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Time to Prove Hospital Disinfectants Work, FDA Says

The FDA says makers of hospital hand cleaning, washing and other antiseptic products need to do more to show they are safe and effective. Imaeyen Ibanga

Hospital workers wash their hands hundreds of times a day. Nurses are constantly using alcohol gels, chemical wipes and iodine washes on themselves and on patients.

Now that there’s a hand sanitizer dispenser at every hospital room door, it’s time to check that they actually do work as well as everyone assumes and that they are safe, the Food and Drug Administration says.

Up until now, FDA’s just accepted that these products work as intended and are safe. But now, FDA says, there are tests available to actually prove they do. And because of the emphasis on hospital infections, institutions are using the products far more frequently than even 10 years ago and in many different ways.

So FDA issued a proposed plan Thursday for reclassifying some of the products, and for requiring makers to show they are safe and effective.

"We're not asking for any of these products to come off the market at this time."

In the meantime. FDA says, there’s nothing for consumers to worry about and hospitals should continue using the products as they have been.

“What it seems they are doing is good due diligence,” says Dr. Susan Dolan of Children's Hospital Colorado and the Association of Professionals in Infection Control.

“They are trying to look at the products, look at how they are being used today, how things have changed,” she added.

FDA raises concerns over antibacterial soaps 3:12

The FDA proposes new rules making companies submit new studies looking at safety issues such as whether heavy, chronic use of the some of the products may cause them to soak in through the skin, or cause resistant bacteria to evolve.

Products that are not shown to be safe and effective by 2018 would have to be reformulated or taken off the market.

"We're not asking for any of these products to come off the market at this time. We're just asking for additional data," Theresa Michele, a director in FDA’s drug center, said in an interview with The Associated Press. "And we're likewise not suggesting that people stop using these products."

Alcohol, iodine benzalkonium chloride and other germ-killers have been used for decades. But not to the degree that they are now.

"Twenty years ago you didn't find people using antiseptic gels 100 times a day. It just didn't happen," Michele said.

FDA points to studies that show some of the products might be absorbed into the body at higher levels than previously thought, showing up in blood and urine. Dolan says not all the studies show this, but it’s worthwhile doing more checks.

“It’s timely and it makes sense,” Dolan said. “I do think consumers should not be worried. These are very effective products.”

The FDA last updated its review of health care hand cleaners in 1994.

“They are trying to look at the products, look at how they are being used today, how things have changed."

“We emphasize that our proposal for more safety and effectiveness data for health care antiseptic active ingredients does not mean that we believe that health care antiseptic products containing these ingredients are ineffective or unsafe, or that their use should be discontinued,” FDA said in its announcement.

The agency agreed to complete its review after a three-year legal battle with the Natural Resources Defense Council, an environmental group that accused the FDA of delaying action on potentially dangerous chemicals. In 2013 the FDA agreed to a legal settlement that included timetables for completing the review of various chemicals, including health care cleaners.

Environmentalists are mainly concerned about an ingredient called triclosan, which is used in most antibacterial soaps marketed to consumers. The agency issued a separate review of triclosan-containing consumer products in late 2013, saying more data are needed to establish their safety and effectiveness.

The Associated Press contributed to this story.