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Medical device recall rates linked to frequency of FDA inspector rotations

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Medical device manufacturing plants in the United States can experience 100 fewer product recalls per year, or a decrease of 20 percent, if the FDA investigators who inspect these plants are placed on a rotating schedule, according to a new study in the INFORMS journal Manufacturing & Service Operations Management.

The authors of the study, “Do Plant Inspections Predict Future Quality? The Role of Investigator Experience,” are George Ball of Indiana University, Enno Siemsen of the University of Wisconsin-Madison and Rachna Shah of the University of Minnesota. Over the course of seven years, they examined 4,767 FDA plant inspection outcomes and 2,863 medical device recalls originating from 2,244 different 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,” Ball says.

The authors found there is a 21 percent increase in the risk of a future recall following the second time an investigator inspects a plant, and that risk jumps to a 57 percent increase after an investigator’s third inspection of that plant.

“These increased recall risks may be symptomatic of increased familiarity between plant management and a repeat investigator, enabling the plant to relax its standards,” adds Siemsen.

Two solutions tested during the study were found to eliminate the issue of increased familiarity, including rotating investigators so they never inspect the same plant twice, or sequencing investigators so they never inspect the same plant two times sequentially. The authors found that putting a rotation strategy in place could lead to a reduction in approximately 100 fewer (20 percent) medical device recalls per year for all medical device plants, at an increase of $800,000 in additional travel expenses for the FDA.

“Our findings demonstrate that the FDA, and likely other federal regulators, must navigate a fine line in their relationships with industry managers,” Shah says. “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.”

For the full study, click here.

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