FDA proposes rules for healthcare antibacterial products

FDA will require additional scientific data to support the safety and effectiveness of certain active ingredients


The U.S. Food and Drug Administration (FDA) will require additional scientific data to support the safety and effectiveness of certain active ingredients used in healthcare antiseptics marketed under the over-the-counter drug monograph, according to an article on the CleanLink website.

Products affected include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations, including pre-injection preparations. Different from consumer antiseptics, the most common active ingredients in products used in healthcare include alcohol and iodines, according to the article.

The FDA is looking for data that supports claims that the products are both safe for use and effective at reducing bacteria.

The American Cleaning Institute (ACI) issued the following response:

“We strongly agree with the Food and Drug Administration’s recommendation that healthcare personnel continue to use antiseptic products as they currently do. These soaps, washes, alcohol rubs, hand scrubs and pre-operative skin preparations are critical to infection control for patients and healthcare workers alike,” said Richard Sedlak, ACI Executive Vice President, Technical & International Affairs."

Read the article.

 

 



May 6, 2015


Topic Area: Industry News


Recent Posts

Case Study: How NYU Langone Rebuilt for Resilience After Superstorm Sandy

Although the damage was severe, it provided a valuable opportunity for NYU Langone to assess structural vulnerabilities and increase facility resilience.


Frederick Health Hospital Faces 5 Lawsuits Following Ransomware Attack

The lawsuits accuse FHH of inadequate cybersecurity, poor breach notification and failing to protect patients from identity theft risks.


Arkansas Methodist Medical Center and Baptist Memorial Health Care to Merge

They have signed a non-binding letter of intent to complete a shared mission agreement to merge the two organizations.


Ground Broken on Intermountain Saratoga Springs Multi-Specialty Clinic

The clinic is scheduled to open and start seeing patients in the fall of 2026.


Electrical Fire Tests Resilience of Massachusetts Hospital

Signature Healthcare Brockton Hospital used opportunity to renovate key systems and components and expand facility operations.


 
 


FREE Newsletter Signup Form

News & Updates | Webcast Alerts
Building Technologies | & More!

 
 
 


All fields are required. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.