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09. 05.2018

Medical device recalls significantly increase during Q1

Category: Insights

The medical device and pharmaceutical industries saw a significant spike in product recalls during the first quarter of 2018, according to the U.S. Recall Index released by Stericycle Expert Solutions.

There was a 126% increase in medical device recalls in Q1 — the most in a quarter since 2005. Software problems made up about 22.7% of device recalls. Software has been a leading cause for recalls for an eighth consecutive quarter.

Pharmaceutical recalls also rose 52% in Q1. The increase makes the quarter the highest number or recalls since 2013. The top cause of drug recalls includes failed specifications, which has also been the top cause for seven consecutive quarters. Failed specifications make up 22% of all pharmaceutical recalls, according to the Stericycle Expert Solutions report.

“The healthcare sector in Q1, both medical device companies and pharmaceutical manufacturers, saw significant increases in recall events,” Mike Good, VP of marketing and sakes operations at Stericycle Expert Solutions, said. “Issues ranging from software to mislabeling in med device, to failed specs and foreign materials in pharmaceuticals caused pretty dramatic spikes and show that you have to be vigilant and act on recalls when they happen, especially when your health is on the line.”

Stericycle Expert Solutions releases its Recall Index to track recall data for the pharmaceutical, medical device, automotive, food and consumer product industries.

Medical device recalls rose to 343 in Q1, higher than the total recalls in 2017. Some of the top causes include software issue, mislabeling issue, quality issue and outside of specifications. Approximately 55% of medical device recalls were nationwide with 186,580,917 average class I units being recalled in Q1.

Pharmaceutical recalls increased to 105. There were nearly 332.5 million units recalled, the highest quarter since the second quarter of 2007. Some of the top causes for pharmaceutical recalls include failed specifications, sterility, mislabeling, foreign materials and sub potency. About 79% of pharmaceutical recalls were nationwide this quarter with 97.8% being class II, 1.3% class III, 0.3% class I and 0.6% unclassified.

Source: Medical Design and Outsourcing