FDA seeks more data on safety of hospital hand cleaners

15th of May 2015
FDA seeks more data on safety of hospital hand cleaners

The US government is calling for more data on medical hand washes and hand sanitisers to ascertain their long-term effects when used daily.

The Food and Drug Administration says more information is needed to establish the safety and effectiveness of common hand cleaners used in hospitals, GP practices and nursing homes.

The FDA wants manufacturers to provide information on the possible hormonal effects of the products as well as their contributions to antibiotic-resistant bacteria.

Antiseptic ingredients such as alcohol and iodine have been used by medical staff for decades. But regulators are concerned at emerging science that suggests antiseptics are absorbed into the body at higher levels than previously thought, showing up in the blood and urine of users. The FDA will also seek information about possible links between the use of antiseptics and the growth of antibiotic-resistant bacteria.

Professional guidelines currently urge medical personnel to sanitise their hands before and after visiting each patient's room. But FDA scientists say their routine use has increased over the last 20 years as healthcare staff work harder to combat hospital infections.

"We're not asking for any of these products to come off the market at this time; we're just asking for additional data," said FDA drug agency director Theresa Michele. "And we're likewise not suggesting that people stop using these products. But 20 years ago you didn't find people using antiseptic gels 100 times a day; it just didn't happen."

Products that are not shown to be safe and effective by 2018 would have to be reformulated or removed from the market, claims the FDA.



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