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Christine Mai-Duc | Tribune Washington Bureau Source: ongo
July 30, 2011

WASH­INGTON — Kather­ine Ayers was 36 when she decided the pain in her hip had become too much to bear. A sur­gically im­planted met­al-on-met­al hip joint soon made her pain-free.

But a few years lat­er, she was star­tled to receive a letter saying the arti­ficial joint was be­ing recalled. “In my mind, recalls were for dishwash­er and cars, not body parts,” she told a con­gres­sion­al hearing.

It was expe­ri­ences such as Ayers’ — and scores of oth­ers with even more se­rious consequences — that led the In­stitute of Medicine, an arm of the National Academy of Sci­ences, to call on the govern­ment to design a whole new system for eval­uating and approving med­ical devices such as her hip joint before they reach the mar­ket.

“It’s not clear that the … process is serving the needs of ei­ther indus­try or pa­tients, and simply modifying it again will not help,” David Challoner, chairman of the committee that wrote the report, said in a state­ment.

Med­ical devices range from simple adhesive strip ban­dages used for minor cuts to con­tact lens­es and pacemakers. When complex devices fail, they can generate health prob­lems and health-care costs, even imperil lives.

Rou­tinely cleared

Surpris­ing as it may seem, the way the present system works is that thou­sands of devices are rou­tinely cleared for mar­ket with­out any of the clin­ical test­ing for safety or ef­fectiveness that is required for pre­scription drugs.

“I thought that any med­ical device that was actually be­ing put into people’s bod­ies had been extensively tested before it was re­leased to the public,” said Ayers, who was one of 96,000 pa­tients who received the im­plant before it was recalled.

Not exactly.

No tests mandated

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 that were nev­er subjected to the kinds of rig­or­ous pre-mar­ket test­ing required for pharma­ceuticals.

And stud­ies have shown that devices approved in the ex­pe­d­ited process are more likely to be recalled.

More than 90,000 arti­ficial hips were recalled last summer af­ter stud­ies showed that about 1 in 8 recipi­ents needed to have them replaced. The hips, manufac­tured by a sub­sidiary of John­son & John­son, were found to re­lease small metallic particles into pa­tients’ blood­streams over time.

In 2009, the In­stitute of Medicine noted, about 4,000 med­ical devices were cleared under the ex­pe­d­ited 510(k) process — more than 90 per­cent of all devices subject to FDA clear­ance. Simple “devices” such as tongue de­pressors and adhesive strips can be sold with­out FDA clear­ance, al­though compa­nies must no­ti­fy the agency.

Crit­ics con­tend that the 510(k) process amounts to a loop­hole for mar­keting prod­ucts with­out adequate at­tention to safety or ef­fectiveness.

Account­ability Office and consumer groups, the FDA initiated two internal reviews of the process in 2009. This year, it out­lined 25 changes it planned to make, including streamlin­ing the review of lower-risk devices.

But the new rec­ommendation, re­leased Friday in a report requested by the FDA, was met with resistance from an agency of­ficial.

“FDA be­lieves that the 510(k) process should not be elim­inated,” Dr. Jeffrey Shuren, di­rector of the agency’s med­ical devices arm, said in a state­ment about the new report. “But we are open to additional propos­als and approaches for con­tinued improve­ment of our device-review programs.”

Device manufac­turers con­tend that the 510(k) process slows the flow of prod­ucts to mar­ket.

“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.

AdvaMed, a lobbying group that rep­resents major manufac­turers, rejected the find­ings of the new report, saying the committee “rec­ommends entirely scrapping this proven process with a vague new plan that con­tains no useful guid­ance.”

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