Pharmaceutical

More government oversight credited for jump in medical device recalls

 More government oversight credited for jump in medical device recalls The number of medical device recalls has doubled in the past 10 years, according to a new report, a result of more government oversight and manufacturers doing a better job of halting sales of defective devices, officials say.

Yearly recalls jumped from about 600 in 2003 to 1,200 in 2012, according to the report, which was prompted in 2011 by the Government Accountability Office (GAO). The largest rise was due to radiological devices, such as MRI and CT scanners, which have been found to register false positives and increase the risk of cancer.

A fifth of the recalls in 2012 involved radiology equipment, with numbers spiking in more recent years after a Food and Drug Administration (FDA) hearing raised concerns about unnecessary radiation exposure from the devices.

The vast majority of recalls were of only moderate risk, known as Class II recalls, five percent were considered high risk, or Class I – a jump from 1 percent in 2003. The top three reasons for recalls were the presence of nonconforming materials, software defects, or design defects.

One of the most notorious recent Class I recalls involved Johnson & Johnson’s DePuy ASR hip replacement device. Made of metal-on-metal parts, the implant was considered more durable than traditional ceramic or plastic devices. However, the all-metal devices were defectively designed, and were failing at a higher rate in just five years or less.

In 2010, Johnson & Johnson issued a worldwide recall, and has since been slapped with thousands of lawsuits from patients who say they were injured by the faulty hip implants. Since then, the FDA has issued warnings that metal-on-metal artificial hips from other manufacturers have also been shown to prematurely fail and cause a type of blood poisoning known as metallosis.

Source: Law360