Voluntary and Mandatory Medical Device Reporting –
Food and Drug Administration
PDF Version of BQA 02-012 (PDF,
Date: July 26, 2002 -- DSL-BQA-02-012
For: All Health Care Providers Regulated by the Bureau of Quality
FROM: Jan Eakins, Chief, Provider Regulation and Quality
CC: Susan Schroeder, Director, Bureau of Quality Assurance
The U.S. Food and Drug Administration has a web site dedicated to
reporting problems with medical devices. It states that "Medical
Device Reporting (MDR) is the mechanism for the Food and Drug
Administration to receive significant medical device adverse events from
manufacturers, importers and user facilities, so they can be detected and
Some health care facilities (e.g. hospitals and nursing homes) are required
to report suspected medical device related deaths to both the FDA and the
manufacturers. Serious injuries need only be reported to the manufacturer.
If the manufacturer is unknown, the serious injury is reported by the
facility to the FDA. Health professionals should familiarize themselves
with their institution's procedures for reporting adverse events to the
FDA. The web site is located at: http://www.fda.gov/Safety/MedWatch/default.htm
(exit DHFS). The form for reporting is located at
(exit DHFS; PDF).
Other health care providers (Community Based Residential Facilities,
Residential Care Apartment complexes, etc.) are not required to report,
but may want to report similar equipment failures to the FDA. The
voluntary website is located at: http://www.fda.gov/medwatch/
Examples of medical devices include siderails, hoyer lifts, feeding
tubes, nebulizers, etc. Many other examples can be found on the FDA web
site. Reporting adverse events and related problems with medical devices
is one additional step in ensuring the overall health and safety of the
many individuals who are served by our numerous health care providers.
This memo is informational only.
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