While the Food and Drug Administration requires devicemakers to conduct postmarket surveillance to monitor the safety of their products, they often wait too long before recalling devices, according to a study published in Production and Operations Management.
For the study, researchers at Minneapolis-based University of Minnesota examined devicemakers' judgment bias when deciding whether to recall a product after receiving adverse event reports from users. Researchers used digital analytics to assess millions of medical device product reports and recall records.
They found a high "signal-to-noise" ratio associated with delayed reactions to safety events, meaning the more adverse events reported for a specific device, the more likely a company will exhibit "under-reaction bias" — or take too long to react — when deciding whether to recall the device, according to the study.
"The reality is, if you look at the results, clearly there is under-reaction" to events that prompt device recalls, study author Kingshuk Sinha, PhD, professor and head of the supply chain and operations department at the university's Carlson School of Management, told the Star Tribune.
"[T]he distribution [of reported problems] has shifted, and is no longer noise. It is actually a signal," Dr. Sinha said. "We should train our executives and decisionmakers just like fighter pilots, to make sure their reaction-time responses are optimal."
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