front 1 Regulation | back 1 A mandatory law or rule that is issued by a governing body |
front 2 Standard | back 2 A uniform method of defining basic parameters for processes, products, services and measurements |
front 3 Standards (regulatory) | back 3 Mandated by the government, if not complied with may cause fines |
front 4 Standards (voluntary) | back 4 A benchmark recommended, but not enforced by the governing body |
front 5 Statute | back 5 A written or enforceable law enacted by a governing body |
front 6 Compliance | back 6 Typically mandatory and can carry fines or lead to legal consequences if not followed |
front 7 Food and Drug Administration (FDA)mission | back 7 A government agency responsible for foods, cosmetics, vet drugs, biological, medical products |
front 8 FDA functions within | back 8 Public Health Services of the US Department of Health and Human Services |
front 9 Class 1 Devices | back 9 Include low risk devices like hand-held surgical instruments, and ultrasonic cleaners |
front 10 Class II Devices | back 10 Considered to pose a potential risk to warrant a higher regulation. Includes most types of sterilizers, biological and chemical indicators. |
front 11 Class III | back 11 Includes heart valves, pace makers and other life sustaining devices |
front 12 Pre and post market requirements | back 12 Unless exempt a 501k submission is required for class I and II devices. Class III require a 501k or a PMA |
front 13 Post Market device requirements | back 13 Requires registration and listing |
front 14 Safe Medical Device Act | back 14 Created in 1990 requires health care facilities to become subject to user reporting requirements |
front 15 Medical Device Reporting | back 15 Beginning in 2000, requires the medical field to report suspect medical devices-related deaths to the FDA within 10 working days |
front 16 Med-Watch Program | back 16 A safety information and adverse event reporting system |
front 17 Medical Device Recalls | back 17 To fix or check a product when it is defective or poses a risk to health |
front 18 FDA Recall Class I | back 18 Highest risk - reasonable chance the product will cause serious health issues or death |
front 19 FDA Recall Class II | back 19 Less serious risk - There is a possibility the product will cause temporary or reversible health risks |
front 20 FDA Recall Class II | back 20 Low risk - Little chance of being expose or hurt from this product |
front 21 FDA Labeling Product | back 21 Created in 1996, to provide guidance for FDA reviewers who evaluate pre market approval applications for medical devices - reprocessing |
front 22 FDA Labeling Product responsibilities | back 22 Manufacturer responsible for: |
front 23 Re-Use of a single use medical device | back 23 Dates back to 1970 states |
front 24 FDA Enforcement Requirements for Hospital Reprocessing for single use devices | back 24 Created in 2000 documents highlighting the reused of medical devices |
front 25 Hemodialyzers | back 25 Equipment used to remove impurities from blood before returning it to the patients body |
front 26 Third party reprocessors | back 26 Regulated by the FDA decides on what SUDS will be reused |
front 27 Center for Disease Control (CDC) | back 27 Federal agency works to promote health and quality of life by preventing disease and injury |
front 28 Department of Transport (DOT) | back 28 Responsible for fast and efficient transport of instrumentation and hazardous/radioactive waste |
front 29 Environmental Protection Agency (EPA) | back 29 Created to enforce the laws relating to cleaner water, air, and land. |
front 30 EPA products must contain | back 30 Product ingredients |
front 31 Clean Air Act | back 31 Created in 1990 to protect the earths ozone layer |
front 32 Occupational Safety and Health Administration (OSHA) | back 32 Creating in 1971 to protect workers from occupational illness and
injuries |
front 33 Association for the Advancement of Medical Instrumentation (AAMI) | back 33 Founded in 1967, voluntary consensus organization to recommend practices and standards around the use, care, and processing medical devices |
front 34 American National Standards Institute (ANSI) | back 34 Founded in 1918, primary mission is to enhance the global competitiveness of US businesses and the American quality of life |
front 35 Association of Operating Room Nurses (AORN) | back 35 Professional organization consisting of pre op nurses |
front 36 World Health Organization (WHO) | back 36 United Nations organization formed to improve health conditions |