The Institute of Medicine (IOM), a part of the National Academy of Sciences, has told the U.S. Food and Drug Administration in a report to come up with a new system for evaluating and approving many high-risk medical devices before they get to patients. The San Francisco Examiner has a nice, brief outline of the IOM’s report.
David Challoner, chairman of the committee, said in a statement that it was unclear whether the current process was serving the needs of either industry or patients. He added simply modifying the process, known as 510(k), will not help.
Medical devices ran the gamut from simple adhesive-strip bandages used for minor cuts to contact lenses and pacemakers, reports Christine Mai-Duc in the Los Angeles Times. When complicated devices fail, they cause health problems, even put lives in danger, and incur healthcare costs.
As Mai-Duc explains, the current 510(k) approval process isn’t very slick. The way it works is that thousands of devices are routinely cleared for the market without any of the clinical testing for safety or effectiveness that prescription drugs go through.
When the FDA was given responsibility for medical devices in 1976, Congress specified that those already on the market could continue to be sold without testing.
At the same time, Congress created the so-called 510(k) process under which new devices could be cleared for market if they were ‘substantially equivalent’ to existing products.
As a result, thousands of medical devices have received FDA clearance based on older devices, neither of which were subjected to the kinds of rigorous pre-market testing required for pharmaceuticals.
A study of high-risk recalls from 2005 to 2009 found that more than two-thirds of medical devices recalled for potentially serious risks had been approved under 510(k).Â For example, artificial metal-on-metal hip joints had to be recalled after they were found to release small metallic particles into patients’ bloodstreams.
Mai-Duc says that critics charge that the 510(k) process is nothing more than a loophole for marketing products without adequate attention to safety or effectiveness. But FDA bowed to pressure from the Government Accountability Office and consumer groups, and started to review the 510(k) approval process (it’s called the 510(k) process after Section 510(k) in the Federal Food, Drug, and Cosmetic Act that deals with the introduction of drugs and devices into the market).
The IOM’s recommendation was met with resistance from the agency. In a statement to the press, Jeffrey Shuren, director of the agency’s medical devices center, said:
Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them.
FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.
Mai-Duc finds that device manufacturers dislike the 510(k) process, saying that it slows the flow of products to market (the hearing she refers to here is shown in the YouTube video, above):
‘It is not technology, science, ingenuity or the economy that is standing in the way of success in developing new medical technologies. In my opinion, it is today the FDA,’ engineer Robert Fischell told a subcommittee of the House Energy and Commerce Committee last week.
Fischell, inventor of an implantable insulin pump and a series of coronary stents, said that the medical device approval process is inconsistent and that the FDA staff is not sufficiently trained.
However, AdvaMed, a lobbying group that represents major manufacturers, rejected the IOM report, saying the committee “recommends entirely scrapping this proven process with a vague new plan that contains no useful guidance.”
Source: “FDA urged to rethink approval of medical devices,” Los Angeles Times, 07/30/11
Source: “July 20, 2011 – Hearing on ‘Regulatory Reform and FDA Medical Devices’ (Part I),” YouTube
Rajendrani "Raj" Mukhopadhyay is a science writer and editor who contributes news stories and feature articles on scientific advances to a variety of magazines. Raj holds Ph.D. in biophysics from Johns Hopkins University.