Third-party reprocessing has entered the group-purchasing arena. Several GPOs have signed agreements with companies that reprocess single-use devices.

The business seems to have been buoyed by statements from the U S Food and Drug Administration (FDA) in the past year. In October, the FDA said third-party reprocessing of single-use items is lawful, provided the third-party company complies with all regulatory requirements. The statement was in a letter to the Association of Medical Device Reprocessors.

The FDA also wrote the Health Industry Manufacturers Association in July, saying it considers third-party reprocessors to be device manufacturers and expects them to comply with good manufacturing practices and other requirements. The FDA noted it had not seen evidence that reusing disposable instruments was harming patients. Such complications, however, would be hard to trace.

Proceeding cautiously, The Health Services Corporation of America (HSCA), a Bridgeton, Mo-based GPO, signed a contract in November with Vanguard Medical Concepts, a reprocessing company in Lakeland, Fla. So far, 101 hospitals have signed up for the service.

"We're not trying to sell anyone on this. We're proceeding cautiously," says Jennifer Moorehouse of HSCA, noting the GPO neither supports nor endorses reprocessing of single-use devices. At the same time, HSCA sees demand growing. The contract was negotiated at the request of the GPO's materials management advisory committee.

HCSA said one reason it chose Vanguard was because the company offers a broad array of reprocessing services for opened but unused as well as products previously used on patients. Examples of used items are pulse oximetry sensors, sequential compression devices, GI biopsy forceps, and electrophysiology catheters.

Hospitals that participate in the Vanguard agreement must decide for themselves what devices to include, notes Marilyn Wolfe, RN, an HSCA consultant.

Directors of surgical services in HSCA's 700 hospitals are "all over the map" in their opinions about reuse, she says. Though the practice is controversial, some "feel they can't afford not to look at it if it works and is safe."

Sequential compression devices are a common item managers are interested in reprocessing. These inflatable vinyl sleeves, operated by a pump, are placed around patients' legs after surgery to help prevent blood clots. They are not invasive, and many managers don't see why they can't be used more than once.

"This is often where people start to establish a comfort level," Wolfe says. Most of the savings, however, are in high-dollar devices, such as cardiac catheters.

St Louis-based AmeriNet has a contract with Alliance Medical Corp of Phoenix. The GPO has been contracting for reprocessing since 1996, originally with Sterile Reprocessing Services (SRS), which was bought by Alliance last fall. The contract covers both open/unused and used devices.

Alliance says it also has deals with several other GPOs. Alliance's vice president for marketing, Arthur Goodrich, says the company is close to an agreement with a "big very well known" health plan on the west coast, believed to be Kaiser.

Previously used items are the fastest growing segment of the company's business. Goodrich estimates 20% of Alliance's business is in open/unused items, and the remainder is in items that have been used on patients. Among the most-requested items: sequential compression garments; electrophysiology catheters; and cutting instruments, such as saw and arthroscopy blades, burrs, and cutters.

Novation, the supply arm of VHA and the University Health Systems Consortium headquartered in Irving, Texas, currently does not have a national contract for third-party reprocessing. Some regional VHA groups do. Asked whether Novation was considering a national agreement, spokesman Lynn Gentry said, "I think we feel comfortable with the agreements we have. It's a sensitive area. We're leaving it to the individual hospital." He noted that the group's perioperative nursing council had discussed the issue, but there had been no pressure for a national contract.

Though a GPO contract may make the business side of reprocessing easier, a sterilization expert advises that it doesn't relieve a hospital or surgery center of its responsibilities. The institution still needs to "examine the pros and cons of reprocessing for each and every brand and model of device being considered for reuse," says Jan Schultz, RN, MSN, of Med-Ascend, Atlanta, sterilization and infection control columnist for OR Manager.

According to the FDA, each facility that reuses a disposable device must be sure the device can be cleaned and reprocessed adequately. The facility must be sure the device's materials and functions won't be adversely affected and that the device remains safe and effective for its intended use. Generally, instructions are not available from the original manufacturer. Essentially, each decision to reprocess a disposable item becomes a research project.

A GPO might be able to facilitate this process, Schultz suggests, by bringing together the resources needed to conduct an evaluation, such as independent consultants who are knowledgeable about materials compatibility and industrial sterilization methods.

A two-day meeting entitled Reuse of Single-Use Devices is being held May 5 and 6 in the Washington, D C, area. Sponsors are the Association for the Advancement of Medical Instrumentation and the Food and Drug Administration. For information, phone 800-332-2264, ext 260.

Posted courtesy of Pat Patterson, OR Manager

Top | Resources | Home