The unregulated practice of reusing medical devices that are either labeled or otherwise intended for use on a single patient began more than 25 years ago as a way for hospitals to reduce cost and waste. From these early efforts, an entire third-party reprocessing industry has evolved to assist hospitals with surgical and endoscopic device reprocessing. With the enactment of the Medical Device Amendments of 1976 to the federal Food, Drug, and Cosmetic Act (FD&C), the original equipment manufacturers (OEMs) were subject to heavy federal Food and Drug Administration (FDA) regulations when marketing new medical devices. The refurbishers and reprocessors of those devices, however, went unregulated. Under the FD&C, reprocessing of single-use devices (SUDs) was permissible, but it raised questions regarding device safety, informed consent, ethics of reprocessing, proper refurbishing, incident reporting, and accurate labeling practices. OEMs were often subjected to criticism and threatened with liability for the SUDs they manufactured and labeled for single use, but which were later refurbished and marketed, both properly and improperly, for patient use by others. This changed several years ago when the FDA subjected SUD reprocessors to virtually the same regulatory standards as OEMs when it issued guidance titled "Enforcement Procedures for Single-Use Devices Reprocessed by Third Parties and Hospitals." So what does this have to do with O&P? Prosthetic SUDs are sometimes offered for resale through various sources. Many of these devices were FDA-approved SUDs when their OEM initially sold them. While the device may be labeled or intended for single use only, it can be used legally by other patients. A reprocessed SUD is defined as an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. Becoming a reprocessor for SUDs by virtue of marketing SUDs creates many obligations on the part of the reprocessor. An SUD may be lawfully reused if it is adequately refurbished so that it is safe and effective, and if its quality and integrity are maintained in accordance with FDA guidelines. Under current federal regulations, any third-party reprocessor, an OEM that refurbishes its own devices, or a hospital that refurbishes its devices, is required to meet the same requirements as the OEM. That means a reprocessor must meet the same FDA regulations as the OEM did when it first marketed the device. The FDA is responsible for overseeing the safety of all medical devices. FDA enforcement actions and sanctions for failure to meet its standards include issuance of health alerts and warning letters, ordering mandatory recall and seizure, obtaining injunctions, imposing civil money penalties up to $1 million per proceeding, and criminally prosecuting offenders for serious violations. In addition, violations of FDA regulations could result in banishment from federal programs such as Medicare. While the regulations and sanctions related to SUD reprocessing might seem harsh in certain circumstances, they are meant to assure the public of the safety of the refurbished SUD. The level of regulation and oversight of reprocessed SUDs is determined by the FDA device classification and the risk associated with use of the refurbished device. Most external-limb prostheses are classified by the FDA as Class II or "medium risk non-critical" along with other medical devices such as powered wheelchairs and intravenous catheters. Class II non-critical SUDs do not need an FDA clearance order to be marketed. There is not yet an established industry to reprocess prosthetic SUDs like there is in the hospital industry, and there may never be. Regulations related to reprocessing are complicated, and compliance is expensive. Except for hospital SUDs, generally only OEMs reprocess SUDs. Anyone who intends to market refurbished prosthetic devices for reuse must fully acquaint themselves with the FDA regulations related to obtaining an FDA marketing clearance order. SUD reprocessing is controversial in both hospital and non-hospital settings. While possibly the most qualified to refurbish SUDs, many OEMs resist SUD reprocessing for many reasons, including the fact that they believe the device is for a single use, and reuse has an adverse impact on new product sales. Supporters of reprocessing, such as hospitals, focus on lower cost. Everyone's concern, of course, is the safety and integrity of reprocessed SUDs. Someday, reprocessing could become more the norm in prosthetics as it is with hospital surgical devices. Until then, take care should you ever consider using and marketing reprocessed SUDs. John Latsko is a partner in the health law practice of Schottenstein, Zox & Dunn, Columbus, Ohio. He can be contacted at 614.462.2329; jlatsko@szd.com
