Concurrent Education Session - 60 minutes
Hand hygiene is one of the most effective measures for preventing the spread of infections and good infection control practice, including use of antimicrobial soaps and alcohol-based hand rubs, has been recognized as an important tool in reducing the need for antibiotics. The FDA Healthcare and Consumer Antiseptic Monographs, which regulate the use of most antiseptic hand hygiene agents in healthcare and household settings, have been undergoing revisions and have received significant mainstream news media attention in the last year. While the changes occurring are part of the FDA’s normal process of finalizing the monographs, the call for additional safety and efficacy data may be confusing to healthcare personnel who routinely and repeatedly use antibacterial soaps and/or hand sanitizers at work and at home. Antimicrobial soaps and antiseptic hand rubs have been separated into two distinct monographs in the consumer setting and have different dates for issuance of Final Rules. These pending changes may significantly impact product availability, which may be different in healthcare settings versus consumer settings. Both groups are likely to be confused by this variation of product availability across different use settings.
Because of their oversight of hand hygiene and infection prevention programs, cross-functional and multidisciplinary activities within healthcare delivery settings, and responsibility for messaging to patients and visitors, infection preventionists are uniquely positioned to interpret the coming regulatory changes and facilitate communications and adaptation to these changes within their organizations. This session will assist infection preventionists in understanding the monographs, the regulatory process, the resulting revisions to the final consumer rinse-off monograph, the proposed revisions to the consumer leave-on and healthcare products monographs, and the FDA’s data needs and timeline for decision-making going forward. This information will assist infection preventionists in designing a course of action for their healthcare facility’s infection control program.