The U.S. Food and Drug Administration (FDA) will require additional scientific data to support the safety and effectiveness of certain active ingredients used in healthcare antiseptics marketed under the over-the-counter drug monograph, according to an article on the CleanLink website.
Products affected include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations, including pre-injection preparations. Different from consumer antiseptics, the most common active ingredients in products used in healthcare include alcohol and iodines, according to the article.
The FDA is looking for data that supports claims that the products are both safe for use and effective at reducing bacteria.
The American Cleaning Institute (ACI) issued the following response:
“We strongly agree with the Food and Drug Administration’s recommendation that healthcare personnel continue to use antiseptic products as they currently do. These soaps, washes, alcohol rubs, hand scrubs and pre-operative skin preparations are critical to infection control for patients and healthcare workers alike,” said Richard Sedlak, ACI Executive Vice President, Technical & International Affairs."
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