Because health care professionals use hand sanitizers dozens of times per day, the Food and Drug Administration recently proposed a rule asking manufacturers to demonstrate that long-term use of these hand sanitizers does not pose any potential health risks. Sanitizers are used in thousands of medical facilities, but policymakers have some concerns about the potential effects of using these products over a long period of time.
The FDA is not asking health care professionals to stop using hand sanitizers. On the contrary, Dr. Janet Woodcock says sanitizers are an important infection-control tool. She advises health professionals to continue using antiseptic hand sanitizers while the FDA gathers data about the long-term effects of such products.
In recent years, there have been some concerns about the safety of using antiseptic products frequently. Researchers worry that health professionals who use hand sanitizers multiple times per day are at risk for developing antibiotic resistance. Because the skin absorbs sanitizers, lotions and other topical products, there is also some concerns about the hormonal effects of long-term sanitizer use.
The proposed rule only applies to manufacturers selling sanitizers made for health professionals. It would not require the manufacturers of consumer-focused products to submit data pertaining to the safety of their products. The FDA says some health care professionals use hand sanitizers more than 100 times per day, making professional use more of an immediate concern than consumer use.
Under the proposed rule, manufacturers would have up to 12 months to submit information about their products. The rule applies to products that do not require a prescription. In addition to liquid hand sanitizers, the FDA plans to review product information for surgical hand scrubs, hand washes and products used to prepare patients for surgery or clean injection sites. FDA officials plan to review common ingredients, such as iodines and alcohol, when determining the potential effects of long-term use.
The FDA wants to see evidence that over-the-counter antiseptics are safe and effective, especially when used dozens of times per day. Research suggests that systemic exposure to the ingredients found in antiseptic products is higher than previously suggested. Some health professionals use hand sanitizers and antiseptic washes so frequently, the active ingredients of these products show up in their urine or blood samples. The FDA is also concerned about the effects of antiseptic products on health professionals who are pregnant or breastfeeding. By gathering safety and efficacy data, the FDA can determine if over-the-counter antiseptic products are safe, or if manufacturers should explore the use of alternative ingredients.
Using antiseptic products frequently increases the risk for antibiotic resistance and exposes health professionals to potentially harmful chemicals. By proposing this rule, the FDA is not taking the position that hand sanitizers are dangerous. Instead, the agency just wants to learn more about the long-term effects of antiseptic products.
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