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Food & Drug Administration Seeks Safety Data On Skin Sanitizers

Disinfectants: Agency to evaluate health care workers’ frequent use of antiseptics

by Britt E. Erickson
May 11, 2015 | A version of this story appeared in Volume 93, Issue 19

Credit: Shutterstock
The growing use of antiseptics in health care settings prompts FDA to call for more safety data.
Photograph of a female surgeon using handwash in a washroom.
Credit: Shutterstock
The growing use of antiseptics in health care settings prompts FDA to call for more safety data.

Federal regulators are planning to reevaluate the safety of long-term daily exposure to skin sanitizers, such as hand washes and surgical hand scrubs, used by workers in hospitals and other health care settings.

FDA has no data suggesting that active ingredients in health care antiseptics are unsafe or ineffective. But the use of these products has skyrocketed since the agency first evaluated them in the 1970s.

“Today, health care professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day,” says Theresa M. Michele, director of nonprescription drug products in FDA’s Center for Drug Evaluation & Research. Emerging science suggests that exposure to some antiseptic active ingredients, such as alcohol and iodine, is higher in health care workers than previously thought, she says.

Because of the higher rates of exposure, FDA is proposing to require manufacturers of these products to provide additional safety data. The information would include the potential for active ingredients to be absorbed through the skin, cause hormonal effects, and contribute to antibiotic resistance.

The agency is not requiring manufacturers to remove any health care antiseptics from the market at this time, Michele emphasizes. “FDA recommends that health care personnel continue to use these products, consistent with infection control guidelines while additional data are gathered,” she says.

Product makers, as well as groups representing health care workers, welcome FDA’s decision to allow the use of antiseptics in health care settings while additional safety and efficacy data are being generated. Manufacturers argue, however, that FDA already has extensive information on the safety and efficacy of their products. Even so, they say they will provide FDA with additional data to answer the agency’s questions and keep health care antiseptics on the market.

“These soaps, washes, alcohol rubs, hand scrubs, and preoperative skin preparations are critical to infection control for patients and health care workers alike,” says Richard Sedlak, executive vice president of technical and international affairs at the American Cleaning Institute, an industry group.



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