Reprocessed SUDs: Cost-Savings without Undue Risk?

Reprocessed SUDs: Cost-Savings without Undue Risk? Page E32 L. George*, D. McLaughlin Close Close preview | Purchase PDF (54 K) | Related articles | Related reference work articles AbstractAbstract Abstract BACKGROUND: The infection control professional and manager of central sterilization proposed that reprocessing of single-use devices (SUDs) presented an opportunity to help control healthcare costs. A multidisciplinary team identified four areas of concern: safety, liability, regulatory compliance, and calculation of savings dependent on recycling compliance. METHODS: Safety, liability, and regulatory concerns were addressed by requesting FDA information on SUDs-related adverse events; proof of FDA and Quality Systems compliance from a third-party reprocessor; and a protocol to track SUDs incidences. To maximize savings, consideration was given to FDA-approved noncritical, semicritical, and critical devices; system-wide initiation; and executive review of financial reports. Assuming 90% recycling compliance, the prior yearʹs cost-savings of $212,238 was determined with a formatted spreadsheet tool. RESULTS: FDA search of SUDs-related adverse events indicated that there is no difference from originally manufactured devices. According to FDA, the burden of liability is on the third-party reprocessor. To date, our facility and third-party reprocessor report no adverse events related to SUDs. Actual facility-specific savings for cath lab for March-December 2003 is $41,256; patient units for July-December 2003 is $22,575; surgery for September-December 2003 is $5,417. Cumulative actual facility-specific savings is $69,248. Reprocessing is under implementation throughout the multifacility system, with an estimated annual savings of >$1,000,000. CONCLUSION: FDA database search evidenced that reprocessed devices are no different from original manufactured. Including all approved devices, systemwide initiation and financial oversight maximized savings. Reprocessed SUDs do not present undue risk and help to offset healthcare costs.