Reprocessing and Remanufacturing of Single-Use Medical Devices



Reprocessing and Remanufacturing of Single-Use Medical Devices


D. J. Vukelich



Worldwide reuse of single-use devices (SUDs) is commonplace. However, historically, regulatory requirements applied to SUD reuse have not been consistent. Because SUDs most often do not come with reprocessing instructions, the reprocessing of SUDs has varied from facility to facility, region to region, and country to country. In 2000, the US Food and Drug Administration (FDA) began to regulate the reuse of SUDs as a medical device manufacturing activity, subject to the same requirements applicable to any other medical device manufacturer. Globally, other nations have begun taking similar regulatory steps, subjecting SUD reuse to medical device manufacturing regulations. The impact of such regulations has generally been the consolidation of SUD reprocessing into a limited number of regulated firms, subject to medical device regulatory agency oversight (eg, FDA).1 Where regulated, health care facilities have generally ceased reprocessing SUDs in-house or in the hospital’s central sterile departments alongside reusable devices; instead, they rely on commercial firms to conduct the reprocessing according to medical device manufacturing standards. The impact of regulation has also been to narrow the scope of SUDs commonly reprocessed to only those for which reprocessors can demonstrate to regulatory authorities that the devices are as safe and as effective as original equipment. Furthermore, the subset of SUDs that are reprocessed is practically limited to those products that are expensive and common enough to make it financially worthwhile to commercial reprocessors. From the patient or health care provider’s perspective, where regulated, this means that reprocessed SUDs are subject to all the same safety and efficacy standards applicable to any other medical device.

The objective of this chapter is to provide historical perspectives on SUD reprocessing, the circumstances that led to its growth, the types of devices commonly reprocessed, and a discussion of the SUD label. Most importantly, this chapter provides an overview of the regulatory requirements for organizations that reprocessors SUDs including hospitals, commercial reprocessor, and/or medical device manufacturers. As part of this, the chapter addresses emerging international regulatory trends applicable to SUD reprocessing.




LABELING

Because SUDs are not intended by the original manufacturer to be reprocessed, no discussion of SUD reprocessing would be appropriate without a discussion of labeling. After all, why would health care institutions want to reprocess devices clearly labeled as disposable or
for single use? It is important to understand the regulatory implications of device labeling. As noted, regulatory requirements, including FDA requirements,4 place the responsibility on the manufacturer to correctly label a device based on the intended use. A US Government Accountability Office (GAO) report succinctly addressed the usage of a single-use label as follows:


The decision to label a device as single-use or reusable rests with the manufacturer. If a manufacturer intends to label a device as reusable, it must provide data demonstrating to FDA’s satisfaction that the device can be cleaned and sterilized without impairing its function. Thus, a device may be labeled as single-use because the manufacturer believes that it cannot be safely and reliably used more than once, or because the manufacturer chooses not to conduct the studies needed to demonstrate that the device can be labeled as reusable.5

In contrast to labeling a device for single use, which requires no cleaning validation or other reprocessing instructions, medical device manufacturers desiring to market a device as reusable must have sufficient data to demonstrate that the device can be reused and that the validated processing instructions will consistently render a device appropriate for use (eg, cleaned, disinfected, and/or sterilized; see chapter 47). Thus, there is a strong regulatory incentive to label devices as single use because the regulatory burden is lower than labeling a device as reusable.

Prior to the 1980s, most medical devices were made of durable reusable materials such as metal, rubber, or glass. These were considered relatively easy to clean. With the advent of new plastic materials, less regulatory demands for SUDs, developments of sterilization technologies (eg, ethylene oxide optimization and the use of oxidizing agents), growing device intricacy, and the threat of iatrogenic HIV transmission in the early 1980s, the demand and use of disposable devices increased. Health care facilities found disposable devices to be convenient and safe and thus the beginning of a greater “throwaway” mentality. The pendulum began to swing back in the 1990s with managed care capping procedural costs, greater financial pressures, and a concern over the environmental implications in relying on disposable medical devices. It was at this time that hospitals began to consider the reuse of some SUDs.6 In addition to these financial and environmental pressures, health care facility skepticism of original equipment manufacturer (OEM) use of the single-use label grew, contributing to greater SUD reprocessing. In 2000, the first GAO report about SUD reprocessing found that some manufacturers had “contributed to the sense that compliance with the single-use label is not always necessary.” The GAO identified a manufacturer of pulse oximeter sensors that provided health care facilities with “remanufactured” sensors at a reduced price if the hospitals returned their used, single-use sensors to the company. This recycling of devices by the manufacturer, who itself had originally labeled the devices as single use, contributed to the sense among health care professionals that the single-use label was primarily for marketing purposes. Hospital skepticism of the single-use label was summarized in the 2000 GAO report, suggesting that health care personnel distrusted single-use labeling with some devices because of issues such as the FDA not being able to require manufacturers to support the designation of a device as single use and the perception that there was an economic incentive to market SUDs that could be reusable.5

Third-party or commercial SUD reprocessors emerged in the late 1990s. The competitive effect of their lower cost offerings placed greater attention on disposable medical devices, prices, and environmental impact (or sustainability). One article at the time estimated that if 1% to 2% of disposable medical devices were reprocessed/reused in the United States at that time, the health care savings could be approximately a billion dollars every year.7 Thus, many factors including economic, regulatory, and marketing considerations contributed to growing reprocessing of SUDs.


DEVICE TYPES

There are three main categories of SUDs commonly reprocessed in the United States: operating room (OR) instruments, noninvasive devices, and cardiovascular products. In the category of OR instruments, prices have escalated for hospitals for such devices including laparoscopic and electrosurgical instruments. Commercial reprocessors have offered reprocessed versions of these instruments including trocars, ultrasonic scalpels, graspers, and forceps, among others. Noninvasive devices include sequential compression sleeves and cuffs, tourniquet cuffs, bed alarms, and pulse oximetry sensors. Cardiovascular products include electrophysiology and ultrasonic cardiac catheters and associated instruments. Internationally, a greater range of SUD types have been subjected to routine processing and in many cases under unregulated controls or insufficient risk considerations. But such uncontrolled processing has heightened attention to the importance of meticulous process controls and safety considerations.8,9,10


REPROCESSING AND REGULATION

Before 1995, there were no federal regulations for the reprocessing of SUDs in the United States and no known regulations in other countries. The Joint Commission on Accreditation of Healthcare Organizations at that time maintained that SUDs should not be reprocessed unless the OEM had provided written instructions. Despite this, in one 1986 survey, the Institute of Health Policy
Analysis reported that 82% of US hospitals reused devices marked as disposable.6 As is much the case internationally, the full extent of SUD reprocessing by US hospitals in the 1980s and 1990s was not fully known. Not until 2000 did federal US regulations apply to SUD reuse and did a clearer picture of the extent of SUD reprocessing emerge.

Commercial SUD reprocessors, distinct from health care facilities that may reprocess devices, were subject to FDA oversight in the United States. Since at least 1998, the FDA considered third-party or commercial reprocessors of SUDs to be medical device manufacturers. Manufacturers could market a device for one more single use from a raw material that was previously used if the device met the same specifications described in the original clearance.11 The FDA did inspect commercial reprocessors in accordance with the quality system regulation (QSR).12 But, as noted, FDA did not assert any regulation against hospitals, surgical centers, or other entities that reprocessed SUDs, or did it assert the agency’s premarket controls against SUD reprocessing, regardless of where it took place. Beginning in 2000, pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA), FDA began requiring all SUD reprocessors to comply with all device manufacturing requirements that apply to OEMs2 as well as some additional requirements added later that apply only to SUD reprocessors.13 They issued guidance in 2000 outlining its enforcement priorities as it phased in new requirements. The implications of this move are multifold. First, this is the first known medical device regulatory authority to assert that the reuse of SUDs is a manufacturing activity and therefore subject to medical device manufacturing requirements. For reasons outlined in the following text, this not only put SUD reprocessors on a level regulatory footing with other device manufacturers but also put in motion a model regulatory approach to SUD reprocessing. Second, for the first time, FDA was asserting its regulatory authority over hospitals. Traditionally, as FDA only has jurisdiction to regulate device manufacturing, most FDA enforcement was against manufacturers at traditional manufacturing operations. Now, despite some protest from American hospitals and their trade associations, FDA would inspect and stop US hospitals from reusing SUDs if not meeting specific requirements. Third, by asserting it had authority over all SUD reprocessing, the FDA essentially forced a consolidation of all US SUD reprocessing into a handful of regulated firms. Hospitals, after a few high-profile warning letters,14,15 ceased to reprocess SUDs in-house and began to depend on FDA-regulated commercial firms. Of note, the scope of FDA’s 2000 guidance did exclude permanently implantable pacemakers, opened but unused SUDs, health care facilities that are not hospitals, and reprocessing of hemodialyzers. Since 2000, FDA has not acted to terminate the exemption for these four exclusions. As a result, medical device manufacturers, third-party, or commercial reprocessors and hospitals are all subject to the same FDA requirements when it comes to reprocessing SUDs.2

Since the issuance of FDA’s 2000 guidance, the agency has required SUD reprocessors, like OEMs, to comply with the agency’s establishment registration and medical device listing, medical device reporting, medical device tracking, reports of corrections and removals, the QSR, and labeling requirements.2 Including in this, like all devices, reprocessed devices are subject to premarket review by FDA, unless the agency has, by regulation, declared the device to be exempt from premarket requirements. Unless exempt, FDA class I and class II reprocessed devices are required to have cleared premarket notification submissions (“510(k)s”).16 In the 18 years since the introduction of FDA regulation of SUD reprocessing, over 250 FDA clearances have been issued for reprocessed SUDs, overwhelmingly to third-party or commercial firms. Only four instances exist where ownership of clearances belong to hospitals, but those hospitals are not registered or listed with the FDA to reprocess.17 It is unclear why these hospitals acquired a clearance to reprocess these devices if they lack the establishment registration and listing to do so.

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May 9, 2021 | Posted by in MICROBIOLOGY | Comments Off on Reprocessing and Remanufacturing of Single-Use Medical Devices
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