The Food and Drug Administration has moved one step closer to implementing guidelines for medical device reprocessors.
During a December 14 meeting with industry representatives, the agency created a list of regulatory issues that will be the main focus of their attention in January 2000. Those items include:
- Guidance on sterility validation;
- An auditing mechanism and/or program for third party reprocessor and healthcare facilities;
- A standardized definition of reuse;
- Collecting, cataloguing and analyzing scientific data.
The FDA currently does not have specific guidelines for companies that reprocess devices labeled for single use, instead expecting those entities to meet a variety of manufacturing standards, including submission of adverse event reports and labeling requirements.
Groups that came out in favor of stricter regulations on reprocessed devices included the Health Industry Manufacturers Association and the International Association of Healthcare Central Service Materiel Management in Chicago, IL. The latter group represents material management professionals or those who are responsible for the decontamination and sterilization of medical devices.
The group's main concern is the lack of regulatory standards for hospitals that reprocess devices in-house, said Anne Cofiell, an IAHCSMM spokeswoman. Cofiell represented the association at the meeting and praised the FDA for its cautious approach to a controversial issue.
"I admire the FDA for doing it this way," she said. "People have complained that it's taking too long, but this is such a complicated issue. There are so many different sides to it."
But not everyone is pleased with the way the FDA is handling the matter. Elizabeth Stoneman is the executive vice president of Paragon Reprocessing Services in Little Rock, AR. She questioned whether the FDA's guidelines were rooted in a sincere concern for public health, or if the agency was bowing to pressure from the disposable device manufacturers.
Stoneman put much of the blame on U.S. Senator Richard Durbin (D-Illinois), who circulated a bill in June 1999 that would require specific regulations for reprocessors. The draft was put forward as an amendment to the Agriculture Appropriations Bill.
"I think the FDA was being very fair to both sides of the issue until Durbin became engaged in this issue. I think they exerted so much political pressure," Stoneman said. "My hope is that the FDA will continue to adhere to the science and not to the political pressure."
"The scientific information in favor of reprocessing is certainly out there and I hope the FDA considers that before putting parameters around it," Stoneman said.
While Stoneman thought the first draft of the policy had some good points, she would like to see issues such as the stratification of risk developed even more.
The current draft divides single-use devices into three categories: High-risk reprocessed SUDs, such as cardiac and balloon angioplasty catheters, would be subject to all of the agency's regulatory requirements such as pre-market approval. Moderate-risk products may bypass the PMA process as long as the reprocessors maintain post-market safety and effectiveness data. Low-risk devices would have to meet Good Manufacturing Practices requirements but would be a low priority for the agency.
The transcript from the December 14 meeting will be ready on January 3, 2000. The FDA is still accepting comments on the draft. To obtain a copy, visit www.fda.gov/cdrh. Submit written comments to: Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5603 Fishers Lane, Room 1061 (HFA-305), Rockville, MD 20852. Docket no. 99N-4491.
By Shalmali Pal
AuntMinnie.com staff writer
December 23, 1999
Copyright © 1999 AuntMinnie.com
