Joint statement by leading healthcare professional organizations on FDA clearance of pediatric face mask

WASHINGTON (September, 29, 2011) – 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) 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.

As pediatric health care 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 Child’s 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 KCHC’s Child’s 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 health care facilities and communities in the event of a national public health crisis.

SHEA is a professional society representing more than 1,900 physicians and other healthcare professionals around the world with expertise in healthcare epidemiology and infection prevention and control. SHEA’s mission is to prevent and control healthcare-associated infections and advance the field of healthcare epidemiology. The society leads this field by promoting science and research and providing high-quality education and training in epidemiologic methods and prevention strategies. SHEA upholds the value and critical contributions of healthcare epidemiology to improving patient care and healthcare worker safety in all healthcare settings.

APIC’s mission is to improve health and patient safety by reducing risks of infection and other adverse outcomes. The association’s more than 14,000 members direct infection prevention programs that save livesand improve the bottom line for hospitals and other healthcare facilities around the globe. APIC advances its mission through education, research, collaboration, practice guidance, public policy and credentialing. Visit APIC online at

PIDS is a membership organization of over 1,000 specialists in pediatric infectious diseases, covering areas from basic and clinical research to patient care. PIDS’ mission is to enhance the health of infants, children, and adolescents by promoting excellence in diagnosis, management, and prevention of infectious diseases through clinical care, education, research, and advocacy. PIDS represents the leading practitioners, policy-makers, and researchers who work with children’s infectious diseases. For more information, please visit

AORN represents the interests of more than 160,000 perioperative nurses by providing nursing education, standards, and practice resources—including the peer-reviewed, monthly publication AORN Journal—to enable optimal outcomes for patients undergoing operative and other invasive procedures. AORN’s 40,000 registered nurse members manage, teach, and practice perioperative nursing, are enrolled in nursing education or are engaged in perioperative research.