Nov. 10, 1999 (Gaithersburg, Md.) -- The FDA is struggling over how to regulate the steadily growing reuse of 'single-use' medical devices such as catheters, sutures, and syringes.
Reprocessing firms and hospitals often sterilize and rework these products, contending that they are just as safe as original products -- and far cheaper -- in repeated go-rounds.
At the same time, entities that reprocess highly complex or potentially risky devices face very few of the regulatory hurdles assumed by the original manufacturers.
The FDA notes that it has scant data about reprocessing's impact on patients, especially the risk of infection from reuse and any risk of performance failure as a result of reprocessing.
As reprocessing expands into increasingly complex devices, the agency has proposed to regulate reprocessors just as it already does original equipment manufacturers. That would mean, for example, that those who reprocess 'high risk' products submit premarket safety and effectiveness data, and that all reprocessors institute safety tracking programs for the products.
The agency today hosted a high-tech videoconference that featured interested parties butting heads over the basic questions.
Pam Furman, a lawyer for the Association of Medical Device Reprocessors, claimed that device manufacturers use 'sophisticated PR' to unfairly create the impression that reprocessed devices are risky. Device manufacturers, she noted, are permitted to label their products as 'for single use only,' without presenting any data to support that claim.
But Josephine Torrente, an attorney for the Association of Disposable Device Manufacturers, insisted that reprocessing brings 'new risks.'
Douglas Nelson, MD, a representative of the American Society for Gastrointestinal Endoscopy, claimed that no U.S. peer-reviewed research has found safety problems with reprocessed devices. He said that many gastroenterologists have long -- and safely -- used such products.
Gerald Naccarelli, MD, who is with the North American Society of Pacing and Electrophysiology, said tighter regulation of hospital reprocessing could not only cost hospitals hundreds of millions of extra dollars but pressure doctors to use fewer devices. "Physicians are patient advocates," he said, arguing that if doctors thought that reused devices were unsafe, they would stop the practice.
On the other hand, Philip Grossman, MD, a doctor in private practice who consults for a medical device firm, provided an account of a reprocessed electrophysiology catheter whose tip broke off and lodged in a patient's heart. He also cited a German analysis of off-the-shelf reprocessed devices that found alarming problems with the products.
Villanova University ethicist John Fielder, PhD, also sharply criticized reuse. "It's really an unethical form of medical experimentation," he declared, as there are no data to show the products are safe and effective. Since reuse brings no therapeutic benefit for patients, he called it "second-class medical care."
In addition to FDA regulation of reprocessing interests looms the issue of "informed consent" to patients on reuse of the devices. Physicians do not now usually tell patients that they are using a reprocessed item. According to Furman, there is "no reason for informed consent", since a "properly reprocessed" device is just as safe as a new product. If a doctor is concerned, she said, he or she shouldn't use a reprocessed item.
Nelson said that the lack of any evidence of "reasonable" risk eliminates the need for doctors to tell their patients about reprocessed devices.
In contrast, Grossman said that patients have a right to know. "There is significant question in the medical community" about reprocessing, he said.
Next month, the FDA will hold a public meeting on the issue.