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.

Radiation Dose Audit Failures: Truth and Consequences

“…Therefore, even if the SAL of the sterilized product is slightly different than a claimed SAL of 10 -6 , the SAL might be only something such as 10 -5.8 , a probability of a viable microorganisms of about one in six hundred fifty thousand, which is certainly not a level that can be called nonsterile as far as patient safety is concerned. 4 In ANSI/AAMI ST67, there are SALs other than 10 -6 that are recognized as "sterile," such as 10 -3 , 10 -4 and 10 -5 , which are acceptable based on certain criteria. 5 Because of this, the issue is not whether the fully processed product is sterile-it is sterile as far as patient safety is concerned.…”

Prosthetic Breast Reconstruction and Red Breast Syndrome: Demystification and a Review of the Literature

“…In another study using a mathematical model to evaluate the relationship of SAL to infection, it was demonstrated that there was no difference in the rate of infection when comparing ADM with an SAL of 10 −3 and 10 −6 . 34…”

The effect of progesterone level prior to oocyte retrieval on the numbers of oocytes retrieved and embryo quality in IVF treatment cycles: an analysis of 2,978 cycles

“…In recent times, the incidence of infertility has progressively increased due to potential factors such as life stressors and delayed child-bearing age [1]. The development of assisted reproductive technologies has dramatically improved the outcomes of in vitro fertilization/embryo transfer (IVF/ET) in recent years.…”