It is commonly accepted that terminally sterilized healthcare products are rarely the source of a hospital-acquired infection (HAI). The vast majority of HAIs arise from human-borne contamination from the workforce, the clinical environment, less-than-aseptic handling techniques, and the patients themselves. Nonetheless, the requirement for a maximal sterility assurance level (SAL) of a terminally sterilized product has remained at 10 -6, which is the probability of one in one million that a single viable microorganism will be on a product after sterilization. This paper presents a probabilistic model that predicts choosing an SAL greater than 10 -6 (e.g. 10 -5 or 10 -4, and in some examples even 10 -3 or 10 -2) does not have a statistically significant impact on the incidence of surgical site infections (SSIs). The use of a greater SAL might allow new, potentially life-saving products that cannot withstand sterilization to achieve a 10 -6 SAL to be terminally sterilized instead of being aseptically manufactured.
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