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

3 Pillars of Stronger Cybersecurity in Healthcare

These strategies can help healthcare facilities stay ahead of evolving cyber threats.


Meridian Acquires Medical Office Building in Pasadena, CA

The property was acquired for approximately $13.35 million.


Expanded Maternity Unit Opens at Inspira Medical Center Mullica Hill

The expanded maternity unit supports a dedicated flow from arrival through delivery and recovery.


Resilience Planning in Remote Healthcare Facilities

Assumptions about equipment failures and response times change when a hospital is hundreds of miles from the nearest major city.


Missouri Southern State University Opens Roy Blunt Health Science Innovation Center

The project broke ground in April 2024.


 
 


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.