Following a seven-year review of US Food and Drug Administration (FDA) inspections of medical device manufacturing facilities as well as medical device recalls, findings have revealed that rotating safety inspectors could help lower safety risks for consumers.
What Are the Benefits of Rotating Safety Inspectors?
The seven-year study was conducted by researchers at the University of Minnesota, the University of Wisconsin and Indiana University. According to researchers, safety inspections were most successful when they were conducted by a new inspector rather than a safety inspector that was already familiar with the facility.
The researchers say that inspection results are very often able to predict when a medical device recall is about to happen, but only if the inspection is carried out by a FDA inspector that has never inspected the medical device manufacturing facility before. Per the results of the study, the chances of a recall happening rose 21 percent the second time the same inspector inspected a facility and the likelihood of a recall rose 57 percent the third time the same inspector inspected a medical device manufacturing facility.
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