Preoperative Preparation Testing

Antiseptic skin preparations are products that are applied to a patient's skin surface prior to surgical incisions or injections and are designed to prevent infection or contamination of the resulting wound.  Skin preparation products may include preoperative, vascular precatheterization, or preinjection skin preparations and these types of prodcuts are generally evaluated using the ASTM E1173 methodology.

FDA's Proposed Classification of Healh Care Personnel Antiseptics

As per the FDA's tentative rule for antiseptics used in health care settings, FDA has revised the log10 reduction criteria proposed for preoperative skin preparations and suggested that based on the timeframes within which patient preoperative skin preparations are commonly used, these products should demonstrate effectiveness at 30 seconds.  The changes between the log reduction requirements for preoperative preparations specified in the 1994 tentative final monograph guidance and the 2015 preoposed new rule for health care antiseptics is outlined below: