Medical Device Recalls Double in Past Decade

The number of recalls of defective medical devices has nearly doubled within a ten year period, according to data compiled by the U.S. Food and Drug Administration (FDA).

As reported by the Wall Street Journal, there were a total of 1190 recalls related to unsafe medical devices in 2012, up from just 604 recalls in 2003. An even more dramatic increase was observed in so-called Class 1 recalls, related to unsafe medical devices associated with a reasonable probability of death. According to the Journal report, there were 57 Class 1 recalls in 2012, compared with just seven in 2003.

The FDA’s analysis of medical device recall statistics was reportedly prompted by a 2011 investigation by the U.S. Government Accountability Office (GAO), which noted that recalls of unsafe medical devices often occur long after a device has been placed on the market, thereby exposing consumers to greater risks.

Steve Silverman, the director of the FDA medical device center’s office of compliance, told the Journal that the increase in medical device recalls may be related to increased inspections by the agency, as well as additional educational outreach efforts that have raised greater awareness.

But a spokesperson for the medical device industry noted that medical device manufacturers are also taking a more proactive approach. According to Wand Moebius, a senior vice-president of AdvaMed, “the increase in recalls reflected in the data can be attributed primarily to companies taking a more cautions, pro-active, patient-centric approach to quality, safety and reports of events to FDA.”