2. Introduction to Medical Device Problem Reporting Under the Saudi FDA January 2008 Joel J. Nobel, Founder & President Emeritus

3. ECRI Institute ― Nonprofit health services research agency ― Collaborating Center, World Health Organization ― Interdisciplinary staff of 300 ― Stringent conflict-of-interest regulations ― International scope with consulting, information support and technical assistance available worldwide ― Offices in Asia-Pacific Region, Europe, Middle East (Dubai), and North America

4. Mission To improve the safety, efficacy, and cost-effectiveness of patient care and healthcare technology, facilities, and procedures

5. Focus  Healthcare technology, its assessment, evaluation, selection, and management  Patient safety  Risk management policies, procedures, and techniques  Quality of care standards and guidelines  Healthcare environmental safety and protection

6. Major Programs  Healthcare technology assessment  Medical product evaluation, comparison, and selection  Evidence-based Practice Center*  National Guideline Clearinghouse*  Patient safety  Medical device problem reporting & accident investigation  Credentialing

7. Largest information provider and consultant worldwide for: Healthcare technology—its assessment, planning, selection, procurement, management, and risk and quality management

8. Integrity Neither ECRI nor any of its staff has a financial interest in the sale of any medical technology. ECRI and its staff accept no royalties, gifts, finder’s fees, or commissions from the medical device or pharmaceutical industries and are not permitted to own stock in or undertake consulting work for such industries.

9. Delivery of Knowledge and Judgment  Publications  Web-based information databases  Telephone, letter, fax, and e-mail consultation  On-site consultation  Technical assistance  Training programs  Symposia

10. Healthcare Technology  Devices, equipment, and related computers and software  Drugs  Biotechnologies  Medical and surgical procedures  Healthcare information systems

11. Medical Devices Devices, apparatus, or systems employed for the prevention, diagnosis, or treatment of disease in humans — that do not normally enter metabolic pathways. ”

12. The Universe of Medical Devices  7,000 Generic Entities  1,500 Capital Equipment Products  2,000 Surgical Instruments  500 Implantable Devices  More than 2,000,000 Brands, Models, and Sizes  More than 30,000 Manufacturers

13. Nomenclature  The name of the device category that defines that exclusive class of entities to which the device under consideration belongs (e.g., single-channel electrocardiograph, steam sterilizer).

14. Universal Medical Device Nomenclature System ™ (UMDNS ™ )  A standard nomenclature developed and maintained by ECRI since 1973 to support data categorization, storage, retrieval, and exchange.  Used in more than 70 nations by government, hospitals, health systems, and industry for medical device planning, procurement, management, and regulation.  Available free to government and nonprofit health facilities.

15. UMDNS Structure  Single term for each distinct entity  Unique code number for each term  Heavily cross-indexed  Hierarchical vocabulary  Widespread use

16. UMDNS Code Numbers Each unique term has a unique five-digit code number. Code numbers do not carry information. Older national systems used alphabetical or numerical codes to convey information such as clinical department or medical specialty. This imposes significant limitations (e.g., many of the same devices are used in different departments or different medical specialties).

17. Challenges in Healthcare Technology  Balanced national, regional, and institutional healthcare priority setting and investment  Selection, procurement, and cost control  Equipment management and support  Clinical level quality control  User error and education  Patient safety  Medical Device Problem Reporting  New technologies, such as biotechnologies, genetics, immunochemistry, molecular biology

18. Special SFDA Arrangement with ECRI Institute to Provide Information & Database Support to KSA Hospitals (Demonstration)  Health Devices Alerts & MAUDE  Medical Device Safety Reports & Posters  Health Device Sourcebase  Health Device System  Healthcare Product Comparison System,  Healthcare Standards  TARGET

19. Passwords  Passwords will be issued to individual hospitals by SFDA  Responses to inquiries and additional training support will be provided by SFDA  Passwords may not be shared with other individuals or institutions within or outside KSA  We will measure usage of the databases by individual hospitals and individual passwords

20. Thank You