FDA to Study Safety, Effectiveness of Healthcare Antiseptics

April 30, 2015

Healthcare antiseptic products used up to 100 times a day by clinicians must prove themselves to be safe and effective, especially over the long haul, to remain on the market under proposed regulations announced today by the US Food and Drug Administration (FDA).

The antiseptic products in question are found in hospitals, nursing homes, physician offices, clinics, and other outpatient settings. Their manufacturers would have to submit safety and efficacy data on 29 active ingredients, which include alcohol, iodine, phenol, and hexachlorophene.

The FDA is looking for information about, among other things, topical absorption, potential hormonal changes, possible bacterial resistance, and the effects, if any, on pregnant and breast-feeding healthcare workers.

The proposed regulations do not apply to consumer antiseptics such as antibacterial soaps and hand sanitizer rubs.

Today's announcement could create cognitive dissonance for physicians, nurses, and other healthcare workers, who are urged to heed increasingly stringent infection control protocols. They include faithful use of hand washes and rubs, including those for surgeons, and preoperative skin preparations for patients, all of which come under the FDA proposal.

At a news conference today, an FDA official encouraged clinicians to stick to their infection-control habits and to continue using the antiseptic products with the 29 targeted ingredients. "We don't believe they're ineffective and unsafe," said Theresa Michele, MD, director of the nonprescription drug department in the FDA's Center for Drug Evaluation and Research.

However, confirmatory studies are needed in light of changing infection control procedures, more frequent use of antiseptic products, new technology that can detect low levels of antiseptics in the body, and new findings about their effects, Dr Michele said. "Emerging science suggests that for some ingredients, systemic exposure is higher than previously thought."

She added that her agency "thought long and hard" about the possibility of clinicians perceiving a mixed message on antiseptics.

"I think for healthcare workers, these [products] are critical elements of infection control," Dr Michele said. "The fact that healthcare workers are now using these much more than they used to emphasizes why we need to gather this additional data."

The 29 antiseptic active ingredients in question currently fall into the FDA regulatory category of GRASE, or generally recognized as safe and effective. The proposed regulations released today would require manufacturers to submit safety and efficacy data in the next 12 months to re-earn this stamp of approval. Meanwhile, the FDA will accept public comments on the proposed regulations for 180 days, followed by a 60-day rebuttal period. The agency then will evaluate the comments as well as the data from manufacturers and publish a final set of regulations that determine the GRASE status for each ingredient. Those that make the cut will stay on the market.

Two healthcare organizations have already weighed in favorably on the proposed FDA regulations.

"Since all infection prevention and control guidelines are evidence-based, it is important to stay up-to-date on safety and effectiveness data to protect healthcare personnel and their patients," the Society for Healthcare Epidemiology of America and the Association for Professionals in Infection Control and Epidemiology said in a joint news release. They also said they agreed with the FDA that clinicians should continue to use antiseptic products while more data are gathered.

Today's FDA announcement is available on the agency website.


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