• K Roth, P Heeg, and R Reichl.
• SMP GmbH, Pruefen, Validieren, Forschen, Waldhoernlestrasse 22, 72072 Tübingen, Germany. kroth@smpgmbh.com
• Surg Endosc. 2002 Jul 1;16(7):1091-7.

ObjectiveTo determine whether reprocessed single-use devices (SUD) would (1) meet regulatory standards for sterility, and (2) meet the same material standards as new devices or if they pose an infection risk to other patients.DesignThe study included in the first stage single-use laparoscopic dissection devices and in the second stage a variety of clinically used and reprocessed SUDs. The suitability of these devices for cleaning, disinfection, and sterilization was examined.MethodsTesting of cleanability was conducted on devices contaminated with radioactively labeled blood. Instruments were cleaned using hospital recommended practices. Gamma counts/second were determined before and after cleaning to localize contaminants, which were additionally visualized using light and scanning electron microscopy (SEM). X-ray photoelectron spectroscopy (XPS) was used to quantify contamination elements on the materials tested. Residual bioburden testing on instruments contaminated with microorganisms suspended in blood prior to reprocessing was carried out to establish the efficacy of disinfection and sterilization.ResultsDuring the first stage of the study all devices remained contaminated after cleaning, but were effectively disinfected. Sterilization could not eliminate the challenge microorganisms completely. The findings during the second stage--examination of clinically used devices--were as follows: 11% of the sterile packages were damaged; 33% of the devices were incomplete and parts were missing; 54% did not meet the criteria for functionality; light microscopy, SEM, and XPS showed contamination on the outside and inside of all devices. Of the tested SUDs, 40% remained unsterile following resterilization.ConclusionsNone of the reprocessed SUDs were effectively cleaned or sterilized. This may provide an opportunity for survival and growth of non-resistant or nosocomial organisms and viruses. The use of such inadequately reprocessed SUDs increases the risk for the patient, and can lead to nosocomial infection and to legal consequences for the health care facility.

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