After a series of recalls and an alarming rise in adverse events, a new report is calling for the U.S. Food and Drug Administration (FDA) to replace its 35-year old clearance process for medical devices, such as pacemakers, heart valves, cochlear implants and artificial hip joints.
The Institute of Medicine (IOM), an arm of the National Academy of Sciences, issued the report at the FDA's request. It recommended that the agency scrap its current regulatory framework and start fresh.
Currently, the FDA approves medical devices without human studies if it is "substantially equivalent" to other devices that were previously cleared or that were on the market before 1975. About one-third of devices entering the market are approved by this test.
But the report noted that the substantial equivalency test cannot assure that devices reaching the market are safe and effective, because most of the devices used as a basis for comparison weren't reviewed under those criteria. However, neither does that mean that the devices are unsafe, especially if they have been used successfully for a long time.
The FDA requires manufacturers to report if a device has contributed to a death or serious industry within 30 days and within five days if a malfunction could present substantial harm to public health. But, the IOM notes, there have been instances where device makers have underreported serious adverse reactions. Moreover, the IOM says the FDA has been slow to review these reports and inconsistent in documenting them.
The number of adverse events reported related to medical devices has more than doubled from 2003 to 2007, from 72,866 to 150,210. However, those numbers may not capture every problem, because some adverse reactions may be delayed in some patients; while physicians increasingly use higher-risk devices, including implants, in their offices rather than a health-care facility where they would be legally required to report failures to the FDA.
The IOM said that an improved regulatory process would make use of the FDA's authority to ensure that medical devices are safe and effective, both before they go on the market and after.