PURELL Sanitizer Nurse using Dispenser

FDA Announces its Proposed Rule for Healthcare Skin Antiseptics - What Does It Mean?

Dave Mackay


By David Mackay

Commercial Business VP & GM

On April 30, 2015, the U.S. Food and Drug Administration (FDA) issued a proposed rule for healthcare skin antiseptics, including hand hygiene products used in hospitals and healthcare facilities. But, what is this proposed rule, and what does it mean?

An Overview of this Proposed Rule
First and foremost, it is important to remember these proposed rules are for the healthcare industry only. This proposed rule does not apply to products used by consumers or by businesses outside of the healthcare field.

The FDA is establishing an expanded framework for all hand hygiene products used by healthcare professionals and is asking for additional data based on advances in testing methods. The FDA has stated it will issue a Healthcare Final Monograph in January 2018.

No Change to Current Hand Hygiene Guidelines
The FDA recommends that healthcare professionals continue to use skin antiseptic products consistent with infection control guidelines. Both the Centers for Disease Control and Prevention (CDC) and the Society for Healthcare Epidemiology of America (SHEA) recommend using alcohol-based hand rubs as the primary method for performing hand hygiene, and washing hands with soap and water when hands are visibly soiled or contaminated.

The FDA went on to say in its proposed role that, “We emphasize that our proposal for more safety and effectiveness data for healthcare antiseptic active ingredients does not mean that we believe that healthcare antiseptic products containing these ingredients are ineffective or unsafe, or that their use should be discontinued…”

In healthcare, hand hygiene is considered the single most important means of preventing the spread of infection. Both alcohol-based hand rubs and handwashing are critical in healthcare settings. As a science-based company, GOJO develops the safest, most effective products to decrease the spread of illness-causing germs in order to save lives and improve public health.

Healthcare professionals are on the front lines in providing care for those who need it most. We commend the FDA on taking this approach to ensure the health and safety of patients and healthcare professionals, and we will continue to provide data to the FDA demonstrating the safety and effectiveness of our products.

Additional Resources
Joint Statement from APIC and SHEA

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