One of the major causes of medical device recalls over the past five years is that technological advances are rushing at such a fast pace, said Chris Harvey, director of recall solutions at Stericycle. (Read the full interview.)
Oftentimes, companies rush to be the first company to bring their products to market. This rush causes software issues which in turn causes a significant amount of recalls, according to Stericycle.
Software recalls continued in the fourth quarter of 2017. About 25.7% of all medical device recalls were because of software issues, the top cause for recalls for the seventh quarter in a row.
Stericycle also reports that although sterility problems caused recalls in the past, it showed improvement in the fourth quarter last year. In 2017, 54 million units were recalled in the largest recall of the year because of sterility problems. Comparably, the largest recall in 2012 was 102 million devices being recalled because of sterility issues.
The top causes for medical device recalls were 25.7% software issues, 23.7% mislabeling issues, 16.4% quality issues and 7.2% manufacturing defects.
Stericycle has done quarterly Recall Index reports for five years to over recalls in a number of industries, including medical device, pharmaceutical, food, automotive and consumer product industries.
“One thing didn’t change over the past five years: consumers, manufacturers, regulators and lawmakers remain concerned about the safety of products. What has changed is the public is paying more attention to the recall process and how effectively brands manage product recalls and notifications,” Mike Good, VP of marketing and sales operations at Stericycle, said. “The challenge now is overcoming the recall fatigue that occurs when consumers are faced with more – and larger – recalls. We created the Recall Index as a public service to help put recall trends into perspective so all stakeholders can make informed decisions grounded in facts.”