An MD&DI October 1998 Column
An association officer, representing the legal and regulatory interests of third-party reprocessors of medical devices labeled for single use, explains the virtues of this practice.
In the past decade, an innovative new industry has emerged that offers a way to realize significant cost savings without compromising patient safety. The third-party medical device reprocessing industry has grown rapidly as a result of the proliferation of managed-care organizations and the ever-increasing pressure they bring on hospitals to extract the greatest value from every health-care dollar.
Hospitals have long recognized that reprocessing medical devices labeled for single use makes sense: in many cases, the single-use designation is completely arbitrary. Device manufacturers, not FDA, choose when to designate a device as being for single use, and there are no FDA regulations or formal standards distinguishing the quality or functionality of reusable devices from single-use devices. In fact, many devices that were once marketed as being reusable are now suspiciously labeled as being for single use only. By relying on reprocessed medical devices, hospitals are able to redirect scarce resources toward improvements in technology and patient care, rather than needlessly expending funds on the purchase of new devices.
CRITICS OF THIRD-PARTY REPROCESSING
Not surprisingly, many OEMs are critics of third-party reprocessing, viewing the option as a potentially formidable competitive threat. In an effort to discourage hospitals from using reprocessed medical devices, some OEMs have used various scare tactics to spread fears about the safety and legality of reprocessing. Their words, however, ring hollow. A look at the facts, the law, and the public policy leads to only one conclusion: third-party reprocessing is safe, it is legal, and it makes sense.
The most common allegation levied by critics of third-party reprocessing is that the industry is unregulated. However, this statement is false, as FDA clearly articulated in a recent letter denying a citizen petition filed by HIMA requesting, among other things, that the agency impose premarket clearance requirements on third-party reprocessors. In its denial letter, FDA stated that the agency already requires third-party reprocessors to comply with a host of regulatory controls and that these controls are sufficient to ensure the safety and effectiveness of reprocessed devices [Docket 97P-0377].
Another refrain frequently voiced by OEMs is that reprocessed medical devices are unsafe. As FDA has plainly stated, however, the facts directly contradict this claim. Indeed, in the denial letter referenced above, FDA noted the "current general absence of evidence of adverse patient outcomes attributed to the reuse of single-use devices."
THE GOLD STANDARD IN THIRD-PARTY REPROCESSING
In the small but expanding marketplace of third-party reprocessors, the member companies of the Association of Medical Device Reprocessors (AMDR; Washington, DC) are gaining growing recognition as the gold standard in third-party reprocessing. It is estimated that AMDR members perform approximately 85% of the third-party reprocessing done in the United States, serving a customer base of hospitals and outpatient surgery centers and reprocessing a broad range of clinical devices including those used in perioperative procedures, cardiology, orthopedics, and respiratory therapy.
AMDR defines third-party reprocessor as an entity that inspects, functionally tests, cleans, packages, and sterilizes medical devices labeled for single use in such a manner that their quality, physical characteristics, and performance are not significantly affected and the devices remain safe and effective for their appropriate clinical uses. Third-party reprocessors do not take title to the devices, but simply return the reprocessed medical devices to their owners who requested reprocessing.
AMDR member companies reprocess three general categories of medical devices labeled for single use:
- Unopened devices whose expiration dates have passed.
- Opened devices that have never been used.
- Previously utilized devices.
AMDR member companies share a common objective: providing hospitals with the safest, highest-quality reprocessing services. This objective can only be accomplished through careful compliance with applicable FDA regulatory controls. FDA requires third-party reprocessors to, among other things, adhere to medical device reporting requirements and comply with applicable quality system regulation requirements (a broad set of provisions governing all aspects of quality assurance). In addition, FDA inspects third-party reprocessors to ensure compliance with agency requirements.
AMDR members accept their obligation regarding all FDA requirements currently applicable to third-party reprocessing. In addition, all AMDR members maintain a minimum of $5 million in liability insurance, and some carry $25 million or more.
The most important indicator of AMDR's unflagging dedication to patient safety, however, is the track record of member companies: to date, there are no documented cases of patient injury resulting from the use of a device reprocessed by an AMDR member. This safety record speaks for itself and is no accident. AMDR member companies have established validated protocols to ensure that every device they reprocess is safe and effective for its intended use.
THIRD-PARTY REPROCESSING: HIGH QUALITY, LOW COST
Traditionally, device reprocessing has been conducted primarily by hospitals. However, hospitals are increasingly turning to third-party reprocessing, which is more cost-effective than in-hospital reprocessing and can also provide an equivalent, if not higher, level of sterility assurance. Third-party reprocessors often have more capital available than hospitals to invest in state-of-the-art cleaning, sterilization, and testing equipment. Furthermore, unlike hospitals, third-party reprocessors are regulated by FDA and must comply with applicable regulatory requirements designed to ensure that medical devices are reprocessed according to the most stringent safety and quality standards.
With respect to cost, the benefits of third-party reprocessing are clear. By outsourcing their reprocessing needs, hospitals avoid the considerable expense associated with establishing their own in-house reprocessing centers. Furthermore, third-party reprocessors typically have significantly lower operating costs than in-hospital reprocessing centers and can thus offer hospitals reprocessing services at a significant cost savings. In addition, assuming that they use an adequately insured reprocessor, hospitals can effectively free themselves from malpractice insurance costs that could arise in connection with the improper reprocessing of devices.
As health-care patients and providers understand, the era of managed care has permanently changed the economics of health care. The days of expecting and providing health care services at any cost are gone. For those hospitals seeking to maintain high-quality patient care during these cost-conscious times, third-party reprocessing is not only the obvious choice, it is the right choice. Indeed, when it can be scientifically proven and validated that a medical device can be cleaned, functionally tested, sterilized, and reused without harm to the patient, then the device should be reprocessed. Not to do so wastes precious health-care resources.
Pamela J. Furman is the executive director of the Association of Medical Device Reprocessors and an attorney at Olsson, Frank and Weeda (Washington, DC), which specializes in food, drug, and medical device law.