Biomaterial Database

Impact of the Safe Medical Devices Act on healthcare facilities. 1993

C Lekhy

Methodist Health Systems, Memphis, TN.

The Safe Medical Devices Act (SMDA) of 1990 (Public Law 101-629) is a federal law that became effective November 28, 1991. The SMDA mandates all facilities that use medical devices (referred to as device user facilities) to report serious injuries, serious illnesses, and deaths to the U.S. Food and Drug Administration (FDA) and the manufacturer. The purpose of the act is to protect the public by ensuring that medical devices are not unsafe for their intended use.

UI	MeSH Term	Description	Entries
D010934	Planning Techniques	Procedures, strategies, and theories of planning.	Planning Theories,Methodology, Planning,Planning Methodology,Planning Technic,Planning Methodologies,Planning Technics,Planning Technique,Planning Theory,Technic, Planning,Technique, Planning,Theory, Planning
D011358	Product Surveillance, Postmarketing	Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.	Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D004282	Documentation	Systematic organization, storage, retrieval, and dissemination of specialized information, especially of a scientific or technical nature (From ALA Glossary of Library and Information Science, 1983). It often involves authenticating or validating information.	Documentations
D004869	Equipment Safety	Freedom of equipment from actual or potential hazards.	Device Safety,Hazards, Equipment,Medical Device Safety,Safety, Equipment,Device Safety, Medical,Safety, Medical Device,Equipment Hazard,Equipment Hazards,Hazard, Equipment,Safety, Device
D006268	Health Facilities	Institutions which provide medical or health-related services.	Facilities, Health,Facility, Health,Health Facility
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration