, patients and all those using a medical device or accessory 1717

to report adverse events. There are multiple numbers of the same device being used by other 1718

patients in other hospitals and reporting the incident will save others from facing the same 1719

accident (reporting is saving). 1720

Accidents or injuries on patients or users caused by a Medical device or accessory must be 1721

reported to SFDA national center for medical device reporting (NCMDR) to protect patients in 1722

other hospitals from facing the same incident (reporting is saving). The center investigates the 1723

accident and a recall, warning, or field safety notice for the device may result from this 1724

investigation. The released statement will include a corrective actions required to be 1725

implemented on the device to avoid the re-occurrence of the incident in other hospitals. 1726

Corrective actions include but not limited to the following: 1727

• Removing the device from service 1728

• Replacing or adjusting some parts 1729

• Advising nursing on proper method for using the device. 1730

• Regular warning 1731

SFDA requires that manufacturers and distributors track the devices they sold within Saudi. 1732

When a recall is issued, the National center for medical device reporting forces the 1733

manufacturer's representative in Saudi to conduct whatever corrective action needed on all the 1734

similar devices available in Saudi to protect patients and users in other hospitals from facing 1735

the same accident. 1736

It is important to note that recalls on Medical devices and equipment take place within the best 1737

brands, best manufacturers and best devices. Sometimes, a manufacturing problem temporarily 1738

takes place, so all batches of devices manufactured during that design problem need to be 1739

removed from service or fixed. Manufacturers must report such problems to SFDA, in addition, 1740

design problems, false claims, wring instructions for use, faults that have caused or may cause 1741

harm to patients or users must be reported to SFDA so that an investigation and root cause 1742

analysis is done. If the investigation results in an action against the device, SFDA will request 1743

the list of customers who bought the device from the manufacturer and follow up with 1744

manufacture or it's representative to perform the desired action to avoid causing harm to other 1745

patients. 1746

1747

66

5.9.1 How to report an adverse event? 1748

1749

Report adverse events by calling 19999 or by visiting the NCMDR web portal: 1750

(https://ncmdr.sfda.gov.sa/), where the adverse event can be reported and followed up. 1751

What should be reported? 1752

1753

1. An event has occurred 1754 1755

1756

Typical events are: 1757

1758

a) A malfunction or deterioration in the characteristics or performance. 1759

1760

A malfunction or deterioration should be understood as a failure of a device to 1761

perform in accordance with its intended purpose when used in accordance with the 1762

manufacturer's instructions. 1763

The intended purpose means the use for which the device is intended, according to 1764

the data supplied by the manufacturer on the labeling, in the instructions and/or in 1765

promotional materials. 1766

b) An inadequate design or manufacture. 1767

This would include cases where the design or manufacturing of a device is found 1768

deficient. 1769

c) An inaccuracy in the labeling, instructions for use and/or promotional materials. 1770

Inaccuracies include omissions and deficiencies. Omissions do not include the 1771

absence of information that should generally be known by the intended users. 1772

d) A significant public health concern. 1773

This can include an event that is of significant and unexpected nature, such that it 1774

becomes alarming as a potential public health hazard, e.g. human 1775

immunodeficiency virus (HIV) or Creutzfeldt-Jacob Disease (CJD). 1776

e) Use error. 1777

• Use Error Resulting in Death or Serious Injury/ Serious Public Health 1778

Concern. 1779

• Use error related to medical devices, which did result in death or serious 1780

injury or serious public health concern, should be reported to the SFDA. 1781

• Use errors becoming reportable: Use errors become reportable to the SFDA 1782

when you: 1783

https://ncmdr.sfda.gov.sa/

67

- Note a change in trend (usually an increase in frequency), or a 1784

change in the pattern of an issue that can potentially lead to death 1785

or serious injury or public health concern. 1786

- Initiate corrective action to prevent death or serious injury or 1787

serious public health concern. 1788

1789

1790

1791

2. The Event Led to One of the Following Outcomes 1792 1793

a) Death of a Patient, User or Other Person 1794

b) Serious Injury of a Patient, User or Other Person. 1795

Serious injury (also known as serious deterioration in state of health) is either: 1796

• Life threatening illness or injury. 1797

• Permanent impairment of a body function or permanent damage to a body 1798

structure. 1799

The term "permanent" means irreversible impairment or damage to a body structure 1800

or function, excluding minor impairment or damage. 1801

Medical intervention is not in itself a serious injury. It is the reason that motivated 1802

the medical intervention that should be used to assess the reportability of an event. 1803

c) No Death or Serious Injury Occurred, but the Event Might Lead to Death or Serious 1804

Injury of a Patient, User or Other Person if the Adverse Event Recurs. 1805

1806

All events do not lead to a death or serious injury. The non-occurrence of such a result 1807

might have been due to circumstances or to the timely intervention of health care 1808

personnel. 1809

The event is considered "adverse" if in the case of recurrence, it could lead to death or 1810

serious injury. 1811

This applies also if the examination of the device or a deficiency in the information 1812

supplied with the device, or any information associated with the device, indicates some 1813

factor which could lead to an event involving death or serious injury. 1814

Include relevant information that might impact the understanding or evaluation of the 1815

adverse event AND that is not included elsewhere in this report. 1816

1817

68

3. The Manufacturer's Device is Associated with the Event 1818 1819

In assessing the link between the device and the event, the manufacturer should take 1820

into account: 1821

a) The opinion, based on available information, from a healthcare professional 1822

b) Information concerning previous, similar events 1823

c) Other information held by the manufacturer 1824

1825

This judgment may be difficult when there are multiple devices and drugs involved. In complex 1826

situations, it should be assumed that all factors, including the device, be associated with the 1827

event. 1828

1829

5.9.2 Dealing with FSNs/Recalls. 1830 1831

Field Safety Correction Action 1832 1833

A field safety corrective action is taken by a manufacturer to reduce the risk of death 1834

or serious deterioration in the state of health associated with the use of a medical 1835

device. Such action should be notified via a field safety notice. 1836

1837

Field Safety Notice (FSN)/Recall 1838 1839

A notification from the SFDA to relevant medical device users in relation to a Field 1840

Safety Corrective Action. 1841

1842

SFDA classifies medical device recalls into three categories, representing the 1843

potential risk to public health: 1844

- Class I High risk. 1845

- Class II Medium risk. 1846

- Class III Low risk. 1847

1848

FSNs/Recalls Weekly Report 1849 1850

69

The NCMDR staff is sending an updated list of recalls on a weekly basis to 1851

healthcare officers. The report contains information such as the manufacturer name, 1852

affected device model and description, and affected lot/batch/serial numbers. 1853

1854

When the health care officer receives the recalls weekly report, he/she shall: 1855

- Ensure that the healthcare facility removes from use any affected 1856

device/product mentioned in the FSNs/Recalls. 1857

1858

1859

1860

If the healthcare facility has any affected device then the officer shall: 1861

- Communicate with the NCMDR Team and Authorized Representative of 1862

the manufacturer to ensure the implementation of the necessary corrective 1863

actions. 1864

- If the FSN requires the user to stop using the device, then the officer shall 1865

take the necessary actions to ensure that the affected device(s) are not in use 1866

until a corrective action is done. 1867

1868

5.10 Special requirements for specific medical devices 1869

1870

Safety of all medical devices for both patients and medical practitioners can be enhanced by 1871

providing user training. However, some especially high risk, medical devices need additional 1872

training to reduce their risk for the following medical devices: 1873

1. Non-implantable active medical devices for: 1874

1875

a. generation and application of electrical energy to directly affect the function of 1876

nerves and / or muscles or the heart activity including defibrillators, 1877

b. intracardiac measurement of electrical quantities or measurement of other 1878

quantities using electrically operated probes or sensors in blood vessels or on 1879

exposed blood vessels, 1880

c. Generation and application of any energy for immediate coagulation, tissue 1881

destruction or destruction of deposits in organs, 1882

70

d. direct introduction of substances and fluids into the bloodstream under potential 1883

pressure build-up, where the substances and fluids can also be processed or 1884

specially treated endogenous substances whose introduction is directly coupled to 1885

a removal function, 1886

e. mechanical ventilation with or without anesthesia, 1887

f. diagnosis using imaging techniques based on the principle of nuclear magnetic 1888

resonance 1889

g. therapy with pressure chambers 1890

h. therapy by means of hypothermia 1891

1892

2. Infant incubators 1893

3. external active components of active implants 1894

1895

The healthcare provider shall not operate or use these high risk? medical devices without 1896

assigning an in-house medical device clinical educator for each type of high risk medical 1897

device. 1898

The Medical Devices Clinical Educator shall be trained by the manufacturer or his 1899

representative on the correct and safe handling, use and operation of the medical device 1900

and their accessories and if the device is subject to be combined and operate with other 1901

devices or within system, the training scope shall be extended to include the whole 1902

combined devices and system. This training shall be based on the IFU and related safety 1903

and maintenance information. This training shall qualify the Medical Devices Clinical 1904

Educator to train the other users of the device and this shall be included in the manufacturer 1905

certification. The healthcare provider shall document this training. 1906

1907

The Medical Devices Clinical Educator’s obligations toward all medical devices assigned 1908

to him are the following: 1909

- Attend the training provided by the manufacturer 1910

- Organize and conduct training for other users of the same medical device from the same 1911

manufacturer in their healthcare provider. 1912

- Document all the training activities that have been executed on the related medical 1913

device and share it with the HTM department. 1914

- Assure the availability of the IFU of this medical device and make it accessible for all 1915

users at all working hours. 1916

71

- Monitor the compliance/ adherence to the requirement of safety and calibration checks 1917

and periodic preventive maintenance. 1918

- Organize on a regular basis discussions to address safety issues regarding the use and 1919

operation of these medical devices with the users, SFDA-Officer, manufacturer or his 1920

authorized representative and the HTM Department and all parties involved in the 1921

operation of these medical devices. Apply corrective action where appropriate. These 1922

discussions shall be documented. 1923

- Update users with and all parties involved in the operation of these medical devices 1924

with all safety issues and recalls issued by the SFDA or the manufacturer. 1925

- Support the SFDA-Officer in case of reporting adverse events, applying SFDA medical 1926

devices recall procedures and manufacturer procedures. 1927

1928

5.11 Special safety requirements 1929

1930

1931

Safety of medical devices for both patients and medical practitioners can be enhanced by 1932

providing proper user training and proper device maintenance. However, some medical devices 1933

needs special safety requirements to eliminate their risk. 1934

1935

5.11.1 Medical Laser Devices 1936

1937

The laser is used in several different applications in healthcare facilities including 1938

dermatology, surgery, and ophthalmology. 1939

When using a laser device, the following precautions should be taken: 1940

• Use of proper protective eyewear for both health practitioner and the patient to protect 1941

the eyes from direct and reflected laser energy. 1942

• Laser warning signs in Arabic and English should be placed on the door of each procedure 1943

room to prevent personnel from entering without wearing protective eyewear. 1944

• Ventilation of airborne contaminants to protect personnel from inhaling noxious fumes. 1945

• Quick operating procedures for using laser equipment shall be posted in each clinic. 1946

• The operator and /or dermatologist shall be licensed by Saudi Commission for Health 1947

Specialties in relevant specialty 1948

• The patient shall sign a consent form that acknowledges procedure hazards and declare 1949

patient's history and physical state, and it should be updated at each visit. 1950

72

• Operators shall be trained on laser emergency incidents, laser safety training and operating 1951

laser equipment. (Training certificate shall be kept on file). 1952

• The eyewear wavelength shall match and cover the device wavelength. 1953

• Eyewear shall be in good condition (Operators shall not use broken eyewear). 1954

• Adequate number of eyewear (at least 3) shall be provided. 1955

• Any reflecting object of the laser beam such as mirrors, metal and any other reflecting 1956

objects shall be covered or removed to avoid inadvertent exposure to direct or scattered 1957

laser radiation. 1958

1959

5.11.2 Ionizing Radiation 1960 1961

Ionizing radiation is a form of energy that acts by removing electrons from atoms and 1962

molecules of materials that include air, water, and living tissue. Ionizing radiation can travel 1963

unseen and pass through these and most other materials. 1964

1965

The main exposure to ionizing radiation is through the use of diagnostic medical exams. 1966

Medical exams that use ionizing radiation include: X-ray, CT scan, PET scan, Fluoroscopy, 1967

and Nuclear Medicine procedures. 1968

1969

The following actions can help reduce the exposure to and risk of harm from diagnostic 1970

ionizing radiation by: 1971

1972

• Checking to see if a test that does not use ionizing radiation can provide similar 1973

information. 1974

• Making certain the least possible amount of radiation needed to obtain a good quality 1975

image is used. 1976

• Using protective lead shielding to prevent exposing other areas of the body to radiation. 1977

• Performing functional tests of quality assurance to ensure that the device is not deviating 1978

from the proper use (KV, mAs, tests, collimator alignment tests, …etc) 1979

1980

5.12 Inventory Accuracy 1981

1982 1983

73

The inventory accuracy shall be maintained so that all devices & spare parts can be tracked 1984

after acquisition by the hospital. All additions, deletions, changes should be made promptly. 1985

The inventory accuracy shall be periodically verified, at least the existence of identification 1986

number, manufacturer and description, with a statistically significant sample each year. 1987

1988

Inventory should include: 1989

1990 • Location of the device. 1991

• Department owning the device. 1992

• Service provider. 1993

• Acceptance date. 1994

• Additional useful information. 1995

• Spare parts. 1996

1997

5.12.1 A Sample Statistical Model for Evaluating Inventory Accuracy 1998 1999

The values chosen below reflect the minimum sample quantities necessary to ensure that the 2000

inventory is at least 85% accurate. A more accurate inventory would require less sampling. The 2001

numbers are derived from the equation: 2002

s = √𝑝(1 − 𝑝)(𝑁 − 𝑛)

𝑛𝑁 2003

2004

where s is the standard error of the sample, p is the mean accuracy of the inventory, n is the 2005

sample size, and N is the population size. 2006

2007

To derive the numbers used here, a mean accuracy for the inventory was assumed to be 90%, 2008

with a standard error of 5%. In this way, the following statement can be made with 95% 2009

confidence: Based upon the sample, if the accuracy of the selected sample is 90% or greater, 2010

then the mean accuracy of the entire population is the same as the accuracy of the sample +/- 2011

5%. This assumes that the selected samples are truly randomly selected. 2012

For example, to find the sample size required, this equation can be rewritten as: 2013

2014

𝑛 =𝑁𝑝(1 − 𝑝)

𝑁𝑠2 + 𝑝(1 − 𝑝) 2015

If the total number of items in the inventory is 100 items, then: 2016

74

𝑛 =(100)(0.9)(1 − 0.9)

(100)(0.5)2 + 0.9(1 − 0.9) 2017

2018

𝑛 = 26.47 2019

This number is then rounded up to the next highest integer. The typical sample sizes used for 2020

accuracy check are: 2021

• < 100 items the audit shall be 27 randomly selected items. 2022

• >100 but < 500 items, the audit shall be 34 randomly selected items. 2023

• 500 but < 1000. The audit shall be at least 35 randomly selected items. 2024

• 1000 the inventory shall consist of 36 randomly selected items. 2025

The accuracy is expected to be > 95%.2 2026

2027

For more details please refer 2013 Association for the Advancement of Medical 2028

Instrumentation ■ ANSI/AAMI EQ56:2013 2029

2030

5.13 Warranty Management 2031

2032 2033

Warranty Management deals with management of all technical services related to medical 2034

devices that are within their warranty period. During this period, the type, quality and 2035

performance of the medical device, as well as the quality of services and technical support 2036

provided by the supplier, is assessed. The responsibility for the device’s technical performance 2037

is primarily with the supplier, and the healthcare facility and HTM program is responsible for 2038

documenting and notifying the supplier of all quality and performance issues so they can get 2039

them rectified free of charge during the pre-agreed-upon warranty period. 2040

2041 2042

• Warranty management procedures shall ensure that all faults of the device occurring 2043

within the contracted warranty period are reported and fixed, and bring the device to its 2044

original working condition. 2045

• The warranty provisions and scope of coverage, are recommended by the HTM/Clinical 2046

Engineering and the device’s clinical department, and based on the device’s purchase 2047

agreement. This would include all warranties provided by manufacturers, local suppliers 2048

and third-party providers. This could include Planned Preventive Maintenance, Corrective 2049

Maintenance, Emergency services, inclusion/exclusion of spare parts, etc. HTM/Clinical 2050

Engineering has to monitor the performance – both in terms of quality of repairs and 2051

75

support response - and ensure that all these activities are in conformance with the purchase 2052

agreement and other procurement documentation. 2053

• All warranty services must be recorded in the CMMS system. Warranty registers must be 2054

continuously monitored for performance. All reports shall be available in the CMMS 2055

which is used for management of all warranty work orders and other activities. 2056

• HTM/Clinical Engineering must monitor all technical services provided during the 2057

warranty period for appropriate responses, quality and types of repairs and turnaround 2058

time. They must ensure that supplier performance is continuously assessed, and the related 2059

clinical department is informed. Supplier performance management and ratings are key 2060

indicators and should be factored during future procurement activity. 2061

• HTM/Clinical Engineering Department should ideally schedule a pre-warranty 2062

completion inspection at six months to warranty completion for major devices, and 3 2063

months for smaller devices to ensure that systems are optimally working at the end of the 2064

warranty. 2065

2066

5.14 Disaster/Contingency Planning 2067

2068 2069

Disaster can strike anytime in the healthcare facility – critical device failures, power failures, 2070

infections etc. HTM/Clinical Engineering needs to have a proactive plan to ensure that the 2071

clinical services in the healthcare facility are not affected or are only minimally affected in case 2072

of disasters related to medical devices. Disasters related to loss of utilities (power, water, 2073

medical gases, IT, etc.) should be included in the plan. 2074

2075

A systematic program of identifying critical and high risk devices, and taking systematic steps 2076

to mitigate their risks, is required. HTM/Clinical Engineering must provide mechanisms to 2077

avoid failures or breakdowns of device during patient treatment, diagnosis or therapy. 2078

2079 • HTM/Clinical Engineering must be proactive in identification of possible points of failure 2080

of device related services and develop contingency plans before the catastrophic event or 2081

possible incident. 2082

• Risk management and scoring of medical devices: One method for assessing and 2083

classifying medical device risk is by assessing a device’s basic function (Function 2084

Description), clinical use risk (Physical Risk to patient), and maintenance requirements 2085

(see 3 charts below). 2086

76

• Risk Scoring: Total risk can be assessed by adding the three categories. Then a 2087

determination can be made as to the disaster plan threshold above which resources should 2088

focus (above 12 in the example below). 2089

- Total Risk EM= Function + Risk + Required Maintenance. 2090

- Device EM> 12 are included in the disaster plan. 2091

- Device EM< 12 are not included in the disaster plan. 2092

2093 Ref: Page 27-28: WHO publication: Medical device Inventory Management by Tania O’ 2094 Connor: WHO Medical 2095 Device Technical Series 9789241501392.

2096

2097

2098

2099

2100

Table 5.2: Maintenance Risk Score. 2101

Table 5.3: Functional Risk Score. 2102

Maintenance requirement Point score

Extensive: routine calibration and part replacement required 5

Above average 4

Average: performance verification and safety testing 3

Below average 2

Minimal: visual inspection 1

Category Function Description Point Score

Therapeutic Life Support 10

Surgical and Intensive Care 9

Physical Therapy and treatment 8

Diagnostic Surgical and Intensive care 7

Additional Physiological monitoring and diagnostic 6

Analytical Analytical Laboratory 5

Laboratory Accessories 4

Computer and related 3

Miscellaneous Patient related and other 2

77

2103

2104

Table 5.4: Physical Risk Associated with Clinical Applications. 2105 2106

2107

2108

2109

2110 2111

5.15 User Training 2112

2113 2114 Safe and effective use of medical device requires that users shall receive appropriate training 2115

as per manufacturer requirements. The training should focus on clinical use and the need to 2116

ensure that all features of the technology are used for best possible patient diagnosis and 2117

therapy. 2118

• The key focus of user training programs would be to enable users to operate the device in 2119

a safe and effective manner. An additional objective will be to ensure that users cooperate 2120

in increasing the useful life of the device, while operating the device safely. 2121

• Training will be mandatory when a new device is installed. 2122

• Training may also be required based on failure data or wrongful use of the medical device. 2123

If any special training is required – either in-house or from manufacturers or specialized 2124

agencies- it shall be provided as requested and agreed upon in the initial purchase or 2125

subsequent support agreements for the life of the equipment.. 2126

• HTM/Clinical Engineering will keep records of the training; content and attendees. 2127

2128

5.16 HTM/Clinical Engineering Training programs 2129

2130 2131

The staff in the HTM department shall be trained as follows: 2132

• The required education for his job. 2133

Description of use Risk Point score

Potential patient death 5

Potential patient or operator injury 4

Inappropriate therapy or misdiagnosis 3

Device damage 2

No significant risk 1

78

• The required training from the manufacturer. 2134

2135

5.17 Spare Parts procurement and management 2136

2137 2138

• HTM/Clinical Engineering staff, based on their engineering assessment, shall source 2139

appropriate and genuine spare parts for maintenance based on manufacturer service 2140

manuals and technical bulletins. 2141

• HTM/Clinical Engineering with the assistance of the device supplier should plan for 2142

appropriate inventories of spare parts to minimize downtime. 2143

2144 Note: Spare parts should cover periodic preventive maintenance spares, as well as spares for 2145

breakdowns. 2146

2147

2148

2149

5.18 On Site Libraries 2150

2151 2152

To maintain devices, and to use devices appropriately, users and clinical engineers need access 2153

to operation and service manuals. A systematic method of maintaining service and user 2154

manuals should be developed to ensure that hard or soft copies of these documents are available 2155

on demand. 2156

• HTM/Clinical Engineering must provide technical staff with appropriate manuals and 2157

documented instructions on maintenance and support of all medical devices. 2158

• On site libraries should include manufacturer authorized and authenticated: 2159

- Service and repair manuals. 2160

- Operation manuals. 2161

- Other manuals including software manuals etc. 2162

- These may be provided in hard or soft copies. 2163

- Surveys of all medical device documentation can identify documentation gaps and 2164

requirements. 2165

- All HTM programs should include a plan for a documentation system with safe 2166

storage and easy access for all information. 2167

- This system should be catalogued based on manufacturer and model number for easy 2168

identification and retrieval. 2169

79

- When a new device is commissioned, a copy of the manuals should be provided to 2170

HTM Department. 2171

- It is suggested that all new devices must come with at least two copies of the manuals. 2172

– One for HTM and the other is for the end-users. 2173

2174 2175

5.19 Workshop Space and Test Devices 2176

2177 2178

A well-equipped workshop space is a mandatory requirement for a HTM/Clinical Engineering 2179

Department. The workshop must be equipped with work benches, test equipment, service 2180

toolkits, personal protective equipment, jigs and fixtures necessary to provide competent 2181

technical services. 2182

2183 2184 2185

Workshop requirements: 2186 2187

- The workshops should be of adequate size to accommodate the service teams, 2188

manuals and documentation. 2189

- Test equipment: Appropriate test equipment for analyzing, performance and safety 2190

of medical devices shall be available. 2191

- Ensure that all test equipment are procured and calibrated as per manufacturer 2192

requirements. 2193

- Ensure that the workshop is appropriately equipped with all safety equipment (fire 2194

extinguishers, PPE, etc.). 2195

- Workshop plans, and drawings must be available. 2196

2197 2198

5.20 Inter Service Coordination 2199

2200 2201

Medical devices are dependent for their optimal performance on many support systems such 2202

as air conditioning, medical gases, electrical power, emergency power (e.g. (UPS), IT, and 2203

other utilities. Failure of these services could result in medical device failure resulting in 2204

catastrophes. To prevent this, regular coordination between these facility services and HTM 2205

will help ensure higher uptime for the medical devices. 2206

2207

80

• The HTM/Clinical Engineering Department must coordinate with many other departments 2208

of the healthcare facility, to ensure that quality services are provided to the healthcare 2209

facility. Typically, these include Facilities Management, IT, Quality, Infection Control, 2210

etc. This process addresses the framework of such coordination. 2211

• Close coordination with many support services in the healthcare facility may require a 2212

formal framework. 2213

• Healthcare Administration should facilitate this formal framework. 2214

• A periodic (e.g. monthly) meeting with representatives of all services is suggested. 2215

2216

2217

2218

2219

5.21 Checklist 2220

2221


Yes

No

In

pro

gre

ss

1 Availability of a dedicated HTM/Clinical

Engineering Department with appropriate budgets

and management.

2 Medical device management plan.

3 Availability of CMMS system

4 Availability of PPM, CM, Safety testing and

performance testing policy

5 The Storage area is in compliance with Medical

Devices manufacturer and any regulatory

requirements

6 All medical Devices are calibrated if applicable

7 Availability of Electrical Safety analyser

81

8 Availability of Quality assurance test equipment as

needed

9 Availability of biomedical test equipment as needed

10 All test Equipment are calibrated

11 Availability of SFDA-Officer

12 Availability and applying of written procedure to

manage recalls published by SFDA

13 Availability applying of written procedure to report

adverse events to SFDA

14 Availability of Medical Devices Clinical Educator

2222 2223 2224

82

2225

Chapter 6: Disposal & Donation 2226

2227


2229

2230

6.1.1 Objective 2231 2232

Ensuring safe and cost effective disposal or donation of medical devices. 2233

2234

6.1.2 Scope 2235

2236

This process applies to the healthcare organization and their staff who will dispose or donate 2237

surplus medical devices. 2238

2239

6.1.3 Ownership 2240 2241

• HTM/Clinical Engineering Department. 2242

• End-user Medical Departments. 2243

• Assets management. 2244

• Legal. 2245

• Finance. 2246

• Quality Department. 2247

• CSSD. 2248

• Related Healthcare admin. 2249

2250

6.1.4 Background 2251 2252

83

Decommission and

Disposal

Device may be

recommended for disposal

because of :

- Beyond economic repairs

- New safety requirements

render the device unsafe

- Recent technology

renders the device

redundant

- Hazardous for use

- Recall advice from

regulatory agencies

HTM/ Clinical Engineering

and Facilities Engineering

shall arrange for the device

to be moved into long term

storage facilities pending

safe disposal

Update the device s status record. The

device s history

shall be kept for at

least 5 years.

In the case of

radiation device,

laser systems etc.

governed by

statutory laws and

regulations,

appropriate

authorities must be

informed.

Planning Procurement Installation Operation

2253 2254

Figure 6.1: Decommission and Disposal Process. 2255

2256

6.1.4.1 Donating of Used Medical Devices (Decommissioning and Disposal) 2257

2258

Medical devices may be donated or sold to other healthcare organizations within the Kingdom 2259

of Saudi Arabia or to foreign countries. However, to improve the quality of donations of used 2260

medical devices process, it is suggested to follow the following guidelines: 2261

• Healthcare organizations shall properly plan for the devices that can be donated and 2262

communicate with the anticipated recipients before removal of the devices from service. 2263

• The used medical devices that are proposed to be donated/ or sold shall be removed from 2264

service after conducting the appropriate testing and removal all patients’ data. The 2265

devices shall be cleaned, disinfected from contamination and transported to a warehouse 2266

of suitable environment before delivering them to the recipient. 2267

• The donating organization shall provide maintenance manuals, documents and available 2268

related spare parts to the receiving organization together with any information about 2269

missing parts, if any. 2270

• The recipient shall assure the availability of the necessary consumables or in-vitro 2271

diagnostic devices (IVD), as well as the availability of a suitable location that contains 2272

the basic space, physical installation (alignment, shielding, etc.) and utility-related 2273

services (e.g. such as electricity, drainage, water supply, nitrogen outlets) as appropriate. 2274

• The recipient of the used medical devices shall review their requirements, healthcare 2275

level, patient workload, number of users, their abilities, and their available technical 2276

experience level prior to acceptance of any used medical devices. 2277

2278

84

• Do not sell or donate medical devices to a third party as follows: 2279

- Any used medical devices that have at least 2 years left of their operational life. 2280

- Devices destroyed as junk, dismantled or having parts removed for spares. 2281

2282

• Used medical devices that will be donated or sold to a third party shall: 2283

- Pass mechanical safety tests, calibration and electrical safety tests, including but not 2284

limited to electrical leakage current testing. 2285

- Be accompanied by maintenance and user manuals whenever possible. 2286

- Be accompanied by usage starting date, periodic maintenance record, periodic test 2287

schedules and all reports describing the status of the device during service, if 2288

available. 2289

- Be free from medical any contamination or biological remains, radiological waste, 2290

splashes or any hazardous medical remains. 2291

2292 • All used medical devices that shall be sold or submitted for public tender shall be kept in 2293

a safe storage area (a warehouse with good temperature and humidity control) within or 2294

out of the healthcare organization. Such devices shall not be left in the open air. It is 2295

preferable to wrap these devices for their safety during storage and transport. 2296

• The healthcare organization shall keep a separate record for all disposed of used medical 2297

devices by device. A separate record shall be maintained for identification of the sold 2298

items in addition to the identity of the purchaser. 2299

2300

6.1.4.2 Decommissioning and Disposal of Medical Device 2301 2302

Decommissioning of Medical device is required when a device needs to be removed from 2303

service. In some cases, there are specific protocols for removal of devices (e.g. devices with 2304

radiation sources) or other statutory laws and regulations (e.g. hazardous waste, patient data). 2305

This is a sensitive and hazardous activity, and in specifically identified cases, must only be 2306

done by experienced staff. When decommissioning a device, consider the following points: 2307

2308

• The organization is expected to have a well-defined and written procedure to coordinate 2309

removal and disposal of medical devices that have been decommissioned. 2310

• The reasons for decommissioning must be clearly identified and may include: 2311

- Beyond economic repair. 2312

85

- New safety requirements render the device unsafe. 2313

- Recent technology renders the device redundant. 2314

- Hazardous for use. 2315

- Recall advice from regulatory agencies. 2316

- Re-sale/public auction. 2317

• Disposal of used medical devices shall follow the standards of disposal of medical waste, 2318

including disposal of nuclear and contaminated wastes. 2319

• Disposal of used medical devices shall be carried out within the same healthcare 2320

organization and under the supervision of qualified professionals or licensed 2321

subcontractors who shall destroy the medical devices on behalf of the healthcare 2322

organization. 2323

• The healthcare organization shall keep all the documents pertaining to the destroyed used 2324

medical devices. 2325

• Spare parts may be Dismantled from used medical devices that are not destroyed due to 2326

contamination or fire or non-conformance or recall by the supplier. 2327

• Spare part(s) to be dismantled from the disposed used medical devices shall conform with 2328

the following guidelines: 2329

- Shall not require disinfection before fixing it on another similar medical device. 2330

- Printed circuit boards or any other electronic part shall not be totally or partially 2331

damaged (e.g. due to heat from solder removal process). 2332

- Shall not be contaminated or cracked or damaged. 2333

- Shall not be expired (e.g. a consumable part passed its operational life as calculated 2334

by the number of hours of use). 2335

- An exposed radioactive part. 2336

- A part that directly or indirectly contributes to the clinical measurements and cannot 2337

be calibrated before using it again in another medical device. 2338

- A part in that has been in contact with the patient or touching the patient’s body 2339

directly or through an interface. 2340

• Dismantling shall be conducted only by a trained and licensed biomedical engineering. 2341

• A record of all dismantled used medical devices shall be kept within the respective 2342

healthcare organization. 2343

• HTM/Clinical Engineering and Facilities Engineering shall arrange for the device to be 2344

moved into long term storage facilities pending safe disposal. 2345

86

• The CMMS data for the decommissioned medical device shall be updated and records 2346

shall kept for 5 years or longer. 2347

• In the case of radiation devices, laser systems or other devices governed by statutory 2348

laws and regulations, appropriate authorities must be informed. 2349

2350

6.2 Checklist: 2351

2352


Yes No In

progress

1 Are reasons for decommissioning are identified

and documented

2 Availability and applying of a medical device

written procedure for disposal and donation.

3 Availability of Group/ Committee for Medical

Devices/Health Technology disposal and donation

with involvement of all related parties in the

ownership.

5 The availability and applying written procedures

of dismantled spare part

6 Availability of record of all disposed medical

devices for at least 5 years

7 Devices to be disposed are isolated in storage area

2353

87

Chapter7: Special Topics 2354


2356

7.1.1 Objective: 2357

2358

Define & demonstrate the special requirements for Medical Device Consumables, Single 2359

Use Medical Devices (SUMD), Implants, and Medical Devices Clinical Trials (Clinical 2360

Investigation). 2361

2362

7.1.2 Scope: 2363

2364

This chapter applies to the following products: 2365

2366

- Medical device consumables (reusable). 2367

- Single use medical devices (SUMD). 2368

- Single patient medical devices. 2369

- Implants. 2370

- Medical devices clinical trials (Clinical Investigation). 2371

2372


2374

Consumables and Accessories in medical devices for this chapter are defined as follows6: 2375

2376

1. Accessories are those items which: 2377

2378

• Connect the medical device to the patient (e.g. breathing circuits, ECG leads, 2379

probes/transducers.). 2380

• Assist with the use of the medical device (e.g. internal trays, foot-switches, 2381

computer mouse). 2382

• Adapt its performance (e.g. different sized adaptors, objectives, lenses). 2383

2384

Note: The accessories are often the main link to the patient, the part most handled by 2385

staff flexed, bent, twisted and, sometimes misused. They are subject to a great deal of 2386

88

wear and tear and often are the most vulnerable problem part of a medical device. Even 2387

for medical device last for many years, accessories may need to be replaced regularly, 2388

therefore accessories must be available for the lifetime of the medical device. 2389

2390

2391

2392

2. Consumables are those items which: 2393

2394

• Are used up and need to be replaced frequently (e.g. each case, daily, weekly) during 2395

the operation of the medical device (e.g. X-ray film, disposable electrodes, laboratory 2396

reagents, ultrasound gel, washing powder, copier toner). 2397

• Consumables are needed throughout the lifetime of the medical device. 2398

2399

- Consumables used in conjunction with a primary medical device are in fact 2400

devices in their own right, albeit they may have a secondary function to the 2401

primary device and may have gone through an independent regulatory review 2402

process. 2403

- The availability of a medical device consumable item is significant. It is often 2404

the case that when a device consumable is no longer available for supply and is 2405

specific to the function of a primary medical device, it renders the primary device 2406

unusable. 2407

2408

2409

Medical device consumables may be single use or reusable. There are some advantages 2410

and disadvantages to both types and some of the re-use management aspects are discussed 2411

later in this chapter. 2412

2413

A Primary electro-medical device (e.g. an infusion pump) that uses or relies on the use of 2414

consumables often may use different brands of accessories or consumables which are not 2415

easily interchangeable. There are, however, a number of key principles that apply to the 2416

safe use and application of these components including: 2417

2418

• Functional compatibility with the primary medical device. 2419

• Purchase from an establishment registered and licensed by SFDA. 2420

89

• The product shall be authorized for marketing (e.g. MDMA & MDNR). 2421

• Standardization and rationalization of as much of the consumable stock items as 2422

possible in order to reduce cost and minimize user training requirements. 2423

• Effective stock control – many consumable items will have a specific shelf life and 2424

this requires an effective monitoring and management process to be in place. 2425

• Ability for clinical users to access e-catalogues to inform staff about the range of 2426

consumable products available in stock or to purchase from approved suppliers. 2427

• Appropriate environmental storage facilities. 2428

• The volume of consumables used and the utilization of the primary device will have 2429

a significant impact on a health technology expenditure. 2430

• An effective dissemination of guidelines for the use of medical devices and 2431

consumables. 2432

• Availability of the consumable (when used in conjunction with a primary health 2433

technology) throughout the entire expected lifetime of the primary device. 2434

2435

2436

The availability and usage of medical device consumables and accessories should be of 2437

significant interest to the healthcare facility. A failure of a device consumable will have a 2438

significant impact on the performance of a primary medical device with potential negative 2439

impacts on clinical service delivery and safety. In addition, the expense profile of a primary 2440

device can be significantly altered based on poor management of device consumables. 2441

Methods to consider managing consumable and accessory cost and performing the 2442

following: 2443

• Direct purchase of consumables. 2444

• Guaranteed price per reportable result (GPPRR) (e.g. Suppliers may offer to provide 2445

their devices free of charge against a fixed price for the supply of consumables.) 2446

• Leased medical devices with or without consumables and accessories included in the 2447

lease cost. 2448

2449

2450

90

Note: HTM/Clinical engineers have a significant role to play ensuring that the following 2451

two aspects (single use and re-use) are effectively addressed should a decision to move 2452

towards a different consumable plan be under consideration. 2453

2454

2455

7.2 Medical device Consumables, Single Use. 2456

2457

• Medical device consumable expenditure can be a very significant component of the 2458

whole life cycle cost of a primary medical device. 2459

• There are also consumables that are not always part of the functionality of a primary 2460

electro-medical device such as syringes, needles, etc. 2461

• There is a wide range of consumables in use within healthcare and it would be 2462

impractical to list them all within this document. 2463

• Manufacturers of single use devices indicate which devices are for single use only. 2464

2465

2466

2467 2468

Figure 7.1: Example of manufacturer labelling for Single Use Device 2469 2470

2471

Examples of SUMD include, but are not restricted to, the following: 2472

• Endodontic reamers and files. 2473

• Saliva ejectors. 2474

• Aspirator tips and three-in-one tips. 2475

• Dental burs. 2476

• Matrix bands. 2477

• Single use patient face masks. 2478

91

2479

2480

2481

7.3 SFDA requirements with regards to reprocessing of single use devices 2482

2483

1. Medical devices designed for single use only in surgical procedures performed in the 2484

tissues and internal organs of the human body shall not be reused for any medical 2485

application. 2486

2. Medical devices that are for single use only utilized for the external organs of the 2487

human body can be reprocessed according to the requirements determined by the 2488

SFDA. 2489

3. Sites that reprocess single use medical devices for themselves or any other party will 2490

be treated in accordance with No.7.3.2 above as a new manufacturer of the medical 2491

device and shall be responsible for the safety and efficiency of the product according 2492

to the requirements specified in the SFDA regulations. 2493

4. Healthcare facilities shall comply with the provisions of above requirements when 2494

reprocessing medical devices. 2495

5. The establishment that reprocesses the single use devices will be treated as a new 2496

manufacturer for that reprocessed single use device. 2497

2498

2499

7.4 Reuse of Reusable, Limited Use & Single Patient Use Medical Devices 2500

2501

The reuse of reusable medical devices and single patient use medical devices shall be in 2502

accordance with manufacturer’s guidance. 2503

2504

7.5 Reuse of Single Use Medical devices 2505

2506

Healthcare facilities that use single use devices for patient care have several options: 2507

• Dispose of all single use devices after a single use and purchase a new device. 2508

• Contract with a regulated reprocessing organization and purchase devices from them. 2509

92

• Become a reprocessing organization and comply with standards for reprocessing 2510

single use devices. 2511

• Use only reusable medical devices as labelled by the manufacturer. 2512

2513

The healthcare facility shall follow the SFDA requirements regarding the reuse of 2514

reprocessed single use medical devices. The reprocessed single use medical device will be 2515

treated as a new medical device. 2516

2517

Key good practice actions4 that should be considered by healthcare providers: 2518

2519

a) Be informed about current laws, regulations and guidance that may affect the 2520

healthcare providers’ decisions regarding use of reprocessed single use devices. 2521

b) Establish an interdisciplinary "reuse committee" to consider the issues that should 2522

inform policies, procedures, and protocols. 2523

c) Educate clinical staff about the facility's policy for use of reprocessed single use devices 2524

and provide a supporting rationale. 2525

d) Develop and implement criteria for selecting the reprocessed single use devices the 2526

healthcare provider will use and for evaluating third-party reprocessing organizations. 2527

e) Review provisions in contracts with original equipment manufacturers (of single use 2528

devices) that would prohibit or inhibit third-party reprocessing of their single use 2529

devices. 2530

f) Ensure that the facility's event reporting system captures adverse events related to 2531

reprocessed single use devices and that a procedure is in place for mandatory reporting 2532

of medical-device-related deaths and voluntary reporting of serious adverse events 2533

related to medical devices to the SFDA. 2534

2535

All reprocessing organizations (e.g. hospitals, manufacturers, third-party vendors) are 2536

required to follow the SFDA licensing requirements. 2537

2538

Through a process of clinical and technical testing and evidence the reprocessing 2539

organization will need to identify the maximum number of reprocessing cycles to which a 2540

device can be subjected while maintaining safe device functionality and performance. 2541

93

Once the maximum number of reuse cycles has been reached the product should be 2542

discarded and safely disposed of. 2543

2544

Reprocessing of single use devices generally consists of the following processes: 2545

a) Cleaning. 2546

b) Disinfection (reduces the number of viable microorganisms). 2547

c) Sterilization (kills all microorganisms and is required for devices that likely will 2548

become contaminated with pathogens during use). 2549

d) Functional testing. 2550

e) Relabeling. 2551

f) Repackaging. 2552

2553

Reprocessing may require disassembly and reassembly to facilitate cleaning. Each 2554

reprocessed item must be inspected before reuse and also function-tested and repackaged 2555

for reuse. After every single use of a reprocessed single use device, the device must again 2556

go through the entire reprocessing system. (Vocalic)2. 2557

2558

7.6 Medical Device Implants 2559

2560

Medical device implants range from simple devices, such as intraocular lenses, cosmetic 2561

implants, orthopedic hardware, stents, and joint replacements, to highly complex devices, 2562

such as retinal implants, artificial hearts, implantable cardioverter-defibrillators (ICDs), 2563

and cochlear implants. 2564

2565

Examples of ‘active’ implants can include the following: 2566

• Implantable nerve stimulators. 2567

• Implantable cardiac rhythm management devices (pacemakers, defibrillators, etc.). 2568

• Leads, electrodes, adaptors for the above. 2569

• Cochlear implants. 2570

• Catheters, sensors for active drug administration technologies. 2571

94

2572

A key feature of the management procedures for medical implants concerns the 2573

management of stock and product requirements. There are a number of options to consider 2574

which will help manage the cost of these often expensive devices. Good practice 2575

considerations include the following actions: 2576

• Establish the full range of device implant suppliers and products used by the 2577

healthcare provider. 2578

• Identify the product volumes consumed. 2579

• Consider any unused stock held on the premises and identify reasons, and follow-up 2580

actions, to more efficiently manage implant logistics. 2581

2582

7.6.1 Tracking Medical Device Implants 2583 2584

The healthcare provider has a responsibility to be able to notify its patient population 2585

should a product recall occur. An inability to notify the recipient of an implanted device 2586

that is the subject of a recall is to be avoided. 2587

The following is an example of data that should be collected by healthcare providers to 2588

enable effective implant tracking to take place. 2589

• Any unique identification number, lot number, batch number, model number, or 2590

serial number of the device or other identifier used by the manufacturer to track the 2591

device. 2592

• The name, address, telephone number of the patient in receipt of the device. 2593

• The date the device was provided for use by the patient. 2594

• The name, address, and telephone number of the prescribing clinician. 2595

• The name, address, and telephone number of the clinician regularly following up care 2596

with the patient, if different from the prescribing clinician. 2597

• The date of the patient's death, if applicable. 2598

• At the device explant point: the name, mailing address, and telephone number of the 2599

explanting clinician. 2600

• When applicable, the date the device was permanently retired from use, explanted or 2601

otherwise permanently disposed of. 2602

95

2603

Device tracking good practice areas for consideration for healthcare providers are provided 2604

below: 2605

1. Ensure that the healthcare provider has implemented a device tracking program that 2606

meets current legal and regulatory requirements. 2607

2. Designate a medical device "tracking manager" to oversee the device tracking 2608

process, to act as a liaison with device manufacturers and the SFDA for tracking 2609

purposes, and to ensure that pertinent staff are educated about the facility's tracking 2610

program. 2611

3. Establish a system for collecting and submitting tracking information to 2612

manufacturers and SFDA. Address whether and how patient consent to the release 2613

of his or her identity will be obtained and documented. 2614

4. If a consent process is established, ensure that it includes a mechanism for 2615

documenting refusals. 2616

5. Verify that a patients’ rights to refuse to release identifying information to the 2617

manufacturer for purposes of tracking are being upheld. 2618

6. Address the need to retain device tracking records and determine the length of 2619

retention. 2620

7. Establish a method by which the healthcare provider can monitor changes to any 2621

list of tracked devices and future SFDA regulations and recommendations 2622

regarding tracking and cooperate with tracking procedures implemented by 2623

manufacturers in response to new or revised regulations. 2624

2625

7.6.2 Implanted Medical Devices Registries in Saudi Arabia 2626 2627

In order to monitor the performance of medical device implants, tracking any associated 2628

side effects or complications that may arise in health facilities in Saudi Arabia, the SFDA 2629

has established the (Comprehensive Implanted Medical Device Registry - CIMDR) that 2630

will help facilitate tracing and tracking of these devices and their users, where potential 2631

risks may or could threaten their safety and health. Additionally, this process supports and 2632

encourages medical research conducted by healthcare providers, researchers, innovators, 2633

96

and manufacturers on medical device implants for verification of their effectiveness and 2634

intended use leading to the best healthcare services. It also provides SFDA with a post 2635

market surveillance tool by analyzing the registry data about the safety, effectiveness, and 2636

quality of medical devices implants. 2637

Currently, there are four established registries: Hip joints, knee joints, stents, and ICDs. 2638

SFDA is planning also to include cochlear implants and breast implants registries in 2019. 2639

The registry captured data includes: demographics, diagnosis, patient history, 2640

comorbidities, previous procedures, complaints/symptoms, surgery information, 2641

outcomes, device information, and follow up information. 2642

More information about this national initiative and how health facilities can participate in 2643

the registry, can be found at: http://cimdr.sfda.gov.sa 2644

2645

2646

7.6.3 Reporting Processes - Medical Device Implants 2647

2648

Good practice recommendations for an effective implant reporting process includes the 2649

following: 2650

2651

1. A closed-loop process that, in addition to the distribution of recalls, includes 2652

confirmation that the recall has been received by a responsible party and 2653

documentation of the remediation efforts taken. 2654

2. A written policy is available specifying, for example, to whom incoming recalls 2655

should be sent, how recalls should be processed, and how the response to those 2656

recalls should be documented. 2657

3. A manufacturer or other organization that issues a recall might direct the recall to 2658

a specific department, to an individual physician, or to others. This data needs to 2659

be captured within a centralized recalls management process. 2660

4. All parties will need to be educated about the process for forwarding recalls to the 2661

correct individual or department. 2662

2663

http://cimdr.sfda.gov.sa/

97

Recalled implanted devices require careful clinical management and follow-up. The 2664

primary responsibility for the clinical management of recalled implants usually rests with 2665

the patient’s clinician and/or referring clinician. When a recall affects an implanted device, 2666

the healthcare provider should notify both clinicians so that they may provide appropriate 2667

follow-up care to patients. 2668

2669

Clinicians whose names are included on the device registration may be notified of the 2670

product recalls directly by the manufacturer. The clinician concerned should report the 2671

receipt of this recall so that this information can be captured in the healthcare providers’ 2672

central medical device recall /patient safety reporting system. 2673

2674

2675

2676

7.6.4 Explanted Medical Devices 2677

2678

Implanted medical devices may be removed for numerous reasons: 2679

• Device may have reached the end of its useful life; or 2680

• Product defect or malfunction may necessitate the explant. 2681

2682

In the case of a recall involving an implant, when the manufacturer notifies the implant 2683

clinician or hospital, an incident report should be filed within the healthcare providers own 2684

health technology recalls or patient safety incident reporting management system. Such 2685

recalls should also be reported to the SFDA for regulatory purposes. Where an implant is 2686

deemed to be a patient safety risk by the implant clinician this matter should be reported to 2687

the SFDA and the original device manufacturer (not the distributor). 2688

2689

It is also recommended that prior patient consent for post-mortem device evaluation and 2690

explantation be documented and, in the absence of such consent, seek approval be obtained 2691

for explantation from family members. Some medical device companies post contact 2692

information and information about where and how to return the devices on their web sites. 2693

2694

2695

98

7.6.5 Medical Devices Clinical Trials (Clinical Investigation) 2696

2697

7.6.5.1 Objectives 2698

2699

To ensure the compliance of medical devices clinical trials to the Saudi Food and 2700

Drug Authority (SFDA) requirements. 2701

2702

7.6.5.2 Scope 2703

2704

Any party who wishes to conduct medical devices clinical trials in KSA. 2705

2706

7.6.5.3 Background 2707

2708

A clinical investigation is defined as a “systematic investigation in one or more 2709

human subjects, undertaken to assess the safety or performance of a medical 2710

device”. 2711

2712

Note: “Clinical trial” and “clinical study” are synonyms for “clinical 2713

investigation”. The objective of a clinical investigation is to assess the safety and 2714

performance/efficacy of the device in question and evaluate whether the device is 2715

suitable for the purpose(s) and the population(s) for which it is intended (ISO 2716

14155:2011). Clinical investigations must take into account scientific principles 2717

underlying the collection of clinical data along with accepted ethical standards 2718

surrounding the use of human subjects. The clinical investigation objectives and 2719

design should be documented in the clinical investigation plan. 2720

2721

2722

7.6.5.4 Ownership 2723

2724

• Institutional Review Board (IRB). 2725

• Principal investigator. 2726

2727

99

7.6.5.5 Requirements 2728

2729

• Shall comply with the Law of Ethics of Research on Living Creatures by National 2730

Committee of Bioethics (NCBE). 2731

• Shall request “No Objection Letter” issued by SFDA before starting the study 2732

recruitments. 2733

• Should be in accordance with: 2734

- Declaration of Helsinki. 2735

- ISO 14155 (or any equivalent standard GCP). 2736

2737

2738

2739

2740

2741

2742

2743

2744

2745

2746

2747

2748

2749

2750

2751

2752

2753

2754

2755

2756

2757

2758

2759

2760

2761

2762

2763

2764

2765

2766

2767

2768

2769

http://bioethics.kacst.edu.sa/PublicServices/Systems-Committee.aspx

http://bioethics.kacst.edu.sa/PublicServices/Systems-Committee.aspx

100

7.7 Checklist 2770

2771


evaluating medical device consumables, single use devices and implant activities and assist 2773

in the development of process improvements. 2774

2775

No Checklist item Status Comments

Yes

No

In

pro

gre

ss

1 Identify the stock of medical device consumables and

implants needed.

2 Provision of an effective stock control system for medical

consumables and implants.

3 Implement a medical device implant tracking process.

4 Availability of Registration Documents by SFDA for any

Medical Device intended to be used for Clinical

Investigation

2776 2777

2778

2779

2780

2781

2782

101

2783

8. References 2784

2785

2786

2787

2788

2789

2790

2791

2792

2793

2794

2795

2796

2797

2798

2799

2800

2801

2802

2803

2804

2805

2806

2807

2808

2809

2810

2811

2812

2813

2814

2815

2816

2817

2818

2819

2820

2821

2822

2823 2824 2825

102

2826

9. Appendices 2827

2828

9.1 Planning: 2829

2830

- Appendix 9.1.2 Includes facility planning examples for Operating rooms, 2831

intensive care units and Imaging. 2832

- Appendix 9.1.3 Includes sample emerging technology descriptions for 2833

multiple modality systems, 3-D printing in healthcare; integrating the 2834

Healthcare Enterprise (IHE) profiles for device integration; medical device 2835

surveillance monitoring; genomics; and a few examples of the use of 2836

artificial intelligence (AI) and big data in healthcare and HTM. 2837

2838

Table 9.1: Typical healthcare facility Utilities for Medical Devices 7

Electrical power - Emergency electrical power

Fire detection and prevention

Elevators (move planning relevant)

Domestic water - Water for dialysis and other special water treatment systems

Heating, ventilation and air conditioning (HVAC)

Hot water

Building temperature control

Cooling & Heating

Humidification

Sanitary sewer

Storm sewer

Medical gases and vacuum

Compressed medical air

Oxygen

Vacuum

Other piped specialty gases (CO2, NO, N2)

Steam

For heating and air conditioning

For sterilizers

Natural gas

For steam

For electricity if co-generation plant

IT *

Wiring infrastructure

Wireless infrastructure

Data closets (MDF, IDFs)

Data centers

Other, non-IT-based communication technologies requiring separate wiring

103

Nurse call

Telephone

2839

9.1.1 Appendix A: Certificate of Need Process 2840 2841

A certificate of need is a review and approval process, typically from a government 2842

agency, to proceed with a major project (e.g. building, large cost equipment purchase) 2843

taking into account the overall needs of the community being served. Many countries 2844

do not have this process in place but it may be something decision makers may want 2845

to consider. For those countries who have or will implement this process, it is 2846

important to take into consideration the following when applying for a certificate of 2847

need. 2848

2849

General Data 2850

- Place. 2851

- Catchment area. 2852

- Epidemiology information. 2853

- Mortality/morbidity. 2854

- Applicant’s data. 2855

2856

Description of need 2857

- Service characteristics. 2858

- Clinical procedures required. 2859

- Number of referred patients to another site. 2860

- Other available equipment in the area. 2861

Proposal 2862

- Medical equipment. 2863

- Staff. 2864

- Infrastructure. 2865

Resources needed 2866

104

- Investment. 2867

- Operational costs. 2868

- Sources of financing. 2869

2870

9.1.2 Planning Examples: 2871 2872

9.1.2.1 Operating Rooms: 2873

Operating Rooms (ORs) provide a safe and fully controlled environment for 2874

patients undergoing diagnostic and surgical procedures under anesthesia and pre-2875

operative care including post procedure recovery. Medical devices are the 2876

backbone of all types of ORs, ranging from the “same day”, short stay OR up to 2877

the most advanced open heart and neurosurgery ORs. Effective lifecycle 2878

management of medical devices ranging from the basic single use devices and 2879

surgical tools, up to the most advanced robotic surgery and imaging equipment 2880

plays a key role in clinical effectiveness and patient’s surgical outcomes. 2881

2882

9.1.2.2 Medical Devices Storage and Special Areas: 2883

From a planning perspective, it is an essential and major requirement to include 2884

sufficient OR storeroom space for medical devices and equipment. Depending on 2885

the type of OR, storage requirements of at least 10 m2 per OR should be provided. 2886

It is important to ensure the following when designing the OR storage and medical 2887

equipment special areas: 2888

a) Storerooms are best designed in an elongated rectangular to allow easy access 2889

to all items. 2890

b) The design of the Operating Unit should allow for ease of access to the storage 2891

areas for delivery of operating room consumables. Controlled access from an 2892

external corridor is highly desirable. 2893

c) Mobile equipment bays need to be provided for equipment such as portable X-2894

ray equipment, stretchers, trolleys, warming devices and mobile equipment. 2895

d) Equipment bays are best designed as elongated rectangular shapes and may be 2896

combined for space efficiency with an area for testing operating room 2897

105

equipment. This room may be co-located with a general storeroom, or a 2898

dedicated room for testing equipment may be necessary. Direct corridor access 2899

to this room is recommended, with controlled access to the remainder of the 2900

ORs. 2901

2902

9.1.2.3 Planning and Design Considerations: 2903

Several factors must be considered when designing operating rooms including 2904

expected utilization, specialties cases expected, and layout of the operating rooms. 2905

The following must be considered: 2906

a) The number of operating rooms and recovery beds and sizes of the support 2907

areas shall be based on the expected surgical workload 2908

b) The surgical suites corridor layout shall be located and arranged to prevent 2909

non-surgery-related traffic through the suite. This is important for infection 2910

control purposes. 2911

c) The operating room suite shall be designed with a sterile core to have no cross 2912

traffic of clean supplies and soiled/decontaminated supplies and areas. Flow 2913

of clean and soiled/decontaminated supplies and equipment to the OR suites 2914

themselves shall be designed to not compromise universal precautions and 2915

aseptic techniques. 2916

d) The surgical suite shall be divided into three distinct areas; unrestricted, semi-2917

restricted, and restricted. 2918

e) Consideration should be given to the effects of building vibration, as building 2919

vibration could interfere with the accuracy of patient position, testing and 2920

delicate surgeries (e.g. ophthalmic procedures). 2921

f) Patient corridors should be a minimum of 8’-0” wide, to accommodate 2922

wheelchairs, equipment, and gurneys. 2923

g) Operating rooms shall have the following: 2924

1. Provision shall be made for a closed-circuit television (CCTV) system. 2925

2. Communication needs are as follows: patient data computer outlets, 2926

nurse call/intercom system, telephone with speakerphone capability. 2927

106

3. All floors of the ORs to be homogeneous with a coved floor base 2928

extending no less than 6” above the finish floor for floor cleaning 2929

purposes. No floor drains are permitted. 2930

2931

9.1.2.4 OR Space Requirements: 2932

OR space requirements vary depending on the standards implemented and the 2933

operating rooms’ layout implemented (e.g. single or double corridor). It is always 2934

the role of hospital planners to consider local needs and national standards for 2935

recommended spaces. 2936

It is important to understand the medical equipment quantities and requirements 2937

in the operating rooms in order to plan for the utility and space requirements. 2938

Radiology equipment is also used in the OR such as the RF C-arms and mobile x-2939

ray units and radiation protection precautions and shielding must be considered. 2940

2941

No. OR space Recommended space (m2)

1 Operating Room, General 41

2 Operating Room, Special Purpose 65

3 Operating Room, Neurosurgery 42

4 Equipment Room, Neurosurgery 17

5 Operating Room, Cardiac 65

6 Pump Room, Cardiac 17

7 Cystoscopy Room 42

8 Cystoscopy Instrument Prep / Storage Room 19

Table 9.2: Recommended Sizes for OR Spaces (Sample)4 2942

2943

Following is a sample list of medical equipment and devices typically found in 2944

operating rooms: 2945

1. Operating table. 2946

2. Operating lights (ceiling mounted and mobile). 2947

3. Surgical and Neurosurgical microscopes. 2948

107

4. Robotics surgery (Orthopedic, neurosurgery, etc.). 2949

5. Patient monitoring systems. 2950

6. Anesthesia and patient ventilation equipment. 2951

7. Electrosurgical units. 2952

8. Surgical sets. 2953

9. Medical gases (O2, Nitrous, Vacuum, Air 4 Bar & 11 Bar). 2954

2955

Modern ORs are complex. Surgical robotics, other minimally invasive surgical 2956

instrumentation, new and larger imaging devices, and more and more other 2957

equipment are being added to ORs all the time. Therefore, new ORs are being 2958

planned larger and larger. In addition, in busy ORs, efficiency and throughput are 2959

critical. All of these factors need to be taken into consideration in all facets and 2960

phasing of the planning processes for new and remodeled operating rooms. 2961

2962

9.1.2.5 Cardiac Operating Rooms: 2963

The cardiac OR requires some special nonstandard spaces such as a perfusion 2964

room. The perfusion room is for the preparation of perfusion equipment, and for 2965

set-up for cardiac procedures. The perfusion room must be near the cardiac OR 2966

and adjacent to a perfusion storage area with the following main requirements: 2967

a) Heavy duty shelving for storage of perfusion fluids and equipment. 2968

b) Computer workstation for a perfusion technician including power and data 2969

outlets. 2970

c) Bench, sink and cupboard unit for servicing of the perfusion machine. 2971

2972

9.1.2.6 Imaging and Radiology Rooms: 2973

Imaging departments are one of the most strategic departments in any hospital 2974

because of both the diagnostic imaging role in clinical outcomes and the high cost 2975

of imaging equipment. The major imaging rooms in a typical diagnostic imaging 2976

department may include the following: 2977

108

a) Chest x-ray rooms: A specific or specialized radiography room used for routine 2978

chest X-rays and those radiographic procedures that can or should be 2979

performed in an upright position. 2980

b) Computed Radiography (CR): CR uses a special plate technology, scanning 2981

and computer processing, to produce a digital image of a patient’s organ or 2982

body part. This digital image can then be output to a digital reading station, 2983

sent to PACS, and/or printed to a dry processor. 2984

c) Computed Tomography (CT): CT employs ionizing radiation to produce axial 2985

(cross sectional) body section images. Data obtained by X-ray transmission 2986

through the patient is computer analyzed to produce these images. This series 2987

of sectional, planar images can be manipulated to produce different planar 2988

views of the areas of interest and eliminate overlying structures such as bone. 2989

Manipulations of data allow for the selective view of either dense tissues such 2990

as bones or diffuse tissues such as the heart, brain, or lung. CT is used for both 2991

head and body imaging and is applicable to diagnosis, biopsy, and therapy 2992

planning. 2993

d) General radiology rooms: Images of the skull, chest, abdomen, spine, and 2994

extremities are produced by the basic radiographic process. 2995

e) Magnetic Resonance Imaging (MRI): This technique utilizes magnetic and 2996

radio frequency fields to produce computer calculated images of human 2997

anatomy (body tissue) and can also provide body chemistry analysis. While 2998

immersed in a magnetic field, the portion of the body to be scanned is exposed 2999

to energy in the radio frequency range. The effects of this exposure on atomic 3000

nuclei position are read by the computerized system and converted into 3001

images. MRI reflects tissue density and body chemistry. 3002

f) Interventional Radiology (IR): This clinical subspecialty uses fluoroscopy, CT 3003

and ultrasound to guide percutaneous (through the skin) procedures such as 3004

performing biopsies, draining fluids, inserting catheters, or dilating or stenting 3005

narrowed ducts or vessels. IR procedures are complex, requiring a team of 3006

doctors and technicians. As such, they are often performed in the surgical suite, 3007

and scheduled in advance as they require special preparation. IR / Special 3008

109

Procedure rooms can be categorized as angiography rooms and/or 3009

vascular/neuro-vascular rooms. 3010

g) Ultrasound: High frequency sound waves are utilized to determine the 3011

location, size and shape of internal organs based on the differential rates of 3012

reflection of different density tissues. In addition, images can be observed in 3013

real time to reveal motion, and ultrasound systems add coloration to indicate 3014

arterial and venous blood flow. Cyst aspiration and fluid removal are also 3015

procedures done with ultrasound imaging assistance. 3016

3017

One important factor to be considered by hospital planners during the planning of 3018

a radiology department is the radiation protection for patients, radiologists, 3019

radiographers and other hospital staff. This is can be done by providing the 3020

required shielding on the walls, doors and even windows to make sure that leaked 3021

radiation is within allowed limits according to the local national standards. 3022

Space requirements for imaging equipment vary between different international 3023

standards. The location of the imaging equipment within the radiology department 3024

is essential. The following diagram illustrates an example radiology department. 3025

3026

3027

3028

3029

3030

3031

3032

3033

110

3034

Figure 9.1: Radiology service (functional diagram)4 3035

3036


Radiology imaging services should be strategically located in order to: 3038

1) Maximize efficiency (i.e., maximizing the use of high cost equipment). 3039

2) Plan to accommodate the high probability that the area may require 3040

expansion in the future. 3041

3) Avoid the substantially higher cost of enlarging a Radiology Suite through 3042

relocation rather than expansion. 3043

4) Locate soft spaces such as administrative and conference areas adjacent to 3044

the high technology/diagnostic equipment areas that have a higher 3045

probability to expand. 3046

111

5) Hospital planners should give special attention to the following when 3047

designing new hospital imaging departments. 3048

6) Structural support, especially for heavy imaging equipment like MRIs and 3049

CTs. 3050

7) Level floors for the radiology department. In addition, placing radiology 3051

departments in upper floors will face challenges in transferring and 3052

installing heavy equipment (e.g. MRI magnet). Easy access floors are 3053

always preferred. 3054

8) Temperature and ventilation for the control and patient rooms. 3055

9) Provision of cable trays, ducts and conduits. 3056

10) Location of other required medical equipment and flow of patients and staff. 3057

11) Other local factors such as male and female waiting areas and changing 3058

rooms. 3059

9.1.2.8 Imaging modalities Space Requirements: 3060

Recommended space for imaging modalities varies between different international 3061

standards. Following is a summary example list of patient space requirements for 3062

some imaging modalities (excluding reception & support areas). 3063

3064

No. Imaging modality Recommended

space (m2)

1 General Purpose Radiology Room 28

2 Chest Room 23

3 Radiographic / Fluoroscopic (R/F) Room 30

4 Ultrasound Room – 1 unit 17

5 Interventional Radiology Procedure Room (including

control room)

56

6 CT Scanning Room 37

7 MRI scanning room 47

8 Stereotactic Mammography Room 20

Table 9.4: Sample Recommended Space Requirements for Imaging Modalities4 3065

112

9.1.2.9 Imaging Room Layout: 3066

Clinical engineers must always refer to the latest manufacturer’s recommendation 3067

for an imaging modality’s layout to make sure the layout accommodates all 3068

possible configurations. The following figure demonstrates a sample MRI 3069

scanning room layout. 3070

3071

Figure 9.2: MRI Scanning Room Layout4. 3072

113

In summary, new imaging systems and departments are high cost, complex and 3073

strategic investments where good, prior planning is paramount to a successful 3074

long-term efficient operation. HTM involvement in imaging equipment planning 3075

and support is required in order to optimize this important healthcare diagnostic 3076

and treatment tool. 3077

3078

9.1.2.10 Intensive Care Units: 3079

There are several types of intensive care units depending on patient type and age 3080

such as Neonatal ICU, Pediatric ICU, Adult ICU and Coronary Care Units (CCU) 3081

in cardiac centers. In this section, discussion will be kept generic to critical care. 3082

The intensive care unit provides a concentration of clinical expertise, technology 3083

and therapeutic resources, which are coordinating care for the critically ill patient. 3084

3085

Typical list of medical equipment needed for all types of ICU units 3086

include: 3087

- Patient monitoring system. 3088

- Patient ventilator. 3089

- Infusion pump. 3090

- Bedhead unit. 3091

- ICU electrical bed. 3092

- Suction unit. 3093

3094


The level of intensive care available should support the role of the hospital. The 3096

role of an ICU will vary, depending on staffing, facilities and support services as 3097

well as the type and number of patients it needs to manage. 3098

3099

9.1.2.12 Main Functional Areas: 3100

a) Intensive Care Units normally consist of the following main functional areas: 3101

b) Family/visitor waiting areas. 3102

c) Patient treatment areas including patient beds and treatment rooms. 3103

114

d) Support areas including clean and dirty utility rooms, storeroom, linen room, 3104

housekeeping/cleaner's room. 3105

e) Administrative / office areas. 3106

f) Staff amenities areas. 3107

3108

The following figure illustrates an example of the ICU functional relation and 3109

layout diagrams: 3110

3111

Figure 9.3: Intensive Care Unit Functional Relationship Diagram3 3112

3113

115

9.1.2.13 Medical Equipment Support: 3114

Depending on the location of the main HTM unit (or biomedical department) and 3115

its distance from the ICU, it must be noted that fastest response is required to 3116

support medical devices in the ICU units. A 24 hours on-call emergency 3117

biomedical support service is recommended. It is common practice to have a full-3118

time biomedical engineer or technician covering OR and ICU during working 3119

hours and on-call emergency service after working hours. The competency list of 3120

biomedical staff covering ICU and OR must include several technical and clinical 3121

skills that must be continuously updated according to an effective outcome-based 3122

competency development program. The training of such biomedical support staff 3123

must be part of the technical specification and tender requirements for OR and 3124

ICU medical devices. 3125

3126

9.1.2.14 Laboratory Support: 3127

All ICU units must have available 24-hr clinical laboratory services. When this 3128

service cannot be provided by the central hospital laboratory, a satellite laboratory 3129

within or immediately adjacent to, the ICU must serve this function. Satellite 3130

facilities must be able to provide minimum chemistry and hematology testing, 3131

including arterial blood gas analysis. It is common practice to have a hematology 3132

analyzer within the ICU unit operated by the ICU nursing staff that are trained by 3133

laboratory staff. 3134

3135

9.1.2.15 Storage Areas: 3136

A dedicated storage area, that is out of traffic paths but conveniently located for 3137

easy access by staff, is required to store mobile equipment such as 3138

cardiopulmonary resuscitation trolleys and mobile x-ray machines, Storage space 3139

considerations should be given to the increasing amount of equipment used in 3140

these units. 3141

3142

116

9.1.2.16 Design and Space Planning: 3143

The recommended space requirements for intensive care units varies between 3144

different international standards, yet it is very common to recommend enough 3145

spaces to allow patient treatment and staff access. 3146

3147

9.1.2.17 Patient Treatment Areas: 3148

Patient bed layout is very important in the ICU. It must provide continuous direct 3149

or indirect visualization for clinical staff. The preferred design is to allow a direct 3150

line of vision between the patient and the central staff station. In ICUs with a 3151

modular design, patients should be visible from their respective nursing 3152

substations. Sliding glass doors and glass partitions facilitate this arrangement and 3153

increase access to the room in emergency situations. 3154

3155

9.1.2.18 Bedside Monitoring: 3156

Bedside patient monitoring systems should be located to permit easy access and 3157

viewing, and should not interfere with the visualization of, or access to, the patient. 3158

The bedside nurse, and/or monitor technician, must be able to observe the 3159

monitored status of each patient at a glance. This goal can be achieved either by a 3160

central monitoring station, or by bedside monitors that permit the observation of 3161

more than one patient simultaneously. Neither of these methods is intended to 3162

replace bedside observation. 3163

Weight-bearing surfaces that support the monitoring equipment should be sturdy 3164

enough to withstand high levels of strain over time. It should be assumed that 3165

monitoring equipment will increase in volume and connectivity over time. 3166

Therefore, space, electrical and IT facilities should be designed accordingly3. 3167

3168

9.1.2.19 Environmental Conditions (Acoustics): 3169

Signals from patient call systems, alarms from monitoring equipment, and 3170

telephones add to auditory sensory overload in critical care units for both patients 3171

and staff. Without reducing their importance or sense of urgency, such signals 3172

should be modulated to a level that will alert staff members yet be rendered less 3173

117

intrusive. For these reasons, floor coverings that absorb sound should be used while 3174

keeping infection control, maintenance, and equipment movement needs under 3175

consideration. Walls and ceilings should be constructed of materials with high 3176

sound absorption capabilities. Ceiling soffits and baffles help reduce echoed 3177

sounds. Doorways should be offset, rather than being placed in symmetrically 3178

opposed positions, to reduce sound transmission. Counters, partitions, and glass 3179

doors are also effective in reducing noise levels3. 3180

3181

9.1.2.20 ICU Space Requirements: 3182

Spaces recommended for the whole ICU and the different sections within the ICU 3183

vary widely between different international standards. Where an open plan 3184

arrangement is provided, bed spaces shall be arranged so that there is a clearance 3185

of at least 1200 mm from the side of the bed to the nearest fixed obstruction 3186

(including bed screens) or wall. At the head of the bed, at least 900 mm clearance 3187

shall be allowed between the bed and any fixed obstruction or wall. 3188

3189

When an open plan arrangement is provided, a circulation space of 2200 mm 3190

minimum clear width shall be provided beyond the dedicated cubicle space4. 3191

Separate cubicles and single patient bedrooms including isolation rooms, shall 3192

have minimum dimensions of 3900 mm x 3900 mm. Following are the main types 3193

of isolation rooms: 3194

Neutral or standard room air pressure, for example standard air conditioning, also 3195

known as Class S. 3196

Positive room air pressure where an immune-compromised patient is protected 3197

from airborne transmission of any infection, Class P. 3198

Negative room air pressure, where others are protected from any airborne 3199

transmission from a patient who may be an infection risk, Class N. 3200

Negative room air pressure with additional barriers, including an Anteroom, also 3201

known as Class Q for quarantine isolation. 3202

3203

118

No. ICU Recommended space (m2)

1 Patient Room, Intensive Care 28

2 Patient Room, Airborne Infection

Isolation

28

3 Nursing station 17

4 Medication Room 10

5 Storage, ICU Equipment 17

6 Workroom, Nurse 11

7 Utility Room, Clean / soiled 11

Table 9.5: Sample recommended spaces for ICU. 3204

3205

3206

9.1.3 Appendix: Emerging Technology Examples: 3207

3208

3209

9.1.3.1 Emerging Technologies Introduction 3210

For new and emerging technologies, it is difficult to predict what will become a 3211

clinical success in the near-future and nearly impossible to predict what will be 3212

commercially successful five to ten years from now. It is also impossible to include 3213

a comprehensive list of emerging technologies in a few pages. Therefore, this 3214

section reviews a few, new and emerging technologies chosen for their potential 3215

impact on healthcare providers and HTM. Included are the following: Multiple 3216

modality systems; 3D printing in healthcare; integrating the Healthcare Enterprise 3217

(IHE) profiles for device integration; medical device surveillance monitoring; 3218

genomics; and a few examples of the use of artificial intelligence (AI) and big data 3219

in healthcare and HTM. 3220

3221

9.1.3.2 Multiple Modality Imaging Systems 3222

Multi-modality imaging such as combinations of CT, MRI, fMRI (functional MRI), 3223

ultrasound, PET, and SPECT imaging combine two of these modalities into one 3224

system with a common gantry. These systems typically use one modality focused 3225

on structure (anatomy) and one focused on function (physiology). Since the patient 3226

119

is placed on a common gantry, problems with patient registration to the correct 3227

reproducible imaging system position are minimized compared to using two 3228

different physical systems and localizing the patient to anatomic landmarks. 3229

3230

Example: in PET/CT, a widely-used technology, the CT scanner is used to image 3231

the brain or other structures, while the PET subsystem provides information about 3232

the function (physiology) of the area in the image. Positron emission tomography 3233

(PET) uses small amounts of radioactive pharmaceuticals called radiotracers, a 3234

special camera detector that detects the radiotracers, and a computer to develop 3235

human-readable images used to evaluate organ and tissue functions. PET scans 3236

measure important body functions, such as blood flow, oxygen use, and glucose 3237

metabolism to help doctors evaluate how well organs and tissues are functioning. 3238

PET is used for brain imaging of patients with seizure disorders, cancer diagnosis 3239

and tumor metastasis determination, heart muscle evaluation and other functions. 3240

Currently, almost all PET scans are performed on instruments that are combined 3241

PET and CT scanners. The combined PET/CT scans provide images that pinpoint 3242

the anatomic location of abnormal physiologic activity. The combined scans have 3243

been shown to provide more accurate diagnoses than the two scans performed 3244

separately. (Griffeth, 2005). 3245

3246

Similar types of multi-modality systems are under development and early 3247

implementation for MR/PET and CT/MR. MR/PET systems have been developed 3248

to stage cancer progression and for the diagnosis and treatment planning for other 3249

diseases. MR imaging has major strengths compared with CT, including superior 3250

soft-tissue contrast resolution, and functional imaging capability through 3251

specialized techniques such as MR spectroscopy. Furthermore, the lack of ionizing 3252

radiation from MR scanners, compared to CT, is highly appealing, particularly for 3253

pediatric and pregnant patients. (Savage, 2013). 3254

3255

In the research stage are systems that combine CT and MR. MR provides high 3256

contrast images and allows doctors to measure functional and even molecular 3257

120

changes. CT provides greater structural detail. Together, they allow doctors to get 3258

a superior picture of processes in action, such as imaging certain types of plaques 3259

on artery walls that are particularly unstable and prone to causing heart attacks or 3260

strokes. A combination of structural, functional, and molecular information is 3261

needed to tell just how dangerous the plaque may be. There are many challenges in 3262

building combined MR/CT systems, including the moving metal of rotating CT 3263

gantries causing interference with MR’s magnetic fields. 3264

3265

Also available are combined CT/radiation therapy linear accelerators and several 3266

combinations of ultrasound scanners with the various other imaging modalities. 3267

These multi-modality systems are all very expensive and complex. Repair and 3268

maintenance of them are primarily the responsibility of the OEM. However, where 3269

HTM staff is appropriately trained, and already supporting the base modality (e.g. 3270

CT scanners), they can be trained to provide some service support for the additional 3271

modality (e.g. PET/CT). In some locations, shared agreements are offered where 3272

HTM shares responsibilities with the OEM and the Healthcare Provider, receives a 3273

discounted service contract. 3274

3275

9.1.3.3 3-D Printing in Healthcare 3276

3-D printers have been used for several years for rapid prototyping of simple and 3277

complex parts in the research and development environment. Parts are made from 3278

various thermoplastic and sintered metal materials. This additive manufacturing 3279

technology has slowly made its way into healthcare and is emerging as a tool for 3280

manufacturing implant parts and custom one-time-use designs, sometimes 3281

originating from patient CT or MRI scans. Applications include custom prosthetics 3282

(e.g. artificial hands); custom assistive devices (e.g. canes, crutches); parts for, and 3283

complete, artificial ankles, knees and other orthopedic implants; casts for fracture 3284

immobilization; and crowns, bridges and other dental products. Another application 3285

is 3-D modeling of anatomy and disease (e.g. tumors) to assist surgeons in complex 3286

surgical planning or construction of complex models of body parts (e.g. heart) for 3287

teaching purposes in lieu of using processed cadavers. (Crawford, 2017). 3288

121

3289

For HTM, 3-D printers have been used to make simple custom parts, such as covers 3290

for protruding connectors prone to damage (Clark, 2017). 3-D printed parts can also 3291

be used for making simple replacement parts for obsolete equipment where the 3292

parts are no longer sold stretching the operational lifespan of these devices. 3293

Regulatory guidance on 3-D printed repair parts is still in its infancy, however, 3294

manufacturer approval should be obtained whenever possible (FDA, 2017). 3295

3296

9.1.3.4 Integrating the Healthcare Enterprise and Emerging Connectivity 3297

Standards 3298

Integrating the Healthcare Enterprise (IHE) is an initiative by healthcare 3299

professionals and the medical device and healthcare IT companies and communities 3300

to improve the way medical devices and computer systems in healthcare share 3301

information. IHE promotes the coordinated use of established standards to address 3302

specific clinical needs in support of patient care. IHE’s Patient Care Devices group 3303

(IHE-PCD) develops medical device integration profiles for a variety of 3304

connectivity “use cases” based on existing standards such as HL-7, DICOM and 3305

IEEE 11073. As more medical device manufacturers develop products that meet 3306

these IHE profiles, and more Healthcare Providers implement them, it will become 3307

much easier to implement the integration of medical devices into the electronic 3308

medical record and other healthcare IT systems. The intent of these IHE PCD 3309

profiles is to give a uniform methodology for representing common data to facilitate 3310

interoperability of systems between different vendors. IHE PCD currently includes 3311

14 different profiles in use or under development ranging from alarm management 3312

to waveform communication (IHE PCD Wiki, 2017). 3313

3314

The following example describes how the implementation of the IHE PCD DEC 3315

profile may help Healthcare Providers and HTM in their device integration projects 3316

now and in the near future. 3317

The Device Enterprise Communication (DEC) profile provides vendor 3318

independent, consistent communication of PCD data to the Electronic Medical 3319

122

Record (EMR) and other clinical repositories. Examples of patient care devices in 3320

this profile include: ICU physiological monitors, vital signs monitors, point of care 3321

blood analyzers, infusion pumps, point of care glucometers, anesthesia systems, 3322

ventilators, and dialysis systems. For example, DEC allows patient monitors to 3323

automatically send vital signs data to the electronic medical record reducing staff 3324

time spent manually entering data and significantly reducing transcription errors. 3325

The data is time stamped with consistent enterprise time. This profile also provides 3326

an option to address the binding of patient identification information (e.g. patient 3327

name, medical record number) with the data from the device (IHE PCD Wiki, 3328

2017). 3329

3330

Another emerging connectivity standards-related technology is FHIR. In order to 3331

improve device integration processes, researchers and the HL-7 organization have 3332

developed a new connectivity standard called Fast Healthcare Interoperability 3333

Resources (FHIR, 2017). Currently (2017) FHIR is published as a “Standard for 3334

Trial Use”. FHIR is a more granular way to exchange data without the rigid 3335

workflow of traditional HL-7. FHIR has a higher emphasis on conformance and 3336

reference implementations than prior versions of HL-7. It has drivers for mobile 3337

healthcare applications and the cloud, medical device integration, and incorporates 3338

more flexible, yet well organized, custom workflow than the HL-7 version 2.x, 3339

currently in widespread use. As FHIR matures beyond the trial use, it is likely that 3340

new applications, and new IHE PCD profiles, will make use of FHIR. 3341

3342

For HTM, IHE and/or FHIR will simplify the integration of medical devices 3343

making support easier. As more and more devices are connected, standards-based 3344

connectivity makes implementing, monitoring and troubleshooting problems 3345

easier. HL-7 private tags and other proprietary constructs are significantly reduced. 3346

New project development time is shortened, problems are decreased, and problem 3347

resolution is quicker. 3348

3349

123

9.1.3.5 Device Surveillance Monitoring 3350

Medical device surveillance monitoring provides self-test data and other device 3351

status information such as battery status to the HTM department automatically from 3352

networked devices. As more and more medical equipment is networked, devices 3353

don't only have the capability to send out clinical data to the EMR, but to also send 3354

device self-test results and other device-status-related information. On some 3355

products, service-related surveillance monitoring is currently available using 3356

proprietary applications. (Zoll, 2017). 3357

3358

In order for medical devices to provide the above described self-reporting, 3359

surveillance features in a standards-based methodology, the IHE PCD group has 3360

drafted a surveillance monitoring profile using HL7-based messaging called the 3361

Medical Equipment Management Device Management Communication 3362

(MEMDMC) (IHE PCD, 2017). MEMDMC covers device identification, 3363

configuration and condition messages (e.g., self-test passed/failed, battery low) and 3364

status (e.g., on/off/standby, battery power/line power). Once a device is already 3365

connected to the network, and delivering clinical data to the EMR, with MEMDMC 3366

that device can also connect to the CMMS or some other HTM-focused application 3367

to send device management and maintenance-related information allowing 3368

problems to be seen prior to any downtime or other clinical impact. IHE PCD’s 3369

MEMDMC profiles has been developed to encode in a standardized manner some 3370

of these maintenance management data. Devices that use this profile will be able to 3371

send to HTM automatically self-tests, battery levels, utilization information (e.g. 3372

hours meter), network parameters, date-sensitive connected consumable (e.g., 3373

defibrillator pads) information that they are nearing their expiration date, and many 3374

other parameters. 3375

3376

9.1.3.6 Artificial Intelligence and Big Data 3377

Clinical decision support systems have been available for several years. For 3378

example, these systems use pattern recognition and other image analysis techniques 3379

to identify potential tumors and other abnormal structures within normal structures, 3380

124

and then display them to a radiologist or pathologist for confirmation and final 3381

diagnosis. These systems also help radiologists and pathologists screen large 3382

numbers of routine scans quicker (e.g. screening mammography). Artificial 3383

intelligence (AI)-based decision making is the next step after computer-aided 3384

decision support. AI can help detect abnormalities on medical images and supervise 3385

diagnostic processes (e.g. what test to do next?). 3386

3387

Technology giants, such as IBM, Google, and Microsoft are building artificial 3388

intelligence solutions to design personalized treatments for some cancers. For 3389

example, instead of spending the time to read through large amounts of research 3390

material themselves, physicians can use IBM’s Watson, the company’s advanced 3391

artificial intelligence platform, to read through dozens of research papers to find 3392

information relevant to a specific patient’s case. Watson has been used in oncology, 3393

radiology and genomics (IBM-Medical Sieve, 2017, IBM-Watson, 2016). 3394

3395

9.1.3.7 Big Data: 3396

Using data analytics electronic health records (EHRs) and other large healthcare 3397

data sets, can be analyzed to help improve the quality and coordination of care, 3398

reduce costs and avoid unnecessary use of resources. Clinical registries, typically 3399

medical specialty or disease focused, provide repositories for large amounts of data 3400

for a specific disease or medical specialty. For example, in 2016, the American 3401

Academy of Dermatology introduced a clinical registry called DataDerm 3402

(DataDerm, 2016). This database contains data on millions of patients from 3403

thousands of dermatologists throughout the US. As more data is collected these can 3404

be used for data analyses, patterns and clinically-relevant trends in diagnosis and 3405

treatment (e.g. which medications work best for a specific skin problem). 3406

3407

Big data can be used in real-time to alert clinicians that a patient’s condition is 3408

trending downward, prior to any obvious symptoms. Within EMRs, and as separate 3409

products, applications are emerging for “early warning” clinical alerts based on 3410

algorithms developed from big data. These applications use multiple parameters, 3411

125

typically vital signs trends plus lab values, and in some cases real-time analysis of 3412

respiratory and cardiac waveforms, with complex computer algorithms and 3413

statistics to predict the risk that an already ill patient will become significantly more 3414

ill very soon. These systems can currently identify that there is a high-risk that the 3415

patient is currently developing serious clinical problems, including early signs of 3416

sepsis, potential for significant bleeding problems, likely respiratory failure leading 3417

to the need for intubation, and some cardiac problems (Moorman, 2017). 3418

3419

For example, if the early warning system shows signs that there is a high risk that 3420

sepsis may be occurring a blood culture can be obtained earlier than typical, and if 3421

positive, early treatment with special antibiotics to help prevent further morbidity 3422

or mortality. Early treatment of sepsis is one key to survival from sepsis. From the 3423

HTM department standpoint, the interface of physiological monitors to the EMR 3424

for vital signs data collection, and waveform analysis in the future, becomes critical 3425

for the proper function of these early warning systems. 3426

3427

9.1.3.8 HTM and Big Data: 3428

Reliability centered maintenance (RCM) and related maintenance strategies have 3429

been used in the airline industry for many years. In the past few years there have 3430

been attempts to use similar data-driven methodologies in HTM to help optimize 3431

planned maintenance. Related efforts are currently underway, from groups under 3432

the auspices of AAMI, to develop standardized data definitions for a variety of 3433

maintenance–related data, and collect data using these standard definitions, with 3434

the ultimate goal to be able to share that data amongst HTM, HTM regulators and 3435

accrediting bodies, and the medical device industry. (Ridgway, 2017). Whether the 3436

HTM field will ever have a widely-shared maintenance data repository remains to 3437

be seen. If this effort ever comes to fruition, there will be an opportunity to use data 3438

analytics to analyze the data and further optimize HTM’s scheduled maintenance 3439

programs. 3440

3441

126

9.1.3.9 Genomic Testing: 3442

The Human Genome Project (HGP) was an international, collaborative research 3443

program whose goal was the complete mapping and understanding of all the genes 3444

of the human being. It was completed in 2003 revealing that there are about 20,500 3445

human genes. Researchers deciphered the human genome in three major ways: The 3446

order or sequence of the bases in our genome’s DNA. The development of maps 3447

which show the locations of genes for major sections of the human chromosomes. 3448

And the production of linkage maps which show how inherited traits, such as those 3449

of genetic diseases, are tracked over generations (Human Genome Project, 2016). 3450

DNA sequence information is important to scientists investigating the functions of 3451

genes. DNA sequencing is a laboratory technique used to determine the exact 3452

sequence of the DNA bases, adenine (A), cytosine (C), guanine (G), and thymine 3453

(T) in a DNA molecule. The DNA base sequence carries the information a cell 3454

needs to assemble protein and RNA molecules. Increasing the speed and reducing 3455

the cost of DNA sequencing technology continues and is resulting in the increased 3456

availability of such testing. 3457

3458

In the clinical arena, genetic screening tests are used for the possible presence of 3459

genetic diseases, or mutant forms of genes associated with increased risk of 3460

developing genetic disorders. Types of mutations include base substitutions (one 3461

base substituted for another); base deletions (one or more bases missing in a DNA 3462

strand), and base additions (one or more bases added to the DNA strand). 3463

3464

From a technology perspective, in order for a potential DNA sample to be analyzed, 3465

it needs to be amplified (copied), fragmented and then analyzed. One common 3466

methodology for amplification is PCR (polymerase chain reaction). This method 3467

involves using short DNA sequences called primers to select the portion of the 3468

genome to be copied. The temperature of the sample is repeatedly raised and 3469

lowered to help a DNA replication enzyme copy the target DNA sequence. The 3470

technique can produce a billion copies of the target sequence in just a few hours. 3471

127

Various other techniques using bacteria and yeast are used to first fragment and 3472

then grow specific segments of the DNA strands for further analysis using 3473

electrophoresis and other analysis techniques. Different sequencers use different 3474

analytic techniques and offer varying speed and accuracy. Choosing a DNA 3475

sequencer and method will typically depend on the clinical and research objectives 3476

and available budget. 3477

3478

Clinical examples of DNA analysis include: Screening for well-known genetic 3479

diseases such as cystic fibrosis, finding mutations that cause intellectual 3480

disabilities; locating certain mutations that cause one form of colorectal cancer that 3481

is treatable with aspirin; tracking donor tissue DNA to track transplant rejection 3482

sooner than when symptoms appear; and tracking tumor DNA to discover cancer 3483

spread sooner. Medications for various cancer and cardiovascular diseases have 3484

been developed that are specific for diseases confirmed by DNA testing. 3485

The increasing use of comprehensive genomic profiling in clinical practice for the 3486

genomic characterization of tumors is having an increasingly important impact on 3487

patients with cancer, empowering the rational use of targeted therapies and driving 3488

smarter, faster drug development. New sequencers and analyzers, and large 3489

databases of DNA test results, are bringing personalized cancer treatment to the 3490

marketplace (Mesko, 2017). 3491

3492

One challenge for the widespread use of genetic testing in clinical practice is that 3493

current electronic medical records (EMRs) store genetic test results only in free text 3494

reports. As the amount of genetic data continues to rapidly grow, EMRs will need 3495

to become capable of allowing physicians to effectively process this new type of 3496

information. Genetic results differ from traditional laboratory tests because of their 3497

persistent nature, broad scope, and complex interpretation. While current EMRs 3498

present laboratory results in a structured and predictable format, genetic data are 3499

often stored as free text and presented as cumbersome, highly detailed reports. 3500

Building EMRs that can adapt to the genetic information needs of the clinician is a 3501

challenge that is yet to be solved. 3502

128

Technology support for sequencers, and the other complex equipment used for 3503

genetic testing, is typically provided by the OEM. Biomedical engineering support 3504

has made some progress with a few third-party and in-house providers supporting 3505

clinical and research systems. As more and more systems and companies develop 3506

products, and the products become less expensive, increased technical training and 3507

support opportunities should become available. 3508

3509

9.1.3.10 Emerging Technology Final Comments: 3510

Of course, there are many more emerging technologies. Medical devices are getting 3511

smaller and smaller, with some integrated into cell phones (e.g. cell phone-based 3512

ultrasound machines). Whether in a patient room, in an MRI gantry, or in surgery, 3513

more and more companies and hospitals are providing entertainment and relaxation 3514

audio and video experiences for the patient. For example, MRI exams are very 3515

noisy and claustrophobic, and can take one hour or longer. The patient needs to 3516

remain very still during the MRI exam. Providing, soothing, relaxing, or distracting 3517

audio and video entertainment, preferably as chosen by the patient, can improve the 3518

patient experience, and reduce exam re-takes. Similar systems are being offered for 3519

operating rooms, and procedure areas. (GE Healthcare, 2017). 3520

3521

There are many other new technologies on the horizon including: Vocal analytics 3522

that use voice patterns to detect various diseases and robotic devices that not only 3523

scan for, and automatically identify suspect skin lesions, but can treat them using 3524

robot-guided laser irradiation (Mesko, 2017). 3525

3526

The above discussion is just a small sample of emerging technologies. Modern 3527

technology is rapidly changing and improving. It remains to be seen which 3528

technologies will have widespread positive impact on population health, healthcare 3529

providers, the practice of medicine, and HTM. 3530

3531

3532

129

9.2 Procurement 3533

3534

Table (9.6): SFDA Storage requirements for medical devices. 3535

Storage Area 1 Storage areas should: Be designed or adapted for the storage of medical devices. Be clean. Be equipped with thermometers/hygrometers. The

thermometers/hygrometers should be placed to allow effective monitoring where temperatures/humidity are most likely to fluctuate or rise.

Have surfaces and shelves, if applicable, made of or covered by an impermeable material to enable proper and safe cleaning.

Be suitably spaced to allow cleaning and inspection. Include a physically separate area for keeping damaged,

defective, expired, counterfeit or recalled medical devices. This area should be clearly labeled and controlled to prevent the use of these devices until a final decision is taken on their fate.

Be adequately lit. Be adequately ventilated. Have an emergency plan set up and used in case of an electricity

shutdown (power outage), if applicable.

Traceability in the Storage

Area

2 In the case of a recall/field safety notice by the SFDA or the manufacturer, the healthcare providers should be able to trace a product in the storage area by its lot/batch/serial number.

3 The expiration dates of medical devices in the storage area should be monitored through periodic inventories to avoid unintended dispatch of expired medical devices.

Transportation

4 Vehicles used to transport medical devices should be properly designed and equipped to ensure protection from different environmental and weather conditions in which it operates.

130

5 Medical devices should be transported in such a manner that does NOT allow exceeding of appropriate temperature and relative humidity conditions which could negatively affect their integrity and quality.

6 Medical devices should be transported and carried carefully in a manner that corresponds to the special transport precautions and requirements.

7 Any case of spoilage or breakage should be reported.

8 The transporting vehicle or containers should be adequately suitable for the intended purpose and cleaned.

Manufacturer’s Instructions/

Requirements

9 Medical devices should be stored, handled and transported under conditions specified by the manufacturer’s instructions/requirements to prevent deterioration. These conditions might be related to one or more of the following:

o Temperature (all the medical devices should be kept during storage and/or transportation at temperature ranges specified by the manufacturer).

o Moister and humidity. o Exposure to light. o The direction the package should face. o The maximum number of packages stacked above each other. o Other specific instructions/requirements.

Note 1: If the packaging labelling do not include information about the required storage and transportation conditions of a medical device, healthcare providers should obtain such information from the manufacturer and/or its authorized representative located within the KSA. Note 2: If the manufacturer does not specify the temperature values or not define the storage conditions on the packaging labelling, see Annex 1 to determine these values and the set of storage definitions. Note 3:

131

If the manufacturer requires medical devices to be stored or transported under certain conditions (e.g. temperature and humidity), healthcare providers should monitor and periodically record these conditions.

Sterile Medical Devices

10 In addition to manufacturer-specific instructions, medical devices that are dispatched in a sterile state, should be stored, handled and transported in a manner that protects their packaging from:

o exposure to moisture. o direct sunlight. o Damage. o dirt and unclean environment.

Note: Sterile medical devices should be considered unsterile if packaging loses its integrity.

Staff

11 Staff involved in the storage, handling and/or transport of medical devices should:

o have proper knowledge about these activities, and o be able to deal with those devices that have different storage and

transportation requirements, if applicable.

Written Procedures

12 Healthcare providers should have a written procedure that describes the practices taken to ensure medical devices are stored, handled and/or transported based on the manufacturer’s instructions/requirements. The written procedure ideally should be part of a quality management system.

3536

3537

3538

3539

3540

3541

3542

3543

132

Table (9.7): Medical Devices Storage Temperature Values and Storage Condition 3544

Definitions. 3545

ON THE LABELLING GUIDANCE VALUES

Freezer The temperatures are between -20 °C and -10 °C.

Refrigerator The temperatures are between 2 °C and 8 °C.

Cold place The temperatures do NOT exceed 8 °C.

Cool place The temperatures are between 8 °C and 15 °C.

Room temperature The temperatures are between 15 °C and 30 °C.

Warm place The temperatures are between 30 °C and 40 °C.

Excessive heat The temperature is above 40 °C.

Do not store over 30 °C The temperatures are between +2 °C to +30 °C.




Do not store below 8 °C The temperatures are between +8 °C to +25 °C.

Protect from moisture No more than 60% relative humidity in normal storage conditions; to be provided to the user in a moisture-resistant container.

Protect from light To be made available to the user in a light-resistant container. 3546

3547

3548

3549

3550

3551

3552

3553

3554

3555

3556

133

9.3 Device Inventory Auditing Example 3557

3558

Equipment inventories can be audited using sampling techniques of which there are many 3559

techniques. A random sample is taken based on the inventory size (population) and 3560

accuracy expected. If the results do not meet the accuracy expected, then a complete audit 3561

is required or depending on the method selected, a second random sample taken if those 3562

results are not met, then a complete inventory audit must be completed. 3563

3564

Sampling

Procedure

ANSI/ASQC

Z1.4

Product Population

Range

Step 1

Sample

Size

Step 1

Accept

Step 1

Reject

Move to step

IF

unacceptable

is:

Step 2

Sample

Size

Step 2

Accept

Step 2

Reject

Single 151 280 32 3 4

Double 151 280 20 1 4 2 to 3 20 4 5

Single 280 500 50 5 6

Double 280 500 32 2 5 3 to 4 32 6 7

Single 501 1,200 80 7 8

Double 501 1,200 50 3 7 4 to 6 50 8 9

Single 1,201 3,200 125 10 11

Double 1,201 3,200 80 5 9 6 to 8 80 12 13

Single 3,201 10,000 200 14 15

Double 3,201 10,000 125 7 11 8 to 10 125 18 19

Single 10,001 35,000 315 21 22

Double 10,001 35,000 200 11 16 12 to 15 200 26 27

Table 9.8: Attribute sampling for inventory audit. Reference: ANSI/ASQC Z1.4. 3565 See: https://www.sqconline.com/sampling-attributes-plan. 3566

3567

3568

For example, in the chart above, (Table 9.8), if there is a population of 5,000 devices, based 3569

on a +- 4% accuracy requirement, two options are provided for an inventory audit. 3570

Option 1: Single sampling: 3571

a) 5,000 devices in device population 3572

b) 4% quality limit (see references for other quality limits) 3573

c) From chart Figure 5.x: 3574

https://www.sqconline.com/sampling-attributes-plan

134

c.1.1 200 device identification numbers randomly are selected 3575

from CMMS or other source. Note the sample has to be 3576

randomly selected or this process does not work! 3577

c.1.2 If the identification numbers match (serial numbers, asset 3578

id numbers etc.) the device passed audit. Otherwise it is 3579

counted as unacceptable. 3580

c.1.3 If 14 or fewer of the 200 devices audited are acceptable, 3581

the process is finished and the audit is complete. 3582

c.1.4 If 15 or more are unacceptable the audit is unacceptable 3583

and all devices would have to be inventoried. 3584

3585

Option 2: Double sampling: 3586

a) 5,000 devices in device population 3587

b) 4% quality limit (see references for other quality limits) 3588

c) From chart Figure 5.x: 3589

c.1.1 125 device identification numbers are randomly selected 3590

from CMMS or other source. Note the sample has to be 3591

randomly selected or this process does not work! 3592

c.1.2 If the identification numbers match (serial numbers, asset 3593

id numbers etc) the device passed audit. Otherwise it is 3594

counted as unacceptable. 3595

c.1.3 If 7 or fewer of the 125 devices audited are acceptable, 3596

the process is finished and the audit is complete. 3597

c.1.4 If 11 or more audited devices are unacceptable the audit 3598

is unacceptable and all devices would have to be 3599

inventoried. 3600

c.1.5 If between 8 an 10 device id audits were unacceptable 3601

then randomly select a second sample of 125 devices and: 3602

c.1.5.1.1 If a total of 18 or fewer of the 250 devices 3603

audited are acceptable, the process is finished 3604

and the audit is complete. 3605

135

c.1.5.1.2 If 19 or more of the 250 audited devices are 3606

unacceptable the audit is unacceptable and all 3607

devices would have to be inventoried. 3608

3609