|Reprocessing Single-Use Devices: Why Does the Debate Continue?|
Medical Device & Diagnostic Industry
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An MD&DI October 1999 Column
When it can be validated that a device can be cleaned, tested, and reused without harm to the patient, the device should be reprocessed, a member of AMDR maintains.
The reprocessing of disposable or single-use devices is one of the fastest growingand most discussedareas in the healthcare industry today. The companies that manufacture such products are generally opposed to reprocessing, taking the position that these items have not been approved for multiple use. Recent discussions about reprocessing have tended to be conducted in vague generalities, and typically fail to focus on specific products. For example, is the item in question used or simply opened and unused? If a decision is made not to reprocess used balloon angioplasty catheters, does it automatically follow not to reprocess opened but unused products or noncritical items like stainless-steel drill bits and saw blades? Finally, any discussion and evaluation of reprocessing should identify exactly who is the reprocessor: a hospital, a third party, an FDA-registered commercial company, or a physician's office.
This article attempts to clarify some of the issues in the current debate over reprocessing. It also supports the proposition that a properly designed reprocessing programcarried out by either a hospital or a third-party reprocessor and in compliance with applicable FDA requirementsoffers the healthcare provider an excellent way to maintain quality patient care while also achieving substantial cost savings.
WHAT DOES "SINGLE USE" MEAN?
There is a great misunderstanding of the term "single use" as it applies to reprocessing. Contrary to popular belief, the designation of a product as single use is at the sole discretion of the manufacturer. An operating room table or a laser could be labeled single use if the manufacturer so desired and the customer would buy it.
There are no published standards that differentiate quality, function, or length of useful life between reusable and single-use devices. FDA simply states that the institution or practitioner that reuses a single-use device should be able to demonstrate that the device can be adequately cleaned and sterilized, that the physical characteristics or quality of the device will not be adversely affected, and that the device remains safe and effective for the intended clinical use. These same criteria should be applied equally to reusable instruments that are reprocessed by a hospital.
It is not feasible to manufacture a surgical instrument that is perfect for one use and no more. Furthermore, it is difficult to define "one use." For example, are laparoscopic scissors to be used to make only one cut, or can they make 10 cuts, or perhaps 20? Obviously, instruments are employed differently in various medical procedures and situations. We do not hear of a single-use instrument wearing out just because one surgical procedure lasts longer than another. Many things affect the life of a surgical instrument. If a pair of scissors is only used once in a surgical case, has its entire useful life been exhausted? The answer, of course, depends on functionalitythe same decision process that occurs regarding reusable instruments in the hospital today. If a disposable instrument is properly cleaned, tested, deemed functional, and properly repackaged and sterilized, it can and should be used again. The same proper handling, cleaning, inspection, and sterilization processes should be in place to determine whether any instrumentreusable or single usewill provide a successful medical result and the expected outcome.
WHAT IS REPROCESSING?
Reprocessing is standard practice in the United States today. As mentioned before, every surgical hospital reprocesses its supply of reusable surgical instruments through cleaning, inspection, and in-house sterilization. Whether a reusable instrument is reused or discarded depends on the hospital's inspection process prior to resterilization.
Certain reusable instruments are often provided to the hospital on loan from a manufacturer. Although such devices sometimes arrive at the hospital packaged and sterilized, more often than not these manufacturer-provided instruments are delivered nonsterile by the company representative in the trunk of his or her carjust in time for the hospital to sterilize them for use in the surgical procedure for which they have been requested. Very seldom are biological indicators (BIs) run to assure the sterility of such loaner instrument trays, even though the bioburden level is totally unknown. Is this practice considered safe? If the answer is "Yes," then why not reprocess and sterilize the single-use saw blade or drill bit as well?
If the inspection of a reusable instrument determines that it will not properly function for its intended use, it is either discarded or sent out for repair. The great majority of instrument repairs (such as sharpening) are done by companies other than the original manufacturer of the instrument. These instrument-repair companies may or may not be registered with FDA. All such repairs are undertaken to ensure the proper functionality of the instrument; if the process is right, the instrument will perform safely and effectively.
The reprocessing of both reusable and single-use medical devices is being done in hospitals today without the formal levels of regulation, protocol, or validation that FDA imposes on registered third-party commercial reprocessors. If adequate protocols and processes are applied, a proper determination can be made concerning the reuse of any instrument, regardless of whether someone chooses to call it reusable, disposable, or single use.
SHOULD ALL SINGLE-USE DEVICES BE REPROCESSED?
When reprocessing is discussed, there are usually no distinctions drawn concerning the risk of reuse of various devices. Reference is inevitably made to a small number of infections in 1984 that were traced to in-house reprocessing of hemodialyzer filters, and to the potential problems with the reuse of angioplasty catheters. Experts agree that scrutiny of hospital records since 1984 would find many other infections that could be traced to in-house reprocessing of reusable products. If sterility were the only criterion and cost was not an issue, few would disagree that all items should be reprocessed by FDA-registered companies using validated procedures. In reality, this is not feasible.
Given proper procedures, there should be no problems associated with reprocessing any product. However, as a practical position, there is often little reason to do so. Here again, it is important to be specific about the item in question.
For example, it is certainly appropriate to reprocess an opened but unused trocar and sheath with chamber. However, a used trocar with a chamber or valve is unlikely to be an acceptable product for reprocessing, even when handled by a third-party commercial company. The reason goes back to a basic tenet of sterilization: "If you can't clean it, you can't sterilize it." This principle should be applied to reusable instrumentation as well as to single-use devices. FDA has acknowledged this point and continues to seek compliance by manufacturers of reusable instrumentation in providing cleaning instructions for their products. In this regard, one driving force behind manufacturers' refusal to admit that their single-use devices can be used more than one time is the fact that it is quicker, less expensive, and easier to tell FDA and the hospital to simply throw away the product after one use. In addition, if a product can only be used once, the number of units sold in any given sales cycle will be greater, which translates into more profit for the manufacturer.
Although it is important to specify the product and the conditions of its use, there is no reason to single out implants or critical devices in the current context of the reprocessing debate. In fact, there seems to be a difference of opinion concerning the definition of a critical device. Thirty-plus years ago, Professor E. Spaulding suggested that devices be classified as critical, semicritical, or noncritical based on the risk of infection each presents. This level of risk, in turn, depends on the device's use and on the number of infection barriers it compromises during its use: the more barriers broken, the greater the need for sterility (i.e., the lower the quantity of bioload that can be tolerated).1 Over the years, this definition has been intermingled with FDA's classifications of critical and noncritical devices, which are based on three categories (Classes I, II, and III) that determine a product's level of regulation. FDA's classification of a noncritical device, for example, deals with the issue of failureif the device fails, how life threatening would the situation become? Contrary to the degree of variance in the Spaulding classifications, most healthcare professionals expect that any product used within a sterile field be sterile. It is important to make clear in any discussion involving reprocessing that FDA's classification system is based on how the device functions, whereas the Spaulding system determines the required levels of disinfection to be used.
THIRD-PARTY REPROCESSING VERSUS IN-HOSPITAL REPROCESSING
There are major differences between reprocessing in the hospital and reprocessing by an FDA-registered reprocessor. The main distinction is that industry operates under far more stringent regulations than do hospitals. Because of major differences in the validation procedures used, a hospital might well choose to reprocess a certain product through an FDA-registered third-party reprocessor while declining to reprocess the same item within its own institution. If concern for patient safety is truly what is driving this debate, why has FDA not used its existing authority to regulate hospital reprocessing? This question can be answered two ways. First, a patient safety problem does not exist. Second, the manufacturers do not want to go against the wishes of their customers. If reprocessed products were causing major patient injuries or infections, the hospitals would have stopped the practice long ago. The end-user continues to be the best judge of quality.
FDA policy concerning third-party reprocessing continues to be unclear. In a letter dated October 1998 directly addressing the legal status of third-party reprocessing, Larry Spears, director of the Division of Enforcement III at FDA's Center for Devices and Radiological Health (CDRH), wrote that:
Third-party reprocessing of devices labeled for single use is lawful in the United States provided that the reprocessing firm complies fully with all regulatory requirements currently imposed on
them. . . .Third-party reprocessors are subject to FDA inspection and enforcement actions will not be taken against them or their products unless FDA has determined that (1) the firm is out of compliance with current applicable regulatory requirements, or (2) the firm's products represent a danger to health.2
On July 9, 1999, Spears again addressed this issue when he wrote:
Third-party reprocessing of devices labeled for single use is unlawful unless those engaged in this practice comply with all regulatory requirements for manufacturers, including premarket notification requirements. However, FDA has exercised and will continue to exercise regulatory discretion for all premarket notification requirements, until a new FDA reprocessing position is adopted. The most significant regulatory requirement, at this time, is compliance with the newly developed Quality System regulation. That regulation requires appropriate manufacturing and quality assurance controls over all the firm's reprocessing operations including cleaning, disinfection, packaging, labeling, sterilization, distribution, etc. Third-party reprocessors are subject to FDA inspection and enforcement actions will not be taken against them or their products unless FDA has determined that 1) the firm is out of compliance with current applicable regulatory requirements (with regulatory discretion for all premarket notification requirements, until a new FDA reprocessing position is adopted), or 2) the firm's products represent a danger to health.3
So what is so different about these two letters? Clearly changing the phrase "is lawful in the United States provided that the reprocessing firm complies fully with all regulatory requirements currently imposed on them..." to "unlawful unless those engaged in this practice comply with all regulatory requirements..." is what is initially noticed. But the agency "will continue to exercise regulatory discretion for all premarket notification requirements" and will inspect and institute enforcement actions when necessary just as it has always done. But does premarket notification ensure a safe medical device? Why are there so many MDRs on new, nonreprocessed products? Operating room nurses across the country will confirm that new products fail every day right out of the package. It seems that the need for premarket notification and 510(k)s is the only argument that the original manufacturers can continue to make in light of the fact that many of their own customers have chosen to reprocess certain items. Could it be that FDA is receiving only one side of the story from the manufacturers and their lobbyists in Washington? As long as it was just hospitals reprocessing any device, it seems that there was no problem. But as soon as third-party reprocessors stepped on the playing field and began to gain acceptance as an industry, the manufacturers cried, "unlevel playing field."
Most infection-control practitioners understand that a validated process is one in which independent testing has determined that if the task is performed exactly the same way each and every time, the end result will be predictable and repeatable. Yet the same people consider it an acceptable practice to run more than one load a day in a sterilizer without testing each and every load with a BI. Or, perhaps more to the point, how many hospitals have policies requiring that the sterilization loads be held until the results of the BIs are confirmed? The generally accepted recommendation from groups such as the Association of Operating Room Nurses and the American Hospital Association is that BIs should be used at least weekly for all sterilizers, daily for steam sterilizers, and with every load for gas sterilizers.4 It is further recommended that any load containing implant products be biologically monitored.
FDA, however, holds third-party reprocessors to a much higher standard, namely the Current Good Manufacturing Practices (CGMPs). The revised CGMPs, set forth in the quality system regulation, were issued in October 1996 and became effective June 1, 1997. These requirements, as applied to the reprocessing of single-use items, would never allow a sterilization load to be released for use without confirmation of the sterility of the cycle, using the universally acceptable validation of SAL 106. And, with the exception of the 510(k)/PMA requirement, FDA's policy for reprocessors is the same as that applied to the original device manufacturers.
WHAT ARE THE BENEFITS OF REPROCESSING?
Everyone is feeling the pressures of the continuing rise in healthcare costs. Couple this with changes in reimbursementsuch as reduced revenues under capitationand healthcare providers face a major financial challenge. The question of how to reduce operating costs without compromising the standard of patient care is confronted daily by healthcare professionals at all levels. Personnel cuts, along with various materials management programs, have already been implemented by most institutions. Unfortunately, the changes have not produced all of the necessary savings, and it appears that the coming years will see further reductions in revenue and allowable patient billings. Reprocessing of selected disposable devices can potentially result in major savings.
Hospitals have long recognized that reprocessing devices labeled for single use makes sense. As described above, the single-use designation on a device is often entirely arbitrary; in many cases, devices that now carry a single-use label previously were reusable or currently have a reusable counterpart. Thus, when it can be scientifically proven and validated that a device can be cleaned, functionally tested, repackaged and sterilized, and used again without harm to the patient, the device can and should be reprocessed. Not to do so wastes precious healthcare resources and needlessly exacerbates the country's environmental waste disposal problem.5
Manufacturers have discouraged reprocessing by giving away expensive capital equipment if the hospital will commit to purchasing a certain amount of disposables. Sometimes, by simply adding plastic to a reusable product, the manufacturer produces a new single-use product that cannot be autoclaved, which is the most popular form of in-hospital sterilization. Some manufacturers, however, have also provided hospitals with guidelines for the resterilization of opened but unused disposable products.
Most manufacturers have stated that they will not stand behind a single-use product should the hospital choose to reprocess and reuse it. This is only fair, since manufacturers cannot inspect a product prior to its reuse and do not have the responsibility for repackaging and sterilization. The manufacturer would retain responsibility for any defects in original materials and workmanship, but the hospital would accept responsibility for the functionality and sterility of the reprocessed product. The same conditions would apply if the hospital were to select a third-party commercial reprocessor, although most third-party reprocessors provide liability coverage for the hospital.
The Association of Medical Device Reprocessors (AMDR) was established in 1997 to provide a viewpoint counter to that of device manufacturers. The group represents the legal and regulatory interests of third-party reprocessors of medical devices labeled for single use, and is dedicated to educating consumers and the healthcare community regarding the safety, legality, and benefits of third-party reprocessing. According to the organization, medial device reprocessing has an excellent safety record. In the 12 years since the third-party reprocessing industry emerged, millions of devices have been reprocessed with few problems. In fact, based on available evidence, including MDRs, the safety record of reprocessed devices is at least as goodor better thanthe safety record of new devices. Indeed, there are numerous, well-documented cases of non-reprocessed medical devices causing patient injury or death. AMDR member companies are careful to adhere to established, validated protocols. Far from maintaining that every device should be reprocessed, the group recommends reprocessing only when it can be scientifically proven and validated that a device can be cleaned, packaged, and sterilized without impairing its functionality.
The reprocessing of selected single-use items can be a viable cost-reduction program when performed under proper guidelines. There is no evidence that such programs in any way diminish patient-care standards. In fact, an effective reprocessing program may actually improve patient care if the associated cost reduction helps maintain adequate hospital staffing levels.
Every product, disposable or reusable, has a functional life, which cannot be precisely determined. Expensive reusable items have been known to break on first use, whereas single-use devices have often proved useful for many successive procedures. Functionality is the key: if a product can be economically reprocessed with validated protocols and deemed to be functional, there is no reason to discard that product after one use.
Our nation is in the midst of a healthcare crisis that shows no sign of resolving itself any time soon. Government agencies, hospitals, healthcare professionals, patients, and manufacturers must all become part of the solution. A prudent program of reprocessing saves money, jobs, and the environmentwithout changing the standard of patient care.
1. VW Greene, "Disinfection and Sterilization of Disposable Devices/Equipment," in Chemical Germicides in Health Care: International Symposium, ed. William A. Rutala, (Washington, DC: Association of Professionals in Infection Control and Epidemiology, 1994).
2. Letter from Larry Spears, director, Division of Enforcement III, Office of Compliance, CDRH, FDA, to Stephen Terman, Esq. (October 19, 1998).
3. Letter from Larry Spears, director, Division of Enforcement III, Office of Compliance, CDRH, FDA, to Stephen Terman, Esq. (July 9, 1999).
4. Association for the Advancement of Medical Instrumentation ST 19, 1985.
5. Nancy J Perry, "Undercover in a Hospital," Money (December 1994), 142.
William B. Stoermer Jr. is executive vice president of Alliance Medical Corp. (Phoenix), and has a long history in the healthcare industry, including positions with original equipment manufacturers, as a hospital administrator, and currently with a reprocessing company. Alliance Medical Corp. is a founding member of the Association of Medical Device Reprocessors (AMDR).