About one percent of medical devices introduced in the United States market get recalled. It seems like a small number, but that number represents thousands of people who have died or been harmed by faulty medical devices. The clincher? Many of those devices were never tested on humans before they were approved for use.
The process is called fast-tracking. Some categories of medical devices can be approved by the Food and Drug Administration (FDA) with little or no testing if they are similar to other devices already approved. Since 2009, 67 individual high-risk devices have been approved through this process because they are “substantially similar” to devices already approved and on the market.
While the process speeds the delivery of innovative medical devices to doctors and their patients, it’s the patients who suffer when their device fails. Katie Korgaokar said she was flabbergasted when she received a letter from her doctor informing her that the artificial hip she received had been recalled and needed to be replaced. She was even more shocked when she found out the state-of-the-art device was never fully tested before it was implanted in her body.
Last year, DePuy Orthopaedics recalled its metal-on-metal ASR hip replacement system when studies showed that the hip implants were failing at an unusually high rate compared to other hip replacements. The device had been approved through the FDA’s fast-tracking program, and was never tested on humans. About 93,000 people are affected by the recall.
The Government Accountability Office (GAO) has recommended changes with the fast-track medical device approval process but little has been done to develop more consistent approval processes for medical devices. As one might expect, medical device companies say the process should stay the same. The FDA is holding action, saying it is waiting on a report from the Institute of Medicine, an independent group that provides advice to policymakers, before making any decisions about the process.