Surgical Mask Manufacturer Responds to PPE Recommendations, Healthcare Worker Concerns

The CDC recently revised its personal protective equipment (PPE) recommendations for healthcare workers caring for Ebola virus disease (EVD) patients to include the use of N95 or PAPR respirators and full coverage of all exposed skin. Emory Healthcare, a targeted treatment facility for EVD patients, also released their Healthcare Ebola Preparedness Protocols draft document. While the CDC recommendations are specific only to direct patient care of diagnosed EVD patients and exclude the use of medical face masks in this specific scenario, Emory's recommendations involve a broader set of EVD scenarios, and specifically recommends the use of face masks in every situation, except during the care of a diagnosed, symptomatic EVD patient. 

Crosstex International, Inc. , a subsidiary of Cantel Medical Corp., and a leading U.S. manufacturer of earloop face masks and other infection prevention control products, has seen increased demand for its SECURE FIT® fitted face masks as a result of heightened concern over the ability of PPE, including surgical masks,  to provide full coverage and protection. 

"I think the tightened protocols and the Dallas nurse who expressed concern over neck exposure where germs could travel up under her mask was an eye opener to the need for PPE, such as face masks, to provide optimal protection," says Gary Steinberg, president of Crosstex.

Face masks are a form of PPE and are FDA-cleared medical devices that are classified according to their filtration and fluid barrier properties.  They are designed and FDA-cleared to prevent large particle (droplet) transmission of infection, from the wearer to others, and from others to the wearer, such as from coughs and sneezes. Their ability to fit the wearer, however, is not a formal requirement.

Lisa Brosseau, director of the industrial hygiene program at the University of Illinois at Chicago's School of Public Health, and committee member of the 2007 Institutes of Medicine panel on reusability of facemasks during an influenza pandemic, stated in a 2003 letter to the FDA: "Drawing from my experience with respirators, I believe surgical mask failure is due in large part, or entirely, to their lack of fit," and added, "The criteria used by FDA to evaluate surgical masks neglect entirely the issue of fit." 

Cantel sponsored published in vitro research to better understand the factors that contribute to mask performance, and mask fit was found to be a critical factor in particle capture. 

"Crosstex's SECURE FIT® line of fitted face masks is a result of this research, and we hope to see further clinical research in this area as well," says Jorgen Hansen, chief operating officer of Cantel. "SECURE FIT fitted masks enable the wearer to adjust the mask to the face and avoid the typical gapping around the sides and bottom of the mask that are seen with most loose-fitting surgical masks."

"The benefits of a proper fitting mask seem obvious, but this kind of research is needed to move healthcare workers into demanding more from a face mask," says Hansen. He adds, "Clinicians have accepted the loose fit because that's all they've been offered. Recent viral threats including H5N1, H7N9, H1N1, and now EVD, are creating heightened attention and concern over the ability of seemingly simple devices such as face masks, to make the difference between health and infection. As an infection prevention and control company, it's our job to make that difference."   

Crosstex is a member of the Secure Mask Supply Association.

Source: Cantel Medical Corp.