Rational selection of appropriate health technology for different clinical interventions

Rational selection of appropriate health technology for different clinical interventions Adriana Velazquez Berumen: Coordinator Diagnostic Imaging and...
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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

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