title: Medical device SALs and surgical site infections: a mathematical model.
abstract: 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.
authors.affiliation: Quality Tech Services, Bloomington, MN, USA. ssrun@qtspackage.com
authors.forename: Sopheak W
authors.initials: SW
authors.lastname: Srun
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Nissen
authors.forename: Trabue D
authors.initials: TD
authors.lastname: Bryans
authors.forename: Maxime
authors.initials: M
authors.lastname: Bonjean
mesh_terms: D001424:Bacterial Infections / Q000453:epidemiology* / Q000517:prevention & control*; D003198:Computer Simulation; D003428:Cross Infection / Q000453:epidemiology* / Q000517:prevention & control*; D004864:Equipment and Supplies / Q000382:microbiology*; D006801:Humans; D015233:Models, Statistical; D015995:Prevalence; D018570:Risk Assessment; D012307:Risk Factors; D013242:Sterilization / Q000706:statistics & numerical data*; D013530:Surgical Wound Infection / Q000453:epidemiology* / Q000517:prevention & control; D014481:United States / Q000453:epidemiology