Organizations Issue Joint Statement on FDA Clearance of Pediatric Face Mask

The Society for Healthcare Epidemiology of America (SHEA), Association for Professionals in Infection Control and Epidemiology (APIC), Pediatric Infectious Diseases Society (PIDS) and the Association of periOperative Registered Nurses (AORN) state that they are pleased that the Food and Drug Administration (FDA) has granted 510(k) clearance to a new pediatric face mask developed by Kimberly-Clark Health Care (KCHC). The KCHC pediatric face mask is the only scientifically validated mask designed for children 5-12 years old.

The organizations add: "As pediatric healthcare workers who provide care for children, as well as manage their infection prevention, the groups urged KCHC and other manufacturers to seek formal FDA clearance and validation of their pediatric surgical face mask in preventing droplet particle spread, the chief way influenza and other respiratory pathogens are transmitted. Until now, no pediatric face mask had been reviewed by the FDA for efficacy in preventing droplet spread.

"The professional organizations collaborated with KCHC to define key considerations that shaped the product design and recommended uses. KCHC has been granted a 510(k) clearance by the FDA to market their Childs Face Mask as a Class II medical device.

"Face masks are widely used during respiratory viral season, often in outpatient settings like emergency departments and clinics to prevent the spread of influenza and other respiratory pathogens among symptomatic patients. They are also used on infected patients, during necessary transport around the hospital. The groups hope the FDA clearance of KCHCs Childs Face Mask leads the way for inclusion of pediatric face masks into the Strategic National Stockpile, a pre-determined national supply of medicines and medical supplies which are available to be dispensed to healthcare facilities and communities in the event of a national public health crisis."