U.S. to Continue Needing 2.2 Billion N95s Per Year Post-Pandemic

N95 mask

This article was originally published at Bloomberg Law

https://news.bloomberglaw.com/health-law-and-business/u-s-to-continue-needing-2-2-billion-n95s-per-year-post-pandemic

The U.S. will continue to need 2.2 billion N95 masks a year, and possibly more, after the Covid-19 pandemic is under control, a top Trump administration official said in an interview with Bloomberg Law.

Domestic production for now is meeting the demand for N95s, with about 181 million expected to be produced by the end of January, said Brig. Gen. David Sanford, director of the supply chain task force.

Hospitals and front-line workers have struggled to get enough personal protective equipment (PPE) since the early days of the pandemic. They are still rationing and reusing masks and gowns, a practice that can endanger doctors, nurses and patients alike. Although there are more supplies available than before, many say it still isn’t enough.

A critical item needed to make N95 masks, known as meltblown material, is being made in sufficient quantities to meet current demand, Sanford said, but he is looking for more opportunities to invest in the industry. Meltblown fabric is used as the middle filtration layer in N95 respirators and is what protects the wearer from external germs. The Department of Health and Human Services and the Defense Department invested a total of $16 million in Lydall Inc. and Hollingsworth & Vose Co. to increase domestic production of meltblown material.

Making meltblown material is difficult, Lydall CEO Sara Greenstein said in an interview. To make it takes years of research, development, testing, and access to the right machinery, and few companies in the U.S. can produce it.

Lydall is set to make enough meltblown material for 140 million N95s per month—or 1.7 billion per year—by May, up from 21 million per month at the start of the pandemic.

PPE Production Innovation

Health-care providers have struggled to get the drugs or equipment they need during the pandemic because so many are made overseas. Researchers and lawmakers have decried the reliance on foreign suppliers for years, but public outcry over drug and equipment shortages during the Covid-19 pandemic has increased attention on the issue.

Sanford is thinking about ways to improve PPE production so that the supplies can be made more quickly and efficiently.

The global demand for gloves was projected to be about 585 billion pairs in 2020, while the supply was about 370 billion, a shortfall of 37%, according to a report by Australian glove manufacturer Ansell. The Strategic National Stockpile also has had difficulty obtaining gloves due to constraints in the glove manufacturing market, Sanford previously said.

The HHS plans to invest a half-billion in the domestic production of nitrile gloves, used for nonsurgical purposes in hospitals, as well as the raw material for those gloves, nitrile butadiene rubber (NBR). Sanford said he expects to announce the award by the end of January and that it will lead to 25 billion gloves produced in the U.S. by June 2022.

The world’s biggest glove producer, Top Glove Corp., was forced to shutter 14 of its 28 factories after an outbreak of Covid-19 in November and was given permission to resume operations Dec. 14. About 65% of the world’s gloves are made in Malaysia.

Doctors and nurses use the gloves for a wide array of routine medical procedures. For safety, they change gloves with each new patient. Some are now wearing two pairs during the pandemic as an extra precaution. They switch the outer pair with each patient.

The new glove production will use automated machinery so the prices can be more competitive, and the machines will also be domestically made, Sanford said.

One private sector example of PPE production efficiency is a new joint venture between DeRoyal Industries Inc. and hospital supply-purchasing group Premier Inc. to make isolation gowns for 34 hospital systems. The factory is automated and will make disposable gowns, circumventing the need for expensive cutters and sewers.

Former Strategic National Stockpile Director Greg Burel previously said that it’s important the HHS look at what it can do to invest in new PPE technologies because the U.S. is reliant on single-use supplies.

The Biomedical Advanced Research and Development Authority, a division of the HHS, is soliciting new and improved mask designs.

Sanford also wants to standardize medical market products with the Centers for Disease Control and Prevention and the Food and Drug Administration. For example, there are different types of gloves, which drive how long it takes to manufacture them. If there was a way to standardize thickness, for example, it could allow more to be produced, he said.

Incentives to Buy U.S.

Sanford, who is a career military official, said he doesn’t know if he will continue working on supply chain issues in the Biden administration, but that he would be “willing and excited” to do so.

One idea he wants to look at is how Medicare and Medicaid payments could be used to encourage hospitals to buy domestically made PPE.

Greenstein agrees that U.S. PPE companies need federal policies to create purchasing demand from health facilities so they can compete with cheaper, foreign-made products. “If left to their own devices, they will likely buy the cheapest,” she said, referring to hospitals.

A government purchasing program for the military and first responders to buy U.S.-made products, a requirement that all components of the PPE be made in America—similar to the requirement that the Defense Department has for textiles—and incentives from the Medicare and Medicaid programs could all help, she said.

PPE makers have struggled to get necessary regulatory approvals from National Institute for Occupational Safety and Health, and the agency could prioritize applications from domestic manufacturers, Greenstein said.