Final reuse guidance: FDA drops risk classification
Final reuse guidance: FDA drops risk classification
In its final guidance on reprocessing of devices labeled for single use, the Food and Drug Administration (FDA) dropped its proposed risk classification scheme and kept the already-established classifications of instruments, to the relief of same-day surgery managers who submitted numerous comments on the classification.
"That’s what we’re used to," says Sherron C. Kurtz, RN, MSA, CNOR, CNAA, director of perioperative services at Henry Medical Center in Stockbridge, GA. "It makes it a little more consistent."
While Henry Medical Center was waiting on the final reuse regulation, it discussed reuse of devices in its ethics committee and among its risk manager and attorney. At this point, the center is only reusing sequential compression sleeves, because they’re noninvasive, and opened but unused devices, Kurtz says. The FDA final regulation clarified that opened but unused items are not regulated by the agency.
Surgery centers are not covered by the regulation. However, managers in those facilities should pay close attention to the rules, as the FDA might later include freestanding centers in the same category as hospital providers, experts warn.
Some hospital managers have raised concerns that surgery centers aren’t going to be covered initially by the reuse regulation.
"I think hospitals have generally have greater resources available to them to resterilize than an ambulatory surgery center," Kurtz says. "Why are we having a double standard? We work hard in our hospitals to not have a double standards. We offer comparable level of care. The Joint Commission hammers us: We have to do the same care for outpatient as inpatient. So why a double standard for hospitals and surgery centers?"
Under the final rule, the FDA will regulate third-party processors and hospitals that reprocess single-use devices the same way the agency now regulates original equipment manufacturers. The final guidance gives hospitals an extra six months to comply with the regulations for nonpremarket requirements. These include registration, listing, medical device reporting, tracking, corrections and removals, quality system, and labeling. In its proposed guidance, the FDA had said it would phase in the enforcement of those regulations over six months from the date the guidance was issued, but the agency extended that phase-in period to a year in the final guidance.
FDA’s enforcement priorities for the premarket submission requirements will be based on the existing medical device classification system: class I for low risk devices, class II for moderate risk devices, or class III for high-risk devices. FDA will enforce the premarket submission requirements for third party and hospital reprocessors in six months for class III devices, in 12 months for class II nonexempt devices, and in 18 months for class I nonexempt devices. The FDA will examine later, on a case-by-case basis, the need to revoke exemptions from premarket requirements for class I and II exempt products, according to the agency.
Some reprocessing agencies predict that hospitals and small reprocessors are likely to get out of the reprocessing business due to the additional paperwork and quality requirements.
"What stood out as important in the final regulation is the amount of detail that will be necessary to meet FDA requirements," says Mary Lynne Weemering, RN, MSN, CNOR, clinical nurse specialist and perioperative consultant in Kingwood, TX. "These details may become so burdensome that managers may choose not to reprocess."
These details include premarket notification and approval requirements, registration and listing of firms, submission of adverse event reports, manufacturing requirements, labeling requirements, medical device tracking, and correcting or removing from the market unsafe medical devices, she says. "Personally, I find the regulation so burdensome that if given a choice, I would choose not to reprocess."
Kurtz agrees. "I don’t see how hospitals are going to do all this work," she says. "I would never do it."
(The final FDA rule, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, is available on FDA’s Web site at www.fda.gov/cdrh/comp/guidance/1168.pdf. It also was published in the Aug. 2 Federal Register, which is available at www.access.gpo.gov/index.html. For information on ordering a copy of the Federal Register, see resource box, p. 123.)
Source
For more information on the final reprocessing regulation, contact:
- Mary Lynne Weemering, RN, MSN, CNOR, 2318 Summit Way Court, Kingwood, TX 77339. Telephone: (281) 358-9497. E-mail: [email protected].
EXECUTIVE SUMMARY
In its final guidance on reprocessing of devices labeled for single use, the Food and Drug Admini-stration (FDA) has announced its intention to use the already-established instrument classification system (class I, class II, and class III), rather than the proposed risk classification scheme, for premarket requirements.
- The final guidance gives hospitals an extra six months to comply with the
regulations for non-premarket requirements. These include registration,
listing, medical device reporting, tracking, corrections and removals,
quality system, and labeling.
- Ambulatory surgery centers won’t be regulated at this time, but same-day surgery experts recommend familiarity with the regulations in the event that surgery centers are included later.
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