Updated October 12, 2022
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"The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products. Currently, patient preoperative skin preparations are not required to be sterile, and bacteria can contaminate these products at the time of manufacture or during product use. Contaminated patient preoperative skin preparations have been associated with clinical infections and adverse outcomes. At this public hearing, FDA is interested in obtaining public comment about certain scientific and product use issues related to patient preoperative skin preparations"
'via Blog this'
Meeting Details:
Date(s): December 12 - 13, 2012
Time: 9:00 a.m. to 4:00 p.m.
Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring
The Ballrooms
8727 Colesville Road
Silver Spring, MD 20910
The Ballrooms
8727 Colesville Road
Silver Spring, MD 20910
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2 comments:
The hearing is intended to look at ways to reduce potentially dangerous bacteria in antiseptic wipes, swabs, pads and solutions, that have been associated with recalls, and in some cases, possibly severe illness or death. Right now, this class of products is used to prep the skin before shots or surgeries, and are not required to be sterile.
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