No abstract

Tissue banks routinely use a sterility test to determine the suitability of processed tissue prior to release. However, many tissue banks also accompany the sterility test with additional types of media to ensure detection of slower-growing or more fastidious organisms that may not be detected in the standard two media/two incubation temperature sterility test. This study was designed to determine if a standard sterility test is capable of detecting the wide variety of organisms that may be isolated from human tissue thereby making the additional plated media unnecessary. More than 100 isolates, representing more than 90 different species were tested. All isolates exhibited growth in at least one of the two standard sterility test media within the 14-day incubation period.

The sterility assurance community is facing significant challenges. A relatively recent challenge is the pressure on manufacturing supply chains resulting from the limited availability of capacity for terminal sterilization of healthcare products. The current challenge is finding solutions for innovative new products, especially biologics and combination products, that offer great promise for patients around the world. This challenge will become more prevalent in the future as products advance. This article frames new paradigms and tools being developed to address these challenges. Foundational principles and current realities from each sector are reviewed so that sterility assurance professionals have a solid base from which to build strategies.

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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.