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Study Shows Medical Device Manufacturers Rely on Doctors to Screen for Product Defects

Medical Center Virus Outbreak Leaves Six Children Dead and 12 Fighting Illness

A new behavioral study that looks into what influences the decision to recall a defective product, found that medical device manufacturers rely on physicians to screen out product defects instead of issuing a recall. According to the results of the study posted on Indiana University’s website, the study also found that some manufacturers appear to hesitate to recall a product until the root cause of the defect is clearly understood as this can reduce recall costs to the firm.

What the Study Found

The study was conducted by professors at the Indiana University Kelley School of Business and the University of Minnesota’s Carlson School of Management. The Food and Drug Administration (FDA) has apparently expressed interest in using this research to improve how they oversee medical device product quality. The research, published in the Journal of Operations Management, is the first behavioral study using actual industry managers to study what influences voluntary product recall decisions

Researchers performed a randomized behavioral experiment with medical device industry managers who make recall decisions in practice. One key finding of the study is that medical industry managers appear to trust physicians to screen out defects on behalf of the firm, “meaning that when the defect is detectable to the physician, managers are less likely to recall.” And this is because there is a perception of increased patient safety when defects are detectable. Researchers also found that managers often hesitated to recall until they first understood the root cause of the medical product defect.

Medical Device Defects

Defective medical devices have the potential to cause serious health complications. Just in recent years, our product defect attorneys have seen a number of medical devices that have caused major issues of patients including transvaginal mesh implants, metal hip implants and knee implants. Pacemakers for heart issues are also another example of medical devices that could malfunction.

This study is cause for deep concern because it shows manufacturers’ apathy when it comes to defective medical devices. They typically wait for the doctors to screen the defects. As attorneys who handle product defect cases, we already know all too well that product manufacturers do not want to issue recalls. It costs them a lot of money and is certainly a major PR nightmare. So, they end up putting profits over the safety and well-being of consumers. And it’s the consumers who pay the ultimate price.




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