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

Rethinking Strategies for Construction Success

Encouraging project team stakeholders to communicate, collaborate, care and align around a common goal.


From Touchless to Total Performance: Healthcare Restroom Design Redefined

Facility managers are raising the bar on hygiene, durability and system performance by turning restrooms into frontline assets for infection prevention and patient confidence.


New York State Approves $53M Construction Program at Niagara Falls Memorial Medical Center

DOH greenlights first $6.5M phase, launching campus-wide upgrades to clinical spaces, infrastructure and patient care services through 2027.


How Health Systems Are Rethinking Facilities Amid Margin Pressure

As insurance uncertainty and consolidation reshape healthcare, facilities managers are turning to efficiency, adaptability and portfolio optimization to control costs.


Ground Broken on New Medical Office Building in Scottsdale, AZ

Hammes is developing a new 34,000-square-foot medical office building in Scottsdale, Arizona, in partnership with Phoenix-based NOVO Development.


 
 


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.