In healthcare settings, hand hygiene is the single most important measure for preventing the spread of infection. Healthcare-associated infections, including those caused by multi-drug-resistant organisms (MDRO), are a significant global problem and challenge within U.S. healthcare facilities in terms of morbidity, mortality, and cost. Antimicrobial agents play an important role in decreasing the incidence of these infections.
Earlier this month, the FDA issued its Final Rule on antibacterial (antimicrobial) soap products marketed to consumers or made available for use in public settings. This ruling excludes healthcare settings. While this rule only applies to a subset of active ingredients and products used outside of the healthcare industry, there might be some confusion as to the regulation’s impact on healthcare.
The FDA Final Rule’s Impact on Healthcare
First, the FDA Monograph that covers healthcare antiseptic products is on a different timeline than the FDA Final Rule for Consumer Antibacterial Ingredients used in consumer soap products. The FDA is expected to issue its final rule for hand hygiene products – antibacterial soaps and hand sanitizers – used in the healthcare industry in January 2018.
In an April 2015 press release, the FDA recommended that healthcare professionals continue to use antiseptic products consistent with infection control guidelines. This includes the use of antimicrobial soaps, which are valuable hand hygiene solutions to reduce the risk of infection in critical settings, like healthcare. In addition, the Association of Professionals in Infection Control (APIC) and the Society for Healthcare Epidemiology of America (SHEA) emphasize that healthcare antiseptics are an important component of infection control strategies in healthcare settings and remain a standard of care to prevent illness and spread of infection.
It is also important to remember that healthcare is a unique setting, and the risk-to-benefit ratio is different for general consumer use compared to healthcare and food industries. Right now, the FDA is asking for additional safety and efficacy data from manufacturers who want to continue marketing healthcare antiseptic products under the Monograph. Once the FDA review is complete, products with active ingredients for which adequate safety and effectiveness data has been provided would continue to be available.
Antibacterial Soaps Play a Strong Role in Infection Control
The target of the FDA’s Final Rule is the use of specific antimicrobials in a wide range of consumer soap products, not the appropriate use in select situations and settings. Use of antimicrobial handwash products in the consumer setting cannot be extrapolated to use in healthcare where there may be a critical need for such products. Stewardship of antimicrobial products, much like antibiotic stewardship, is needed to ensure safe and appropriate use.
APIC, SHEA, the Centers for Disease Control and Prevention (CDC), and World Health Organization (WHO) all stress the importance of hand hygiene in helping to prevent healthcare-associated infections.
As an industry education leader Pocket Nurse® strives to distribute products that are the best hand hygiene solutions possible. We support the FDA’s evidence-based approach.
Please see our complete line of GOJO products at www.PocketNurse.com.