Medical Device Recalls Have Double in Last Decade - FDA
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Medical Device Recalls Double in Last Decade

Medical device recalls have doubled in the last decade from 2003 to 2012 according to a newly released FDA report.

The FDA report was generated in response to a 2011 GAO report (Government Accountability Office) that called on the FDA to increase its oversight of medical device manufacturers, to identify trends in devices most frequently recalled, and to particularly focus on Class I recalls of defective medical devices whose continued use involves the greatest risk of injury or death to patients.

There were 604 medical device recalls in 2003 as compared to 1190 in 2012 according to the FDA report, a nearly 50% increase, and Class I recalls of medical devices increased from 7 in 2003 to 57 in 2012.

For its part, the FDA partially links the uptick in recalls to their increased inspections of device manufacturers. The FDA also focused its attention on medical imaging devices like CTs and x-rays equipment because of the dangers associated with radiation exposure, and since the highest number of recalls involves a medical imaging device, followed by cardiac defibrillators.

Device manufacturers also claim to be more pro-active when it comes to patient safety, and are reporting adverse events to the FDA and consumers in a timelier manner, helping to drive more medical device recalls.

Although this is a step in the right direction, more communication is needed between the FDA, manufacturers, hospitals and healthcare providers.

Manufacturers must be more transparent about device safety issues, and immediately advise the FDA of any defects or problems. Prompt recalls are the first step in ensuring improved patient safety.

In turn, the FDA needs to be timelier in notifying hospitals and health care providers about these recalls, and must develop a system to advise hospitals and healthcare providers which are the most important recalls and those that should be addressed first. “With the huge increase in the number of recalls, one of the things hospitals need to be able to do is to prioritize them,” explained Eric Sacks, Director of the Healthcare produce alerts for the ECRI Institute.

Hospitals and healthcare providers must prioritize patient safety by having the necessary staff and communications systems in place to ensure medical device recalls are immediately followed and implemented.

Attorneys have also played a role in bringing about an increase in medical device recalls over the last decade. Some recalls are prompted by attorneys bringing claims on behalf of patients injured by faulty devices, thus raising consumer and government regulators’ awareness about dangerous and defective products. Sadly, by then a faulty device has already injured someone and a recall is too late.

We hope the increased focus on patient safety is a trend that continues and eventually becomes “standard operating procedure” for all parties involved. Greater manufacturer oversight, improved communication between the parties—FDA, device manufacturers, hospitals and health care providers—and increased recalls of defective medical devices will benefit us all by preventing injuries from happening in the first place.