Medical Device Universe and Nomenclature Saudi Food Drug

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

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

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 3

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

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 5

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 6

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

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. Page 8

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 9

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 10

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

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 12

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

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

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

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 16

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) 17

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

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

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

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

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 invitro grown tissue matrix fit? 22

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 Brands, Models, and Sizes • More than 35, 000 Manufacturers 23

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 24

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 25

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 26

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

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. 28

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 29

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 30

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 31

Concepts and Definitions 32

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. Page 33

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. Page 34

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. Page 35

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

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

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. Page 38

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. , singlechannel electrocardiograph, steam sterilizer). Page 39

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. Page 40

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

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

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

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

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. Page 45

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

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. Page 47

Universal Medical Device Nomenclature System™ (UMDNS™) 48

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. , singlechannel electrocardiograph, steam sterilizer). Page 49

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. 50

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 51

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 52

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). 53

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. 54

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. 55

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 56

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

Thank you 58