Medical Device Manufacturers More Likely to Issue Recall After Subsequent Visits from Same FDA Inspector

According to a new study published in the journal Manufacturing & Service Operations Management, US-based medical device manufacturers could decrease their annual product recalls by as much as 20 percent if they were visited by different FDA representatives for each inspection. The switch to a rotating inspector schedule could prevent 100 devices from being recalled each year.

“We found that FDA medical device plant inspection outcomes are highly predictive of future medical device recalls originating from that plant,” said George Ball, Assistant Professor, Operations and Decision Technologies Department at Indiana University, “but only when it is the first time the FDA investigator has inspected that plant.”

Ball and his colleagues studied over 4,700 documents from manufacturing plant inspections conducted over a seven-year period. In that time, nearly 2,900 medical device recalls were issued originating from approximately 2,200 manufacturing facilities.

Their findings suggest that each subsequent visit to a plant by the same FDA inspector increases the risk of a future medical device recall. After an inspector’s second visit to a facility, the risk of recall increases by 21 percent; the third visit pushes this risk up to 57 percent.

“These increased recall risks may be symptomatic of increased familiarity between plant management and a repeat investigator, enabling the plant to relax its standards,” said Enno Siemsen, Executive Director of the Erdman Center for Operations & Technology Management at the University of Wisconsin-Madison.

By implementing a rotating strategy whereby FDA personnel don’t inspect the same facility more than once, the researchers believe that annual medical device recalls could be decreased by 20 percent. However, this improvement in medical device safety would come cheap; its estimated that the rotating schedule would cost the FDA $800,000 in additional travel expenses.

“Our findings demonstrate that the FDA, and likely other federal regulators must navigate a fine line in their relationships with industry managers,” said Rachna Shah, Associate Professor Supply Chain and Operations at the University of Minnesota. “If overly familiar relationships allow complacency to creep in, it comes at a high cost for medical device consumers who are at risk of a significant increase in medical devices failures leading to recalls.”

In 2016, the FDA recalled 39 medical devices, many of which were classified as a Class I recall indicating that the devices could cause injury or death. This year, the agency has already recalled 29 devices.