FDA Creates UV Microbial Reduction Device Category
The FDA created a new medical device category covering UV devices to microbial reduction, requiring authorization before coming to market.
The FDA created a new medical device category covering UV devices to microbial reduction, requiring authorization before coming to market.
The primary goal of the trial is to determine if filtering and sterilizing operating room air with the Aerus Medical Guardian reduces serious surgical site infections, complications, and death within 30 days after surgery.
The American Hospital Association and the Centers for Disease Control and Prevention have published best practices on using the healthcare physical environment to prevent infections. The document, available as a free PDF download, contains guidance on the flow of patients, personnel, equipment, and waste, among other topics.
The FDA created a new medical device category covering UV devices to microbial reduction, requiring authorization before coming to market.