Software leads to almost a quarter of medical device recalls

We write frequently about recalls of dangerous medications and other healthcare products. Recalls are often necessary to fix technical problems with medical devices, clarify warnings for pharmaceuticals and eliminate access to products too dangerous for patient use. Interestingly, the Food and Drug Administration (FDA) has recently learned that a certain kind of defect leads to almost 25 percent of medical device recalls.

It turns out that almost a quarter of medical devices recalled due to danger or defect are taken off the market due to a software problem. As a result of this discovery, the FDA has decided to crack down on the kinds of software quality issues that lead to medical device recalls.

Specifically, the Office of Science and Engineering Laboratories unit of the FDA will be spending more time and resources on testing the security and overall quality of medical device software. The FDA hopes to head off poorly written or badly designed software before it is installed in devices placed on the market for patient use.

After the FDA released its findings on software failure rates in medical devices earlier this month, the agency then released a statement that it is developing "techniques and laboratory expertise to assist our review staff in identifying potential vulnerabilities and evaluating risk mitigation measures" with regard to software.

Though it is technically the responsibility of manufacturers to ensure software security and quality, it is up to the FDA to help ensure that dangerous and defective devices are either excluded from the marketplace or are promptly fixed. The FDA's new focus on software quality will hopefully achieve the ultimate objective of increasing patient safety.

Source: CSO Online, "FDA eye on medical device software after recall link," Antone Gonsalves, June 22, 2012