Coronavirus Technology Solutions
February 10, 2021

 

Mask Policies Need to be Revised

NXTNano Can Contribute Nanofiber Advantages

Armbrust American is Ready to Step Up with Substantial Production Increases

TMS Can Increase Production by 16 Million per Month

Shortage of N95 Masks for Medical Workers Still Exists

ASTM Standard for Respiratory Fit will Encourage Better Designs

NIOSH September Observations on EHMPRs

SPG Tests Show That Flat Fold N95s Provided Better Seal Than Cup Shaped

Eight Million Deaths Caused by Polluted Air Each Year

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Mask Policies Need to be Revised

The initiative for OSHA was covered in the Alert yesterday.  There is agreement that  tight fitting efficient masks will save thousands of lives which will otherwise be lost by people wearing cloth masks. Erick Couch is working with INDA and McIlvaine to present evidence which could be helpful in guiding the Biden Administration to create appropriate policies and funding. Facts and insights are needed in four areas.

 

 

QUALITY:  Minimum standards such as being issued by ASTM provide the first step in insuring quality. Expert guidance will result in the best choices using both qualitative and quantitative  methods. The role of government will be to embrace the minimum standards and to encourage the reliance of purchasers on expert advice. Air leakage, breathability, and particle removal are all important.

USE: The motivation has to be push and pull. Push or enforcement has to be minimum standards such as ASTM. Pull can be education as to the advantages of effective masks but also the creation of safe bubbles where with effective masks more normal life can be enjoyed.

AVAILABILITY: The mask need assessment should include uses by the medical profession,  other countries, and for other applications as well as for the U.S. public. The timing by which additional masks can be made available needs to be determined.

COST: Initial mask cost and life are needed to assess total cost. Since mask deterioration with time may be slow and steady there is opportunity  to decrease cost and increase availability.

 

NXTNano Can Contribute Nanofiber Advantages

NXTnano supplies nanofiber media for masks and cites the life as well as efficiency as attractive features.  Here is our interview with Andy McDowell.

Bob: What is the relationship between NXTnano and suppliers of masks?
 
Andy: NXTnano works very closely with our mask/respirator customers to down-select the filtration media of best fit depending on their design. Often times we will even help manage the testing of the products through SGS or Nelson for them, with all of our lab equipment we can make sure their products are testing well before going out to the labs.  Once we do send them out, we’ve looked at so many results now and can help our customers spot pitfalls or inconsistencies to avoid unnecessary delays. For programs where there is N95 approval being sought we see them as strategic partners, our technology is effectively locked in when they receive approval. 
 
Bob: Since a nanofiber media mask does not rely on a temporary electrostatic charge what is your estimate of reusability?

Andy: We have done several studies on this now, most recently our employees wore one of our customers (Filti) respirators for eight hour shifts, for five days straight. We measured the initial efficiency, then the efficiency every morning before they wore it again. After day one we lost a few percentage points of efficiency, but overall the respirators were performing very well. After this initial loss, which was likely inherent static, they leveled off. After five days we called it,  the respirators we getting dirty from general handling, food, makeup etc. but the efficiency was still over 90% on the TSI. 
 
Bob:  Explain the range of efficiencies and related resistance which are available.
 
Andy: At the moment we are most commonly producing material to the N95 standards, in a finished respirator form using our nano I expect to see resistance values of 10-12 mm of H2O at 85 L/min flow with 97%-98% efficiency on the TSI with 0.26 micron NACL (mean mass).  It’s easy enough to go down the scale and produce less restrictive media; with something at 65-70% efficient (0.26 micron NACL) at 85 LPM our restriction can be as low as 2.5 mm.  if you plot those two points out, establish a trend line the fit between them and then check against actual produced materials you will find the “fit” is quite linear. So for a customer this translates to a conversation of:  I must have “x" efficiency, or I must have less than “y” pressure drop.  
 
Bob:  If an unlimited market were available how much production could you  achieve in four months?

Andy: Our nano lines are running 24/7 right now but we are keeping up and making running productivity improvements weekly. When we last talked the conversation was what would it take for NXTNano to add more lines, we have now pulled that trigger. Line 4 will be up in April, and line 5 is looking like June with the option to take it to possibly 130” wide instead of our current 80”. The average through put we see for customers is about 250,000 respirators / per machine / per week on an eight hour shift.  For us that’s about 12,500 sq meters of material they need per week per shift, which is only around six hours of run time on one of our lines. As we add capacity we will easily grow with our mask customer base. For our customers, several of them have the capability to turn out several million masks per week based on their current equipment, and additional equipment can generally be added and running in 60-90 days. 

Bob: What are the limiting factors in terms of obtaining electrospinning equipment for media, mask machines or other products and services?

Andy: Most of what people are doing in electrospinning is at the lab scale. For serious volume production there are only a handful (less than 5) companies to select from globally. Most of the equipment I’ve seen simply won’t support economical manufacturing both from a throughput perspective and an uptime perspective. Those that will, are proprietary designs heavily guarded, and rightfully so, by the companies that operate them. Mask machines aren’t exactly hard to get ahold of, there are domestic and offshore options. What we have seen most commonly is a structural issue in knowledge - people know the mask they want to make but don’t necessarily understand how to get home on performance of the mask.  

Armbrust American is Ready to Step Up with Substantial Production Increases

Lloyd Armbrust  replied to the Couch request with a  forecast of substantial production increases should funding be available “We originally designed our Texas facility to produce 1.4 Billion masks annually, complete with vertical integration making all of the nonwoven fabric in house. We are partially through this building process having already invested nearly $10M. Additionally, we have real MEPCA implementation plans, existing factory space, plus many of the machines actually on the ground here in Texas.

“In fact, I would bet that we are the only company in the world that has nonwoven equipment capable of producing 300 tons per month ready to be hooked up in less than 30 days’ time in the US. The only issue is that our current FDA-registered facility doesn't have the appropriate power requirement. Because of this, we decided to build a new facility which has pushed our production timeline back. However, we have all of the original plans and approvals to move forward with our existing facility if we wanted to pay to the premium price to bring 4000amps of power into that building.

 

TMS Can Increase Production by 16 Million per Month

Dan Grayson replied to the Couch request.  He estimates that with government funding  production could be  increased by 16 million masks per month over the next four months.

Shortage of N95 Masks for Medical Workers Still Exists

There is a shortage of N95 mask. So Don Milton, MD and Professor at the University of Maryland thought it was notable that FEMA has authorized US N95 manufacturers to export 1 million N95 masks per month.

The main focus of the Alert today is to address the potential with OSHA and masks for the U.S. public. But we need a holistic approach. If there is still a shortage of masks for medical workers then it will be more challenging to suppl masks to the public.

Also until the poorer countries have masks or vaccines, the U.S. will be impacted economically but also by the transmission of new variants. The poorer countries also account for the majority of the 8 million people per year dying due to air pollutants (see article in this Alert). So mask demand has to be viewed holistically from a geographic and application perspective.  

A year ago, hundreds of desperate consumers were emailing Mike Bowen's Texas medical supply factory every day, looking to buy N95 medical respirator masks that can filter viruses: "Scared Americans and moms and old people and people saying, 'Help me,' " Bowen recalls in an interview with NPR.

Today, most consumers still aren't able to buy N95 masks because the supply available to retailers remains very limited. Even hospital workers are still being asked to ration and reuse their supplies of N95s, and the website of the Centers for Disease Control and Prevention says, "N-95 respirators should not be used [by the general public] because they should be conserved for healthcare personnel."

Meanwhile, consumer demand for N95s and medical-grade, surgical-style masks keeps growing as the Biden administration emphasizes the use of masks by the public to slow the spread of the coronavirus — especially as new variants of it spread rapidly around the world.

From the start of the coronavirus pandemic, Bowen's company, Prestige Ameritech, and most other makers and distributors have prioritized supplying health care workers, who say they still don't have enough masks and other personal protective equipment.

The Biden administration has invoked the Defense Production Act to prioritize production of N95s and other medical supplies. But even with those measures, U.S. hospitals remain worried about their supply of these medical masks — more formally called respirators — despite efforts by factories to churn out billions more.

The story of N95 production over the last year in many ways reflects shortages seen throughout the U.S. medical supply during the pandemic — from ventilators and exam gloves to syringes and vaccines. The demand is global and sustained, putting pressure on a fragile supply chain that remains stressed and unable to keep up.

"Global demand continues to outpace production," says Nancy Foster, vice president of quality and patient safety at the American Hospital Association. Availability of N95 masks has improved since last spring, Foster says, but "we are continuing to use conservation measures within hospitals to protect the supplies we have, to extend the wear of N95s designed for one-time use." That includes asking hospital workers to wear each mask longer.

Costs for N95s — and other medical supplies, like medical gloves and gowns — have at least doubled. The use of N95s has increased 500% since July, according to Premier, a company that buys medical supplies on behalf of about 40% of U.S. hospitals.

"In most of the hospitals, nurses are wearing their N95s for five shifts," or up to 60 hours, says Mary Turner, president of the Minnesota Nurses Association and an intensive care nurse working with COVID-19 patients. "It's becoming the norm to not wear N95s the way they're supposed to be used."

November survey by National Nurses United found the lack of protective gear like N95s remains a huge safety concern for its members. More than 80% of nurses reported reusing single-use items like N95 respirators, and about 20% of hospitals had recently limited the use of N95s.

Before the pandemic, there was little consumer demand for these products. Purchasers included people with compromised immune systems or others working in wildfire areas or on dusty home improvement projects.

That has changed. Everyone — from front-line grocery workers to travelers to teachers to people visiting vulnerable family members — is looking for the specialized masks.

N95s are the gold standard in masks because unlike cloth, surgical and KN95 alternatives, they're tested and approved by a federal agency as having demonstrated that "they can filter out a minimum of 95% of airborne particles under worst case test conditions," according to the CDC.

Nonetheless, N95s are still rarely available to consumers.

Shepard Medical Products, an Illinois-based company that sells supplies to drugstores and other retailers, hasn't sold a single N95 since March of last year. That's when makers of N95s called the company's president, Chris Humbert, to tell him, " 'We're done — we won't have any more product available for 2020.' "

So far this year, Humbert says, that shortage hasn't yet eased. Some wholesalers large enough to order directly from factories in China occasionally can get N95s to sell at hardware stores, for example, but "it's still very fragmented." The priority, he says, has been to supply health care facilities and government agencies. "I stopped trying, until hospitals are covered." 

Fraud is also a major concern. Everyone, from nurses, hospitals, manufacturers and distributors, says vetting fake suppliers or identifying copycat N95 masks has been a huge concern.

Humbert says many new upstarts tried to sell him products billed as N95s, but because he couldn't verify their quality or efficacy, he decided it would be safer to remain out of stock.

"We didn't like being out of stock and disappointing any of our customers by not being able to supply, but we did not feel that we had a reliable source that could provide those products for us on par with the product that we had in place," Humbert says.

Exactly when American consumers might once again gain broader access to N95s depends on a lot of factors.

"I think if the vaccine rolls out faster, you're going to be able to get N95s faster," as the risks diminish and fewer people need N95s, says Kaitlin Wolak, a supply chain expert and assistant professor at the University of Notre Dame. (Public health workers urge even those immunized to continue pandemic precautions — including consistent mask-wearing — for now, until the pandemic is tamed.)

Broader availability of N95s also depends on manufacturing speed, Wowak notes, and on when backlogged orders from hospitals and other medical facilities can be filled.

The Biden administration has touted its plans to use the Defense Production Act to stimulate production. Wowak says that might mean manufacturers get more federal help finding the raw materials needed or coordinating distribution of supply. But it won't address some of the main challenges that affect the speed of manufacturing.

Wowak says how fast products like N95s are made is determined by three primary factors: the complexity of the equipment used to make the product, the availability of raw materials and the availability of trained workers.

Making vats of hand sanitizer at a rum distillery, in other words, is very different from ramping up an N95 factory, because of the cost and complexity.

Managing those costs and complexities has made the past year extremely busy for Mike Bowen, the co-owner of Prestige Ameritech. He and his partner started the company in 2005; it is one of the few makers of N95s based in the United States. Demand overwhelmed his factory a year ago when China stopped exporting the masks that most U.S. hospitals relied on for most of their supply.

"I've gotten requests for maybe a billion and a half masks if you add it up," Bowen told NPR in late February of last year. At the time, Bowen's company could produce 75,000 N95s a month.

He was troubled by the influx of orders, he said. They put him in a bind.

To make more N95s, Bowen would need new mask machines, each of which takes four months to custom build and costs as much as $1 million. To justify building extra machines, he needed assurance that U.S. hospitals and government agencies wouldn't just go back to buying cheaper Chinese-made masks once the pandemic was over.

He'd been burned before. A decade earlier, during the H1N1 flu pandemic, Prestige had made what Bowen called "the mistake" of investing in new machines and ramping up production for a need that dried up as suddenly as it began.

"One day — and it is literally one day — it just quits," Bowen told NPR last spring. "The demand is over."

He eventually did decide to expand last spring, as the COVID-19 pandemic worsened.

Bowen asked U.S. hospitals to sign multiyear deals for N95s. That gave him the funds to build nine new N95 machines, some of which are still coming online. The factory now makes 80 times more masks than it did a year ago.

"We're now selling 6 million [a month], and we have another 4 million coming on board," he says.

For the first time in a very long time, Bowen says, he has some excess supply he could start selling into the consumer market.

https://www.npr.org/sections/health-shots/2021/01/27/960336778/why-n95-masks-are-still-in-short-supply-in-the-u-s

 

ASTM Standard for Respiratory Fit will Encourage Better Designs

An evaluation of the new ASTM standard was posted on the NIOSH website January 26, 2021 by Christopher Coffey, PhD; Lisa Brosseau, ScD, CIH; M. E. Bonnie Rogers, DrPH; and Jonathan Szalajda, MS.

One of the most important criteria for any filtering facepiece air-purifying respirator to be effective is that a good seal is formed between the respirator’s facepiece and the wearer’s skin. The ability to achieve this seal is called the respirator’s fitting characteristic.

In 1995, when NIOSH put Title 42 Code of Federal Regulations Part 84 (42CFR84) into operation, it did not include an evaluation of the fitting characteristics of respirators approved only for particulates.1 In addition, no voluntary consensus or other government-unique standards existed to evaluate the fit capability of a filtering facepiece respirator prior to it being used in the workplace in an OSHA-regulated fit testing program. Therefore, several studies have been conducted to determine how well NIOSH-approved particulate respirators, especially filtering facepiece respirators, fit wearers.2-8 These studies found a high number of filtering facepiece respirators on the market at the time had poor fitting characteristics. Filtering facepiece respirators that do not fit most employees place an unacceptable burden on respirator program administrators, who must then provide many models and sizes to ensure that every wearer can find a respirator that fits properly.9 In addition, poorly fitting respirators increase the number of fit tests required, increasing costs.10

The ASTM RFC Standard will enable respirator manufacturers to develop better designed models that fit the worker population. Respirators passing the RFC Standard test method are expected to have better fitting characteristics. The RFC standard will lower costs to respiratory protection programs by reducing the number of different models needed in the program. Purchasers of particulate-only respirators could reference ASTM F3407 in their procurement packages to ensure receiving those with good fitting characteristics. The RFC Standard can be used by organizations, such as NIOSH, to ensure a minimum performance level of for all respirators used within an approval program.16 Both conventional respirator designs as well as novel respirators (such as ones without the prevalent two-strap head harness to provide adequate tension during use and even distribution of pressure) can be evaluated using the RFC standard.19

Ultimately, this RFC Standard defines performance requirements that could be used as part of a conformity assessment program to ensure that NIOSH-approved respirators will fit a specified percentage of the intended user population, thus providing workers with better protection. This is crucial in all industries in which workers are exposed to a variety of agents, one of the most notable examples being the Healthcare and Social Assistance industry sector. Healthcare workers may be exposed to biological agents, e.g., seasonal influenza, Ebola, Severe Acute Respiratory Syndrome (SARS), Influenza A H1N1, and more recently SARS-CoV-2, the virus that causes COVID-19, as well as to chemical agents.17-19

ASTM F3407 can be read for free at https://www.astm.org/COVID-19/ or purchased at https://www.astm.org/search/fullsite-search.html?query=Respirator%20fit%20capability.

 

NIOSH September Observations on EHMPRs

The high demand and limited supply of N95 filtering facepiece respirators (FFRs) during the COVID-19 pandemic have led organizations to rely on other types of respirators, such as reusable elastomeric half mask respirators (EHMRs).

Photo Courtesy of MSA


An EHMR is a non-powered NIOSH-approved respirator that has a tight-fitting facepiece that covers the nose and mouth.1 The facepieces are made of synthetic or natural rubber material permitting repeated cleaning, disinfection, storage, and reuse. EHMRs use replaceable filters or cartridges, and they provide the same, or greater, level of protection as single-use N95 FFRs. While EHMRs have been used in many workplace settings for years, their utility in healthcare settings has not been as common.

CDC developed strategies to optimize the supply of EHMRs during conventional and surge demand situations, as experienced during the COVID-19 pandemic.NIOSH-approved EHMRs provide an alternative respiratory protection option capable of reducing the total number of respirators required because EHMRs may be cleaned, disinfected, and reused numerous times.1 Unless the EHMR filter cartridges become visibly soiled or wet, visibly damaged, or if the respirator becomes notably harder to breathe through, current practice shows that conservatively, the filters could be used for at least one year.1 Although more popular in industry settings, EHMRs have been leveraged both before and during the COVID-19 public health emergency and have been highlighted in several recent media reports.2-5

Although EHMRs require a higher up-front cost than N95 FFRs, the EHMR facepiece and cartridge reusability may provide cost-savings advantages and may create less hospital waste compared to the disposable N95 FFR.6 For example, due to COVID-19 N95 FFR shortages, one large academic medical center—comprising 12 hospitals—purchased and deployed 10,000 EHMRs that reduced N95 FFR usage to zero.7,8 The center reported a significant cost benefit. The one-time cost and storage of EHMRs was 10 times less expensive after one month of use when compared to disposable N95 FFRs.7,8

Research has shown that user acceptance, fit testing, and disinfection are not barriers to implementing EHMRs.9-12 With proper use, fit, and maintenance training, EHMRs provide an effective solution to supplementing the supply of N95 FFRs.

Generally, EHMRs have exhalation valves, which should be taken into consideration before use in a sterile setting or for use as source control. Until more research is available, masks with exhalation valves or vents should NOT be worn to help prevent the person wearing the mask from spreading COVID-19 to others (source control). Here are some tips when it comes to exhalation valves: 

  • Wear a respirator without an exhalation valve when both source control and respiratory protection are required.
  • If only a respirator with an exhalation valve is available and source control is needed, cover the exhalation valve with a surgical mask, procedure mask, or a cloth mask that does not interfere with the respirator fit. 

https://blogs.cdc.gov/niosh-science-blog/2020/09/08/elastomeric/

 

SPG Tests Show That Flat Fold N95s Provided Better Seal Than Cup Shaped

Twenty subjects underwent quantitative respirator fit testing with two styles (flat fold, cup-shaped) of N95 filtering facepiece respirators (N95 FFRs). Passing a fit test was followed by stereophotogrammetry to determine the face seal area and computation of seal pressure. There were significantly different seal pressures (p < 0.01) between standard size flat fold and cup-shaped N95 FFRs but no significant differences in face seal area. No significant differences were noted in fit factors, but more individuals passed fit testing wearing flat fold respirators. The ability of flat fold N95 FFRs, at lower seal pressures, to obtain similar fit factors as cup-shaped N95 FFR at higher seal pressures offers the possibility of enhanced facial comfort without a loss of protection. Stereophotogrammetry offers a relatively simple, non-invasive technology to evaluate various properties of N95 FFR fit.

SPG enables the determination of geometric properties from photographic images. This process involves estimating the three-dimensional (3D) coordinates of points on an object. Photographs are taken from multiple locations (lines of sight) and, using the principle of triangulation (mathematical intersection of lines of sight), the X, Y, and Z coordinates of each point of interest are determined.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4545596/

 

Eight Million Deaths Caused by Polluted Air Each Year

New evidence on the harm caused by air  pollutants needs to be considered when creating HVAC and mask strategies.

More than eight million people around the world die each year as a result of breathing polluted air that contains particles from fossil fuels, a new study has found.

Burning fossil fuels such as coal and oil produces greenhouse gases that trap solar radiation in the atmosphere and cause climate change. But it also releases tiny poisonous particles known as PM2.5. Small enough to penetrate deep into the lungs, these particles can aggravate respiratory conditions like asthma and can lead to lung cancer, coronary heart disease, strokes and early death.

Research has also found a link between higher levels of long-term pollution and more deaths from Covid-19.

In a study published in the journal Environmental Research on Tuesday, researchers from Harvard University, in collaboration with the University of Birmingham, the University of Leicester and University College London, found that exposure to particulate matter from fossil fuel emissions accounted for 18% of total global deaths -- almost one in five -- in 2018.

Exposure to dirty air in the world&#39;s most polluted region linked to pregnancy loss, study finds

 

The figure is much higher than previously thought. As recently as in 2019, scientists were estimating that 4.2 million people die each year from outdoor airborne particulate matter pollution, a figure that included people who die because of pollution from dust and smoke from wildfires and agricultural fires.

The new study shows that in 2018, estimated 8.7 million deaths were linked to fossil fuel emissions alone

Eloise Marais, an associate professor in physical geography at UCL and a co-author of the study, said the research adds to the "mounting evidence" that air pollution from fossil fuels is detrimental to global health.

"We can't in good conscience continue to rely on fossil fuels, when we know that there are such severe effects on health and viable, cleaner alternatives," she said in a statement.

The scientists used a global 3D model of atmospheric chemistry developed at Harvard to get a better picture of pollution at a more local level.

Traditionally, satellite and surface observations were used to estimate the average global annual concentrations of PM2.5 particles in the air. By using the 3D model, the scientists were able to divide the globe into a grid with boxes as small as 50 kilometers by 60 kilometers (31 miles by 37 miles) and look at pollution levels in each box individually.

This allowed them to assess the impact of the pollution in places where people live and to distinguish between different sources of pollution.

They found that China, India, parts of the eastern US, Europe and Southeast Asia were the worst impacted. According to the data, as many as 30.7% of deaths in Eastern Asia, 16.8% in Europe and 13.1% in the US can be attributed to fossil fuel pollution.

To model the pollution, the researchers used real emissions and meteorology data, mostly from 2012. The year was picked to eliminate the influence of the El Niño phenomenon, which can worsen or improve pollution depending on the region. They then updated the data to reflect a 44% fall in fossil fuel pollution in China between 2012 and 2018.

The researchers estimate that China's move to cut its fossil fuels emissions saved 2.4 million lives worldwide, including 1.5 million in China.