A committee of 12 experts convened by the Institute of Medicine said the process allows a device to slowly evolve from its “substantially equivalent” ancestor without ever getting its own assessment for safety and effectiveness. Furthermore, many older devices that are basis for the comparison themselves were never fully tested.
“The public thinks that if the FDA clears and ‘approves’ a device that safety and effectiveness has been considered. But that is not always the case,” said David R. Challoner, a physician who headed the panel.
While the committee did not offer details for a new process, any change would almost certainly require more work by device makers, many of which are small, entrepreneurial companies betting millions of dollars on the success of a single item.
Somewhat surprisingly, the FDA’s initial response to Friday’s report was to reject its central finding.
“FDA believes that the [current] process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” said Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health. That center had asked for the IOM’s advice on the matter.
The 280-page report comes as device makers have been urging the FDA to streamline the approvals system. A group of manufacturers has also been campaigning to undermine the report, saying the 12-member panel of physicians, lawyers and policy experts doesn’t represent all points of view.
The panel took pains to say it “does not believe . . . there is a public health crisis related to unsafe or ineffective medical devices.” The fact that so many devices that haven’t been “systematically reviewed” are in use offers some assurance they are safe, the panel members wrote.
Representatives of device-makers argued that this observation undermined the rest of the committee’s report.
“They’re calling for these sweeping, revolutionary changes without any evidence there’s a problem,” said David Nexon, a senior official of the Advanced Medical Technology Association, an industry trade group. “The last thing you want to do is throw in a whole new system. . . . Even if it’s a great new system, it would take years to get the FDA and manufacturers to use it efficiently, so you’d see a huge slowdown in getting devices to market.”
Nexon also noted the panel’s acknowledgment that for many reasons, new medical devices will never undergo as extensive human testing as new drugs.
The authors of the report said that a greatly beefed-up system of looking for problems after a device goes into use may be as important as more “pre-market” testing and could effectively replace it in some cases.
The FDA puts medical devices into three classes based on risk.
About two-thirds of devices — such as crutches and adhesive bandages — require virtually no pre-market review because they pose no hazards to patients. The current debate is on Class II devices, which pose “moderate risk.” Device-makers each year ask the FDA to clear for use 3,000 to 4,000 such devices by making the argument that the devices incorporate small modifications and are “substantially equivalent” to things already in use. Last year, 77 percent of such devices were cleared through this “510(k) process,” which is named after a section of law.
By contrast, the agency gets only 30 to 50 applications each year to approve Class III devices — such as mechanical hearts, pacemakers and cochlear implants — that pose high risk to patients. They must undergo a full “premarket approval” process proving safety and effectiveness.
The current system has allowed external cardiac monitors to morph from an oscilloscope, in which each heartbeat makes a blip on a screen, to current models that provide a full EKG tracing, analyze the heart rhythm for abnormalities and ring an alarm when an event is worrisome.
A device that recently ran into problems was a surgical mesh used for the repair of pelvic prolapse in women. It was judged to be substantially equivalent to mesh that had been used by surgeons for years to repair hernias. But when used in the pelvic operations, it led to many complications, including infections, fistulas and “a very large number of defective results,” Challoner said in an interview.
In some cases, devices that are no longer on the market are cited by manufacturers as ones the new item is substantially equivalent to. That’s the case with a vertebral plate used in neck surgery that was first approved in 1979, according to FDA records.
The panel said there is a special need for better guidance on devices with computer software — a category that reportedly includes about half of all new medical devices.
“There’s been an easy path as software has drifted into use,” said Challoner at the news briefing. “There’s a real vulnerability here.”
The FDA’s less than enthusiastic greeting of the report was understandable, said Diana Zuckerman, of the National Research Center for Women & Families, who has advocated for more rigorous regulation of devices.
“This was not what the FDA
bargained for,” she said. Instead, she speculated, FDA officials were hoping to get the IOM’s endorsement of more modest changes the agency has already floated, such as subjecting certain sub-categories of Class II devices to greater scrutiny.
“I’m sure they in some ways they feel like they’ve ended up with nothing out of this because they were told this program is so bad it can’t be fixed and you need something new,” said Zuckerman. “And they don’t have the resources to do that.”