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Barry Meier
July 30, 2011

The govern­ment’s system for reg­u­lating many med­ical devices like arti­ficial hips should be abandoned and replaced because it fails to exam­ine their safety and ef­fectiveness before sale, accord­ing to a report re­leased yes­ter­day by one of the nation’s top sci­entif­ic groups.

The report’s un­equivocal find­ing was un­expected, and it unleashed re­actions including out­right rejection by indus­try of­ficials, an embrace by pa­tient groups, and seem­ing disbe­lief from fed­eral reg­ulators, who had commis­sioned the review.

The report by the In­stitute of Medicine fol­lows sev­eral high-pro­file recalls of med­ical devices in re­cent years, like one in­volving so-called met­al-on-met­al arti­ficial hips that have failed in thou­sands of pa­tients, crippling some of them. In its report, the pan­el found that exis­t­ing rules used to approve many devices were nev­er in­tended to play the crit­ical role of screening out dan­ger­ous or inef­fective prod­ucts.

The pan­el urged the Food and Drug Admin­istration to devise a new approval system for so-called moderate risk devices – a cat­egory that now includes arti­ficial hips, external heart defib­rillators, and hos­pital pumps – concluding that the current one was not fixable.

“If you want to make sure that a prod­uct is safe and ef­fective, you have to start by ask­ing the question whether it is safe and ef­fective,’’ said William Vodra, a member of the 12-per­son pan­el as­sembled by In­stitute of Medicine and a lawyer who has worked closely with device produc­ers. The In­stitute of Medicine, a part of the National Academy of Sci­ences, is a prom­inent orga­ni­zation that is asked to review many complex public health issues.

It is not im­me­diately clear what impact, if any, the report will have or how its find­ings can be imple­mented; the rec­ommendations are only advi­sory to the FDA. But at a minimum it quickly de­fined the bound­aries of what is likely to be a high-powered Wash­ington lobbying bat­tle in com­ing months over the out­lines of fu­ture device reg­u­lation.

Even before the report’s re­lease, indus­try allies had waged an aggressive campaign to dis­cred­it it and had tak­en le­gal steps in­tended to bar the FDA from adopting its rec­ommendations.

Yes­ter­day, the Advanced Med­ical Technology As­sociation, a trade group that rep­resents device indus­try gi­ants like Medtron­ic, Boston Sci­entif­ic, and John­son & John­son, dismissed the report, saying it did not deserve se­rious consid­eration from Congress or the White House.

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