Safety and efficacy of ethylene oxide sterilized polyethylene in total knee arthroplasty.

Eleven unassembled metal backed patellar interfaces were inoculated with 0.1 ml of Sportol (Bacillus subtilis variety niger spore) and then assembled. Ten of the 11 implants were exposed to 1/2 of a standard ethylene oxide sterilization cycle. The remaining implant was left unsterilized as a control. All the implants were separately incubated in soybean casein digest broth for 7 days at 30 degrees to 35 degrees C and tested for positive growth of Bacillus subtilis. To measure residual ethylene oxide content, 4 ultrahigh molecular weight polyethylene tibial inserts were exposed to a full ethylene oxide sterilization cycle. The implants were removed from the sterilization chamber and tested for residual ethylene oxide at 3, 5, 8, and 9 days after sterilization using an exhaustive extraction headspace technique. Residual ethylene oxide was measured in 3 additional implants 26 days after sterilization. No growth of Bacillus subtilis occurred on any of the 10 inoculated and ethylene oxide sterilized metal backed patellar components, whereas positive growth occurred on the inoculated, unsterilized control implant. Residual ethylene oxide measured in the tibial inserts at 3, 5, 8, and 9 days after sterilization was 23, 15, 12, and 9 ppm, respectively. Twenty-six days after sterilization, residual ethylene oxide was below the minimum detectable level of the measurement technique (5 ppm).