Inspectors could reduce medical device recall rates by 20%

The Food and Drug Administration (FDA) could reduce the amount of recalled medical devices by 20 percent by placing product inspectors on a rotating schedule, according to a study published in Manufacturing & Service Operations Management.

The recall of medical devices strains both manufacturers and consumers, so researchers from Indiana University, University of Wisconsin-Madison and University of Minnesota developed a set of recommendations to decrease medical device recalls.

Over the course of seven years, researchers evaluated 4,767 FDA plant inspections and 2,863 medical device recalls originating from 2,244 different manufacturing plants.

"We found that FDA medical device plant inspection outcomes are highly predictive of future medical device recalls originating from that plant, but only when it is the first time the FDA investigator has inspected that plant," said author George Ball of Indiana University.

Results showed a 21 percent increase in future recall risk following the second time a single investigator inspects the plant; this risk increases to 57 percent the third time the plant is inspected. In response, researchers developed two solutions that could reduce medical device recalls by 20 percent.

Recommendations included having rotating investigators so the same plant is never inspected twice by the same inspector and sequencing investigators so they do not visit the same plant twice in a row. These two steps, while costing an additional $800,00 in travel expenses, results in an average of 100 less medical device recalls.

"Our findings demonstrate that the FDA, and likely other federal regulators must navigate a fine line in their relationships with industry managers," wrote lead author Rachna Shah of 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."