A significant spike in product recalls rocked the healthcare industry in the first quarter of 2018 as both pharmaceutical and medical device companies experienced an unusually high number of problems, according to the latest U.S. Recall Index released May 8 by Stericycle Expert Solutions. The Recall Index covers recalls in the pharmaceutical, medical device, and other select markets.
Pharmaceutical recalls increased 52 percent to 105, making it the highest number of recalls since Q3 2013. Failed specifications were the top cause of drug recalls for the seventh consecutive quarter, comprising nearly 22 percent of all pharmaceutical recalls.
(Image © Stericycle Inc. 2018 and courtesy of www.stericycleexpertsolutions)
“The healthcare sector in Q1, both medical device companies and pharmaceutical manufacturers, saw significant increases in recall events,” said Mike Good, vice president of marketing and sales operations, Stericycle Expert Solutions. “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.”
Medical device recalls increased 126 percent to 343 in Q1 2018, more than double the last quarter and the largest quarter since 2005. The biggest culprit for medical device recalls was software, which comprised 22.7 percent, making it the top cause for the eighth consecutive quarter.
(Image © Stericycle Inc. 2018 and courtesy of www.stericycleexpertsolutions)
About the Index
The Stericycle Recall Index aggregates and tracks recall data to help manufacturers and other industry stakeholders navigate the regulatory environment and identify trends. Each quarter Stericycle analyzes data from the U.S. Consumer Product Safety Commission (CPSC), the National Highway Traffic Safety Administration (NHTSA), the FDA, and the USDA.
To track trends in pharmaceutical and medical device recalls, the Stericycle Recall Index uses information publicly available in news releases posted on the FDA website. For additional insight into recalls governed by the FDA, Stericycle collects and analyzes data from the agency’s weekly enforcement reports, which provide additional details including recall class, quantity of units affected, and number of reported incidents.
In addition to pharmaceutical and medical device recalls, the company issues quarterly informaton on recalls in the food & beverage, automotive, and consumer product industries. The full Q1 2018 Recall Index is available for download.
(Source: Stericycle Expert Solutions)
