Antibiotic Stewardship

Concurrent Education Session - 60 minutes

2100 - Making Sense of the FDA Antiseptic Monographs: What the Infection Preventionist Needs to Navigate Regulatory Changes around Antimicrobial Hand Products

Thursday, June 15
10:15 AM - 11:15 AM
Location: Oregon Convention Center, A 105-106

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.

Learning Objectives:

Sponsored By: 

Paul DeLeo

Associate Vice President, Environmental Safety
American Cleaning Institute
Washington, District Of Columbia

Paul DeLeo is associate vice president for Environmental Safety at the American Cleaning Institute. His responsibilities span broad interest areas related to product stewardship and the sustainability of cleaning products and their ingredients for the 140 association member companies of the $30 billion U.S. cleaning products industry. He directs research supporting the environmental safety of cleaning product ingredients and develops tools to further advance the science of consumer product ingredient safety. His particular interest is in the development of human and environmental exposure assessment tools for chemicals in products. In addition, he directs association policy development in areas of chemical management at the state and federal level.


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David Macinga

Director, Regulatory Affairs and Clinical Science
GOJO Industries, Inc.
Akron, Ohio

David Macinga, PhD, is director of regulatory affairs and clinical science at GOJO Industries, Inc., and an adjunct research assistant professor at Northeastern Ohio Medical University. Dr. Macinga has extensive pharmaceutical drug discovery and antimicrobial product development experience. His areas of expertise include antibiotic and biocide mechanisms of action and resistance, molecular biology, protein biochemistry, and microbiological methods development. He has been with GOJO since 2003, developing new and innovative antimicrobial and antiviral skin hygiene products. He moved into a role in regulatory affairs in 2015. He is currently engaged in industry efforts to provide additional safety and efficacy data to support finalization of FDA regulations governing skin antiseptics used in healthcare and consumer settings. Dr. Macinga has been widely published since 1995 in the areas of antimicrobial resistance and hand hygiene.


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Andrew Maier

Associate Professor of Environmental Health
University of Cincinnati
Cincinnati, Ohio

Andrew Maier, PhD, is an associate professor of environmental and industrial hygiene at the University of Cincinnati College of Medicine. He serves as the director of the University’s Risk Science Center and as deputy director of the National Institute for Occupational Safety and Health (NIOSH) Education and Research Center’s Continuing Education Program. He is board certified in toxicology and industrial hygiene. He serves as a Toxicology Fellow at NIOSH and as a science advisor for the International Life Science Institute’s Food Chemical Safety Committee. His areas of research interest include developing and applying new methods for safety and risk assessment for occupational and environmental exposures.


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William Phillips

Vice President, Regulatory Affairs North America
Ecolab Inc.
St. Paul, Minnesota

William Phillips supervises regulatory compliance programs for Ecolab North America, including raw materials, product hazard communication, product registration, sustainability, toxicology, and resolution of adverse incidents.


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Timothy Bowers

Infection Preventionist
Penn Presbyterian Medical Center
Philadelphia, PA

Timothy Bowers is currently an Infection Preventionist at Penn Presbyterian Medical Center in Philadelphia, PA focusing on educating his assigned units, CDI (CDAD) reduction, MRSA Screening program and the NHSN MDRO Module compliance. Previously he worked


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2100 - Making Sense of the FDA Antiseptic Monographs: What the Infection Preventionist Needs to Navigate Regulatory Changes around Antimicrobial Hand Products

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