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

Building Disaster Resilience Through Collaboration

The ability to respond quickly and recover effectively depends on the strength of an organization’s external bonds.


Amae Health Expands to New York City

This expansion brings its integrated care model to serve individuals with complex mental health conditions.


Hospital for Special Surgery Opens Two New Facilities in New Jersey

The two facilities are a full-service outpatient center and a surgery center.


Should We Be Testing Toilet Water in Patient Restrooms?

Research suggests transmission of Legionella pneumophila through toilet flushing should be considered when investigating a Legionnaires’ disease case.


Healthcare Union Petitions for Increased Staff Safety at HCA Florida Hospitals

The petition follows a recent nurse assault and 160 calls to law enforcement this year at one hospital alone.


 
 


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.