Surgeon handwashing
IN PHOTO: A surgeon washes his hands before starting procedures to clean the wound of an amputee patient with MRSA (Methicillin resistant Staphylococcus Aureus) in the prep-room next to the operating theatre at the Unfallkrankenhaus Berlin (UKB) hospital in Berlin February 29, 2008. MRSA is an antibiotic resistant so-called 'super-bug', which can cause deadly infections. Reuters/Fabrizio Bensch

Workers from health care facilities use hand sanitisers countless times in a day and now, the U.S. Food and Drug Administration, or FDA, issued a proposal on Thursday to reassess how safe and effective these health care antiseptics are.

Hand sanitisers are important in any healthcare facility as it is one of the strategies for infection control. FDA Center for Drug Evaluation and Research Director Janet Woodcock said that these healthcare antiseptics remain to be a “standard of care to prevent illness and the spread of infection.” After 40 years, the FDA is requesting more scientific data from manufacturers of antiseptics, which include “washes and rubs, surgical hand scrubs and rubs,” as stated in the FDA press release.

According to the release, the request for data stems from new scientific information that became a cause for concern among scientific groups and medical experts. There is a need to provide added data on the active ingredients and indicate the long-term effects these substances have on the skin when used daily.

The release also states that the FDA requirement does not mean that the agency assumes that the products are unsafe or ineffective. According to Theresa Michele, director at FDA’s drug centre, the agency is not saying that the products should be taken off the shelves; they only want more data.

“We’re likewise not suggesting that people stop using these products,” she said in an interview with The Associated Press. FDA made it clear that health workers should continue the use of common antiseptics in the healthcare setting to prevent infections.

FDA regulators said that they will use the data they have gathered to define safety limits for vulnerable groups of users, such as pregnant and breastfeeding women. The FDA will also probe into the link between antiseptic use and the growth of antibiotic-resistant bacteria.

Manufacturers have one year to meet the requirements and submit the needed information before the agency begins setting regulations on antiseptics. The agency also welcomes public opinion for six months.

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