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Those reading this commentary who were not around during those "good ol’ days" may not know that the availability of SUDs dates back to the early 60’s. Despite their being heavily promoted as being easy to use, highly efficient, worry-free and, of course, labor saving, the mind-set of the provider community simply didn’t buy into their attributes and regarded them as being unduly expensive and wasteful. Nevertheless, their popularity accelerated not because of their attributes but rather were skewed by a reimbursement system that allowed the healthcare provider to charge Medicare for the cost of the SUD to which he could add an additional 35% to 40% "handling charge." Thus, as a line-item charge, the SUDs became revenue generators. The difference in the cost of a comparable, less-expensive item processed in-house was irrelevant.

By 1982, the packages for more than two-thirds of the thousands of sterile devices used read "for single-use only."1 Since the line-item charge for SUDs is now an integral part of today’s prospective reimbursement system and the 467 Diagnostic Related Groups (DRG), it is more than likely that the percentage may be even higher.

Even so, a variety of surgical items labeled for ‘single-use only’ continued to be reprocessed in-house. In response to a 1998 survey, 70% of the operating room managers that responded indicated that items such as drill bits, mesh, ear implants, vascular grafts, felt, sutures, disposable endoscopy instrumentation, gowns, cautery hand pieces, trocars, saw blades, transurethral prostatic resection loops, laser fibers, burs, biopsy force for gastrointestinal endoscopy, and endoscopy staples were being reprocessed. This can only be interpreted to mean that millions of dollars were being wasted annually by those institutions that were not reprocessing these types of SUDs.

Furthermore, it is to be noted that many of the items labeled as SUD are no different from those being shipped to other countries (e.g. Canada, Europe and Australia) where they are not considered to be SUDs.

Nationally, and for a period of approximately 3.5 years (August, 1996 through December, 1999), the FDA’s Medical Devise Reporting (MDR) system documented only 245 adverse events associated with the reuse of SUDs.2

This is relatively few compared with the literally thousands of MDR’s that the FDA receives on a yearly basis for new devices. (Personal communication, FDA). In addition, the Centers for Disease Control and Prevention (CDC) has few reports of adverse outcomes associated with the reuse of SUDs.

Not to be overlooked is a report released by the General Accounting Office (GAO) that indicated that the cost of reprocessing a single-use item was less than 10% of the cost of a new one, thus making it a very safe and cost-effective process.3

Hospitals’ impeccable records and the economic benefits that accompany their reprocessing of all the medical devices in-house are a given. Under the circumstances, it is not reasonable to believe that this would warrant the FDA’s ‘grand-fathering’ those SUDs that have been reprocessed in-house rather than having the institutions comply with their costly reprocessing regulations?

The costs for the development of the FDA’s regulations are significant. Even years prior to their enactment in 2000,4 the agency had already indicated that it
required $1,000,000 to evaluate device reprocessing. Subsequently, a bill appropriating $55,000,000 for 522 full-time equivalents required to monitor the premarket reviews submitted by both hospitals and outsourcers was proposed in the U.S. Senate. ⁵

As stated earlier, those hospitals that have been reprocessing SUDs in-house are now considered by the FDA regulations to be manufacturers. Thus, they must submit the same type of paperwork as third-party reprocessors. Because the agency was not able to differentiate between them, they arranged for a survey to find out how many reports had been submitted by hospitals. They found that 76% of the hospitals were NOT reprocessing SUDs. Of the remainder, 20% were outsourcing the reprocessing and only a meager 4% - 200 of our nation’s healthcare institutions, were reprocessing in-house.

Another survey of 675 hospitals (sponsored by a joint group - the American Hospital Association, the Association for Professionals in Infection Control and Epidemiology, the American Society of Hospital Central Service Personnel and the Federation of American Hospitals) found that only 25% of hospitals used resterilized SUDs. Despite these relatively small numbers, an FDA policy analyst was quoted as saying that the agency had not been able to make as many inspections as they would have liked because of the ratio of hospitals to investigators.

That having been said, the question that logically arises, is whether it is really the FDA’s intent to discourage hospitals from reprocessing SUDs? If so, for whose benefit? In addition, is the agency’s return on the investment of their regulations commensurate with the benefit to the healthcare consumer?

1) The FDA should immediately mandate that OEMs stop and decease labeling SUDs as they have been doing for all these years. To permit the manufacturers to continue this self-serving, deceiving and deliberate misrepresentation of products that have been proven to be reusable is unconscionable.

2) For those hospitals that have the capability of reprocessing the newly labeled reusables, those items should be grandfathered and the hospital relieved from having to comply with the agency’s reprocessing regulations. They will then be permitted to begin and/or continue to process the items without intervention.

3) The FDA should then continue to regulate and monitor the third-party reprocessors as they have been and in the same manner as they have been doing of the OEMs. Those hospitals that do not have the capability of reprocessing the medical devices can continue to utilize the outsourcer’s service. Those for whom a third-party reprocessor is not available can simply continue to discard the items after their use just as they have been doing.

Every healthcare provider is beleagured with the never ending and escalating pressures to not only contain costs to a minimum but to reduce them as well. Those that have the capability to reprocess their requirements economically in-house should therefore be encouraged to do so. To needlessly add a burdensome and needless layer of cost of administrative functions to their doing so is unreasonable.

References

1. Bruch, S.C., In-hospital versus industry sterility assurance: is there a double standard? Current perspectives, American Association for the Advancement of Medical Instrumentation, Arlington, VA, 1982, Technology assessment report 4-82, 19-32

2. Reusing medical devices:ensuring safety the second time around, FDA Consumer Magazine, 2000:34-37

3. Pugliese, G. and Favero, M.S., GAO issues report on reuse of singloe-use medical devices, Infection Control and Hospital Epidemology, September 2000, Vol 21, No. 9, p 574

4. Enforcement Priorities for Single-use Devices Reprocessed by Third Parties and Hospitals, Rockville, MD, U.S. Department of Health and Human Services: Food and Drug Administration, Center for Devices and Radiological Health, Division of Enforcement 111, Office of Compliance, August 2000

5. Medical devices,diagnostics and istrumentation, "The gray sheet". FDC Rep 25-1