Get ready to be treated like a device manufacturer, if FDA has its way
Feds propose revisions to policy on reprocessing single-use items
Are you ready to be treated like a device manufacturer by the Food and Drug Administration (FDA)? Based on the FDA’s proposed revisions to its policy on reprocessing of single-use devices, that’s exactly how you might be treated.
"The FDA has made it quite clear in a number of presentations, that reprocessing is an activity they regulate," says Douglas B. Nelson, MD. Nelson is chairman of the Technology Committee and Task Force on Single-Use Accessories for the American Society for Gastrointestinal Endoscopy in Manchester, MA, and assistant professor of medicine at the University of Minnesota in Minneapolis. "Whether in an ASC, or hospital, or third-party reprocessor, they consider that the same activity."
And you might be impacted by the final regulation even if you use a third-party processor, warns Sherron Kurtz, RN, MSA, CNOR, CNAA, director of perioperative services at Henry Medical Center in Stockbridge, GA. Kurtz was a presenter at the May 1999 conference on reprocessing sponsored by the FDA and the Arlington, VA-based Association for the Advancement of Medical Instrumentation. (For more information on the conference, as well as tips to help you evaluate reprocessors, see Same-Day Surgery, July 1999, pp. 77, 79.)
Third-party reprocessors might incur additional costs to comply with the final regulation, she says. "If it gets a lot more expensive for reprocessors, they will pass costs along to us. My thought is: Is this going to make it cost-prohibitive?"
The FDA published their proposed policy revisions Nov. 1 in the Federal Register. (See list of devices, p. 3. For information on how to access a copy of the proposed revised policy and how to submit comments, see box, at right.)
Here are FDA’s biggest proposed changes:
• The FDA suggests using a three-tiered device categorization system (low risk, moderate risk, and high risk) that would consider factors such as the complexity of the reprocessing procedures, the risk of infection from reusing the device, any risk of performance failure, and the scientific information available on reprocessing the device.
• The FDA is considering pre-market application or pre-market notification requirements for moderate and high-risk devices that hold reprocessors to the same responsibilities as manufacturers.
And the enforcement doesn’t end there. On Oct. 26, the Reprocessed Single Use Medical Device Patient Safety Act of 1999 (HR 3148) was introduced in Congress and referred to the House Commerce Committee. In addition to pre-market safety controls, the legislation would require informed consent of patients prior to using reprocessed class II, class III, and critical class I medical devices. Also, the bill would require providers to report any injuries or infections that occur as a result of using a reprocessed medical device.
Which same-day surgery devices will be labeled as low risk, and which will be labeled moderate or high risk?
"That seems to be an open question at the moment," says Pamela J. Furman, Esq., executive director of the Association of Medical Device Reprocessors in Washington, DC.
The FDA won’t necessarily make a list, she emphasizes. Instead, the agency apparently intends to develop a decision flowchart that reprocessors, including facilities, can follow to determine a device’s risk category.
Most devices will be labeled moderate risk, Nelson says. "It’s clear in material from the FDA that moderate risk is their default classification."
That classification could mean much more work for SDS managers that reprocess single-use devices, because the FDA is considering pre-market notification and approval requirements for moderate-risk and high-risk devices. These requirements would be implemented after six months for high-risk devices and after two years for moderate-risk devices.
What’s the cost of risking lives?
In other developments, in October the FDA rejected a petition filed by group of device manufacturers to ban reprocessing. The FDA said it was "unable to find clear evidence of adverse patient outcomes." This is the second time in recent years that the FDA has taken this position, Nelson says.
However, not everyone agrees. In introducing the Reprocessed Single Use Medical Device Patient Safety Act of 1999 to Congress, Rep. Anna G. Eschoo (D-CA) said, "Delicate devices, such as balloon catheters and biopsy forceps, are being reused on patients and causing infection and injuries." In fact, a biopsy patient was contaminated with hepatitis B from reused biopsy forceps, she said, quoting an article in Sept. 20, 1999, US News and World Report.
"I understand the fiscal constraints hospitals are under," Eschoo said. "Managed health care has cut their payments so drastically that they feel pressured to cut costs wherever possible. However, we can’t continue putting patients at risk in order to save a few dollars."
In the meantime, the FDA is moving ahead by obtaining input on its proposed revisions. Furman and other sources urge same-day surgery managers to offer comments soon. The timetable for implementation is uncertain, but the FDA appears to be pursuing revisions in an aggressive manner, Furman says.
Kurtz hopes final guidelines will be decided quickly. "As a manager who’s doing it, I’d like for us to put it to bed and reach a consensus," she says. "It seems that there’s a place we can meet, a place in the middle of the road, where we can all find a place to live together."
(For more on reprocessing single-use devices, see SDS, March 1998, p. 33, for information on the ethical dilemmas; September 1997, p. 118, for advice from the Association of periOperative Registered Nurses; and June 1997, p. 69, for information on liability, safety, and ethical issues.)
For further information on the proposed revisions to the policy, contact:
• Pamela J. Furman, Esq., Executive Director, Association of Medical Device Reprocessors, 1400 16th St. N.W., Suite 400, Washington, DC 20036. Telephone. (202) 518-6796. Fax: (202) 234-0399.
• Sherron Kurtz, RN, MSA, CNOR, CNAA, Director of Perioperative Services, Henry Medical Center, 1133 Eagle’s Landing Parkway, Stockbridge, GA 30281. Telephone: (770) 389-2356. Fax: (770) 389-2158. E-mail: skurtz@ hmc-ga.org.
• Larry D. Spears, Center for Devices and Radiological Health (HFZ-340), Food and Drug Administration, 2094 Gaither Road, Rockville, MD 20850. Telephone: (301) 594-4646.