Researchers at Indiana University are examining the process behind issuing recalls for medical devices. And a new study finds that often, manufacturers might rely on physicians to screen out defects themselves, rather than issue a recall.
Kelley Assistant Professor George Ball is the lead author of the study. He says the Food and Drug Administration doesn’t usually mandate medical recalls, because it’s hard to definitively determine that there is a defect. Instead, the FDA will rely on manufacturers to make that decision themselves. The study aims to examine what factors the company will consider before issuing a recall.
Ball says researchers prompted test subjects with a variety of fictional scenarios involving a defective product, and found that the subjects were more likely to trust physicians to screen out products with the defect and keep patients safe.
“They perceived a reduced likelihood of harm to the patient when the defect was detectable, because they were trusting, apparently, the physician to screen out the defect and not use it on the patient,” Ball says.
Ball says that decision could vary depending on what the medical device is. If the defect is easy to spot, he says, manufacturers may feel more comfortable relying on physicians to screen it out.
Ball says there was another key finding to the study. He says test subjects were more likely to hold off on a recall until they knew exactly what the root cause of the defect was. He says that’s because they could then be more specific in what items they were recalling – and by doing so, minimize the financial losses of a recall.
“When you understand the root cause, you usually know, well, it’s not everything. It’s things that were built on this piece of equipment, on this shift, by this operator,” Ball says. “So you usually can recall fewer units.”
Ball says while the FDA won’t mandate a recall, it will sometimes hold back new product approvals until a company addresses quality problems or defects.
Ball says the study aims to show that the decisions behind a recall are not objective – and to prompt change in the ways the decision is made in the future.
