There's the Rub: FDA Concerned about Healthcare Workers Constant Exposure to Antiseptics

July 28th, 2015

Infection preventionists and employee health professionals have until Oct. 28, 2015 to submit comments on a controversial proposed rule by the FDA calling for a comprehensive review of the active ingredients in healthcare antiseptics like alcohol-based hand hygiene solutions.

Now ubiquitous in hospitals, the hand rub solutions and many other healthcare antiseptics are being used in the absence of updated scientific data on the effects of prolonged exposure to healthcare workers, particularly those who are pregnant or considering starting a family.

“Alcohol-based healthcare antiseptics are not only used frequently in the healthcare setting, but they are also recommended for use by authoritative bodies such as the CDC,” Colleen Rogers, PhD, lead microbiologist in the FDA’s Division of Nonprescription Regulation Development said at a preliminary hearing on the proposed rule. “There are no data on the effects of systemic alcohol exposure due to healthcare antiseptic use during pregnancy, but maternal alcohol ingestion is the leading known cause of developmental and cognitive disabilities in children and a preventable cause of birth defects. Based on alcohol exposure data from non-pregnant adults, moderate hand rub use led to a maximum systemic exposure, which was equivalent to approximately 10% of the alcohol in a standard alcohol-containing drink, such as a glass of wine or bottle of beer. The implications of even this low exposure are unclear, given that no known safe threshold exists for fetal alcohol exposure.”

The FDA would have to find compelling evidence to limit the use of alcohol rubs in hospitals, as a former CDC outbreak investigator made it perfectly clear what was at stake.

“This would lead to increased healthcare associated infection rates and take U.S. infection control backwards at least 15 to 20 years,” warned William Jarvis, MD, an infection control consultant who spoke on behalf of industry at the FDA hearing.

The FDA proposed rule requests additional scientific data to support the safety and effectiveness of certain active ingredients used in healthcare antiseptics marketed under the over-the-counter drug monograph.

“The FDA recommends that healthcare personnel continue to use these products consistent with infection control guidelines while additional data are gathered,” the agency said in a statement. “Healthcare antiseptics are primarily used by healthcare professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing homes. They include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations, including pre-injection preparations. The most common active ingredients in healthcare antiseptics marketed under the over-the-counter drug monograph include alcohol and iodines. These products are different from consumer antiseptics, such as antibacterial soaps and hand sanitizer rubs, which are not part of this proposed rule.”

Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that healthcare antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective for their intended use to reduce bacteria that potentially can cause disease. Since the FDA began review of healthcare antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use.