Requiem for Reuse of Single-Use Devices in US Hospitals

The subject of reusing single-use devices (SUDs) is one that has been discussed, debated, dissected, promoted, and damned seemingly forever. I have been attending conferences and professional and scientific meetings that discussed the pros and cons of reusing SUDs for more than 25 years and, until recently, it was the same story. Those who favored, and indeed practiced, reusing SUDs pointed out the substantial cost savings and the absence of records of adverse patient reactions. Those who opposed the practice listed many worrisome issues, especially for those devices that were complicated in design and function: cleaning and sterilization, infections and pyrogenic reactions, functionality and its validation, materials compatibility, germicide residue, patient consent, liability, ethics, and so on. The United States Food and Drug Administration (FDA) during those years stated that the Medical Device Amendments of 1976 of the Food, Drug, and Cosmetic Act gave the agency regulatory authority over the manufacture of medical devices but not their use. The FDA did not regulate medical practice, and those hospitals that chose to reuse SUDs were responsible for the device and accepted the liability for the device. The FDA expressed concern but did not recommend against the practice of reuse.1 In the year 2000 all of that changed. Within months, the FDA issued policy statements that were unprecedented and that, for all practical purposes, abolished the practice of reusing SUDs in US hospitals. Subsequent to a number of meetings sponsored by the FDA and the Association for the Advancement of Medical Instrumentation (AAMI), the FDA in February 2000, issued for public comment two draft guidelines for reprocessing SUDs and on August 2, 2000, released a guidance document on enforcement for reprocessing of SUDs by hospitals or third parties. That document presented the FDA’s intent to enforce premarket submission requirements within 6 months (February 2001) for class III devices (eg, cardiovascular intra-aortic balloon pump, transluminal coronary angioplasty catheter); 12 months (August 2001) for class II devices (eg, blood pressure cuff, bronchoscope biopsy forceps), and 18 months (February 2001) for class I devices (eg, disposable medical scissors, ophthalmic knife). The FDA uses two types of premarket requirements for non-exempt class I and II devices: a 510(k) submission that must show that the reprocessed device is as safe and effective as the same device when new, and a premarket approval application (PMA). The 510(k) submission must provide scientific evidence that the device is safe and effective for its intended use. The FDA is giving hospitals a year to comply with the non-premarket requirements (registration and listing, reporting adverse events associated with medical devices, quality system regulations, and proper labeling). Thus, if a hospital (or third-party reprocessor) is reprocessing devices intended for single use, then it must comply with the federal controls that apply to a new manufacturer of the medical device. For hospitals, the options are to stop reprocessing SUDs, comply with the rule, or outsource to a third-party reprocessor. The FDA guidance document does not apply to permanently implantable pacemakers, hemodialyzers, opened but unused SUDs, or healthcare facilities other than hospitals. The FDA states that SUDs are medical devices, and hospitals or third parties that reprocess SUDs will be considered “manufacturers” and will be regulated in the same manner as the original equipment manufacturer.2 On April 23, 2001, the FDA sent a letter to hospital administrators and risk managers indicating that enforcement would begin by August 14, 2001. The FDA does not recommend against reusing SUDs, but because SUDs now must be reprocessed with the same quality assurance and safety criteria used by the original manufacture, and premarket clearance is needed for each device, the FDA’s new policy