Reprocessing single-use devices—regulatory roles

AORN Journal,  July, 2002  by Debra Dunn

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The FDA has hired additional personnel to assist with the anticipated increase in paperwork. The FDA has asked the Centers for Medicare and Medicaid Services (CMS) and JCAHO to assist with enforcement of the act. Both agencies have been asked to include SUD reprocessing as part of their hospital quality-of-care standards and to report back to the FDA. This will help expedite the FDA's efforts to review applications for SUD reprocessing and the timely completion of new medical device premarket notification application reviews. As of mid-May 2000, JCAHO agreed to inform hospitals about the FDA's policy on SUD reuse and to ask three questions on behalf of the FDA.

* Does the hospital reprocess and reuse SUDs? If so, which devices are being reprocessed?

* Is the hospital aware of the FDA's requirements?

* Does the hospital intend to continue to reprocess and reuse?

The Joint Commission will provide the FDA with this information on an aggregate basis, and hospitals will not be identified individually. (35) In addition, JCAHO was contracted by the FDA to determine the extent to which reprocessing of SUDs is occurring in hospitals. The Joint Commission initial survey results from 200 responding hospitals indicate that 36 (ie, 18%) reuse SUDs. Nine of these hospitals reprocess in-house, and 27 use third-party reprocessors. Although conclusions cannot be made yet, the results thus far indicate that reuse of SUDs is not widespread. (36)

Another major problem with the guidance directive is that it applies solely to hospitals that reprocess and third-party reprocessors. The guidance does not apply to ambulatory surgery centers, including in vitro fertilization clinics; physician offices, some of which perform invasive procedures such as cystoscopies; dental offices; or other nonhospital health care facilities. In addition, the SUD enforcement priorities do not apply to permanently implantable pacemakers, opened but unused SUDs, or hemodialyzers. (37) There is no official agency recommendation on how hospitals should handle opened but unused supplies, which includes unused items on the surgical back table. (38)

Finally, the changes mandated by the FDA may increase significantly the amount and expense of administrative oversight required to manage a reprocessing program. The net effect on SUD reprocessing, therefore, is uncertain, and it may lead to an overall decrease in the number of SUDs reprocessed, at least until the new regulatory system is functioning well. If this happens, there is a chance that OEM prices will increase as the competitive alternative of reprocessing becomes less viable. Although third-party reprocessors and the Association of Medical Device Reprocessors (AMDR) endorse the new guidelines, the regulatory burden will take a toll on reprocessors, causing some to go out of business and others to consolidate into larger firms. Regardless, third-party reprocessors are better prepared to deal with the FDA regulations than hospitals because they already collect some of the data required by the FDA. Their ability to adjust to the new requirements, however, is not assured. For example, they may find it difficult to conduct clinical trials needed to submit PMAs. Hospitals, on the other hand, either may stop reprocessing altogether or switch from in-house reprocessing to outsourcing to third-party reprocessors because they are inexperienced with FDA regulations regarding medical devices and manufacturing processes. (39) This would increase the third-party reprocessors' workload.