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

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

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

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

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

Priority medical devices through the continuum of care

Methodology to select medical devices, (Cancer 2015)

General (for all interventions) and specialized medical devices

Medical devices required to perform interventions according to guidelines.

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.

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

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

July 2014 status of nomenclature for medical devices globally

General statistics of different nomenclature systems in 175 MS

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).