From the Big-picture View to Workshop Focus

1. From the Big-picture View to Workshop Focus Medical Device Problem Reporting Workshop 29, 30 November 2005, Riyadh Michael Cheng World Bank Missions with Saudi Arabia

2. Searching for a Management Framework • The medical device universe is complex • How do we develop a national program to manage medical devices?

3. Current proliferation of medical device management topics with unclear technical terms For example: from technology management journals • Strategic technology planning • Technology acquisition strategy • Technology incorporation • Technology evaluation • Technology assessment • Risk management • Risk-based preventive maintenance • Computer generated maintenance schedules • Quality control manual • Quality improvement • Medical equipment repair and maintenance • Medical equipment control system • Medical equipment management system A huge task to plough through and digest these topics

4. Going Back to the Basic Essentials • Let us look at a simple three-level policy and regulatory framework .....the big picture view • Then I shall link the different presentations in this workshop to this framework

5. Background: Developing a Framework for the Overall Management of Medical Devices The Interantional Forum in 2003 • Participants • World Bank, World Health Organization and other international development agencies • Country representatives from four continents • Manufacturers associations • Public non-profit organizations • Recognized management experts • Outcome: conception of a holistic three-level policy and regulatory framework

6. Toward a Holistic Policy and Regulatory Framework for Medical Devices Market Product Adoption / Selection Utilization / Disposal (1st Level) (2nd Level) (3rd Level) Qualified User Safe and Effective use Safety / Performance Globally Harmonized Criteria (from GHTF) National / Regional Health Policies Needs assessment Health Technology Assessment (HTA) Basic Questions Good Management Practice

7. Advantages of this Framework • A simple expression of complex professional activities in terms of essential functions easily understood by all stakeholders including decision makers • Linking different professionals that should function as a continuum well coordinated for efficient operations • All professional activities are accountable to the listed essential functions • Guiding principles or essential elements for professional activities are established. (e.g. World Health Organization and the World Bank documents) • A basic reference for developing medical device management programs

8. Policy and Regulatory Framework Market Product Adoption / Selection Utilization / Disposal (1st Level) (2nd Level) (3rd Level) Qualified User Safe and Effective use Options for regulations and their impact on the market place National / Regional Health Policies Needs assessment Health Technology Assessment (HTA) Basic Questions Good Management Practice Mr Alan Kent’s presentation

9. Safe and Effective Use of Medical Devices • Recent medical device regulations are based on risk management schemes • There is no product that is guaranteed 100% safe; user vigilance in monitoring its safety and performance is a must • The Global Harmonization Task Force (GHTF) has recommended regulatory requirements for medical device Post-Market Surveillance and Adverse Event Reporting for corrective measures to prevent the recurrence of the same problem

10. Policy and Regulatory Framework Market Product Adoption / Selection Utilization / Disposal (1st Level) (2nd Level) (3rd Level) Qualified User Safe and Effective use Global (GHTF) Guidelines on Post-Market Surveillance and Adverse Event Reporting National / Regional Health Policies Needs assessment Health Technology Assessment (HTA) Basic Questions Good Management Practice Tomorrow Dr Stösslein’s presentation

11. A Critical Interaction between 1st Level and 3rd Level • Regulatory requirements for Post-Market Surveillance and Adverse Event Reporting from 1st Level rely largely on compliant implementation by manufacturers / vendors, healthcare providers and users at 3rd Level • There must be two-way communication and cooperation among these stakeholders

12. A Critical Interaction between 1st Level and 3rd Level

13. Workshop Focus The focus of this workshop is on healthcare providers and device users responsibilities: • vigilance in using medical devices • medical device incident investigation techniques • medical device alert and recall management programs in healthcare facilities • available tools to implement vigilance programs

14. Policy and Regulatory Framework Healthcare Provider and User Responsibilities Market Product Adoption / Selection Utilization / Disposal SFDA Regulations Government and Healthcare Provider Cooperation Qualified User Safe and Effective use Safety / Performance National / Regional Health Policies Needs assessment Health Technology Assessment (HTA) Basic Questions Good Management Practice Workshop Focus and ECRI Presentations

15. Next Presentation Market Product Adoption / Selection Utilization / Disposal SFDA Regulations Government and Healthcare Provider Cooperation Qualified User Safe and Effective use Options for regulations and their impact on the market place National / Regional Health Policies Needs assessment Health Technology Assessment (HTA) Basic Questions Good Management Practice Mr Alan Kent’s, Presentations