Comparison of two models of biofilm formation on reusable stainless steel medical device material.

Abstract

Reusable medical devices require reprocessing before subsequent patient use. Inadequate reprocessing can create suitable conditions for contaminating microbes to form biofilm. Despite this threat, there is a lack of guidance for medical device manufacturers to make biofilm assessment on their device labelling and instructions for use. Currently, there are no US Food and Drug Administration-recognized standardized models for biofilm formation on medical devices or device materials. To assess esta