The idea of reusing single-use devices may bring to mind the recent news of a Las Vegas urologist who was investigated in March for supposedly resuing single-use devices. As the Las Vegas Review-Journal reports, Dr. Michael Kaplan is accussed of reusing, but not not decontaminating, endocavity needle guides. While Dr. Kaplan’s specific case may be unique, the idea of reprocessing single-use devices is not.
The trend to reprocess disposable, or single-use, instruments, a movement that dominates specialties like gastroenterology, cardiology and general surgery, is creeping into otolaryngology. By doing their homework on industry trends, otolaryngologists are in a position to influence purchasing decisions in their practices or hospitals, experts say. In the U.S., the types of reprocessed single-use head and neck instruments are limited mainly to microdebrider blades, certain navigation systems markers, cautery pens, coblation/radiofrequency handles and suction. However, third party reprocessors (TPR) routinely handle forceps, scissors, dissectors, myringotomy kits and many other devices.
Safety Issues
In 2000 and again in 2007, the U.S. Government Accountability Office (GAO) studied the safety of reprocessed single-use devices (SUD) and concluded that they pose no additional safety or health risks to patients.
With the passage of the Medical Device User Fee and Modernization Act (MDUFMA) in 2002, the U.S. Food and Drug Administration (FDA) also increased its oversight of reprocessing, including strict labeling requirements and specific MedWatch forms to report adverse events.
Reprocessing may be an option if the third party SUD reprocessor receives FDA approval, according to Daniel J. Vukelich, president of the Association of Medical Device Reprocessors in Washington, D.C., which promotes the proper reprocessing of medical devices labeled as single use.
Although thousands of SUDs have been approved for reprocessing, the practice generally remains limited to FDA Class I and II devices. The latter group accounts for up to three-quarters of reprocessed devices, which include pulse oximeter sensors, ultrasound catheters, drills, compression sleeves and most laparoscopic equipment.
In its 2008 report on the topic, the GAO found that 320,000 adverse reports associated with medical devices were filed between 2003 and 2006. Only 65 of these had a possible connection to reprocessed devices, and these were similar to adverse events reported for new devices. In fact, single-use medical instruments are often just reengineered versions of reusable instruments that easily lend themselves to reprocessing, Vukelich said.
“Part of the reason we’re in the business of reprocessing devices labeled for single use is that manufacturers no longer offer a reusable alternative,” he said. “If you buy a single-use reprocessable shaver, you’re going to get more bang for your buck, not to mention reducing your waste stream.”
Sending instruments to a TPR also mitigates risk within the practice, because the vendor is legally responsible for compliance with FDA requirements, Vukelich added. Medical device manufacturers, however, contend that reprocessed instruments don’t have the same stability as new ones and could harbor microscopic traces of blood or tissue, leading to infection. Reprocessors counter that they only accept devices that can be reused safely and allege that manufacturers have moved toward SUDs to boost sales. Nevertheless, reprocessing is generating less controversy than it once did. In December 2009, major device manufacturer Stryker Corp. of Kalamazoo, Mich., even acquired TPR Ascent Healthcare Solutions.
Guidelines
More than a decade ago, Oakland, Calif.-based Kaiser Permanente (KP) formed an SUD reprocessing oversight committee that works with a TPR to determine which instruments can be reprocessed safely. Evidence-based guidelines direct the use of steam sterilization for reusable sterile instruments that can be decontaminated easily and are not heat sensitive, said Sue Barnes, RN, CIC, a board member of the Washington, D.C.-based Association for Professionals in Infection Control and Epidemiology and national program leader in infection prevention and control in KP’s patient safety department.
For each instrument, the TPR vendor must have rigorous, FDA-approved processes that involve remanufacturing as well as reprocessing, according to Barnes. The TPR’s objective is to return the instrument in a sterile state, performing at or above its previous condition.“This program has the potential to save a tremendous amount of money and significantly reduce the quantity of landfill waste, which is an important consideration related to the environmental impact of health care,” she said.
Some sterile instruments, such as devices with very small lumens, are too complex to clean adequately prior to sterilization. “When considering whether to add a certain instrument to an SUD reprocessing program, patient safety always comes first,” she added. As the content expert, the sterile processing manager should facilitate this decision, with input from the nurse manager and managing physician of the otolaryngology practice or department.
“Focus on whether the reprocessed or remanufactured sterile instrument is equal or better in quality than new,” Barnes said. “Additional considerations are cost of the disposable instrument versus the reusable version, cost of the third party reprocessor and the number of times the instrument can be reused during its life cycle compared to the cost of a new instrument.”
Build a Case
Michael O’Connell, MHA, FACHE, FACMPE, vice president, operations and physician services, at Huron Hospital, a Cleveland Clinic hospital, agreed that patient safety is the overriding factor in determining whether to reprocess SUDs.
That being said, many vendors in supply chain management are assisting health care organizations in making reprocessing decisions. O’Connell’s hospital places items for reprocessing across all specialties in a single container, and the vendor sorts them. For otolaryngology, those items typically include shavers, scissor kits, cartilage knives and endoscopic and laparoscopic trocars and instruments.
“It comes down to working with a vendor that can support your efforts and knowing what’s available,” O’Connell said. He suggested networking with other otolaryngologists to determine which devices they most commonly reprocess and piloting each device in house to gain physician trust.
Working with the hospital’s TPR, Cleveland Clinic also developed a scorecard that tracks reprocessing costs, the number of devices reprocessed by category and estimated savings compared to best practice. The scorecard allows O’Connell to track trends, including his hospital’s experience compared to other hospitals in the system, and offers the opportunity to expand reprocessing to other SUDs.
The scorecard also reports environmental savings, including the number of SUDs and the estimated amount of waste diverted from landfills through reprocessing. For the most recent 12-month period, Huron Hospital diverted more than 2,000 units, weighing an estimated 600 pounds, for a waste reduction savings of $309. The vendor’s best practice indicates that hospitals of equivalent size can divert nearly 6,000 pounds from landfills over a year’s time, saving nearly $3,000.
That opportunity will grow over time, as “every quarter, some item is being evaluated for the potential to be reprocessed,” O’Connell said. “Every surgeon needs to look at reprocessing of medical devices, which not only protects the environment but also can boost the bottom line for health care organizations.”
Seek Physician Buy-In
Before considering reprocessing SUDs, an otolaryngologist should ensure that the practice meets appropriate safety standards across the board, according to Gina Pugliese, RN, MS, vice president of the Safety Institute for Premier Healthcare Alliance in Charlotte, N.C.
“You don’t want to talk about cost-effectiveness of reprocessing if a practitioner in your office is not disinfecting the current reusable instruments properly,” Pugliese pointed out. Premier suggests reviewing the Centers for Medicare and Medicaid Services infection control worksheet (available at http://www.premierinc.com/quality-safety/tools-services/safety/topics/safe_injection_practices/Downloads/Infection-control-worksheet.pdf).
The biggest push in health care is the effort to standardize procedures, equipment and purchasing practices, said Cynthia L. Dunn, RN, FACMPE, a principal in the MGMA Health Care Consulting Group, based in Cocoa Beach, Fla. In addition to looking at functionality, practices considering whether to reprocess SUDs should weigh tradeoffs in cleaning, packaging, storage and labor. In addition, check with payers to ensure that reprocessed equipment will be reimbursed.
Although it’s sometimes impossible to have a group of otolaryngologists use the form, let alone the same equipment, a standardized approach is the way to go, said Kenneth T. Hertz, FACMPE, also a principal in the MGMA Health Care Consulting Group. “If you standardize your practices and procedures, you will streamline training for your staff, improve your work flow, lower your costs and generally make your practice more efficient,” he said.
Practice administrators should consult with vendors and colleagues about reprocessing SUDs, but it’s even more essential for physicians to talk with their peers before moving forward.
“Practice administrators have to present an effective case,” Hertz said. “But doc to doc is the most useful conversation. Has the other practice switched to reprocessing devices? Has it been successful? Have the physicians been pleased? And has the change had a financial impact on the practice?”
As with any change in clinical practice, a physician champion should take the lead in introducing a different medical device, Dunn added. Ask TPR vendors for a free trial period to give your physicians a chance to evaluate a reprocessed SUD and allow the practice to assess cost savings, she suggested.
In ambulatory and inpatient settings, where purchasing costs for sterile instruments are shared, tap sterile processing managers to assist in purchasing decisions, Barnes suggested. KP also includes perioperative nurse managers, outpatient department managers, infection preventionists and surgeons in these decisions. Supply chain management should also be involved in purchasing negotiations, and members of the OR team should assist when surgical instruments are involved.
“The process needs to be multidisciplinary so you can understand all of the challenges,” O’Connell said.