Medical Device Reporting: Improvements Needed in FDA's System for
Monitoring Problems With Approved Devices (Letter Report, 01/29/97,
GAO/HEHS-97-21).

Pursuant to a legislative requirement, GAO reviewed user facilities'
compliance with the Safe Medical Devices Act of 1990's (SMDA 90)
reporting requirements, focusing on whether: (1) the enactment of SMDA
90 has led to an increase in reporting of device-related adverse events
to the Food and Drug Administration (FDA); (2) the amount and quality of
information from user facilities have enhanced FDA's ability to quickly
identify and take action on device problems; (3) manufacturers and FDA
have responded to device problems identified in user facility reports;
(4) FDA routinely communicates device problem trends and corrective
actions taken to user facilities and the public; and (5) changes need to
be made to the user facility reporting requirements and FDA's adverse
event reporting system to improve medical device problem reporting.

GAO found that: (1) although the amount of information reported to FDA
about medical device problems has increased dramatically since SMDA 90
was enacted, FDA does not systematically act to ensure that the reported
problems receive prompt attention and appropriate resolution; (2) as a
result, FDA's adverse event reporting system is not providing an early
warning about problem medical devices as SMDA 90 intended; (3) during
fiscal years (FY) 1991 through 1994, FDA received almost four times as
many adverse event reports from device manufacturers as it did during FY
1987 through 1990; (4) however, the extent to which user facility
reporting under SMDA 90 directly accounted for the increased volume of
reports is unclear because, until recently, FDA did not require
manufacturers to disclose whether serious injury reports originated from
user facilities or from some other source; (5) this increased volume
made it difficult for FDA to process and review reports in a timely
manner; (6) to address this problem, FDA chose to give priority to death
and serious injury reports, which resulted in its delaying for nearly 2
years processing and reviewing almost 50,000 malfunction reports, which
are essential in alerting FDA to potentially serious device problems
before they result in death or serious injury; (7) to better manage the
reporting workload in the future, FDA has initiated several changes to
the adverse event reporting system; (8) FDA has received significantly
fewer adverse event reports from user facilities than it expected; (9)
much of the information that user facilities did provide was of poor
quality and incomplete, in part because FDA did not issue the final
medical device reporting regulation in a timely manner or periodically
educate user facilities about their responsibilities under SMDA 90; (10)
although FDA contends that it notifies manufacturers and user facilities
about imminent hazards and industrywide safety concerns, it does not
routinely document the corrective actions it takes or those taken by
manufacturers to address reported medical device problems; (11) FDA does
not keep track of the length of time it takes to process, review, and
initiate action on serious device-related problems or the time that
elapses before manufacturers resolve the problems; (12) manufacturer and
user facility representatives told GAO they do not know how FDA uses
adverse event reports to protect the public health; and (13) FDA and re*

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  HEHS-97-21
     TITLE:  Medical Device Reporting: Improvements Needed in FDA's 
             System for Monitoring Problems With Approved Devices
      DATE:  01/29/97
   SUBJECT:  Medical equipment
             Reporting requirements
             Product safety
             Consumer protection
             Statistical methods
             Food and drug law
             Hospitals
             Government information dissemination
IDENTIFIER:  FDA Medical Device Reporting System
             FDA Medical Device and Laboratory Problem Reporting Program
             FDA Manufacturer and User Device Experience System
             FDA Medical Products Reporting Program
             FDA MedWatch System
             FDA Good Manufacturing Practices Compliance Program