Federal regulators are seeking more information on the use of hand sanitizers and washes in healthcare settings to examine their effectiveness in protecting against the spread of infection.
The U.S. Food and Drug Administration published a proposed rule on Thursday asking manufacturers of over-the-counter antiseptics marketed for healthcare personnel use to provide evidence demonstrating that long-term, daily skin exposure to their products does not pose a potential health risk. Companies would have to provide data on the potential hormonal effects of chronic use, as well as the likelihood of developing antimicrobial resistance.
“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,” Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. “The FDA recommends that health care personnel continue to use these products, consistent with infection control guidelines, while additional data are gathered.”
Safety questions have been raised in recent years as healthcare professionals have increasingly used antiseptic products. Most healthcare settings have established more stringent infection-control standards for their staff out of concern for the high prevalence of healthcare-associated infections in U.S. hospitals. More than 700,000 patients developed infections in acute-care hospitals in 2011, according to the Centers for Disease Control and Prevention, resulting in an estimated 75,000 deaths.
Healthcare professionals now use antiseptic products as often as 100 times a day, according to the FDA.
Companies would have up to a year to submit the requested information for FDA review. The review will focus on common active ingredients found in the products, such as alcohol and iodines. The proposed rule does not include review of consumer products such as antibacterial soaps or sanitizers.
The proposed rule is similar to draft regulation the agency published in December 2013 that required manufacturers of consumer soaps and sanitizers labeled as antibacterial to prove they were safe and provided greater benefit than using simple soap and water.
The American Cleaning Institute, the biggest trade organization for the cleaning products industry, released a statement applauding the FDA for recommending that healthcare personnel continue to use the antiseptic products while they're under review.
“We believe that the FDA already has in its hands a wealth of scientific data that detail the safety and effectiveness of these critical antiseptic products—these products have been used safely and effectively by healthcare workers for decades,” Richard Sedlak, executive vice president for the trade group said in a statement. “We need to ensure these products remain available to help save lives in thousands of hospitals and healthcare settings across the United States.”