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Recalls of defective medical devices on the rise

According to the Food and Drug Administration, the recalls of medical devices have been on the rise in recent years. Back in 2006, 4,500 deaths were linked to the use of medical devices. One of the biggest reasons for defective medical devices today -- a problem that affects patients in West Virginia and other states -- is design problems.

Since 2010, problems with the designs of medical devices have accounted for about 35 percent of the root causes of device recalls as determined by FDA or firm investigation. Design problems include labeling designs, process designs, software designs, packaging designs and component designs. Issues involving the design of a device are actually the most common cause of the recalls of medical devices.

Unfortunately, design-related defects are the most likely to lead to serious medical problems or even death. Equally unsettling is the fact that medical device companies are still struggling to figure out the correct mitigations for the recurrence of these hazards. Even when medical device companies try to emphasize safety to their employees in an effort to counteract the negative trend of rising medical device recalls, these safety behaviors tend to fade over time, thus creating an environment where another design error and subsequent recall is inevitable.

West Virginia patients who are harmed by defective medical devices have the right to seek justice through the civil court system. They can file product liability claims against the device manufacturers, seeking the reimbursement of damages sustained. Although monetary compensation cannot reverse the events that caused harm to a patient who used a defective medical device, it may help to provide closure in such a case.

Source:, "What's Behind Medtech's Recall Epidemic? Part 1: Device Design", June 27, 2016

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