Rational selection of appropriate health technology for different clinical interventions Adriana Velazquez Berumen: Coordinator Diagnostic Imaging and Medical Devices
OSLO 2013
Adriana Velazquez Berumen
Health technologies resolution WHA60.29 • Approved by all member states in May 2007 • 60 World Health Assembly • From member states: – – – –
Information on medical devices Regulations of medical devices, harmonization National units of health technologies / medical devices Policies and strategies on medical devices
• From WHO , secretariat – Norms, standards, glossary – Clearinghouse on medical devices information for selection. – Work with NGO, CC, Academia and all stake holders Adriana Velazquez Berumen
Epidemiological Changes: increasing NCDs
Adriana Velazquez Berumen
New developments, rising costs: need to allocate resources in rational way
Cancún, dic. 2002
Adriana Velazquez Berumen
Essential technologies still not available in many settings!
Adriana Velazquez Berumen
Medical devices network , May 2013 World Bank
IAEA
I IHF
UNFP A
IFMBE IFHE IUA
UNICEF
NGO’s
U.N.
ISR WFUM ISRRT
Medical devices at WHO
Collabor ating Centers
Norway Senegal Canada
HTAI INAHTA EUROSCAN
MOU Brazil Colombia Mexico
China, Malaysia
IOMP Adriana Velazquez Berumen
Priority medical devices report: Managing the mismatch • Launched in 2010. • Problems to select and manage technology • Link with clinical procedures. methodology • Define Research agenda Medical devices should be: Safe and Effective Appropriate, Affordable Accessible Available Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Clinical Engineering, health technology management
Adriana Velazquez Berumen
Database of Universities and professional societies in Biomedical Engineering • • • • •
Started 2009 A total of 592 contacts 466 teaching units 115 associations in 90 Member States.*
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Needs Assessment , ….Procurement
plus 60 technical specifications To develop continuously in wiki type work, all invited to help
Adriana Velazquez Berumen
Approved medical devices for national procurement or reimbursement
Adriana Velazquez Berumen
Donations
Humatem, in French speaking countries OTAN, for donations in military cases CHA , Catholic Hospitals To reach out in a meeting in 2013 with various donating agencies Adriana Velazquez Berumen
Maintenance of medical equipment
Adriana Velazquez Berumen
Health systems financing • Funds allocated to medical devices by country • Lists of medical devices by health care facility • Reference Pricing of medical devices •
http://www.internationalhealthpartnership.net/
/ • With UNICEF, UNFPA, WORLD BANK and WHO en/tools/one-health-tool
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
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
Adriana Velazquez Berumen
Lists of devices per facility or clinical procedure • Examples: • Per hospital • Per health center • Per area of care: – ICU – Surgery
• Per disease – H1N1 – HIV – Vaccines Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Health Care Facilities Health post
Provincial hospital
Health center
Specialized hospital
District hospital
Adriana Velazquez Berumen
Areas in Health Care Facilities •
Health post –
•
Complementary Diagnostic Inpatient Outpatient Treatment
District hospital – – – – –
Complementary Diagnostic Inpatient Outpatient Treatment
Provincial hospital – – – – – –
Outpatient
Health center – – – – –
•
•
•
Chemotherapy Complementary Critical Medicine Diagnostic Inpatient Outpatient
Specialized hospital – – – – – –
Complementary Critical medicine Diagnostic Inpatient Outpatient Treatment
Adriana Velazquez Berumen
Chemotherapy
Complementary
Diagnostic
Inpatient
Healt post
Outpatient
Treatment
Critical medicine
X
Health center
X
X
X
X
X
District hospital
X
X
X
X
X
Provincial hospital
X
X
X
X
X
X
X
Specialized hospital
X
X
X
X
X
X
X
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
Adriana Velazquez Berumen
100 Core medical equipment data sheets.
Adriana Velazquez Berumen
Core medical equipment examples • Analyzer, Laboratory, Hematology, Blood Grouping, Automated • Anesthesia Unit • Apnea Monitors • Aspirator • Auditory Function Screening Device, Newborn • Bilirubinometer • Blood Gas/pH/Chemistry Point of Care Analyzer
• Glucose Analyzer • Hematology Point of Care Analyzer • Hemodialysis Unit • Immunoassay Analyzer • Incubator, Infant • Laser, CO2 • Mammography Unit • Monitor, Bedside, Electroencephalography • Monitor, Central Station • Radiotherapy Systems Adriana Velazquez Berumen
Prequalified medical devices
Adriana Velazquez Berumen
•
H4+ Interagency List of Essential Medical Devices for Maternal and Newborn Health
Objective. Provide a publication containing a list with the essential interventions and medical devices related to them.
•
June 2012- Copenhaguen August 2012-Geneva November 2012- Geneva
UNFPA, UNICEF and WHO in 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
Meetings held Adriana Velazquez Berumen
2011 2008
2010
Adriana Velazquez Berumen
Adriana Velazquez Berumen
FAMILY PLANNING TEMPLATE
Interventions
Medical Devices
Adriana Velazquez Berumen
Interventions for Childbirth
Adriana Velazquez Berumen
Medical Devices
Adriana Velazquez Berumen
Technical Specifications 1. 2. 3. 4.
Medical Device Specification Name and Coding General Technical 1. 2. 3. 4.
5.
Technical Characteristics Physical Characteristics Energy Source Accessories, Spare Parts, Consumables
Bidding / Procurement Terms / Donation Requirements 1. 2. 3. 4. 5.
Environmental and Departmental Considerations Standards and Safety Training and Installation Warranty and Maintenance Documentation
Adriana Velazquez Berumen
Name and coding NAME AND CODING 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 GMDN definition
Cryosurgery, cryotherapy
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
General use GENERAL 1
USE
1.1
Clinical purpose
To treat precancerous cervical lesions
1.2
Used by clinical department/ward
Gynaecology clinics, outpatient clinics
Level of institution Overview of functional requirements
District hospital, provincial hospital, specialized hospital, specialized clinics
1.3 1.4
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
Adriana Velazquez Berumen
Technical Technical characteristics 2
TECHNICAL CHARACTERISTICS
2.1
Clinical performances
2.2
Technical characteristics (specific to this type of device)
2.2
Technical characteristics (continued)
2.3
Settings
2.3
Settings (continued)
2.4
User's interface
2.5
Software and/or standard of communication
Handheld compressed gas (nitrous oxide or carbon dioxide) operated cryosurgical unit capable of achieving temperatures at the cryotip below - 20°C. The unit shall have a trigger mechanism to control the freeze/thaw cycle (active defrost preferred but not essential), removable circular, closed design cryotips (19 +/- 2) mm diameter with flat surfaces or with a cone extrusion not exceeding 5 mm, insulated cryoshaft of length 170 mm tod 200 mm, hose assembly (high pressure) with cylinder connector, pressure gauge and relief valve, and exhaust port to which a hose can be connected to safely vent the exhaust gas Gas type (nitrous oxide or carbon dioxide) to be specified at time of purchasing equipment to make certain that local gas suppliers can refill the cylinders and that the correct gas connector fittings are supplied N/A N/A N/A N/A
Physical characteristics 3
PHYSICAL CHARACTERISTICS
3.1
Dimensions (metric)
Hand unit approximately 250 mm by 150 mm, hose length > 1.5 m
3.2
Weight (lbs, kg)
Hand unit less than 400 g
3.3
Configuration
N/A
3.4
Noise (in dBA), heat dissipation
N/A
3.5
Mobility, portability
Portability limited by size and weight of gas cylinder. If moved there must be adequate means of safely supporting the gas cylinder in an upright position.
Adriana Velazquez Berumen
UN Commission Defining a list of overlooked life-saving commodities for women and children
Identifying key barriers preventing access to and use of these commodities Recommending innovative action to rapidly increase both access and use
Adriana Velazquez Berumen
RMNCH Continuum of Care
Commodity
Usage
Reproductive health
Female Condoms
Family planning/Contraception
Implants
Family planning/Contraception
Emergency Contraception
Family planning/Contraception
Oxytocin
Post-Partum Hemorrhage
Misoprostol
Post-Partum Hemorrhage
Magnesium sulfate
Eclampsia and Severe Pre-Eclamsia/Toxemia of Pregnancy
Injectable antibiotics
Newborn Sepsis
Antenatal Corticosteroid (ANCS)
Respiratory Distress Syndrome for preterm babies
Chlorhexidine
Newborn Cord Care
Resuscitation Equipment
Newborn Asphyxia
Amoxicillin Oral Rehydration Salts (ORS) Zinc
Pneumonia Diarrhea Diarrhea
Maternal Health
Newborn Health
Child Health
Adriana Velazquez Berumen
Every woman every child
Adriana Velazquez Berumen
Essential medical devices for NCDs Prevention and control of NCDs 1.Cardiovascular disease 2.Chronic Respiratory disease 3.Diabetes mellitus 4.Cancer* Source: non communicable disease in WHO website
Cross-Linkage
Global Burden Disease (Projected DALYs 2030) 1. Unipolar depressive disorders 2. Perinatal conditions 3. Ischemic heart disease 5.5% 4. Road traffic accidents 5. Cerebrovascular disease 4.3% 6. COPD 3.8% 7. Lower respiratory infections 3.2% 8. Hearing loss 9. Refractive errors 10. HIV/AIDS 11. Diabetes mellitus 2.3% 12. Malignant neoplasms 2.2% 13. Cataracts 1.9% 14. Alcohol use disorders 1.9% 15. Diarrheal diseases
Global Burden Disease (Estimated DALYs 2004) 1. Perinatal conditions 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
Lower respiratory infections 6.2% Diarrheal diseases Unipolar depressive disorders Ischemic heart disease 4.1% HIV/AIDS Cerebrovascular disease 3.1% Road traffic accidents Tuber Malaria COPD 2.0% Refractive errors Hearing loss Alcohol use disorders 1.6% Diabetes mellitus 1.3%
Innovations for Ageing Population
Prevention Women’s cancer
Source: global burden of disease in WHO website priority medical devices in WHO website
Adriana Velazquez Berumen
Next steps • Work on the interagency list that needs to be for December 2012, with UNICEF and UNFPA. • Global needs of medical devices with Japanese • Medical devices for non communicable diseases • Medical devices for ageing population • Place all this information into database in web. Adriana Velazquez Berumen
Global medical devices information system (GMDIS) Clinical information
• •
Disease related to procedure Clinical indication Procedural use of medical devices
Areas of use within a given health care system • • •
linkage
Region/healthcare system Type of facility Group of healthcare section
• • • •
Procedural information Regulatory information Procurement information Assessment information
Medical device information • • • • •
Device name Description/Definition Technical information Picture Economic information
Adriana Velazquez Berumen
Medical devices website at WHO
Adriana Velazquez Berumen
Partnerships and Productive Collaborations WHO Medical Devices Reports (2008-2011)
Country Publications
WHO Regions
Adriana Velazquez Berumen
Thank you very much
[email protected] [email protected] www.who.int/medical_devices.en
Adriana Velazquez Berumen