1. Page 1 Medical Device Universe and Nomenclature Saudi Food & Drug Authority November 2005 Joel J. Nobel, M.D. Founder and President Emeritus, ECRI

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

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

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

8. Page 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. Page 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. Page 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. Page 11 The Universe of Medical Devices and Healthcare Technology in Perspective

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

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

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

16. Page 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 National Health Budget Disease Prevalence and Conditions, Epidemiological Data Healthcare Priorities and Resources

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

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

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

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

28. Page 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. Page 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. Page 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. Page 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. Page 32 Concepts and Definitions

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

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

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

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

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

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

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

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

49. Page 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. Page 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.

51. Page 51 Universal Medical Device Nomenclature System (UMDNS) Single term for each distinct entity Unique code number for each term Heavily cross-indexed Hierarchical vocabulary Widespread use

52. Page 52 Universal Medical Device Nomenclature System (UMDNS) (contd.) Translated into various languages Frequently updated Fully supported The key to all major information systems and databases on medical devices Promulgated by ECRI and WHO

53. Page 53 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).

54. Page 54 Information Principle (1) The more general a term, the easier it is to file data and the harder it is to find (e.g., you could file everything in the world under “miscellaneous,” but you couldn’t find anything quickly). If you used several general categories (e.g., animal, vegetable, mineral, synthetic), medical device data would fall in three of the four files and would be difficult to file and still difficult to find.

55. Page 55 Information Principle (2) The more specific a term, the more time-consuming it is to file the information initially, but the easier and faster it is to find. Since information is labeled or filed once and retrieved frequently, it is more cost-effective to expend the energy up front than later.

56. Page 56 Information Principle (3) Hierarchical terms work best for paper-based filing systems and also facilitate computer databases. Hierarchical terms begin with the most general and proceed to increasingly specific descriptors, for example: Rifle, caliber.30, gas operated, M-1 Electrocardiograph, multichannel, interpretive Densitometer, bone, isotope, dual-photon absorptiometry Defibrillator, external, automated

57. Page 57 UMDNS Translations French German Polish Russian Spanish Turkish English-language base system translated into:

58. Page 58 Thank you