FDA Proposed Rule for Skin Antiseptics Used in Healthcare

On April 30, 2015, the U.S. Food and Drug Administration (FDA) announced a proposed rule for healthcare skin antiseptics, including hand hygiene products used in hospitals and healthcare facilities. The proposed rule does not apply to products used by consumers or by businesses outside of the healthcare field.

More Data Requested on All Antiseptic Ingredients

The FDA is establishing an expanded safety 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.

Review the FDA Proposed Rule News Release

FDA Recommends Healthcare Professionals Continue to Follow Infection Control Guidelines 

The FDA recommends that healthcare professionals continue to use skin antiseptic products consistent with infection control guidelines. According to the FDA, “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.”

The Centers for Disease Control and Prevention (CDC) Hand Hygiene Guidelines for Healthcare recommend alcohol-based hand rubs as the primary hand hygiene method and washing with soap and water when hands are visibly soiled.

Perspective from Public Health Experts

Hand Hygiene Helps Save Lives in Healthcare 

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. GOJO, as a science-based company, develops the safest, most effective products to decrease the spread of illness-causing germs in order to save lives and improve public health. We will continue to provide data to the FDA demonstrating the safety and effectiveness of our products.

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.

View GOJO Corporate Statement