Software issues drive medical device recalls for 10th consecutive quarter, report finds

Software issues continued to drive medical device recalls during the third quarter of 2018, reflecting the growing popularity of internet-connected products, according to a recent analysis of U.S. recall data.

Each quarter, product recall management company Stericycle Expert Solutions releases a "recall index" that details the frequency and causes of U.S. product recalls in the food, pharmaceutical, automotive, medical device and consumer product industries.

To compile its report on the third quarter of 2018, Stericycle analyzed data from the Consumer Product Safety Commission, the FDA, the Food Safety and Inspection Service of the U.S. Department of Agriculture and the National Highway Traffic Safety Administration.

The firm identified 284 recalls from 171 businesses in the medical device sector during the third quarter of 2018, down 21 percent from 360 recalls reported during the second quarter. The average recall size was 103,375, compared to last quarter's 117,774.

Recalled units dropped 31 percent to 29.4 million, marking the lowest quarter for recalled units since the first quarter of 2017.

For the 10th consecutive quarter, the plurality of medical device recalls — 22 percent — were caused by software issues. Other top causes for medical device recalls included mislabeling issues (15 percent) and quality issues (15 percent).

Stericycle attributed the ongoing influence of software issues on recalls to the "increasing technological sophistication and complexities of modern medical devices as they become part of the expanding internet of things," or networks of internet-connected devices.

To download Stericycle's report, click here.

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