FDA moves to toughen hospital reuse policies
ICPs have until April 11, 2000, to comment
Hospitals that reprocess single-use devices will face more oversight and tougher regulatory hurdles if draft guidance by the Food and Drug Administration is finalized as recently proposed. While the guidelines would be phased in over time, the FDA is essentially moving to a system that will require hospitals and independent third-party reprocessors to meet the same standards.
"Although we have no data to indicate that people are being injured or put at increased risk by the reuse of SUDs [single-use devices], the results of our own research and the information provided by various stakeholders have convinced us that this growing practice needs closer scrutiny and oversight," David W. Feigal, MD, director of the FDA Center for Devices and Radiological Health, said in explaining the proposals to the U.S. Congress Subcommittee on Oversight and Investigations. FDA outlined the proposals in two companion draft guidance documents posted on its Web site. (See editor’s note below right for the Web site address.) A notice of the availability of the draft guidelines and of the beginning of a 60-day comment period was published in the Feb. 11, 2000, Federal Register.
Devices to be classified based on risk
While hospitals that reprocess devices labeled for single use have been allowed to do so as long they assume all liability, the FDA proposes changing to a system based on the risk of reprocessing the device. Reused devices are classified as low risk (i.e., sharps containers), moderate risk (i.e. anesthesia breathing circuits), or high risk (angioplasty balloon catheters). "Based on our own studies, we have determined that cleaning and sterilizing these [high-risk] devices is very difficult," Feigal said. "Hospitals and third parties that reprocess these devices would be required to submit [premarketing notification] demonstrating that their reprocessing of these devices is safe and effective."
In a plan to phase in the requirements, FDA would enforce premarket notification and premarket application requirements within six months of issuance of final guidance if the reprocessed device is categorized as high risk; within 12 months if the device is categorized as moderate risk; and within 18 months if the device is categorized as low risk. "After receiving public comment on our draft guidance, including factors used to categorize risks and timing of our enforcement based on those risks, we will issue final guidance and begin implementation of our enforcement strategy that would regulate [original equipment manufacturers] and third-party and hospital reprocessors in the same manner," Feigal said.
Phased-in implementation recommended
However, hospitals are to be given an additional six months after the finalization of the guidelines before having to make any changes. "Possible unintended and unpredictable consequences of the agency’s immediate enforcement of all requirements (e.g., potential shortages in certain hospitals) support the need for a phased-in implementation period," the FDA guidelines state. "Moreover, the agency is aware that establishments such as hospitals may be unfamiliar with FDA regulations and will need time to learn about the requirements and to develop programs to comply with these requirements."
As proposed, the FDA changes would not apply to reprocessing in non-hospital medical settings, which the agency will consider at a later date. The FDA also is considering changes to the manufacturing labeling requirements for single-use devices. "One option the agency is considering is requesting [manufacturers] who label their devices single-use’ to provide, as part of the device’s labeling, any information of which they are aware regarding the potential risks associated with reusing their [devices]," Feigal said. "This information would serve as a caution to users and reprocessors who might attempt to reprocess."
[Editor’s note: Copies of the FDA draft proposals are available at www.fda.gov/cdrh/reuse/1029.pdf or CDRH Facts on Demand at (800) 899-0381 or (301) 827-0111. Specify No. 1029 when prompted for the document shelf number. Public comment on the FDA draft guidelines should be submitted to the Docket number assigned to the notice in the Federal Register, Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061 (HFA-305), Rockville, MD 20852.]
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