FDA Proposes Rules On Healthcare Antibacterial Products, ACI Responds

Orig. Post May 4, 2015 by Clean Link | Re-Post May 6, 2015

The U.S. Food and Drug Administration (FDA) first began looking into the safety of antibacterial hand soaps and body washes back in 2013. A rule was proposed that would ask manufacturers “to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.” Products that failed safety standards would require reformulation or new labels to remain on the market.

The rule was part of a larger initiative of the active ingredients in antibacterial products. Specifically, the FDA stated that “some data suggests that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.” This 2013 rule did not affect hand sanitizers, wipes or antibacterial products used in healthcare settings. (FDA Acts On AntiMicrobials for details on this 2013 rule.)

Now, after further research, the FDA is proposing a similar rule that specifically relates to antiseptics used in healthcare. Last week, the FDA announced the requirement of “additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph.”

Products being targeted 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. With this proposed rule, the FDA is looking for data that supports that the products are both safe for use and effective at reducing bacteria. (University of Berkley’s Comment On FDA’s Decision for full details on this new rule.)

“Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other health care settings, and remain a standard of care to prevent illness and the spread of infection,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered.”

In light to this most recent proposed rule, 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.

“We believe that the FDA already has in its hands a wealth of scientific data that details the safety and effectiveness of these critical antiseptic products. These products have been used safely and effectively by healthcare workers for decades.

“While manufacturers have submitted extensive data already, we will continue working with the FDA and provide the necessary information to answer their questions. We need to ensure these products remain available to help save lives in thousands of hospitals and healthcare settings across the United States.”

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