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.
Explore This IssueJune 2011
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.”
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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.