Some hospitals may drop in-house reprocessing

FDA requirements for some devices difficult’

Some hospitals that have been reprocessing single-use medical devices likely will abandon the practice or farm it out to third parties rather than deal with new premarket requirements by the Food and Drug Administration (FDA), officials tell Hospital Infection Control.

In issuing its final guidance on the issue, the FDA scuttled its proposed risk classification plan in favor of using an existing device classification code. (See editor’s note, p. 124, for information on obtaining the FDA guidance.) The Code of Federal Regulations (CFR) will be used to set enforcement priorities for premarket submission requirements for hospitals and third-party reprocessors. The FDA intends to enforce premarket submission requirements [i.e., premarket notification 510(k) and premarket approval applications (PMA)] within six months of issuing the guidance for all class III devices, which include those generally considered at higher risk of causing possible infections or adverse outcomes due to reprocessing.

Examples of reprocessed devices by the CFR code listed in an appendix of the document included an irrigating syringe (class I), surgical gowns (class II), and an implanted infusion pump (class III). Most of the class I devices and a few of the class II devices are exempt from premarket requirements, according to the document’s appendix. Premarket submission deadlines for class I and II devices that are not designated as exempt are 18 months and 12 months, respectively.

"When it comes to the products that are exempt from premarket notification, we believe that some hospitals in the country should be able to stay in the [reprocessing] business provided they can come up to adequate standards in terms of the safety of the process and documentation," said Larry Kessler, ScD, director of the office of surveillance and biometrics in the FDA center for devices and radiological health.

"Hospitals will find it more difficult to submit premarket notifications, the 510ks and PMAs. They are basically not manufacturers. They will find it difficult, but some may be successful. We have not put this guideline out specifically to put anyone out of the business who knows what they are doing. If they don’t know what they are doing, they should leave the business," Kessler explained.

Hospitals get one-year grace for education

Indeed, the FDA also cited comments that it was imposing "burdensome regulations" on hospitals. As a result of those concerns, the FDA established a one-year phase-in for active enforcement of the non-premarket requirements (i.e., registration, listing, medical device reporting, tracking, corrections and removals, quality system, and labeling). The agency will use the one-year period to educate hospitals about their regulatory obligations.

As part of that effort, the agency is planning a national broadcast/teleconference on Nov. 7, 2000, for third-party reprocessors and hospitals. "The focus will be on the quality system requirements," Kessler said.

The agency stated that the one-year extension of enforcement discretion after issuing the guidance document will not pose any significant public health risks "because the agency has no evidence at this time to demonstrate that reprocessing and reuse of single-use devices is posing any imminent danger to public health."

While hospitals that reprocess devices labeled for single use traditionally have been allowed to do so as long as they assume all liability, the FDA issued a series of documents in November 1999 and February 2000 proposing changing to a new system that would phase in requirements based on the risk of reprocessing the device. (See Hospital Infection Control, April 2000, pp. 53-55.)

Reused devices were to be classified as low, moderate, or high risk and enforcement phased in accordingly. However, the agency cited comments on its draft proposals that included concerns that the risk prioritization scheme lacked clarity and was too subjective. (See related story, p. 123.)

"To demonstrate that point, several [of those who commented] used the scheme to evaluate their products," the FDA stated in the guidance document. "In all cases, [their] risk category for their devices ranked higher or lower than FDA’s risk category for the same devices."

The agency concluded that disagreements over the risk category for a single-use device could cause delays in complying with premarket submission requirements. "The existing CFR device classification system, on the other hand, is an established categorization system that is familiar to all device manufacturers and many device users," the FDA document states.

Avoiding an ethical dilemma

For ICPs in hospitals that are not currently reprocessing due to liability concerns, the guidance clears the way to contract with third-party reprocessors and save some money by reusing at least the Class I devices, added Patti Grant, RN, BSN, MS, CIC, director of infection control at RHD Memorial Medical Center in Dallas. "It helps remove me from the ethical dilemma," she said. "That’s what I like about it. Right now, a lot of the third-party reprocessors have been held accountable, but it was never really cemented like this. The good news is the [classification] system is real easy to understand. It’s a matter of us now learning the specifics."

However, Grant questioned the FDA’s decision to exclude "opened but unused" single-use devices from the guidance pending further study. Because such devices should be sterilized, Grant questioned whether it would become a materials integrity issue if opened but unused devices are repeatedly resterilized. "Many times, the manufacturer has concerns about the integrity of the material," she said. "A good example would be aneurysm clips. We can no longer say, If you opened it, you can’t use it.’" I urge people to check with the manufacturer to see how many times they really feel that the material can be reprocessed."

[Editors note: The FDA document — "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals" — is available on the FDA’s Web site at www.fda.gov/cdrh/comp/guidance/1168. pdf. Patti Grant invites comment on the "opened-but-unused" issue in a comment posted in the "Infection Control Forum" on the Hospital Infection Control Web site at www.HIConline.com. ICPs are invited to share their thoughts on this or any other infection control subject by participating in the forum.]