IOM to make recommendations on FDA medical device approval process

The Institute of Medicine (IOM) this week is expected to offer advice on the Food and Drug Administration’s fast-track process by which medical devices are approved for use in patients in hopes of cutting down on injuries and recalls.

The accelerated approval process, known as 510(k) is widely used by the agency to get much-needed medical devices on the market. It is allowed on devices that are considered “substantially equivalent” to existing products. About 3,000 products are approved by the FDA through this process each year. Critics say this accelerated approval process puts medical devices on the market before they have been thoroughly tested for safety, and thus puts patients at risk.

There are numerous examples where this prophecy has come to pass, including the ASR hip replacement system made by Johnson & Johnson subsidiary DePuy Orthopaedics. The hip implant was fast-tracked through the 510(k) process because it resembled other artificial hips.

However, instead of using ceramic parts, the ASR device used metal-on-metal parts. Last year, after five years on the market, the artificial hips were recalled for their unusually high failure rates. Patients were also testing positive for heavy metal in their bloodstream. About 93,000 people worldwide are affected by the DePuy recall.

The FDA’s device unit has been the focus of much scrutiny with its high staff turnover and inadequate funding. The agency proposed last year to make changes to the program, which included creating a new category of more risky devices that would require more data in order to secure approval even through the 510(k) process. This is just one of the areas the IOM is expected to address in its report this week.

Source: Reuters