-- More frequent rotation of plant inspectors at medical device manufacturing facilities could benefit consumers and lead to fewer product recalls.
That's the finding of a seven-year review of Food and Drug Administration inspections of and subsequent recalls at such facilities.
The study, by researchers at Indiana University, the University of Wisconsin and the University of Minnesota, found that plant inspections worked well when they were conducted by someone new, rather than by an investigator already familiar with the manufacturing facility.
"We found that FDA medical device plant inspection outcomes are highly predictive of future medical device recalls originating from the plant, but only when it is the first time that the FDA investigator has inspected that plant," said George Ball, assistant professor of operations and decision technologies at the IU Kelley School of Business and the study's lead author.
"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 co-author Enno Siemsen, executive director of the Erdman Center for Operations and Technology Management at the University of Wisconsin.
Previous research has noted the complacency that investigators may develop during repeated visits to the same facilities but has focused on the number of violations found during inspections.