FDA policy on reprocessing not for surgery centers
New draft for single-use devices released
The latest draft policies from the Food and Drug Administration (FDA) on reprocessing of single-use devices appears to apply to hospital settings only, although that question is still up in the air, says William Stoermer, executive vice president of Alliance Medical Corp., a reprocessing company in Phoenix, and president of the Association of Medical Device Reprocessors in Washington, DC.
The FDA confirmed for Same-Day Surgery that the draft policies apply to hospitals, defined as "acute care facilities," but not surgery centers. And it’s possible that the draft policies might not apply even to hospital-owned surgery centers that reprocess their single-use devices at the main hospital facility, Stoermer says. "It’s still a question to be resolved."
The draft policies are "Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals" and "Guidance for Industry and FDA Reviewers: Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme." The policies are posted on the FDA Web site and available by fax. (See resource box, p. 41.) 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.
Same-day surgery experts advise readers to follow the proposed rules closely and comment on them. (For information on how to submit comments, see resource box, p. 41.) The guidance might eventually apply to the entire surgery field, including freestanding centers and physician offices, they point out.
The draft policies include revised flowcharts and a revised worksheet for determining whether a reprocessed device is low risk, moderate risk, or high risk. (See flowcharts and worksheet inserted in this issue.) The draft policies also include a list of devices and a designation of whether the devices are low, moderate, or high risk. (See excerpt inserted in this issue.)
Designation affects when data are turned in
The designation of risk won’t change the classification of the device. The designation merely affects when data must be submitted to the FDA, Stoermer emphasizes.
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.
David W. Feigal, MD, director of the FDA Center for Devices and Radiological Health, explained the proposals to the Subcommittee on Oversight and Investigations. "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."
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."
The FDA is considering changes to the manufacturing labeling requirements for single-use devices. "One option the agency is considering is requesting [manufacturers] that 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." (For information on earlier proposed revisions from the FDA on reprocessing of single-use devices, see Same-Day Surgery, January 2000, p. 1.)
Copies of the draft proposals are available at www.fda.gov/cdrh/reuse/1029.pdf or Center for Devices and Radiological Health 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 draft guidelines should be submitted to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, U.S. Food and Drug Administration, 5630 Fishers Lane, Room 1061 (HFA-305), Rockville, MD 20852. Include the docket number 00D-0053.
For more information on reprocessing of single-use devices, contact:
• William Stoermer, Executive Vice President, Alliance Medical Corp., P.O. Box 8469, Asheville, NC 28814. Telephone: (828) 232-1022. Fax: (828) 232-1024. E-mail: wstoermerj@hotmail. com.