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Defective Medical Devices Show Need for More Regulation

Feb 8, 2008 | Parker Waichman LLP Defective medical devices like Stryker hip implants, Medtronic Defibrillators and the Kugel Mesh Hernia Patch have injured countless people.  Now researchers from the University of California, San Francisco (UCSF) have asserted that medical devices are not subject to the same rigorous review process as pharmaceuticals and this needs to change to improve health outcomes.  The team analyzed the problem and proposed solutions in a "Perspectives" article in the January 2008 issue of the Journal of General Internal Medicine.  UCSF researchers Mitchell D. Feldman, MD, MPhil, and Jeffrey A. Tice, MD, edited the issue.

The team found once a device receives Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial.  According to the team, this data would improve health professionals' awareness of "the potential promise and pitfalls of new technology.”  Feldman, professor of medicine at UCSF said, "These days, patients are asking their doctors for the newest technologies from genetic tests to specific radiation treatments and many physicians don't know where to turn for the latest evidence-based information.  Sometimes, the only information out there is what the manufacturer provides."

The UCSF analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit.   Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the scrutiny required for new drugs.  Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved.  Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

"FDA approval should be the start of the process toward clinical application, not the end," Feldman said. "Physicians and patients just aren't aware of the limitations of the FDA process of initial assessment and oversight of new medical technologies.  Assessments by objective entities are a necessary addition to FDA approval, so that deficiencies in clinical evidence, and patient safety issues that may arise after approval, are recognized before widespread adoption into clinical practice."   The purpose of independent review organizations is to provide transparent, objective evaluations, Feldman said.  Some, like the California Technology Assessment Forum (CTAF) conduct open, public meetings.  Among others, their review board is filled with experts in medicine, representatives from medical professional societies, technology manufacturers, policy maker,s and insurance providers.  The UCSF Division of General Internal Medicine currently subcontracts with CTAF to provide technology assessments.

"In order to be considered in an assessment, CTAF requires that information already be published or accepted by a peer-reviewed journal. This encourages companies to make their trial results available to the public," said Tice, attending physician in the Division of General Internal Medicine at UCSF.  "CTAF also requires improvements in patient-oriented outcomes, not surrogate markers.  For example, we want to see improvements in disease-free survival and patient quality of life, not just a reduction in tumor size."

Eventually, the authors suggest, independent review boards should summarize their findings into uncomplicated take-home messages that patients can easily find on their own.

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