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