The FDA asks for new data on the safety and efficacy of antiseptics used in hospitals and other health care settings.
Exposure to an infection is a significant risk for hospitalized patients. The Centers for Disease Control and Prevention estimated that 722,000 patients acquired a health care-associated infection (HAI) in 2011 alone. This is despite the fact that medical care professionals repeatedly use antiseptics in order to reduce the risk of HAIs.
The U.S. Food and Drug Administration (FDA) recently issued a proposed rule which requests additional data and research to determine whether commonly used health care antiseptics are “generally recognized as safe and effective” for killing the bacteria which cause many HAIs.
Health care antiseptics include the washes and rubs medical care professionals use between patients and before surgery, as well as pre-operative skin preparations for patients. These products are commonplace in medical facilities where a single provider may use them many times a day. The most common active ingredients are alcohol and iodine, although other active ingredients are used as well.
An FDA advisory committee has expressed concern that most of the scientific data supporting the safety and efficacy of these commonly used antiseptics are now many years old and may no longer meet research standards. The FDA last reviewed these ingredients in 1994. Consequently, the FDA is looking for updated research ensuring that current health care antiseptics are both safe and effective.
The proposed rule would require those who wish to continue marketing health care antiseptic products to provide the FDA with additional data. The proposed rule would not remove any products from the current market. It is further limited to only those antiseptics marketed as over-the-counter drugs for use in clinical health care settings; it does not include consumer products, such as hand sanitizers.
Of particular concern is the risk to health care workers associated with repeat exposure to antiseptics. Clinical practices and research on chronic low level exposure have changed significantly since the last review.
Dr. Theresa Michele, the medical director of the FDA’s Center for Drug Evaluation and Research, states that modern “health care professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day.” Thus, the level of exposure to these products is significantly higher than was originally evaluated.
Furthermore, modern research has suggested that the level of systemic exposure to the active ingredients in these antiseptics from skin contact is higher than was thought in 1994. Modern testing can detect lower levels of these active ingredients in both blood and urine. The proposed rulemaking reports that “studies have shown detectable blood alcohol levels after use of alcohol-containing health care personnel hand rubs or surgical hand rubs.”
Additionally, the current data suggest that the active ingredients used in hospital-grade sanitizers may have hormonal effects, particularly on the thyroid and reproductive systems. Such changes may not be visible in the exposed individual but are particularly relevant for pregnant or breast-feeding providers, as exposure to even low levels of hormonally active compounds during early development might have long-term adverse effects.
The FDA is also seeking additional research on the risk of antimicrobial resistance caused by antiseptics. Preliminary lab studies have indicated that bacteria may become resistant to antiseptics as well as antibiotics.
The proposed rule contains specific descriptions of the studies the FDA expects will be necessary to close the current data gaps and ensure that sanitizer ingredients are safe for health care workers with sustained exposure.
Additionally, the proposed rule requests studies on the effectiveness of these antiseptics at killing bacteria. A review of the studies from 1994 apparently indicated significant deficiencies. In particular, the FDA suggests bacterial log reduction and in vitro testing to ensure effectiveness.
The FDA cautions that its review “should not be taken to mean the FDA believes that these products are ineffective or unsafe.” Thus, the agency advises health care workers to continue using these products in accordance with standard industry practices during the review period.
The proposed rule is open for public comment. Manufacturers can submit the requested information over the next 14 months, and the FDA will work with manufacturers on developing the appropriate data. At the end of this period, the FDA will issue a final rule as to whether each active ingredient is generally recognized as safe and effective.