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Health Care Industry

Reprocessing single-use devices—regulatory roles

AORN Journal, July, 2002 by Debra Dunn

Reprocessing single-use devices (SUDs) is a controversial and complex subject with sound reasoning both to support and repudiate the practice; however, patient safety remains the paramount issue. A reuse program must demonstrate that reprocessing used or previously opened but unused items is as safe as reprocessing medical devices that are reusable. Table 1 contains a list of terms pertinent to resterilization and reuse of single-use devices.

THE ROLE OF THE FEDERAL GOVERNMENT

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The US Food and Drug Administration (FDA), through its Center for Devices and Radiological Health, has responsibility for implementing those portions of the Federal Food, Drug, and Cosmetics Act that deal with the approval, marketing, and distribution of medical devices. (1) Recently, the FDA has come under increased pressure from consumers, legislators, and equipment manufacturers to regulate the reprocessing of SUDs. Reprocessing has grown steadily during the past few years, as has the complexity of medical products being manufactured. There are concerns about patient safety, informed consent, ethics, and the equitable regulation of original equipment manufacturers (OEMs) and facilities that reprocess. (2)

The FDA is responsible for ensuring the safety and effectiveness of medical devices sold in the United States, the packaging and labeling that describes how they should be used, and the facilities that manufacture them. These regulations are called Good Manufacturing Practices (GMPs) for medical devices. (3) Currently, all manufacturers and reprocessors (ie, hospitals, third-party reprocessors) are subject to the GMPs discussed in the quality system regulations (QSR). Quality system refers to the organizational structure, responsibilities, procedures, processes, resources, and programs to implement quality management. (4) The topics addressed in the QSR are noted in Table 2. Good Manufacturing Practices govern products ranging from bandages to thermometers and include invasive supplies, such as cardiac catheters and artificial hearts. Approximately 80,000 to 100,000 models of medical devices currently are used in the United States. The domestic market for medical devices totaled approximately $56 billion in 1999. (5)

Product classification system. The current requirements set by the FDA for approving medical devices are based on the device's potential for harming patients. The Code of Federal Regulations (CFR) is a book that contains final regulations concerning medical devices, radiological health, and certain other regulations administered by the FDA. It is an established categorization system familiar to all device manufacturers and many device users. Items are categorized into one of three classes. Class I, or low-risk items, includes items such as bandages and orthopedic saw blades, which pose the lowest potential for risk and require the least regulation. Class II devices (ie, medium-risk devices) include urethral catheters and blood pressure cuffs. Class III devices, such as heart valves, percutaneous transluminal coronary angioplasty catheters, and intra-aortic balloon angioplasty catheters, support or sustain human life and present significant risk factors to the patient. (6)

Most Class I items are exempt from FDA regulations. These items only need to be registered with the FDA, and they can be marketed without obtaining prior approval from the FDA. Some Class I and most Class II items are considered nonexempt today, and a premarket submission must be completed. There are two types of premarket submissions--a premarket notification (ie, 510k) and a premarket approval (PMA). The purpose of the 510k or PMA is to demonstrate to the FDA that a device can be reprocessed safely a specific number of times without compromising its function. The 51 Ok application provides enough information for the FDA to determine that the device is safe, effective, and substantially equivalent to one already on the market. All Class III devices must apply for a PMA to demonstrate that the medical device is safe and effective and that there are no substantially equivalent devices already on the market. Submission of scientific evidence, including clinical experimental studies, often is required for a PMA to demonstrate that the device is safe and effective. Clinical studies of significant risk devices need prior FDA approval with an investigational device exemption application before the study may begin. One 510k or PMA application is to be submitted for each device being reprocessed. (7) In the near future, the FDA intends to reevaluate all items that have been labeled as Class I exempt and Class II exempt to determine whether their exemption status should be revoked. These devices will be evaluated on a case-by-case basis. (8)

Historical precedence. The idea of reusing SUDs has been circulating since the late 1970s. To date, a consensus does not exist regarding whether reuse of medical supplies truly is feasible. The US Department of Health and Human Services (HHS) used to recommend against reprocessing and reusing SUDs. This recommendation was based on the potential for nosocomial infection rate increases. In 1985, however, evidence to support this concern was not available. The HHS rescinded its recommendation and issued new guidelines indicating that items that could be cleaned and sterilized or disinfected without changing their physical integrity and function would be candidates for reprocessing. The guideline also stated that reprocessed items retaining residual toxicity or having been compromised in safety should be avoided. (9)

Health Care Industry

Reprocessing single-use devices—regulatory roles

AORN Journal, July, 2002 by Debra Dunn

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