Stephen C. Hammill

Reprocessing of Electrophysiology Catheters: Clinical Studies, Regulations, and Recommendations. A Report of the NASPE Task Force on Reprocessing of Electrophysiological Catheters

The reuse of medical devices labeled for single use evokes concern because of the possibility that this practice may increase procedural risks for patients. The debate over this controversial issue extends well beyond the area of electrophysiological studies and is clouded by financial incentives for hospitals, manufacturers, and reprocessors. It is compounded by the ambiguous criteria for “single use” labels and doubt about the uniformity of reprocessing standards. The broad scope of single use devices (SUDs) that are frequently reprocessed is shown in Table I. These devices vary considerably in their materials, technical complexity, fragility, and risk of reuse. On February 10, 2000, the Subcommittee on Oversight and Investigations of the Committee on Commerce of the United States House of Representatives presided over a hearing to examine the risks to patients, the need for informed consent when SUDs are reused, regulatory fairness, and appropriate regulatory measures. A subsequent hearing by the Senate Committee on Health, Education, Labor, and Pensions included the General Accounting Office (GAO) report on medical SUDs. The purpose of this North American Society of Pacing and Electrophysiology (NASPE) policy statement is to examine the basis of concerns about reprocessing catheters and the measures proposed by the Food and Drug Administration (FDA) to address this issue. Development of Single Use Labels and Reprocessing Policies Prior to the late 1970s most medical devices were considered “reusable” and were hand wiped, soaked in disinfectants, and resterilized by heat. As the demand for disposable equipment rose, hospital administrators and physicians began to notice that some products labeled “single use only” were similar to devices that had been formerly distributed as “reusable.” For example, a letter written by USCI Cardiology & Radiology Products to a hospital explained that although USCI had decided to change the label on a particular device from reusable to single use, it had made no structural changes to the device. Specifically, USCI stated “our manufacturing processes of Woven Dacron Intracardiac Electrodes have not changed. These electrodes are made with the same materials and in the same manner they have been in the past.” In response to what many physicians and hospital administrators perceived as an arbitrary labeling policy, the practice of reprocessing SUDs evolved to reduce costs and the amount of medical waste generated by the use of disposable devices. As this practice encompassed critical devices such as electrophysiological catheters, the complexity of decontamination and sterilization procedures increased. The role of hospital committees made up of physicians, nurses, infection control specialists, risk managers, hospital lawyers, and professional reprocessors evolved to monitor the safety of resterilization methods. Many hospital administrations believed this practice was safe, some made use of third party reprocessors, and others abandoned the practice altogether. Concerns about reprocessing often pertain NASPE POLICY STATEMENT