The rapid pace of innovation in medical devices resulted in an unfortunate side effect of increasing medical device recalls in the second half of 2016. Stericycle ExpertSOLUTIONS looks at trends in this industry and others in the recently released Recall Industry Spotlight.
The biannual Industry Spotlight, which examines trends in a specific industry, found that medical device recalls heated up quickly as the year progressed, increasing 44 percent from the first half of the year. There were more than 650 medical device recalls in Q3 and Q4 2016, the second highest since at least 2000. More than 180 million products were recalled in total, making it the third highest half year on record since 2000 as well.
While the top causes of recalls fluctuated quarter to quarter, a clear pattern emerged: software problems drove the highest number of recalls across the two quarters, with product mislabeling a close second. When examining the number of units affected, quality issues were the leading cause followed by mislabeling, parts problems, and sterility concerns.
The safety of lithium-ion batteries in medical devices was a noteworthy contrast to other industries, the report found. Unlike the battery’s fire hazard problems plaguing consumer products like hoverboards, lithium-ion battery problems have not been as prominent in medical devices.
A likely reason for the disparity is quality control. Consumer electronics are one of the most counterfeited product types in the U.S., making them far more likely to include subpar batteries that put the public at risk. Consumer products also tend to suffer much greater wear and tear. Medical devices have not yet experienced these kinds of threats at the same level. The Industry Spotlight report does, however, caution manufacturers that lithium-ion battery problems could become more commonplace in medical devices as their use increases. Manufacturers would be wise to start making contingency plans for potential recalls since the batteries have specialized transportation, permitting, and destruction requirements.
For more information, download the report here.
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The FDA has announced a new Toolkit to combat counterfeits and other substandard medical products.… https://t.co/ifpjNuidD8
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