Hospital workers often use antiseptic sanitizers to quickly disinfect their hands as they go about their duties, but according to the United States Food and Drug Administration, this may not be as safe and effective as most people think.
The FDA has asked manufacturers of hand sanitizers to present additional data on their products, especially its long-term effects on the skin if used daily.
According to the health agency, modern scientific findings suggest that systemic exposure to antiseptic ingredients is more prevalent than initially thought. The available data raise questions about the potential effects of repeated exposure to these ingredients on the human body.
The FDA views people working in health care settings as the most affected, especially workers who are pregnant and breastfeeding, because they are exposed to topical absorption of the active ingredients more often.
Theresa Michele, director of the FDA's drug center, explained that health care professionals depend on antiseptic products more often than they used to, with some using it up to 100 times a day.
She said that the FDA's proposal aims to ensure that the health agency's evaluations and determinations for all antiseptic active ingredients used for health care purposes remain consistent and up-to-date. These products must also accurately reflect modern scientific knowledge and patterns of use followed by health care professionals.
The proposed rule states that companies are required to submit up-to-date studies about the major safety issues concerning their product. This includes potential effects on the hormones and contributions to antibiotic-resistant bacteria. If a product is deemed not safe and effective by 2018, it will be reformulated or taken off the market.
The Food and Drug Administration's new policy will cost hand sanitizer manufacturers an estimated $64 million and $90 million in order to comply with its guidelines. The companies are given a year to present the required new data and information on their products and 60 days to provide a rebuttal.
While the FDA continues to gather information on the potential effects of hand sanitizers on the health, the health agency still recommends that health workers continue to use hand washes, surgical scrubs and sanitizers to prevent the spread of infections.
"We're not asking for any of these products to come off the market at this time," Michele added. "We're just asking for additional data. And we're likewise not suggesting that people stop using these products."
Photo: OnCall team | Flickr
