Medical Device Recalls Doubled in Past Ten Years

 Posted on April 15,2014 in Defective Medical Devices

A new report from the Food & Drug Administration's Center for Devices and Radiological Health says that defective devices have spiraled out of control in the last decade. Between 2003 and 2012, device recalls have increased by 97 percent. Defective medical devices have caused injuries, pain, and complications for patients who use them.

The report indicates that the most common causes for recalls are software problems, nonconforming material, component issues, or device design defects. The government agency put most of the responsibility on device manufacturers, saying with some careful inspection and research it could be possible to prevent up to 400 recalls every year.

The FDA has increased its focus on the medical device industry after numerous complaints and allegations indicated a string of problems with devices. Some patients discovered too late that devices didn't work properly, putting them at risk of injury or death.

Some of the government initiatives to reduce recalls and support safer devices have included improvements in internal processes for identifying root causes in recalls, establishment of a recall process improvement team, systematic analysis of recall information reported by consumers, and newer methods for communicating recall information.

Although problems with devices may be reported relatively early in a product's history on the market, it can take upwards of 230 days for the device to be officially recalled. This is because of a complex chain of events at the federal level requiring investigation and notification about dangerous products.

In addition to physical problems with devices, more attention is being given to the strength of security programs with which medical devices are equipped. Security breaches can make patients vulnerable when the device can be accessed by another individual. If you have been injured or put at risk by a defective medical device, contact an Illinois personal injury lawyer today.