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Medical Device Universe and Nomenclature

Saudi Food & Drug AuthorityNovember 2005

Joel J. Nobel, M.D.Founder and President Emeritus, ECRI

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Discussion Outline

• ECRI Background

• Universe of Medical Devices

• Characteristics of Device Problems

• The Challenge of Problem Reporting

• Nomenclature

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ECRI Attributes

• Nonprofit health services research agency• Collaborating Center, World Health

Organization• Interdisciplinary staff of 250• Stringent conflict-of-interest regulations• International scope with consulting support

information and technical assistance available worldwide

• Offices in Asia-Pacific Region, Europe, Middle East, and North America

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Mission

To improve the safety, efficacy, and cost-effectiveness of patient care and healthcare technology, facilities, and procedures

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Focus

• Healthcare technology, its assessment, evaluation, selection, and management

• Patient safety• Risk management policies, procedures, and

techniques• Quality of care standards and guidelines• Healthcare environmental safety and

protection

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Major Programs

• Healthcare technology assessment• Medical product evaluation, comparison,

and selection• Evidence-based Practice Center*• National Clinical Guideline

Clearinghouse*• Patient safety• Medication error prevention

*as designated by U.S. government

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Largest information provider and consultant worldwide for:

Healthcare technology—its assessment, planning, selection, procurement, management, and risk and quality management

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Integrity

Neither ECRI nor any of its staff has a financial interest in the sale of any medical technology. ECRI and its staff accept no royalties, gifts, finder’s fees, or commissions from the medical device or pharmaceutical industries and are not permitted to own stock in or undertake consulting work for such industries.

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ECRI Medical Device Reporting System

• In operation for 34 years

• Preceded all other systems

• Based on reports from 3,000 member hospitals worldwide

• Linked to technical investigation capability, feedback to manufacturers & dissemination of information to the health community

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ECRI Medical Device Reporting System

• User education and feedback to reporters

• Close cooperation with medical device regulatory agencies such as U.S. FDA & European organizations

• Worldwide adverse effects investigation

• Undertakes more on-site investigation of injuries and deaths than does FDA

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The Universe of Medical Devices and Healthcare Technology

in Perspective

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Perspective

When we focus on a very specific tree, such as medical devices, we tend to to lose sight of the forest. Let us first gain a broad perspective of where devices fit in the grand scheme of things so we can apportion our efforts appropriately to achieve the greatest good

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Healthcare Objectives

• Prevent significant disease

• Diminish pain and disability

• Postpone death—when it is meaningful to do so

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Disease

Low human energy

Low efficiency

Low productivityLow income

Low capital accumulation

Low investment in:• Medical care• Preventive medicine• Sanitation• Housing• Education

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Fundamental Challengers to Healthcare Technology

• Malnutrition

• Regulating fertility

• Environmental factors

• Education

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National Healthcare Determinants and Healthcare

TechnologyNational Characteristics

• Social Structure• Political System• Conflicts• Values• Law• Custom• Religious Beliefs• Educational attainment• Wealth

National Priorities

National Budget

National Health Budget

Disease Prevalence and Conditions,

Epidemiological Data

Healthcare Priorities and Resources

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Healthcare Priorities and Resources

• Leadership

• Management systems

• Personnel

• Rules and regulations

• Standards of care

• Education and training

• Facilities

• Research

• Communications

• Healthcare technology

(Drugs, Devices & Procedures)

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Healthcare Technology

• Devices, equipment, and related computers and software

• Drugs

• Biotechnologies

• Medical and surgical procedures

• Healthcare information systems

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Technology Diffusion

The degree to which a specific technology is adopted and comes into broad use.

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Life-Cycles of Healthcare Technologies

Source: Banta HD, Behny CJ, Willems JS. Toward rational technologyin medicine. New York: Springer Publishing Company; 1981.

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Medical Devices

Devices, apparatus, or systems employed for the prevention, diagnosis, or treatment of disease in humans—that do not normally enter metabolic pathways

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Hybrid Devices

Despite this classical definition there are, for purposes of regulatory classification, anomalies and hybrids such as drug eluting stents. Technology convergence will lead to more hybrid “devices.” Where does a in-vitro grown tissue matrix fit?

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The Universe of Medical Devices

• 7,000 Generic Entities• 1,600 Capital Equipment Products• 2,000 Surgical Instruments• 700 Implantable Devices• More than 2,000,000 Brands, Models, and

Sizes• More than 35,000 Manufacturers

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Changing Nature of Medical Devices

Medical Devices, until the 1960’s were a three element system of device, user and patient. Since then many have evolved into a five element system

• Device• Computer• Software• User• Patient

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Five Element Medical Devices

Embedded or connected microprocessors and computers and their associated software have often increased diagnostic and therapeutic capabilities, speed and sometimes safety, but at the cost of complexity and new risks on occasion as well. Adverse effects are sometimes caused by multiple elements and factors

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Device Use Environments• Hospital• Outpatient clinic• Freestanding specialty center (e.g., dialysis,

surgery)• Hospice• Home• Ambulance and EMS• Field hospital (military or disaster teams)• Industrial dispensary

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Device Users

• Healthcare personnel (physicians, nurses, aides, technicians, technologists, EM staff, corpsmen)

• Lay personnel (patients, their family members, companions, and others)

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User Error versus Use Error

The traditional term of “user error,” which had the advantage of clarity, is being replaced by the politically correct term “use error,” which muddies the notion of individual responsibility. Most device related patient injuries and deaths are caused by user error.

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Device Users

• The majority of medical device users are not physicians

• The more specialized the user & limited their range of tasks e.g. a radiology or laboratory technician, the fewer errors they tend to make, assuming reasonable training

• The more general the user, the more errors tend to occur

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Factors Impacting Medical Device Adverse Effects (1)

• Core device concepts

• Design

• Human factors and ergonomics

• Software

• Manufacturing quality

• Clinical trial validity

• Regulatory concepts and actual practices

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Factors Impacting Medical Device Adverse Effects (2)

• Institutional healthcare priority setting and investment

• Selection, procurement, and cost control• Equipment management and support• Clinical level quality control• Training & education• Risk management program• Internal incident reporting program• Information culture

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Concepts and Definitions

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Acceptance Test

A detailed procedure to verify the safety and performance of a device prior to its use, either after initial receipt (i.e., incoming or commissioning inspection) or following major repairs, modifications, or overhaul.

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Calibration Determination of a device’s accuracy, using test equipment of verified and appropriate accuracy, and adjustment of that device to meet recommended accuracy requirements.

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Ease of Use

Ease of use is determined by equipment human factors design, the user-friendliness of software, and the availability and clarity of instructional materials and training programs.

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Effectiveness

A technology’s ability to fulfill its intended clinical purpose under actual, real-world conditions.

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Efficacy

The ability of a diagnostic or therapeutic modality to fulfill its intended clinical purpose under ideal conditions.

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Inspection

Checks the physical integrity and function of a device and ensures that it meets appropriate safety and performance requirements of the manufacturer and biomedical engineering service.

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Medical Device Nomenclature

The name of the device category that defines that exclusive class of entities to which the device under consideration belongs (e.g., single-channel electrocardiograph, steam sterilizer).

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Modification

Replacement, remounting, adjustment, or addition of components or subsystems to a device to improve safety, reliability, or performance, as recommended by the manufacturer or other recognized source.

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Overhaul

Replacement of worn parts, upgrading or modification, calibration, or refinishing according to or in conformance with manufacturers’ recommendations.

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Performance

The ability of equipment to fulfill its intended purpose and its conformity with its technical specifications.

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Preventive Maintenance

Periodic procedures to minimize the risk of failure and to ensure continued proper operation.

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Reliability

A measure of consistent performance and safety without failure.

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Repair

Troubleshooting to isolate the cause of device malfunction, followed by replacement or adjustment of components or subsystems to restore normal function, safety, performance, and reliability.

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Safety

Safety is a systems concept, rather than simply a product attribute.

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Technology Management A disciplined group of interrelated processes that supports the safe and cost-effective clinical application of technology, ensures its readiness and reliability, protects economic investment in technology through appropriate service and maintenance, and ensures that clinical personnel use equipment safely, effectively, and with appropriate selectivity.

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Universal Medical Device Nomenclature System™

(UMDNS™)

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Medical Device Term

The name of the device category that defines that exclusive class of entities to which the device under consideration belongs (e.g., single-channel electrocardiograph, steam sterilizer).

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Universal Medical Device Nomenclature System™ (UMDNS™)

• A standard nomenclature developed and maintained by ECRI since 1973 to support data categorization, storage, retrieval, and exchange.

• Used in more than 70 nations by government, hospitals, health systems, and industry for medical device planning, procurement, management, and regulation.

• Available free to government and nonprofit health facilities.

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Universal Medical Device Nomenclature System (UMDNS)

• Single term for each distinct entity• Unique code number for each term• Heavily cross-indexed• Hierarchical vocabulary• Widespread use

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Universal Medical Device Nomenclature System (UMDNS)

(contd.)

• Translated into various languages

• Frequently updated

• Fully supported

• The key to all major information systems and databases on medical devices

• Promulgated by ECRI and WHO

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UMDNS Code Numbers

Each unique term has a unique five-digit code number. Code numbers do not carry information. Older national systems used alphabetical or numerical codes to convey information such as clinical department or medical specialty. This imposes significant limitations (e.g., many of the same devices are used in different departments or different medical specialties).

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Information Principle (1)

The more general a term, the easier it is to file data and the harder it is to find (e.g., you could file everything in the world under “miscellaneous,” but you couldn’t find anything quickly). If you used several general categories (e.g., animal, vegetable, mineral, synthetic), medical device data would fall in three of the four files and would be difficult to file and still difficult to find.

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Information Principle (2)

The more specific a term, the more time-consuming it is to file the information initially, but the easier and faster it is to find. Since information is labeled or filed once and retrieved frequently, it is more cost-effective to expend the energy up front than later.

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Information Principle (3)Hierarchical terms work best for paper-based filing systems and also facilitate computer databases. Hierarchical terms begin with the most general and proceed to increasingly specific descriptors, for example:

• Rifle, caliber .30, gas operated, M-1• Electrocardiograph, multichannel, interpretive• Densitometer, bone, isotope, dual-photon absorptiometry• Defibrillator, external, automated

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UMDNS Translations

• French• German• Polish• Russian• Spanish• Turkish

English-language base system translated into:

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Thank you