No Need for Skin Preps to Be Sterile, FDA Told

WASHINGTON — Requiring that antiseptic skin preparation products be sterile — a standard not currently mandated by the FDA — is unnecessary and wouldn’t produce a dramatic drop in infections, manufacturers, clinicians, and policy analysts told the FDA Wednesday.

The requirement would instead cause undue burden for companies, manufacturers said at a public hearing on the issue hosted by the FDA.

Topical antiseptic products are used before surgery, before an injection, or to reduce the risk of skin infection, but some have been recalled recently because of microbial contamination. There have been roughly 40 reports of contaminated antiseptic products submitted to the FDA, noted Joyce Ryan, DNP, director of clinical affairs at Sage Products in Cary, Ill., which makes antiseptic products.

To address the issue, the FDA is examining ways to reduce the risk of contamination and the patient complications and infections that could follow.


The FDA noted Wednesday that the lack of studies on sterile antiseptic products shouldn’t translate to them not being safer.


Instead, providers and clinicians need to focus on education and proper use of antiseptic products, said Hudson Garrett, PhD, senior director of clinical affairs at Professional Disposables, an antiseptic products maker in Orangeburg, N.Y. Too often, products aren’t used as directed or intended, he noted.

“It doesn’t matter who the provider is,” Garrett said. “We need to focus more on the appropriate use of these products.”

Clinicians who want to reduce infections can focus on a number of areas they can control — such as patient nutrition and prolonged hospital stays, he added.

Michelle Stevens, MD, medical director of the 3M Company’s infection prevention division, said the FDA needs to enforce its current manufacturing regulations to better prevent product contamination.

Jennifer Yttri, PhD, senior fellow at the National Research Center for Women & Families in Washington, noted there’s a general lack of awareness from providers that these types of products aren’t sterile.

“We need to have better communication that a product is not sterile,” Yttri said, adding that could come from product labeling.

The biggest problem comes from multi-use solutions used outside of the operating room, the FDA said Wednesday.


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