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H4+ Interagency List of Essential Medical Devices for Maternal and Newborn Health, and other medical devices projects.
December 11, 2012
Adriana Velazquez Berumen
Coordinator of medical Devices
Essential Medicines and Health Products
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Agenda medical devices (interagency aspects)
Agenda medical devices (interagency aspects)
� Medical devices definition
� UN commission and update of Interagency list of essential medical
devices for reproductive health
� Technical specifications
� Innovative medical devices
� Assessment and management of medical equipment
� Nomenclature issues
� Regulations
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Medical deviceMedical device
� An article, instrument, apparatus or machine that is used in
the prevention, diagnosis or treatment of illness or
disease, or for detecting, measuring , restoring, correcting
or modifying the structure or function of the body for some
health purpose.
� Typically the purpose of a medical device is not achieved
by pharmacological, immunological or metabolic
means.Reference to GHTF, 2005.
� Examples: syringes, intraocular lenses, ophthalmoscopes,
pacemakers, hip replacements, defibrillators, anesthesia
machine, scalpel, stents, iv lines,…x ray equipment
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Medical devices are indispensable for health car
XXI C. still many have no access to essentialsWe all can help, what will you do?
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Interagency work on reproductive, maternaand new born health
Interagency work on reproductive, maternaand new born health
� Maternal new born and child
– Interagency Lists of medical
devices and medicines for
PMNCH
– UN life saving commodities
• UNICEF, UNFPA, WHO, BMGF, PATH,
• Regulations,
• Delivery chain - procurement and safe
use
• Market shaping
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RMNCH Continuum of Care
Commodity Usage
Reproductive health Female Condoms Family planning/Contraception
Implants Family planning/Contraception
Emergency Contraception Family planning/Contraception
Maternal Health Oxytocin Post-Partum Hemorrhage
Misoprostol Post-Partum Hemorrhage
Magnesium sulfate Eclampsia and Severe Pre-Eclamsia/Toxemia of
PregnancyNewborn Health Injectable antibiotics Newborn Sepsis
Antenatal Corticosteroid
(ANCS)
Respiratory Distress Syndrome for preterm babies
Chlorhexidine Newborn Cord Care
Resuscitation Equipment Newborn AsphyxiaChild Health Amoxicillin Pneumonia
Oral Rehydration Salts (ORS) Diarrhea
Zinc Diarrhea
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20112008
2010
Interagency list of essential medical devices, medicines for reproductive health
Interagency list of essential medical devices, medicines for reproductive health
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Methodology and scopeMethodology and scope
� Life cycle and continuum of care of mother and newborn :– Family Planning– Pregnancy– Childbirth– Post-natal mother– Newborn ( 40 days)
� Level of care:– Community level (Includes Health Post)– First level (Includes Health Center)– Referral level (Includes District Hospital– and Referral Hospital)
� Guidelines,
� Interventions,
� Medical devices and medicines
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Health Care Facilities consideredHealth Care Facilities considered
Health Post Health Center
District Hospital Referral Specialized Hospita
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H4+ Interagency List of Essential Medical Devices forReproductive, Maternal and Newborn Health
H4+ Interagency List of Essential Medical Devices forReproductive, Maternal and Newborn Health
� Objective. Provide a
publication containing a list with
the essential interventions and
medical devices/medicines
related to them.
� Meetings held
– June 2012- Copenhagen
– August 2012- Geneva
– November 2012- Geneva
� UNFPA, UNICEF and WHO.
� collaboration with specific WHO
areas:
• Injection Safety
• Blood transfusion
• Safe Surgery
• Diagnostic and Laboratory
• Reproductive Health
• Maternal Health
• Neonatal Health
• Waste management
• STI’s
• Infertility
• Cancer
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Table of contents of new publicationTable of contents of new publication
� Background
– Introduction: Briefing of the H4+ partnership.
– Objectives of the Interagency List of Essential Medical Devices and Medicines
(ILEMDM) for Reproductive, Maternal and Newborn Health (RMNH)
– Definitions for the purpose of this book:
• Levels of Care/Levels of delivery of interventions
– Community level (health post)
– First level (health center)
– Referral level (specialized, regional, university)
»District hospital
»Referral hospital
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• Continuum of Reproductive Healthcare (Definitions)
– Family planning (contraceptive)
– Maternal (pregnancy, childbirth, postnatal)
– Newborn (up to 28 days)
• Medicines
– Essential Medicines List
– Vaccines
• Health Counseling, education and promotion
– Job aids
– Educational programs
– Methodology
• Review of referral books + WHO guidelines + work with specialist
• Selection of interventions
• Selection of essential devices
�
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� General considerations by health care facilities• Standard Precautions
• Infrastructure: Energy, Water, Medical Gases, Waste disposal
• Sterilization
• Basic equipment dotation by level of care
• Laboratory
• Clinical transfusion
• Surgical Sets
• Health Counseling by Continuum of Reproductive Healthcare
� FAMILY PLANNING:
– Medical devices
– Medicines
� PREGNANCY CARE
– Medical devices
– Medicines
� CHILD BIRTH
– Medical devices
– Medicines
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� POSTNATAL CARE
– Medical devices
– Medicines
� NEWBORN CARE
– Medical devices
– Medicines
� Special notes
– First part: (Special notes related to program)
• Safe blood and Clinical transfusion
• Diagnostic tests & Laboratory
• Core infection prevention and control interventions for health-care facilities
• Injection safety
• Surgery and Anesthesia
• Disinfection and sterilization at healthcare facilities
• Health care waste management
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– Second part: (Special notes related to medical devices)
• Medical devices regulations
• Label and instructions for use for medical devices
• Units and biomaterials used for medical devices
• Surgical instruments stainless steel
• Surgical sutures
• Textiles used for linen and clothing in healthcare facility
� Guidance for supply quantification for procurement
– For supply
– In case of emergency
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Interventions were reviewed according to evidence-based
guidelines from WHO and with specialists.
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InterventionsInterventions
Medical DevicesMedical Devices
FAMILY PLANNING TEMPLATEFAMILY PLANNING TEMPLATE
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The commodities were selected according to the Master List
of UNICEF and some additions and modifications have been
done.
For example, the addition of the colposcope and the
inclusion of the specifications for the items.
Also for the nomenclature of the commodities, the GMDN
categorization and coding was used.
For medicines the EML definitions are used.
The commodities were selected according to the Master List
of UNICEF and some additions and modifications have been
done.
For example, the addition of the colposcope and the
inclusion of the specifications for the items.
Also for the nomenclature of the commodities, the GMDN
categorization and coding was used.
For medicines the EML definitions are used.
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A crossmatch was needed for each of the interventions and the devices which are needed to perform them, according to the levelof care of the health facility.
Pregnancy
Inte
rve
ntio
n 1
Inte
rve
ntio
n 2
C F D R C F D R
Equip 1 Code 1 X X X X
Equip 2 Code 2 X X X
Equip 3 Code 3 X X X X
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Special notesSpecial notes
– First part: (Special notes related to program)
• Safe blood and Clinical transfusion
• Diagnostic tests & Laboratory
• Core infection prevention and control interventions for health-care facilities
• Injection safety
• Surgery (or surgical environment?) and Anaesthesia
• Disinfection and sterilization at healthcare facilities
• Health care waste management
– Second part: (Special notes related to medical devices)
• Medical devices regulations
• Label and instructions for use for medical devices
• Units and biomaterials used for medical devices
• Surgical instruments stainless steel
• Surgical sutures
• Textiles used for linen and clothing in healthcare facility
Some special sections were identified as key complementary services and added in each of the life cycle periods.
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timelinetimeline
� December 2012
– Conclude medical devices revision by intervention
– Send template to “medicines” specialists to fill template
– Include the “special notes” for medicines
– Ensemble the “book” and give data to data base developers
– Include information on technical specifications based in UNICEF,
UNFPA and WHO catalogue, Add pictures as required database
� January… March 2013
– Have a first draft book through GRC, and publication clearance
– Review the database and applications
• Website, excel, access, ipad, mobile,,, etc
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Work discussed with WB then UNICEF and UNFPAWork discussed with WB then UNICEF and UNFPAWork discussed with WB then UNICEF and UNFPAWork discussed with WB then UNICEF and UNFPA
Technical Technical Technical Technical Specifications Specifications Specifications Specifications
for medical devices: part for medical devices: part for medical devices: part for medical devices: part
1111, medical equipment, medical equipment, medical equipment, medical equipment
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Approved medical devices for national procurement or reimbursement
Approved medical devices for national procurement or reimbursement
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1. Medical Device Specification
2. Name and Coding
3. General
4. Technical1. Technical Characteristics2. Physical Characteristics3. Energy Source4. Accessories, Spare Parts, Consumables
5. Bidding / Procurement Terms / Donation Requirements1. Environmental and Departmental Considerations2. Standards and Safety3. Training and Installation4. Warranty and Maintenance5. Documentation
Technical SpecificationsTechnical SpecificationsTechnical SpecificationsTechnical Specifications
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Name and coding
General use
1
1.1 Clinical purpose To treat precancerous cervical lesions
1.2Used by clinical
department/ward
Gynaecology clinics, outpatient clinics
1.3 Level of institution District hospital, provincial hospital, specialized hospital, specialized clinics
1.4Overview of functional
requirements
Hand held unit with probe capable of achieving a probe tip temperature of at least -20°C that can be applied to the
lesion on the cervix to freeze the lesion
USE
GENERAL
GMDN name Cryosurgical units, general purpose
GMDN code(s) 11067
GMDN category 04 Electro mechanical medical devices
UMDNS name Cryosurgical units, general purpose, Cryotherapy units
UMDNS code 11-067, 18-051
UNSPS code (note: code 42151615 applies to dental cryosurgical units
Alternative name(s) Cryosurgery unit/equipment, Cryotherapy unit/equipment
Alternative code(s) N/A
Keywords Cryosurgery, cryotherapy
GMDN definition An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g.,
liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction
and removal. The system typically includes a mechanical regulator to control the flow of cryogen,
contained in an attached cylinder, and the probe(s) to apply the cold. The system is typically used
NAME AND CODING
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9.1 Warranty Typical product lifetime (years): 10
9.2 Maintenance tasks technicians, engineers, medical staff, manufacturer/service staff. Any maintenance of the gas supply
9.3Service contract clauses,
including prices
WARRANTY AND MAINTENANCE
Documentation10
10.1Operating manuals, service
manuals, other manuals
Manufacturer's documentation on installation, operation, trouble-shooting, maintenance, advanced maintenance
tasks
User, technical and maintenance manuals to be supplied in English or specified language. List to be provided of
equipment and procedures required for local and routine maintenance
10.2Other accompanying
documents
N/A
10.3Recommendations for
maintenance
DOCUMENTATION
Warranty and maintenance
11
11.1 Other information Contact details of manufacturer, supplier and local service agent to be provided.
11.2Recommendations or
warnings
NOTES
Notes
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Intensive-care ventilatorIntensive-care ventilator
� NAME AND CODING
GMDN name Intensive-care ventilator, adult/infant
GMDN code(s) 42411
GMDN category 02 Anaesthetic and respiratory devices , 11 Assistive products for persons with disability
UMDNS name Ventilators, Intensive Care
UMDNS code 17-429
UNSPS code
Alternative name(s)
Alternative code(s)
Keywords
GMDN definition A mains electricity (AC-powered) automatic cycling device used to provide long-term alveolar ventilation support for
infant (neonatal/paediatric) to adult patients in critical care settings; most use positive pressure to deliver gas to the
lungs at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy. It typically
consists of a breathing circuit, a control system, monitors, and alarms. The gas is typically delivered via an
inhalation limb with sites where it may be heated/humidified; an exhalation limb includes an exhaust valve to
release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient
triggered).
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Electrocardiographic monitorElectrocardiographic monitor
� General
1
1.1 Clinical purpose Continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors
attached to the patient
1.2Used by clinical
department/ward
1.3 Level of institution Health centre, district hospital, provincial hospital, specialized hospital
1.4Overview of functional
requirements
Continuous display of patient ECG and heart rate on screen
Allows display of single, 3 lead ECG or simultaneous display of at least 3 waves selected from up to 12 points
Operator can set audiovisual alarm levels for low or high heart rate
Operates from mains voltage or from internal rechargeable battery
Patient connectors that are sterilisable and reusable are preferred, though reusable cables that attach to
disposable connection patches are also acceptable
Hard copy printout of traces will not be required
USE
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Suction systemSuction system
� BIDDING / PROCUREMENT TERMS / DONATION
REQUIREMENTS10
10.1Operating manuals, service
manuals, other manuals
User, technical and maintenance manuals to be supplied in ************** language.
List to be provided of equipment and procedures required for local calibration and routine maintenance
10.2Other accompanying
documents
List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration
and inspection to be provided.
10.3Recommendations for
maintenance
10.4 Others
11
11.1 Other information Contact details of manufacturer, supplier and local service agent to be provided
11.2Recommendations or
warnings
DOCUMENTATION
NOTES
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Future steps in technical specificationsFuture steps in technical specifications
� Provide them to industry to verify no specific to one vendor
� Upload in WHO website and other UN organizations
� The ones from UNICEF integrate in same template and
add to the database of the interagency list
� On going work ,continuous collaboration with NGO,
proffessional organizations, CC, MoH units of technology
and the industry.
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Research and development based on needs
Health
Technology
Assessment
Regulations :
Medical devices
Registration and
premarket approval
Needs
Assessments/
Selection
User
training
and clinical
effectivene
ss
Decommissioning
, Replacement
Installation,
Inventories;
CMMS,
Maintenance
Post market surveillance and Adverse event
reporting
Policies/ plans and human resources ( Biomedical Engineers)
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Three Dimensions to Consider
When Moving Towards Universal Coverage
Health systems financing: the path to universal coverage. Executive Summary,
The World Health Report, WHO/IER//WHR/10.1, 2010
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To achieve universal coverage, in the medical devices arena:
To achieve universal coverage, in the medical devices arena:
Regulations
Management
Assessment
Research and innovat
ion
IMDRF, GHTF,
Clinical Engineering:Selection, incorporation, AccessSafe useIFMBE
HTAi Evaluations, CE, priority setting
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Medical devicestechnical seriesMedical devicestechnical series
to ensure improved access,
quality and use of medical
devices:
Policies
Innovations R&D
Regulations
– HTR
Assessment
– HTA
Management:
– Clinical engineering
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Innovation: Scoping study on local production of medical devices
Innovation: Scoping study on local production of medical devices
� Overview of the medical device production in low-resource settings.
– Global medical devices market, Innovation of medical devices, Research and development for medical devices, Technology transfer and intellectual property, Governance and regulation, etc.
� Country case studies phase I:
– Brazil¦ Americas Region
– China¦ Western Pacific Region
– Ethiopia¦ Africa Region
– India¦ South-East Asia Region
– Jordan¦Eastern Mediterranean Region
� Country cases phase II: – Ethiopia, Nigeria, South Africa, Tanzania
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Innovation: Medical devices and ehealth solutionscompendium (60)
Innovation: Medical devices and ehealth solutionscompendium (60)
Future: Innovative tech with UNICEF: Pneumonia
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Status of Nomenclature Systems in 144 MSStatus of Nomenclature Systems in 144 MS
68
11 15
16
14
1
4
1
4
10
65
none
other
only UMDNS
only GMDN
only nationally developed
UMDNS + GMDN + nationallydeveloped
UMDNS + GMDN
UMDNS + nationally developed
GMDN + nationally developed
no info
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Clinical Engineering, health technology managementClinical Engineering, health technology management
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Medical device technical seriesMedical device technical series
� The first eight books were published in May 2011:– Development of medical device policies,
– Health technology assessment of medical devices,
– Needs assessment for medical devices,
– Procurement process resource guide,
– Medical device donations
– Introduction to medical equipment inventory management,
– Medical equipment maintenance programme overview,
– Computerized maintenance management system
� Currently working on : and would like to have interagency documents!!
• Human resources for MDs
• Decommissioning of MDs
• Regulation of MDs
• Safe use of MDs
• Measuring clinical effectiveness of MDs
• Innovation for MDs
• Nomenclature for MDs
• Regulation of MDs
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Lack of awareness of The hidden costs of medical devices… (
iceberg).
Lack of awareness of The hidden costs of medical devices… (
iceberg).
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Knowledge management: Documents available in
medical devices website and EMP library
WHO Regions
Country PublicationsWHO Medical Devices Reports (2008-2011)
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Barriers faced in commercializing/selling medical devices
Barriers faced in commercializing/selling medical devices
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From GHTF to IMDRF to global harmonization
From GHTF to IMDRF to global harmonization
� GHTF: (1992- 2012) last session Japan November .
� Other harmonization groups, like AHWP. ( Asian H. Work P)
� IMDRF: 2012: Singapore February, September Australia. Members
– Australia
– Brazil
– Canada
– China
– Japan
– Europe
– United States
– Observers: WHO, AHWP, APEC,
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International Medical Devices Regulators Forum, 2012 tasks:
International Medical Devices Regulators Forum, 2012 tasks:
� Regulated Product Submission
� Review of NCAR ( Adverse reporting) system.
� Implementation of UDI ( unique device identifier) system,
� Medical Devices Single Audit Program
� International standards recognized by IMDRF
Management Committee Members
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Most important Challenges on medical devices
Most important Challenges on medical devices
To have a global nomenclature that we can use for medical devices
across all stakeholders: UN family, and Member states, regulators, and
industry.
To support regulatory process SPECIFIC for medical devices being
implemented in member states.
To support health technology management: from needs assessment,
selection, procurement, inventories, maintenance and safe use, as well as
logistics as core business.
To support biomedical engineers as the responsible human resource for
development, regulation and management of medical devices globally.