REGULATORY UPDATE: Important Information from FDA to Consider When Implementing a New Arm Scrub

Following inquiries from members considering implementation of an alternative arm scrub method, AABB is reminding members about information provided about this topic during the 2021 Annual Meeting “Ask the FDA” session.

The Food and Drug Administration responded to the following question:

Can you provide some guidance or point in the direction of where to find FDA’s currently approved antiseptic scrubs for use on blood donor arms to minimize bacterial contamination and should the method be validated?

Response: “FDA does not provide ‘pre-clearance’ or ‘pre-approval’ for antiseptic products since they are considered over-the-counter (OTC) products. Use of an OTC antiseptic product would be acceptable for the skin scrub provided that the intended use of the antiseptic product describes skin preparation prior to surgery or injection, or for blood donor collection. You should validate the arm scrub method used in manufacturing blood components.”

FDA regulations at 21 CFR 640.4(f), “Prevention of contamination of the blood,” provide that “the skin of the donor at the site of phlebotomy shall be prepared thoroughly and carefully by a method that gives maximum assurance of a sterile container of blood.” 

AABB reminds facilities to be proactive in evaluating potential supply chain concerns and how they may affect the continuity of their operations. They should work to identify conservation methods, alternative suppliers, resource sharing and alternative methods. Consideration should be given to necessary procedural updates, validation protocols for new devices/methods, and staff training and competency.

Members with questions may contact regulatory@aabb.org.