Girardi | Keese

FDA report reveals startling increase in medical device recalls

We rely on medical professionals to provide us with the best possible care in order to ensure that we live long and healthy lives. We also rely on medical device manufacturers to build products that are both safe and reliable in order to ensure the exact same result.

However, as shown by a recent report from the U.S. Food and Drug Administration, at least one of these groups are perhaps failing to meet these expectations.

Last Friday, the FDA released its "Medical Device Recall Report," which contains some truly remarkable findings concerning the number of recalls in this area over the course of the last decade.

For instance, the FDA determined that from 2003 to 2012 recall events involving medical devices almost doubled from 604 to 1,190. Furthermore, 2012 saw 2,475 medical devices included in recall events, which can cover more than one product.

As if this wasn't disconcerting enough, the FDA found the number of Class I recalls jumped from a mere seven in 2003 to an astounding 57 in 2012. Looking at things from another perspective, Class I recalls went from representing just one percent of total medical device recalls in 2003 to almost five percent of all medical device recalls in 2012.

For those unfamiliar with a Class I recall, it is defined by the FDA as one in which there is "a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

Why then have the number of medical device recalls jumped so high over the last decade?

According to the report, the increase in Class I recalls can likely be attributed to agency efforts to improve classification of product recalls, while the overall increase can be attributed to improved internal monitoring by medical device manufacturers.

"We believe the increase is the result of increased awareness prompted by targeted interactions with industry and individual manufacturers," reads the report. "Moreover, these interactions triggered efforts within industry to improve safety of devices, which are expected to improve device performance over time."

While the FDA report paints a classic good news/bad news scenario, there really shouldn't ever be any bad news when it comes to medical devices. Indeed, those harmed by defects in these products should always remember they have rights and options for securing justice.

Source: The Boston Business Journal, "Life-threatening medical device recalls up eightfold since 2003," Don Seiffert, March 21, 2014

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