FDA sets hearing to gather information on sterility issues related to pre-op skin prep wipes
HOUSTON, TEXAS, December 6, 2012-
The US Food and Drug Administration has scheduled a hearing for December 12 and 13 in the Washington, DC area to gather information on sterility and contamination issues connected with pre-operative skin preparation products. The FDA website explained that "FDA is interested in obtaining public comment about certain scientific and product use issues".
The FDA site noted that "Currently, patient preoperative skin preparations are not required to be sterile, and bacteria can contaminate these products at the time of manufacture or during use. Contaminated patient preoperative skin preparations have been associated with clinical infections and adverse outcomes."
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