Reuse of single-use items: Common sense or higher risk?
Reuse of single-use items: Common sense or higher risk?
Debate continues as FDA looks at proposed regulation
Although the issue of reprocessing single-use items has been a topic of hot debate among health care facilities, manufacturers, and reprocessors for years, the first step of Food and Drug Administration (FDA) involvement took place in early May with a conference jointly sponsored by the FDA, the Association for the Advancement of Medical Instrumentation (AAMI), of Arlington, VA, and the International Association of Health Care Central Service Materiel Management (IAHCSMM), of Chicago.
The purpose of the conference was to see if there is a need for regulatory control of single-use items as they are reprocessed, says Kathy Warye, program coordinator for the AAMI. Manufacturers want a formal control program, which means research and submission of documentation, while reprocessors do not want strict regulation, she explains.
"The FDA has legal authority to request proof that single-use items can be safely cleaned and sterilized," says Josephine M. Torrente, JD, president of the Association of Disposable Device Manufacturers (ADDM), in Washington, DC. Manufacturers that produce single-use items do not provide data because they do not intend for the item to be cleaned and sterilized, she says.
Manufacturers represented by ADDM want the FDA to require submission of a 510(k) or pre-market approval request (PMA) supplement by a reprocessor who changes an item from single-use to reusable, Torrente says. Both the 510(k) and PMA are methods of providing data that prove the intended use of the item is safe for patients when a manufacturer changes or modifies the intended use of an item. If the original manufacturer wants to change the item’s intended use from single-use to reusable, a 510(k) or PMA is required, but these requirements are not enforced with reprocessors, she explains.
Although reprocessors do not submit data for individual items, the FDA does have a process to register and inspect reprocessors, says Vern Feltner, president of Alliance Medical Corp., a full-service reprocessor based in Asheville, NC. "Reprocessing a single-use item is no different than reprocessing a reusable item," he says. "There may be plastic parts that can’t be autoclaved so we use a gas sterilizer."
The most common reprocessed single-use items include drill bits, saw blades, laparoscopic instruments, catheters, trocars, and pulse oximeter sensors, says Feltner.
"Manufacturers began labeling items as single-use in the late 1950s and early 1960s to make it easier for hospitals to get full reimbursement from Medicare’s cost plus’ reimbursement system," Feltner says. "Today, there are many items labeled as single-use that are the same item as a reusable," he says.
"I’ve been through the list of items reprocessors claim are the same as the reusable and there are differences. They are not the same item, and they were never tested for reuse," says Torrente.
The reprocessors and the disposable device manufacturers also disagree about patient safety reports. While Feltner says that there "have been no documented patient injuries attributed to the reprocessing of a single-use device," Torrente says there is documentation of adverse incidents.
A presentation by Mark Bruley, vice president of accident and forensic investigation for ECRI in Plymouth Meeting, PA, reported at total of 62 incidents attributed to reuse published in medical literature between 1976 and 1997. Forty of these incidents were not related to hemodialysis equipment and included items such as breathing circuits, cataract extraction probes, electrodes, and pulse oximeter probes.
In a review of the FDA’s database, Bruley found a total of 2,050 incident reports related to reuse of a single-use device. Of these, only 181 or 9% of the total involved devices not related to hemodialysis.
Bruley’s research was part of the production of an ECRI publication titled Reuse of Single-Use Devices: Making Informed Decisions. The publication does not make a recommendation for or against reuse of single-use devices but does give readers a comprehensive presentation of information that they can use to reach a decision, says Bruley. (For ordering information, see source box, p. 80.)
Liability a concern for surgery staff
"I’ve never liked hearing the comment that everybody else is doing it," says Deborah J. Brizgys, support services coordinator at El Camino Surgery Center in Mountain View, CA. "I’ve had manufacturers’ representatives tell me that everyone is reprocessing single-use items, and I’ve heard it from reprocessors," she says.
Even when a manufacturer’s representative tells you that it can be done, it’s a gray area, she points out. "Read the label, and it clearly states that the item is for single-use and will not be warranted for other uses," says Brizgys. "When the manufacturer doesn’t back their product beyond one use, I don’t feel comfortable putting a patient at risk," she adds.
Two thousand items in the freestanding surgery center’s inventory are single-use, and they are not reprocessed. "In fact, if we have an opened but unused item, we toss it," she says. "We don’t want to take a chance that it is inadvertently contaminated."
The IAHCSMM produced a position statement that was presented at the May conference.
"Our concern is to look after a patient’s safety," says Anne Cofiell, consultant and the IAHCSMM’s representative to the FDA/AAMI conference. "Because reprocessing a disposable device requires a vast amount of testing, validation, and documentation, there are few central service departments capable of meeting these requirements," she says. For this, and other reasons outlined in the position statement, the IAHCSMM recommends that health care central service departments not reprocess single-use items, she says.
Evaluate the reprocessors
Although the IAHCSMM does not recommend that members reprocess the items, the organization does recognize that some members will want to investigate third-party reprocessors as a way to cut costs, says Cofiell. For this reason, the position statement includes suggestions to help members find a qualified reprocessor, she says. (See evaluation tips, above.)
Legal liability to the day-surgery program can be minimized by choosing a reprocessor that assumes responsibility for the item, says Feltner. "Although the original manufacturer no longer assumes responsibility once a single-use item has been used, the reprocessor assumes liability for the item," he explains.
Even if the reprocessor assumes the risk, Mark Phillips, CNOR, assistant director of nursing for surgical services at Southern Regional Medical Center, in Riverdale, GA, says his facility will not reprocess single-use items. "We reprocess our reusable items in-house, and we did take a look at reprocessing single-use items, but we had questions about our liability if we were not able to clean and sterilize them properly," he says.
"We have been investigating the cost savings that outsourcing might provide, but we are not sure we want to give up control of the item," Phillips says.
Concern about knowing exactly how the item is cleaned and sterilized and tracking how many times it is reused, is also the reason Brizgys’ surgery program has backed away from outsourcing. "We did try a reprocessor for some blades, but when the first batch came back, the sterilization indicators on the packaging didn’t work properly so we had no way of knowing if the item was sterile," she says. The staff threw out the blades and have not tried outside reprocessing again.
Following the May conference, the FDA announced that it is working on a proposed policy to present this October, says Torrente. "Although comments will be solicited at that time, people can submit comments and concerns now," she says. "In fact, comments from surgery programs expressing their concerns will help the FDA develop a document that ensures patient safety."
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