Regulation
A mandatory law or rule that is issued by a governing body
Standard
A uniform method of defining basic parameters for processes, products, services and measurements
Standards (regulatory)
Mandated by the government, if not complied with may cause fines
Standards (voluntary)
A benchmark recommended, but not enforced by the governing body
Statute
A written or enforceable law enacted by a governing body
Compliance
Typically mandatory and can carry fines or lead to legal consequences if not followed
Food and Drug Administration (FDA)mission
A government agency responsible for foods, cosmetics, vet drugs, biological, medical products
FDA functions within
Public Health Services of the US Department of Health and Human Services
Class 1 Devices
Include low risk devices like hand-held surgical instruments, and ultrasonic cleaners
Class II Devices
Considered to pose a potential risk to warrant a higher regulation. Includes most types of sterilizers, biological and chemical indicators.
Class III
Includes heart valves, pace makers and other life sustaining devices
Pre and post market requirements
Unless exempt a 501k submission is required for class I and II devices. Class III require a 501k or a PMA
Post Market device requirements
Requires registration and listing
Medical device
reporting/tracking/corrections/removal
Quality system
regulations
Labelling
Safe Medical Device Act
Created in 1990 requires health care facilities to become subject to user reporting requirements
Medical Device Reporting
Beginning in 2000, requires the medical field to report suspect medical devices-related deaths to the FDA within 10 working days
Med-Watch Program
A safety information and adverse event reporting system
Medical Device Recalls
To fix or check a product when it is defective or poses a risk to health
FDA Recall Class I
Highest risk - reasonable chance the product will cause serious health issues or death
FDA Recall Class II
Less serious risk - There is a possibility the product will cause temporary or reversible health risks
FDA Recall Class II
Low risk - Little chance of being expose or hurt from this product
FDA Labeling Product
Created in 1996, to provide guidance for FDA reviewers who evaluate pre market approval applications for medical devices - reprocessing
FDA Labeling Product responsibilities
Manufacturer responsible for:
Supporting the claim of reuse
with adequate labeling on how to reprocess the equipment
Documentation of tests
Re-Use of a single use medical device
Dates back to 1970 states
(a) the item can be cleaned and
sterilized
(b) the quality of the item will not be effected
(c) device will remain safe
FDA Enforcement Requirements for Hospital Reprocessing for single use devices
Created in 2000 documents highlighting the reused of medical devices
Hemodialyzers
Equipment used to remove impurities from blood before returning it to the patients body
Third party reprocessors
Regulated by the FDA decides on what SUDS will be reused
Center for Disease Control (CDC)
Federal agency works to promote health and quality of life by preventing disease and injury
Department of Transport (DOT)
Responsible for fast and efficient transport of instrumentation and hazardous/radioactive waste
Environmental Protection Agency (EPA)
Created to enforce the laws relating to cleaner water, air, and land.
EPA products must contain
Product ingredients
Direction for use
Product precautions
and warnings
Directions for storage and disposal
Registration number
Clean Air Act
Created in 1990 to protect the earths ozone layer
Occupational Safety and Health Administration (OSHA)
Creating in 1971 to protect workers from occupational illness and
injuries
May intervene when no specific regulation covers a situation
Association for the Advancement of Medical Instrumentation (AAMI)
Founded in 1967, voluntary consensus organization to recommend practices and standards around the use, care, and processing medical devices
American National Standards Institute (ANSI)
Founded in 1918, primary mission is to enhance the global competitiveness of US businesses and the American quality of life
Association of Operating Room Nurses (AORN)
Professional organization consisting of pre op nurses
World Health Organization (WHO)
United Nations organization formed to improve health conditions