Medical Device Universe and Nomenclature Saudi Food & Drug Authority November 2005

1. Medical Device Universe and NomenclatureSaudi Food & Drug AuthorityNovember 2005 Joel J. Nobel, M.D. Founder and President Emeritus, ECRI

2. Discussion Outline • ECRI Background • Universe of Medical Devices • Characteristics of Device Problems • The Challenge of Problem Reporting • Nomenclature

3. ECRI Attributes • Nonprofit health services research agency • Collaborating Center, World Health Organization • Interdisciplinary staff of 250 • Stringent conflict-of-interest regulations • International scope with consulting support information and technical assistance available worldwide • Offices in Asia-Pacific Region, Europe, Middle East, 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 Clinical Guideline Clearinghouse* • Patient safety • Medication error prevention *as designated by U.S. government

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. ECRI Medical Device Reporting System • In operation for 34 years • Preceded all other systems • Based on reports from 3,000 member hospitals worldwide • Linked to technical investigation capability, feedback to manufacturers & dissemination of information to the health community

10. ECRI Medical Device Reporting System • User education and feedback to reporters • Close cooperation with medical device regulatory agencies such as U.S. FDA & European organizations • Worldwide adverse effects investigation • Undertakes more on-site investigation of injuries and deaths than does FDA

11. The Universe of Medical Devices and Healthcare Technologyin Perspective

12. Perspective When we focus on a very specific tree, such as medical devices, we tend to to lose sight of the forest. Let us first gain a broad perspective of where devices fit in the grand scheme of things so we can apportion our efforts appropriately to achieve the greatest good

13. Healthcare Objectives • Prevent significant disease • Diminish pain and disability • Postpone death—when it is meaningful to do so

14. Disease Low investment in: Low human energy • Medical care • Preventive medicine • Sanitation • Housing • Education Low efficiency Low capital accumulation Low productivity Low income

15. Fundamental Challengers to Healthcare Technology • Malnutrition • Regulating fertility • Environmental factors • Education

16. National Healthcare Determinants and Healthcare Technology • National Characteristics • Social Structure • Political System • Conflicts • Values • Law • Custom • Religious Beliefs • Educational • attainment • Wealth National Priorities National Budget Disease Prevalence and Conditions, Epidemiological Data National Health Budget Healthcare Priorities and Resources

17. Leadership Management systems Personnel Rules and regulations Standards of care Education and training Facilities Research Communications Healthcare technology (Drugs, Devices & Procedures) Healthcare Priorities and Resources

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

19. Technology Diffusion The degree to which a specific technology is adopted and comes into broad use.

20. Life-Cycles of Healthcare Technologies Source: Banta HD, Behny CJ, Willems JS. Toward rational technology in medicine. New York: Springer Publishing Company; 1981.

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

22. Hybrid Devices Despite this classical definition there are, for purposes of regulatory classification, anomalies and hybrids such as drug eluting stents. Technology convergence will lead to more hybrid “devices.” Where does a in-vitro grown tissue matrix fit?

23. The Universe of Medical Devices • 7,000 Generic Entities • 1,600 Capital Equipment Products • 2,000 Surgical Instruments • 700 Implantable Devices • More than 2,000,000 Brands, Models, and Sizes • More than 35,000 Manufacturers

24. Changing Nature of Medical Devices Medical Devices, until the 1960’s were a three element system of device, user and patient. Since then many have evolved into a five element system • Device • Computer • Software • User • Patient

25. Five Element Medical Devices Embedded or connected microprocessors and computers and their associated software have often increased diagnostic and therapeutic capabilities, speed and sometimes safety, but at the cost of complexity and new risks on occasion as well. Adverse effects are sometimes caused by multiple elements and factors

26. Device Use Environments • Hospital • Outpatient clinic • Freestanding specialty center (e.g., dialysis, surgery) • Hospice • Home • Ambulance and EMS • Field hospital (military or disaster teams) • Industrial dispensary

27. Device Users • Healthcare personnel (physicians, nurses, aides, technicians, technologists, EM staff, corpsmen) • Lay personnel (patients, their family members, companions, and others)

28. User Error versus Use Error The traditional term of “user error,” which had the advantage of clarity, is being replaced by the politically correct term “use error,” which muddies the notion of individual responsibility. Most device related patient injuries and deaths are caused by user error.

29. Device Users • The majority of medical device users are not physicians • The more specialized the user & limited their range of tasks e.g. a radiology or laboratory technician, the fewer errors they tend to make, assuming reasonable training • The more general the user, the more errors tend to occur

30. Factors Impacting Medical Device Adverse Effects (1) • Core device concepts • Design • Human factors and ergonomics • Software • Manufacturing quality • Clinical trial validity • Regulatory concepts and actual practices

31. Factors Impacting Medical Device Adverse Effects (2) • Institutional healthcare priority setting and investment • Selection, procurement, and cost control • Equipment management and support • Clinical level quality control • Training & education • Risk management program • Internal incident reporting program • Information culture

32. Concepts and Definitions

33. Acceptance Test A detailed procedure to verify the safety and performance of a device prior to its use, either after initial receipt (i.e., incoming or commissioning inspection) or following major repairs, modifications, or overhaul.

34. Calibration Determination of a device’s accuracy, using test equipment of verified and appropriate accuracy, and adjustment of that device to meet recommended accuracy requirements.

35. Ease of Use Ease of use is determined by equipment human factors design, the user-friendliness of software, and the availability and clarity of instructional materials and training programs.

36. Effectiveness A technology’s ability to fulfill its intended clinical purpose under actual, real-world conditions.

37. Efficacy The ability of a diagnostic or therapeutic modality to fulfill its intended clinical purpose under ideal conditions.

38. Inspection Checks the physical integrity and function of a device and ensures that it meets appropriate safety and performance requirements of the manufacturer and biomedical engineering service.

39. Medical Device 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).

40. Modification Replacement, remounting, adjustment, or addition of components or subsystems to a device to improve safety, reliability, or performance, as recommended by the manufacturer or other recognized source.

41. Overhaul Replacement of worn parts, upgrading or modification, calibration, or refinishing according to or in conformance with manufacturers’ recommendations.

42. Performance The ability of equipment to fulfill its intended purpose and its conformity with its technical specifications.

43. Preventive Maintenance Periodic procedures to minimize the risk of failure and to ensure continued proper operation.

44. Reliability A measure of consistent performance and safety without failure.

45. Repair Troubleshooting to isolate the cause of device malfunction, followed by replacement or adjustment of components or subsystems to restore normal function, safety, performance, and reliability.

46. Safety Safety is a systems concept, rather than simply a product attribute.

47. Technology Management A disciplined group of interrelated processes that supports the safe and cost-effective clinical application of technology, ensures its readiness and reliability, protects economic investment in technology through appropriate service and maintenance, and ensures that clinical personnel use equipment safely, effectively, and with appropriate selectivity.

48. Universal Medical Device Nomenclature System™(UMDNS™)

49. Medical Device Term 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).

50. 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.