Convened under the auspicious of esteemed endorsers - ISTA

Poster: 107Proposed Aggressive Cleaning and Sterilization Procedure for OrthopaedicSurgical InstrumentsIntroduction*Gregg Schmidig - Stryker Orthopaedics - mahwah, usaMayur Thakore - Stryker - Mahwah, USAYanoso-Scholl, Laura - Stryker Orthopaedics - Mahwah, USA*Email: gregg.schmidig@stryker.comSterilization of orthopaedic instruments tends to be more aggressive at European hospitals whencompared to hospitals in the United States. This is due to the potential of prion associatedinfectious diseases such as Creutzfeldt-Jakob and spongiform encephalopathy (mad cowdisease). The stability of prions make them difficult to destroy by standard steam autoclavingmethods. 1The purpose of this study was to propose an aggressive cleaning and sterilization method basedon previous research that would be more effective in Europe. This method was tested on anexisting orthopaedic instrument to determine if the parameters used would be tolerated bysurgical instruments.MaterialsOffset Adapters (Stryker Orthopaedics, NJ, n=9), size 8mm.Ultrasonic Cleaner (VWR, PA) with MetriClean2 (pH>11) (Metrex, CA) for 10 minutes at98 o C.Autoclave (Steris, OH,), pre-vacuum at 137 o C for 18 minutes.MethodThe offset adapters were assembled onto a Triathlon Tibial Baseplate (Stryker, NJ), size 8,during testing. A worst-case loading condition was enforced by orienting the offset adapters toproduce increased moment forces (Figure 1, A). A wrench was then used to disengage it fromthe tibial baseplate. Component failure was defined as disassembly not occurring.The components were tested for 240 cycles to simulate 10 years of use with a safety factor of 2.The simulated cleaning and autoclave treatment was batched for efficiency and to vary exposureto conditions. In addition, pin protrusion length (Fig. 1, B) was measured before and after 240cycles were completed.ResultsDuring mechanical testing it was found that all test samples were able to disengage from thetibial baseplate. This indicated that the highly aggressive cleaning and autoclaving proceduredid not compromise the integrity of the instrument. The pin protrusion length varied between1.29-1.38mm before testing and 1.33-1.38mm after testing with the 95% confidence interval atfile:///E|/ISTA2010-Abstracts.htm[12/7/2011 3:15:47 PM]