FDA Asks for Safety Data on Antiseptics

FDA Asks for Safety Data on AntisepticsEarlier this year, the U.S. Food and Drug Administration called for a review of common healthcare antiseptics, including hand sanitizers, surgical scrubs, and antiseptic washes. The manufacturers of these products are now required to conduct specific tests and submit their findings to the FDA. Interestingly enough, the focus is not just on antiseptic effectiveness, but on safety. (Consumer antibacterial products are not included in the review.)

As super-bugs have emerged and hospital-acquired infections (HAIs) have become a top concern, most hospitals and healthcare facilities have adopted stringent infection prevention policies. Antiseptics are a critical component of infection control plans: some patient encounters can require up to five hand washings to comply with existing guidelines, according to this graphic by the World Health Organization. The FDA estimates that providers are using antiseptic products up to 100 times a day.

The review was initiated after the FDA identified gaps in scientific data for antiseptic ingredients like alcohol and various types of iodine. (Chlorhexidine has been excluded from the review, amidst some controversy about its inclusion.) Basically, these ingredients have been used for so long that the existing research no longer meets scientific standards. Specific areas of interest include:

  • Concerns that topical antiseptics do not remain on the surface of the skin, but are absorbed into the bloodstream. New methods to measure blood serum levels and urine concentrations are available and seem to indicate that systemic exposure is occurring.
  • Concerns that providers are using antiseptic products more frequently than ever before, meaning even small amounts of absorption could add up over time.
  • Concerns about long-term exposure and absorption over the course of a long career—and potential adverse events that may stem from this exposure.
  • Factors that affect long-term exposure and absorption rates, including healthcare job role, surface area of exposed skin, the age and gender of the worker using the antiseptic, and the formulation used.

Because of these concerns, the FDA is asking for a maximum use trial, animal absorption studies, toxicity studies, an evaluation of hormonal effects, and an evaluation of the antiseptic’s potential to promote resistant strains of microbes.

So what does this mean for nurses and other providers? Until the review is complete, you should continue to follow existing policies and guidelines for infection prevention and control. The goal is to keep both providers and patients as safe as possible, by implementing current scientific knowledge and up-to-date usage guidelines.

The current, industry-wide focus on reducing HAIs is expanding career opportunities for nurses who want to specialize in infection prevention. Are you interested in keeping patients safe from pathogens in a hospital environment? If planning, implementing, and evaluating infection prevention and control measures appeals to you, consider making this in-demand field your career specialty. As a first step, you can develop new skills and empower yourself with knowledge through an online RN to MSN degree with a specialization in infection control from American Sentinel University, an innovative, accredited provider of online nursing degrees.