Recalls Continue Through Pandemic: Report
Although Stericycle predicted a drop in product recalls during the Covid-19 shutdown of the U.S. economy that started at the end of the first quarter, recalls continued at their typical level, according to the company’s second-quarter report. The report section on medical devices says those companies arguably have the toughest road ahead when it comes to product safety and recalls.
Demand for devices needed for Covid-19 response remains high, Stericycle says, and recall activity reached levels not seen in two years, surpassing 300 recall events for the first time since Q2 of 2018. “We saw not only a consistent drumbeat of FDA medical device recalls,” the report says, but also a flurry of “unofficial” recall activity.
Medical device recalls jumped by almost one-third to 341 events in the second quarter, putting the industry on track to experience an annual increase of 35% over 2019 to some 1,200 recalls. The average Q2 event size of 86,000 units was the smallest average recorded over the last 13 quarters.
Some 14.1% of the recalls were for safety issues, overtaking software issues for the first time in 16 consecutive quarters. Sterilization issues accounted for 62.9% of all affected units, largely the result of one anomalous recall of syringes affecting more than 16 million units.
On the pharmaceutical side, Stericycle says, two main Covid-19 concerns for FDA were hand sanitizers and so-called Covid-19 fraud, involving medical products making fraudulent and unproven claims related to preventing or treating Covid-19. However, the report says, arguably the most critical task on the agency’s priority list is oversight of foreign drug manufacturers. It cites a Government Accountability Office updated drug safety report that found that FDA’s ability to ensure a safe drug supply has been hampered by its inability to inspect overseas facilities.
Stericycle projects that with growing recalls due to contaminated active pharmaceutical ingredients, FDA will want to monitor for quality and safety issues originating from foreign facilities. To the extent that domestic inspections resume before international activities, it says, companies should expect:
- FDA will likely focus on high-demand, high-risk product categories;
- FDA may use U.S.-based facilities as a conduit to inspect overseas suppliers;
- “bad actors” will be a top priority;
- FDA will make its usual documentation requests; and
- Covid-19 will not be an acceptable excuse.
In Q2 there were 67 drug recall events, down 28% from the Q1 total. The recalls involved 17.5 million units, down 65.9% from Q1. The report says these decreases are not surprising, given the FDA focus on Covid-19. It says the industry is on track to have about 320 recalls in 2020, just shy of the 336 events last year.
Some 23.9% of the recalls involved failed specifications, the 14th time in the last 18 quarters. Some 59% of the units recalled were for foreign material, with the results of one anomalous recall affecting 8.8 million units. Eight of the recalls were related to NDMA contamination.