Medical device manufacturers faced off in Maryland on Dec. 14 over the issue of reprocessing single-use devices at a public forum hosted by the Food and Drug Administration. The FDA's proposal would regulate the reuse of single-use devices (SUDs), such as cardiac catheters and guidewires, biopsy needles, and balloon angioplasty (PTCA) catheters.
Currently in the public comment period, the proposal has met with both praise and concern from manufacturers. At the moment, the FDA does not have specific guidelines for companies that reprocess devices labeled for single use. The agency instead expects those entities to meet a variety of manufacturing standards, including labeling requirements and submission of adverse event reports.
According to the FDA, the practice of device reprocessing began in the 1970s, when hospitals "began to see products labeled 'single-use only' that were similar to devices that had been formerly distributed...as 'reusable,'" according to the FDA's request for comments document. The primary motivation was economic. Hospitals began cleaning and reusing the devices to save money; soon after, reprocessing companies began cropping up.
The meeting was the third time the FDA has sought industry opinion on the suggested guidelines: In May 1999, the agency met with the Association for Advancement of Medical Instrumentation and others in the reprocessing industry to draft the initial proposal. In November of this year, the FDA held a teleconference to hash out the matter even further, in a discussion that touched on the ethical implications of reusing SUDs. Dr. John Fielder, a medical ethics expert from Villanova University in Philadelphia, called reprocessed devices a "form of medical experimentation" and suggested that patients be given an option to have new or reused devices.
Supporters of the proposal include the Association of Disposable Device Manufacturers (ADDM) in Washington, DC. The group submitted several studies to the FDA earlier in 1999, outlining the "high degree of risk associated with reuse," said Josephine Torrente, president of ADDM. In a letter to the FDA, Torrente said reprocessed devices should meet PMA standards or be banned outright.
Other groups favoring the proposed regulations are the Medical Device Manufacturers Association and the Health Industry Manufacturers Association. The latter, also based in Washington, DC, cited a decline in product quality and safety, and an increase in liability when reprocessed products are used. The Cook Group, a Bloomington, IN, manufacturer of single-use devices such as cardiac catheters, also supports the proposal, according to David McCarty, a spokesman for the company.
The reprocessing contingency is represented by the Association of Medical Device Reprocessors in Washington, DC, which has come out against the proposal based on the amount of time it says would be needed to have all of the devices re-approved for reuse.
"As a practical matter, (the proposal) would eliminate virtually all reprocessing. Preparation and FDA prior approval of such applications would require approximately 6 to 12 months. Yet, the current market life of a medical device product is an average of only 24 months," the group said in a written statement.
At the November meeting, Mark Salomon, a spokesman for reprocessor Vanguard Medical Concepts of Lakeland, FL, suggested that reprocessors and original equipment manufacturers (OEMs) work together to create standards for reuse.
Highlights from the FDA proposal
Divided into eight sections, the FDA's strategy to regulate SUDs is a lengthy one. Here are some aspects of the proposal:
To obtain a copy of the proposal, visit www.fda.gov/cdrh. Written comments can be sent 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 PalAuntMinnie.com staff writer
December 14, 1999
