Analysis calls for medical device information to better serve patients a...(port. Most new applications are approve...)

Date:1/31/2008

port. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Plus, the agency relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients, the report states.

FDA approval should be the start of the process toward clinical application, not the end, Feldman said. Physicians and patients just arent 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 of new medical devices and to inform the public, physicians and policy makers, Feldman said. Some, like the California Technology Assessment Forum (CTAF), which is profiled in the Perspectives article as a case study, have meetings open to the public and populate their review board with experts in medicine, representatives from medical professional societies, technology manufacturers, policy makers and insurance providers, among others. CTAF selects devices for review based on their impact and the availability of relevant clinical data.

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 and co-author of the study. CTAF also requires improvements in patien
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Contact: Lauren Hammit lhammit@pubaff.ucsf.edu 415-476-2557 University of California - San Francisco Source:Eurekalert

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