Matt Muller: Protecting health care workers also protects domestic manufacturers
Image via Bay News 9.

Hospitals do not have to reuse and rely upon lower-quality masks produced overseas to meet the needs of their doctors and nurses.

As the emergence of the COVID-19 delta variant brings more challenges to our health care systems, why are we forcing health care workers to use poorly manufactured personal protective equipment (PPE)?

While we have come a long way from the early days of the pandemic when doctors and nurses were using bandannas to protect themselves, it’s puzzling that health care systems continue to rely on PPE produced overseas that does not meet the standards our health care workers deserve and is often not used correctly.

Our policies should adjust to better protect our health care workers and rely on a domestic supply chain that can meet both the quality and cost efficiencies our health care systems, and first responders need and deserve.

Understandably, the start of the pandemic was riddled with uncertainty and supply chain disruptions. The federal government appropriately moved to implement an Emergency Use Authorization (EUA) for surgical N95 masks, which allowed hospitals to procure PPE with lower safety thresholds — most of which were manufactured in China.

It was an acceptable temporary fix given the urgent need and lack of supply at the time, but supplies of domestically produced, surgical N95 masks approved by the Food and Drug Administration and Centers for Disease Control, are readily available now at pre-COVID-19 costs.

Hospitals do not have to reuse and rely upon lower-quality masks produced overseas to meet the needs of their doctors and nurses.

The Food and Drug Administration should reverse the EUA on surgical N95 masks, which would immediately ensure our health care workers are appropriately protected, with the highest quality PPE available, and that the surgical N95 masks they use are fully approved by the FDA and CDC through their methodical testing and evaluation process.

When the pandemic started, our company answered the call of governments and hospitals to manufacture surgical N95 masks domestically at a globally competitive cost.

We went through the rigorous audit and approval process of the federal government to be approved for the highest-rated surgical N95 mask possible.

Investing in technology and a workforce in Lakeland, Florida we can produce NIOSH and FDA-approved surgical N95 masks at a scale that meets the needs of the medical community and first responders at a price that is competitive with the global pre-COVID-19 market.

Today, we have the capacity to domestically produce 1.5 million surgical N95 masks per day and are partnering with the health care community to provide them with the safety they need to conduct their work during this evolving wave of the pandemic.

We are proud to be competitive on the open market. However, the EUA today is providing an unfair competitive advantage to companies based overseas whose products do not meet NIOSH and FDA safety standards.

This is happening at great risk to our health care workers who now have access to available high-quality approved surgical N95 masks at low cost.

As the delta variant rips through our health systems, we believe now more than ever our health care workers deserve the very best protection the world has to offer. The truth is the highest quality PPE is made right here — in America — and it’s readily available at very low cost.

The FDA should remove the inferior foreign mask mandate and immediately reverse the outdated EUA on surgical N95 masks.


Matt Muller is president of Advanced Concept Innovations in Lakeland, one of the nation’s largest production lines for N95 respirator masks.

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One comment


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