Efficacy of Device Monitoring Under Fire
Recent cases of adverse events associated with medical devices are stirring controversy about the safety monitoring process after FDA approval. One example is the Davol, Inc. (a subsidiary of C.R. Bard, Inc.) recall of its hernia repair device, the Kugel patch. The manufacturer issued a product recall for the large patches in late 2005 following reports of internal injuries after device breakage. An FDA review later revealed problems with Davol’s handling of device compliants.
The FDA has monitoring guidelines to asses problems with devices and adverse events after manufacturers receive approval. Manufacturers are required to report patient morbidity and mortality related to device problems. However, manufacturers may determine their own system to track, analyze, and respond to complaints filed by healthcare workers. Device manufacturers are also allowed to conduct internal review of device problems and then submit only those deemed device-related to the FDA.
Boston Scientific recalled a device in 2004 following a death attributed to, in part, problems with the device designed for GERD patients. Following an FDA review, Boston Scientific overhauled its system to handle complaints.
Some question whether the FDA post-market guidelines are adequate, particularly in light of the increasing number of devices now coming to market. See report from The Washington Times.
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March 19, 2007 Related topics: Quality, Safety, Errors