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David Brown and N.C. Aizenman
July 29, 2011 ET

An influ­ential pan­el that advises the fed­eral govern­ment on sci­ence pol­icy proposed Friday that the Food and Drug Admin­istration scrap the process it uses to clear many med­ical devices for use because the current method can’t en­sure they are safe and ef­fective.

The FDA should require more extensive test­ing of thou­sands of “moderate-risk devices” — from wheelchairs to arti­ficial hips — that come to mar­ket with lit­tle study because manufac­turers can argue that the devices are “sub­stantially equiva­lent” to prod­ucts already in use, the pan­el said.

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.

FDA response

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.

Here is the report if you want to read it…

Back to the Article…

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.

Risk ratings

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.”