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The decision to recall a product has profound effects on a company’s image and its bottom line. Medical device companies regularly monitor product performance such as failure rates, time on the market, and safety and health impact to the patient. When complaints from physicians and/or patients about a medical device are received, they alert the company to a potential medical device defect.
When concerns are raised, medical device companies can initiate a meeting to evaluate potential product problems. This usually includes assembling a team of managers from the quality, manufacturing, clinical, and medical disciplines to assess the situation, and decide whether to initiate a recall or to further monitor product performance.
The decision balances potentially conflicting factors, such as the credibility and financial performance of the company, and the safety and health of customers/patients.
According to the Food and Drug Administration (FDA), a product is to be recalled if it presents a risk of injury, gross deception, or is otherwise defective. This gives a lot of leeway to companies.
A study of the behavior of companies in deciding to recall medical devices has recently been published in the Journal of Operations Management. The study used vignette-experiments, where hypothetical situations were posed to managers from a medical device company.
The study tested how physician concern, defect detectability, and root cause understanding of the defect influenced the decision to recall a medical device.
One key finding was that a company would be less likely to initiate a recall and instead rely on doctors to screen out defective products, if the defect could be observed by the doctors. The thinking was that increased patient safety would result when defects were detectable.
Another key finding of the study had to do with the manager’s way of thinking. Most of the managers were more technically oriented. As such, they were likely to seek more information to understand why the product failed, such as the root cause, before feeling comfortable recalling a device.
The other, more intuitive managers allowed relational factors, such as their gender, work experience, and perception of the company’s relationship with the FDA, to inform their decision. The intuitive managers were more likely to issue recalls than the technical managers.
These findings have attracted the attention of medical device companies and the FDA.
Companies can use the findings to develop decision-making training programs to educate managers to be aware of unwanted bias to use defect detectability as a factor in the recall decision.
FDA regulators can emphasize to companies that a root cause understanding of the problem is not a precondition for recall.
Medical devices are not perfect, and neither is the product recall process. If you have experienced problems with a medical device, it is important to get help in evaluating whether you may be entitled to compensation. To contact one of the experienced Philadelphia medical device lawyers at Brookman, Rosenberg, Brown & Sandler, call us at 215-569-4000 or complete an online form for a free initial consultation. We serve clients throughout the greater Philadelphia area and across the state of Pennsylvania.