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Reducing the risk of medical device recalls might be as simple as increasing the rotations of FDA plant inspectors. This was the key finding from a study that sampled seven years of data from FDA inspections and recalls. If the FDA decides to implement the findings, researchers believe it will lead to higher quality facilities and fewer recalls of medical devices.
The initial findings from researchers from the University of Minnesota, University of Wisconsin, and Indiana University found that when an inspector has spent some time at a facility, recall rates increased, though no findings of fault were revealed in inspection reports. When an inspector at a facility was new to that facility, recall rates decline for a time before creeping back up.
The team took an unusual approach to the problem. They found they could predict future recalls based entirely on the first report provided by an inspector. This provided researchers with two clear facts:
By demonstrating a connection between the number of visits by an inspector and the number of recalls later, the team demonstrated that the idea of a fresh set of eyes is a good one.
Enno Siemsen, who co-authored the study, believes the increased recall risks result because plant management and inspectors become more familiar. The increased familiarity allows a relaxing of standards, which leads to increased medical device failures. The increased failures lead to increased independent product inspections, and in turn to recalls.
The team noted that previous research considered the violations written as compared to time at a facility by inspectors. A similar trend was noted, but the team expressed caution that while fewer violations at a plant could indicate the inspectors are becoming lax, it could also indicate that the factory has improved conditions.
If you or a loved one has been harmed by a defective medical device, contact a Pennsylvania defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler. For a free consultation, call 800-369-0899 or 215-569-4000 or contact us online. We serve clients throughout the Philadelphia area and New Jersey including Philadelphia County, Chester County, and Delaware County.