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Manufacturers help infection control experts make sense of FDA rules on antiseptic ingredients

* Manufacturers-help.jpgThe American Cleaning Institute is helping infection control experts better understand the process and possible results from pending US Food & Drug Administration decisions on the safety and effectiveness of certain active ingredients used in healthcare antiseptics in early 2018.

Dr Paul DeLeo, ACI associate vice president, Environmental Safety, will be part of a team of experts speaking at the 2017 Association for Professionals in Infection Control & Epidemiology Convention in Portland, Oregon.

Joining Dr. DeLeo will be Dr David Macinga, director, Regulatory Affairs & Clinical Science, Gojo Industries; Dr Andrew Maier, associate professor of environmental health, University of Cincinnati; and William Phillips, vice president, Regulatory Affairs North America, Ecolab.

The FDA is in a multi-year process of establishing a new Healthcare Antiseptic Monograph, which regulates the use of most antiseptic hand hygiene agents in healthcare settings, including what are commonly known as antibacterial soaps, hand sanitisers and pre-operative scrubs.

While FDA's actions are part of the normal process of finalising Over-the Counter drug monographs, the call for additional safety and efficacy data may be confusing to healthcare personnel who routinely use antibacterial soaps and/or hand sanitisers at work.

The pending decisions may significantly impact product availability, according to ACI.

"Healthcare antiseptics are an important component of infection control strategies and remain a standard of care to prevent illness and infection," says Dr DeLeo. "We want to help healthcare professionals better understand the FDA process and proposed rules.

"Manufacturers continue to advance the science and are providing the FDA with state-of-the art scientific data and research of the safety and efficacy for specific ingredients used in antibacterial soaps and hand sanitisers as part of the FDA framework."

In an FDA statement announcing the proposed healthcare rules in May 2015, the agency said:

"The FDA recommends that healthcare personnel continue to use these products consistent with infection control guidelines while additional data are gathered."

The presenters' session at the APIC conference today will assist infection control specialists in understanding FDA's rules and related regulatory process, the resulting revisions to the final consumer rinse-off monograph, the proposed revisions to the healthcare products monographs, and the FDA's data needs and timeline for decision-making in the future.

ACI has made extensive submissions to the FDA on antibacterial product safety and efficacy for healthcare and consumer settings. To view those comments and other related statements, visit ACI's website:


22nd June 2017

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