Key words: infection, sutures, staphylococcus, SAL, standards, tech support
A project to determine the adequacy of sterility assurance levels (SAL) was undertaken. The specific scientific question asked was how many organisms (Staphylococcus) does it take to cause an infection, or what is the infection rate with low numbers of organisms on an implanted device. With the data obtained, a risk analysis assessment could be undertaken to determine the impact on infection risk if the SAL were changed so that as many as 1/1000 items in a sterilization procedure could be non-sterile rather than the 1/1,000,000 which is the current standard. Infection risks with 3 organisms and 9 materials using a mouse model were determined. The infection risk with between 10 and 20 organisms is approximately 30%. The infection risk with less than 10 organisms is approximately 6%. The data are being evaluated by ODE for consideration of a different SAL for materials that undergo degradation with the more intensive sterilization procedures.