Pharmacy & Therapeutics - June 2008 - (Page 350)

Evaluating and Standardizing Medical Devices Medical Device Low risk and exempt from intense premarket evaluation? Yes No Similar to previously approved, legally marketed “predicate” device? Yes Yes No Does study of the device pose a “significant risk”? Yes No Compliance with Good Manufacturing Practices? Yes Premarket Approval Application mandated by FDA for this type of device? No Investigational Device Exemption application Registration and listing “Substantially equivalent” 510(k) application Premarket Approval Application Figure 1 Overview of the medical device approval process. (Reproduced with permission from Maisel WH. Ann Intern Med 2004;140:297. American College of Physicians.) technologies that the FDA has never seen before because they are considered high risk.8 A more stringent review process that calls for clinical trials is also undertaken for high-risk iterative medical devices, such as pacemakers, heart valves, and implantable pumps, as well as for those that have new indications for use or have changed significantly from the predicate device.1 The 510k medical device application process does not usually require clinical data from randomized efficacy and safety trials, and many devices, therefore, are approved on the basis of limited data. The FDA’s resources, abilities, and policies regarding medical devices are sometimes considered inadequate. Because clinical trial testing is not required for most medical devices, new products are rapidly approved, have an increasingly compressed life cycle, and become obsolete more quickly.11 According to Alan Minsk, “the 510k process typically only takes anywhere from three to nine months, depending on whether clinical data are required, how well the submission is done, and the workload of the agency.” Sheri Dodd, Vice President Worldwide, Health Economics and Reimbursement at Ethicon, Inc., a Johnson & Johnson company, noted that within “six months, you can have five new entries to the market, because the regulatory pathway for a 510k process is the ‘lowest bar.’ There are many devices in the marketplace that have been subjected to appropriate preclinical testing, but not in humans, which is a very different model [than] pharma.” The volume of applications for new products being introduced to the market also creates a challenge for the FDA, as well as for hospital committees, to keep current. The FDA has warned of a lack of program resources for medical devices. The agency has stated that these resources “have been reduced in recent years, and there have been indications that review performance has begun to decline.”8 The FDA has limited ability to conduct postmarketing surveillance for both medical devices and drugs.8 Instead, manufacturers, academic staffs, and clinical investigators initiate most of the recalls and failure reports.8 The FDA has also had to recall a number of previously approved devices.12 Because of these recalls, some wonder whether medical devices are being appropriately scrutinized by the FDA prior to approval.12 Data to Support Evidence-Based Decisions Are Lacking The lack of clinical data available to medical device review committees in hospitals is largely attributable to the fact that the FDA’s application process for most medical devices does not require such information. Because the data are not required, manufacturers have little incentive to conduct studies needed to answer relevant clinical questions. 8 Dr. Nash commented, “There’s not enough published literature to rely on. It doesn’t exist because there is no compelling reason. Without an FDA mandate, no device manufacturer is going to undertake a rigorous evaluation.” Significant gaps also persist in postmarketing surveillance data.8 A lack of clinical data also puts insurance reimbursement in question, because evidence of efficacy is often required for determining payer coverage and reimbursement.1 In addition, when the FDA requires clinical data, insurers may find the study endpoints to be insufficient.1 Insurers, therefore, often have incomplete information when a new medical device is first marketed, and conclusive evidence is often available only after the device has been in use for quite a while.1 Instead of being guided by clinical data, the evaluation and use of medical devices are often significantly influenced by industry and professional societies.8 Hospital review committee staff members are aware of the critical role of accurate data to support decisions about prodcontinued on page 353 350 P&T® • June 2008 • Vol. 33 No. 6

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.