Decontaminated single-use devices: an oxymoron that may be placing patients at risk for cross-contamination.

摘要

OBJECTIVE: To determine whether reprocessed single-use devices would meet regulatory standards for sterility and meet the same materials standards as a new device. DESIGN: The study included single-use and reusable biopsy forceps and papillotomes and a reusable stone retrieval basket. The suitability of these devices for cleaning and disinfection or sterilization was examined. METHODS: Testing of cleanability was conducted on devices contaminated with technetium 99-radiolabeled human blood. Instruments were cleaned using hospital recommended practices for manual cleaning. Gamma counts per second were determined before and after cleaning to localize contaminants, which were additionally visualized using light and scanning electron microscopy. X-ray photoelectron spectroscopy was used to quantify contamination elements on the materials tested. Residual bioburden testing on instruments contaminated with microorganisms suspended in coagulable sheep blood was carried out to establish the efficacy of disinfection and sterilization. RESULTS: All devices remained contaminated after cleaning, but single-use devices and the stone basket tended to be more heavily contaminated than reusable forceps and papillotomes. Cleaning procedures facilitated distribution of contaminants further into the lumens of the disposable forceps. Decreased concentrations of silicon and increased concentrations of carbon and nitrogen suggested that layers of silicon lubricant had been removed and contaminants were organic material. Reusable devices were effectively disinfected, but single-use devices were not. Sterilization could not eliminate the challenge microorganisms completely. CONCLUSIONS: None of the reprocessed single-use instruments were effectively cleaned, disinfected, or sterilized. This condition may provide an opportunity for the viability of nonresistant or nosocomial organisms and viruses. Additionally, reprocessing procedures may result in material destruction of fragile devices. Cost-saving initiatives that have inspired reprocessing of single-use devices, despite the absence of data establishing the efficacy of decontamination and the durability of materials throughout reprocessing, should be pushed into the background.