1. Medical devices, new developments and concerns
IPC
Adriana Velazquez
Essential Medicines and Health Products Department

2. Medical Devices New development and concerns
Priority medical devices
For Reproductive Maternal New born and Child, 2015
For NCDs,
Cancer management
Technical specifications for procurement
Challenges
Nomenclature of medical devices
Current situation and problems
Way forward

3. SDG3: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services

4. Policies, Country profiles, Human resources, Innovation and Regulations of medical devices.

5. Health technology Assessment, Health technology management and lists of priority medical devices.

6. Priority medical devices through the continuum of care

7. Methodology to select medical devices, (Cancer 2015)

8. General (for all interventions) and specialized medical devices

9. Medical devices required to perform interventions according to guidelines.

10. Technical specifications for procurement are indispensable for good health services.
Problems, lack of good technical specifications:
Increase: costs, corruption, possibility of getting bad quality products, or not compatible to setting or inappropriate.
Bad bidding process with not appropriate TS lead to:
Lack of right consumables,
Equipment not being installed
Human resources not trained
Warranties not available
Maintenance not performed…etc.
Consequences:
misdiagnose, mistreatment, delay in service provision, bad quality and unsafe
Outcome:
Patient’s health in risk of becoming complicated
Patient need to pay costly out of pocket to get health service urgent.

11. Technical specifications, WHO actual template
Name and coding
General use
Technical characteristics
Physical characteristics
Technical
Energy source
Accesories-spare parts-consumables
Bidding/procurement terms/donation requirements
Standards and safety
Training and installation
Warranty and maintenance
Documentation

12. Name and coding: Lack of Nomenclature of medical devices cause confusion and health provision problems
Lack of global public nomenclature
Multiple nomenclature systems coexist
Confusion, lack of synergy
Copyright nomenclatures, not public good
Different systems are being used, even inside countries or by procurement agencies
There is no link between regulation and management ( supply chain) and maintenance.
Different systems in WHO, UN organizations and health tech providers

13. July 2014 status of nomenclature for medical devices globally

14. General statistics of different nomenclature systems in 175 MS

15. Conclusions The needs to define a way forward to:
Disseminate the list of priority medical devices
Disseminate the list of priority assistive devices
Develop technical specifications for all these products, to increase availability in the market and better health service provision.
Work on technical specifications in a harmonized way using same template across UN agencies, adapted to type of technology.
Define the strategies to have a common publicly available nomenclature of medical devices (similar to the INN).