COVID-19 for selecting N95 masks has been acquiring personal protective equipment (PPE) to help keep clinicians safe. As organizations have turned to vendors at home and abroad to source products, many have discovered that not all masks are created equal.
Becker’s ASC Review recently spoke with Laurent Dreyfuss, DO, emergency physician and Director of Global Medical and Clinical Affairs at O&M Halyard, about different types of medical face masks and how to identify the most appropriate PPE for healthcare teams.
Not all medical masks are N95 respirators and not all N95 respirators are approved for use in a medical setting
During the interview, Dr. Dreyfuss grouped medical face masks into three categories: 1) procedure masks; 2) surgical masks and 3) N95 respirators. While all three categories are sometimes referred to as “medical masks”, there are important differences between them.
Procedure masks are held to the face with stretch loops behind the ears. Surgical masks, intended for use during surgery, have two sets of ties to ensure a more secure fit. Respirators typically have over-the-head elastic bands to hold them firmly in place. Further, respirators typically have higher levels of filtration performance than procedure and surgical masks. And respirators are designed to provide a better seal which provides better protection to the wearer than procedure masks.
Healthcare organizations must determine what type or types of masks are best suited for their employees. “When selecting masks, healthcare providers should consider several questions. What is the hazard and how infectious is it? Is the hazard transmitted by contact, droplets or airborne? And if it’s airborne, what is the particle size of the hazard?” explained Dr. Dreyfuss.
With novel pathogens like COVID-19, the answers to these questions may not be clearly known. As a result, the CDC recommends using the most protective type of mask, the N95 respirator, if there is a risk that the pathogen could be transmitted by respiration.
Healthcare organizations must also recognize that even within the respirator category, important distinctions exist. The first purchase consideration is whether the National Institute for Occupational Safety and Health (NIOSH), an agency of the CDC, has certified the respirators in question. Only NIOSH approved respirators can be called N95’s.
NIOSH-certified N95 respirators meet federal standards for breathability and filtration. They must show the ability to filter out at least 95 percent of very small particles (defined as 0.3 micron) from the air at high flow rates. In addition, the quality systems used in the manufacturing of N95s must be approved and routinely audited by NIOSH.
“Not all N95 respirators are NIOSH certified. As healthcare providers search for PPE, they may see references to KN95 respirators. These masks are made and certified in China [by the National Medical Products Administration]. They have not been tested and certified by NIOSH,” noted Dr. Dreyfuss.
Another key purchasing criterion for N95 respirators is whether they have also been cleared by the FDA for use as medical face masks. The FDA requires respirators for medical use to also meet criteria for flame resistance, biocompatibility, and the ability to resist penetration from splashes from fluids such as blood. The ASTM F2100 standard for medical face masks establishes three levels of splash resistance. Level 1 roughly correlates to low, 80mmHg blood pressure; Level 2 at 120mmHg blood pressure; and Level 3, the highest rating, is 160mmHg blood pressure.
“Just as not all N95 respirators are NIOSH certified, not all N95s are ASTM rated. Many N95 respirators are designed for industrial settings, rather than medical environments. These products may have no ASTM rating or they may have a lower performance rating, such as Level 1 or Level 2,” said Dr. Dreyfuss.
Once you’ve acquired N95 respirators, fit and employee use cannot be overlooked
Unlike surgical or procedure masks, OSHA mandates that N95 respirators must be fit tested for each wearer. Fit testing ensures a good seal to the face so that respirated air passes through, not around, the respirator. If organizations purchase different brands of N95 respirators, employees must be fit tested for each brand. High levels of protection depend on a snug fit that is unique for each individual.
With the COVID-19 vaccine rollout, hopes are high that life will eventually return to normal. In the months ahead, however, masks and other PPE will continue to be essential to keep providers safe. Healthcare organizations should consult FDA requirements to ensure that they are using properly certified equipment.
This article was sponsored by Owens and Minor.