Pharmacy & Therapeutics - June 2008 - (Page 349)

Evaluating and Standardizing Medical Devices available on therapeutic equivalencies and treatment outcomes for medical devices than for pharmaceuticals.4 In addition, because Food and Drug Administration (FDA) requirements for long-term safety and efficacy can be less stringent for medical devices, a new device is brought to market much more rapidly, making it difficult for hospitals and other institutions to stay current.4 Assessment of product equivalencies for items with different features developed by diverse manufacturers is also problematic.4 Cost comparisons or effectiveness evaluations are not always possible because manufacturers rarely reveal pricing voluntarily.4 Dr. David Nash, MD, MBA, Professor and Chair of the Department of Health Policy at Jefferson Medical College, agreed: “Pricing is largely hidden from the public analysis process, especially when you factor in rebates, discounts, and all kinds of separate payment schemes.” Unlike the situation with drugs, it is also far more difficult to substitute an alternative surgical implant if a patient does not respond well to the one specified by a formulary.4 Limitations in the choice of manufacturer or device for a given medical procedure might also not be desirable, because surgeons often need to customize their selection according to specific patient needs and their surgical training experience.9 Manufacturers rarely reveal pricing voluntarily. … “Pricing is largely hidden from the public analysis process, especially when you factor in rebates, discounts, and all kinds of separate payment schemes.” Similar to what caused the Joint Commission on Accreditation of Hospitals (JCAH [now known as the JCAHO]) to recommend the formation of P&T committees to review drugs in the 1950s,6 advances in technology have led to an onslaught of medical devices reaching market and thus an increased need for evaluation. However, because of the obstacles mentioned, P&T committees rarely evaluate medical devices. Instead, an ad hoc team effort is made through the coordination of expertise from various departments, depending on the device.10 This process varies by hospital. According to Dr. Vogenberg, “You get variations depending on the sophistication of the hospital and the organization and how many committees they have.” Dr. Nash also explained: Our P&T committee is very large, with a number of super-specialized subcommittees. There is no dedicated device subcommittee, so we draw on the specialties of our other subcommittees. We will likely evolve into having permanent experts, but it would be hard to mandate, because there aren’t enough experts out there. tionship, intercommittee, and interdepartmental discussion about what’s the best way to deal with new technologies. It’s a newer scenario and something that hospitals, as well as health plans and Medicaid, are just beginning to come to grips with.” The decision-making process for medical devices is highly complex and subject to many constraints. The FDA’s Medical Device Review Process The FDA’s regulatory policy is largely responsible for the rapid introduction, as well as the large quantity, of medical devices coming to market and the lack of clinical data for the majority of them. The growth of medical technology has been explosive.8 According to FDA estimates, more than 8,000 new medical devices are marketed each year in the U.S.1 By the late 1990s, the FDA had approved about 500,000 medical device models produced by approximately 23,000 different manufacturers.8 Within the FDA, the Center for Devices and Radiological Health (CDRH) is responsible for premarket assessment of medical technologies,8 good manufacturing process guidelines, and postmarket surveillance (Figure 1).1 However, the premarket evaluation of most medical devices by the FDA, before their introduction to the market, is not as thorough as it is for drugs.8 Whereas all new drugs must undergo rigorous premarketing testing in randomized clinical trials to receive FDA approval, such testing is required for relatively few new devices.8 Instead, the FDA regulates new devices according to classification as low risk (I), moderate risk (II), or high risk (III).8 Half of the medical devices marketed each year are considered to be low-risk products (bandages, splints, and surgical drapes), and these are exempt from all premarket review requirements.1 Most of the remaining new products are iterations that have undergone an incremental change made to a previously marketed version; the FDA classifies these incremental products as having a medium risk.1 Such products include endoscopes, patient-monitoring equipment, dialysis catheters, and diagnostic imaging devices (computed tomography, magnetic resonance imaging, and ultrasound scanners).1 For these products, the FDA requires only a premarket notification application (510k), because they are assumed to be essentially equivalent to those already approved.8 Alan Minsk, Esq., Partner and Chair of the Food and Drug Practice Team at the Arnall Golden Gregory law firm, noted, “Most devices go through a 510k premarket notification process where you provide notice to the FDA that your product is substantially equivalent to a product they’ve already seen.” 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.8 Alan Minsk also observed,“About 95% to 98% of the products on the market take the 510k route, where clinical trials aren’t required. There are safety and efficacy standards, but they aren’t going through the same level of review as drugs.” In contrast to the 510k process, a premarket approval (PMA) application and formal clinical trials are required for novel The decision-making process for medical devices is highly complex and subject to many constraints (e.g., surgeon’s choice, vendor pricing, and time pressures).10 Group decisionmaking is necessary, because it provides expertise and achieves goals that are beyond the range of one single individual.10 Dr. Nash agreed: “There isn’t a single person with the complete skill set for device evaluation.” Some new technologies also affect therapeutic decisions in multiple areas. Dr. Vogenberg noted: “There is more demand for interrela- Vol. 33 No. 6 • June 2008 • P&T® 349

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.