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Study shows medical device managers delay recalls

A recent behavioral study gives important insight into how the voluntary recall process works. The study found that medical device firm managers let physicians identify defects in their product, rather than issuing a voluntary recall when they suspect a problem. Indiana University and the University of Minnesota jointly conducted the research.

The recall process

Companies recall medical devices when they find a defect or discover a harmful side-effect. Most recalls are voluntary, according to the Food and Drug Administration (FDA), which regulates medical devices. Companies may discover the defect on their own, or an outside group like the FDA alerts them to a problem. Occasionally, the FDA requires a recall. Because recalls are usually voluntary, the FDA relies on companies to be self-regulating. No company wants to be associated with a problem. The bad publicity is often enough of a motivation for companies to pull bad products from the shelves. In the case of a medical device, however, the fact that a doctor may have already implanted the product into someone's body magnifies the problem. 

The purpose of the study


The study looked at several medical device manufacturers to understand what factors the companies considered when deciding to issue a recall. The authors recognized that the recalls can impact not only the financial well-being of the company and the safety of its customers, but also the operation manager's career.

The study identified several factors that go into the decision, including potential harm to customers and financial cost of the recall. One surprising factor stood out, however. Many managers waited to issue a recall until they understood more about the nature of the defect. For that, they relied on physicians to screen the product.

Why the delay?

According to the study, the decision-making delay is not for the reasons one might think. Although delaying the recall did reduce costs to the firm, that is not the only motivation. The managers tended to focus on learning more about the defect before recalling it. They seemed to have a belief that if the physicians can catch the defect, it must not be that dangerous.

FDA protocol does not require a company to understand why something is defective before recalling the item. Nor does it give clear guidelines on how to balance the many factors that go into a recall decision. Given the competing factors for the managers between their careers, the firm and customer safety, the managers' delay is not so surprising. 

The good news is that the companies involved in the study all made changes to their recall protocol based on these findings. The FDA is also considering how they can use the research to improve their oversight of medical devices. The researchers think their insights could be expanded to quality control and recall of other types of products, as well.   


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