FDA Proposes New Rule Requesting Antiseptic Studies

The Food and Drug Administration (FDA) has proposed a rule requesting scientific studies be undertaken on the safety and effectiveness of hospital sanitizing products. Antiseptics in the form of hand washes, sanitizing rubs, and patient preoperative skin sanitizers are expected to fall under the proposed rule while hand sanitizers available to consumers would not be subjected to the same qualifications. While the FDA does have reviews that have been in place since the 1970’s, the Administration is concerned that changes in the ways antiseptics are used. Dr. Theresa Michele, director of CDER’s Division of Nonprescription Drug Products, explains the FDA’s concerns saying;

“Today health care professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day. Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals.”

The FDA is concerned both for the safety of the healthcare professionals who use these products on a daily basis and about the effectiveness of the products to reduce disease causing bacteria. The FDA does stress that the proposed rule is not intended to suggest that the FDA believes the products in question are ineffective of unsafe. Products are not being pulled from hospitals as a result of this proposed rule. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), explained saying;

“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. The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered.”

A renewed effort to combat bacterial infections in hospitals has been expected following several incidences of drug resistant bacterial infections being spread in hospitals. While the infections in hospitals across the nation were related to medical equipment and not hand and skin sanitizing products, studies that investigate the results of repeated and long-term use of sanitizing agents could shed some light on drug resistance.


Read More – FDA Proposed New Rule to Address Data Gaps for Certain Active Ingredients in Health Care Antiseptics (FDA)

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Originally from Gaithersburg, Maryland, Millan is a senior at the George Washington University studying Biological Anthropology.



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