MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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MD + DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY July 2016 | 15 that federal law does not require individual physicians to 'self-report' adverse outcomes associated with the use of FDA-approved medi- cal devices back to FDA. This critical professional failure," it says, "has led to the premature or unnecessary loss of many unsuspecting American women's lives." In their Obstetrics & Gynecology paper, Walter and her coau- thors cite not only the Dalkon Shield disaster that led to the 1976 Medical Device Amendments, but also "several controversies sur- rounding medical device safety in the field demonstrating potential shortcomings of current regulation. In 2011, the FDA issued a safety warning on transvaginal mesh resulting from the risk of pelvic organ injury. Powered laparoscopic morcellators have been implicated in peritoneal seeding and possible upstaging of leiomyosarcoma. Es- sure, a permanent sterilization device, was originally approved along the premarket approval pathway." They also attack industry's main hope for legislative relief from FDA stringency, the 21st Century Cures Act. "Before any possible amendments," their paper says, "certain provisions would reduce the strength of regulation surrounding medical devices by broadening the interpretation of 'valid scien- tific evidence' required by device manufacturers including the use of case histories rather than clinical trials to determine safety and efficacy as well as allowing third parties to review changes to already approved medical devices." The authors also challenge industry's frequently used charge that increased FDA regulation would lead to a decrease in medical device innovation, although they acknowledge that compared with recent analyses of cardiology and ophthalmology device approvals, obstet- ric and gynecology devices underwent more stringent clinical evi- dence requirements, with only one approval between 2010 and 2015. "Directly attributing the relatively low number of obstetrics and gynecology device approvals to the higher quality of clinical evi- dence leading to approval is difficult," they wrote, "given that medi- cal device innovation is multifactorial with complex economic, technological, and clinical considerations. Although the medical device industry has argued that a higher burden of proof would slow innovation, there is limited evidence supporting this assertion. "There remains a need to raise the burden of proof without stifling medical device innovation," the authors conclude, adding, "Unique payment models that tie reimbursement to clinical effect have been implemented but remain rare in the United States." They call on both government and physician-specialty organi- zations representing obstetrician–gynecologists to "require more rigorous regulatory standards for the approval and post-approval tracking requirements for high-risk devices." Further, they write, FDA should increase the use of its obstet- rics and gynecology advisory committee in device reviews, and "obstetrician–gynecologists need to be more than mere end-users. Specialties such as gastroenterology and cardiology have recruited the support of physician societies to spur medical device develop- ment through device-specific registries. Organizations representing obstetrician–gynecologists should expand their efforts in this area." As this column went to press, FDA had made no contact with the authors. Jim Dickinson is MD+DI's contributing editor. 2

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