APIC and SHEA statement on FDA proposed rule on safety and effectiveness of healthcare antiseptic products
Washington, April 30, 2015 – The Association for Professionals in Infection Control and Epidemiology (APIC) and the Society for Healthcare Epidemiology of America (SHEA) issued the following statement in response to release of a proposed rule by the U.S. Food and Drug Administration (FDA) relative to healthcare antiseptic products.
Today’s FDA action is requesting additional safety and effectiveness data for certain ingredients in antiseptic products used in healthcare facilities.
APIC and SHEA strongly agree with FDA’s advice that these products continue to be used consistent with infection control guidelines while additional data is being gathered. Healthcare antiseptics are an important component of infection control strategies in hospitals, clinics, and other healthcare settings, and remain a standard of care to prevent illness and spread of infection.
Healthcare antiseptics include healthcare personnel handwashes and rubs, surgical hand scrubs and rubs, and patient preoperative skin preparations, including pre-injection preparations. Alcohol and iodines are the most common active ingredients in the healthcare antiseptics affected by this rule.
Since all infection prevention and control guidelines are evidence-based, it is important to stay up-to-date on safety and effectiveness data to protect healthcare personnel and their patients.
Hand hygiene and prevention of surgical site infections are cornerstones of any infection prevention and control program designed to protect patients and personnel in healthcare facilities. A strong hand hygiene program and surgical skin preparation are essential to control transmission of dangerous multidrug-resistant organisms and prevent healthcare-associated infections (HAIs), which are associated with the deaths of 75,000 Americans each year.
Additional information from FDA:
- Proposed rule: “Safety and Effectiveness of Health Care Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use”
- Press release: “FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics”
- Health Care Antiseptics: Q&A for Health Care Professionals
- Health Care Antiseptics: Q&A for Consumers
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APIC’s mission is to create a safer world through prevention of infection. The association’s more than 15,000 members direct infection prevention programs that save lives and improve the bottom line for hospitals and other healthcare facilities. APIC advances its mission through patient safety, implementation science, competencies and certification, advocacy, and data standardization. Visit APIC online at www.apic.org. Follow APIC on Twitter: www.twitter.com/apic and Facebook: www.facebook.com/APICInfectionPreventionandYou. For information on what patients and families can do, visit APIC’s Infection Prevention and You website at www.apic.org/infectionpreventionandyou.
The Society for Healthcare Epidemiology of America (SHEA) is a professional society representing physicians and other healthcare professionals around the world with expertise and passion in healthcare epidemiology, infection prevention, and antimicrobial stewardship. SHEA's mission is to prevent and control healthcare-associated infections, improve the use of antibiotics in healthcare settings, and advance the field of healthcare epidemiology. The society leads this specialty by promoting science and research, advocating for effective policies, providing high-quality education and training, and developing appropriate guidelines and guidance in practice. SHEA upholds the value and critical contributions of healthcare epidemiology and improved antibiotic use to improve patient care and healthcare worker safety in all healthcare settings. Visit SHEA online at www.shea-online.org,www.facebook.com/SHEApreventingHAIs and @SHEA_Epi.