The New York Times called it a “clunky mask” that “may be the answer to airborne disease.” The Times reports an industrial hygienist at the University of Maryland Medical Center calls it a “Darth Vader” mask. We in the safety equipment industry call it an “elastomeric.” No matter the nomenclature, reusable elastomeric half-mask respirators (EHMR) are making headlines, and ISEA is making waves.

ISEA is On It

ISEA has been promoting the use of EHMRs in healthcare for over a decade and continued to do so through the pandemic. The association and its members lauded the Food and Drug Administration (FDA) for issuing an emergency use authorization (EUA) in March 2020 authorizing the emergency use of all NIOSH-approved respirators, including elastomeric half and full facepiece respirators, in healthcare settings by healthcare personnel.

This EUA, which removes any regulatory barrier to elastomeric use in healthcare settings, remains in effect today. ISEA has encouraged the FDA to make it permanent or create a regulatory system to allow all NIOSH-certified respirators to be permitted for use in healthcare settings.

ISEA’s Take: There is Always More to be Done

This July 5 New York Times article asserts the US government, including the Centers for Disease Control (CDC), has done little to promote the use of EHMRs in health care facilities and industries. While ISEA agrees there is more to be done, it’s important to recognize the efforts that HAVE been made in recent years.

In addition to FDA’s EUA mentioned above, the Occupational Safety & Health Agency (OSHA) issued a public memo in April 2020 to healthcare personnel and others affected by the N95 supply shortages, urging employers to consider the use of NIOSH-approved, non-disposable elastomeric respirators, or powered, air-purifying respirators (PAPRs). In fact, efforts by employers to obtain reusable elastomeric respirators were considered when issuing citations.

When PPE manufacturers and FDA determined the exhalation valves on EHMRs were a potential threat to healthcare patients, mask makers redesigned the respirators to either remove the exhalation valve or fit it with a new filter and valve to trap particles inside. At the height of the pandemic, NIOSH prioritized testing and approval of these new products in record time.

In September of 2020, the CDC issued a request for information and comment regarding the deployment and use of EHMRs in healthcare settings and emergency medical services (EMS) organizations during the COVID-19 crisis. And, in February of 2021, the US Dept. of Health and Human Services (HHS) posted a request for bid to supply the Strategic National Stockpile with 375,000 elastomeric that meet the new NIOSH requirement. The contract was awarded in November 2021.

What’s to Come

ISEA looks forward to results from current NIOSH studies regarding the use of EHMRs in healthcare. As part of the agency’s Nationwide EHMR Demonstration Projects, NIOSH will send a portion of the respirators it buys under the federal contract to about 90 healthcare organizations to test the best practice guidelines. NIOSH will then use that information to draw up official best practices for healthcare providers nationwide.

ISEA and its members will work closely with NIOSH as it prepares to publish guidelines and best practices.

ISEA in the Conversation

Respiratory protection continues to be a trending topic, in healthcare and beyond. And ISEA remains an authority, with invitations to serve as an industry expert on multiple upcoming panels:

On July 14, ISEA will join a high-level discussion with federal agencies and other public health emergency response stakeholders about identifying standards gaps in PPE. As part of a broader effort with Health and Human Services (HHS) to evaluate the healthcare supply chain, NIOSH will lead the discussion, and ISEA will discuss the consequences of over-engineered standards. This is a private, invitation-only meeting.

On July 20, ISEA will participate in a webinar, sponsored by National Academies of Science, about meeting the needs of workers without respiratory protection programs. This webinar will also provide an opportunity to engage with federal agencies and other key stakeholder organizations on practical considerations for implementation. The discussion will also include an overview of the broad range of available respirators.  This webinar is open for registration.

On July 28, the National Academies of Sciences will host a second webinar on respiratory protection, this time to discuss products for the public. ISEA will again provide an overview of all available respiratory protection. This webinar is open for registration.

For more about ISEA’s position on elastomerics in healthcare, please contact Dan Glucksman at [email protected].