After some of the most famous medical outbreaks have occurred in recent years, FDA has determined that not all surgical protective apparel is equal. FDA recently published a “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings” reclassifying the levels of protection for surgical equipment. The guidance illustrates what apparel is to be concerned least protective to most protective. Not only does the guidance explain the level of protection, but it also puts the apparel (i.e. gowns) into classes, demonstrating their specific level of protection as well.
To find out more on the background of the new standards and information on the guidance, check out Alexander Gaffney’s article on raps.org here.