CATER Mask Decisions

January 12, 2021

Extending the Life of Surgical and N95 Masks

Anti-microbials can Eliminate Cleaning and Damage to Masks

Nexera Guardian FFP 2 Mask Lasts Fourteen Days and Costs $10 Dollars

The Pandemic Could be Over in Weeks with High Efficiency Masks

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Extending the Life of Surgical and N95 Masks

The masks used by the public as compared to medical workers differ in a number of ways. The risk in medical settings is greater because of

·         higher viral loads (number of individuals  with COVID)

·         vulnerable populations ( e.g. cancer patients)

For the medical worker dealing with COVID cases the chance of being in the vicinity of a COVID emitter is nearly 100%. In the worst case public scenario one out of every hundred individuals is a transmitter and typically it is only 1 in 1000.

Protection is all about reducing the odds. If  a person because of occupation is 1000 times more likely to need the protection than another he should not consider compromising mask efficiency by extended wear.


A person in a poor country whose alternative is a cloth mask which  has an FFE of 10% would be better off with a mask which is initially very efficient but over time deteriorates. It is still a better choice until it reaches an FEE of 10%.

Deterioration can involve fit and filter media efficiency. Another factor is transmission of virus from the mask surface. Masks with anti-microbial media do not have to be cleaned as frequently.  This may greatly extend the life.

Nexera recommends its FFP 2 mask for use of up to 14 days.  It costs approximately $10. So the cost per day of use is 71 cents.


The mask is rated FFP 2 with 6% penetration and less than 8% inward leakage. So the FFE rating would be 86%. $30 CATER masks have been tested at an FFE of 90%. The recommended life of these masks is up to 90 days. A  $2 upgraded surgical mask with a brace might have an FFE above 85%. The brace has potentially 1 year of life. The surgical mask might have a life of weeks. 

Various mask types are likely to deteriorate at different rates.  For rough comparison purposes we used a high deterioration rate (A) and a slower one (B).

A brace could cost $15 or could be a DIY version.  With 4 per year x $2 plus 15 for the brace the total is $22 per year. For a country such as India this would be a $22 billion/yr expense.

The wealthiest citizens will want CATER masks and purchase at least four per year at $30 each.  A middle class group could spend $50/yr each while 3.2 billion people would average only $25 each.

2021 Mask Market $ millions

Segment

# millions

$/yr/person

$ millions

Wealthiest 10%

800

$120

96,000

Middle Class 30%

2400

$50

120,000

Lower  40%

3200

$25

80,000

Bottom  20%

1600

0

0

Total

8000

 

296,000

 

This results in 2021 market of $296 billion. This investment would insure the end of the pandemic and would be a small price to pay considering the lives saved and economic benefits.


Anti-microbials can Eliminate Cleaning and Damage to Masks

Anti-microbials in high risk settings can be justified just on the risk reduction associated with viruses transmitted from the mask surface. In low risk settings these anti microbials can be justified based on reduced mask cleaning and resultant deterioration.

Asten Johnson provides Foss media. Sciessent provides antimicrobials to be used with the media.  Nexera and  Haynes are supplying masks using the media

Thorough testing has shown the silver-copper antimicrobial compounds to be nontoxic and effective, making the agents perfectly suited for antimicrobial respirator masks. These same antimicrobial agents are National Science Foundation (NSF) and U.S. Federal Drug Administration (FDA) listed and U.S. Environmental Protection Agency (EPA) registered. They are also listed with the Cosmetic, Toiletry, and Fragrance Association as a cosmetic preservative and have the standard approval in Europe under the Biocidal Products Directive.

 

The cornerstone of the technology is silver (Ag), a naturally occurring, safe, and effective antimicrobial agent in its ionic form. The delivery system is a zeolite carrier that allows a controlled and effective release of the silver ions, on demand, thus killing and inhibiting the growth of bacteria, viruses, mold, and fungus over long periods of time. This stable ion exchange process is non-reactive and allows the compound to be used in virtually every imaginable manufacturing process.

Silver and copper active elements are released at a steady rate as they interact with humidity in the environment, producing an antibacterial/antifungal/antiviral surface. The moisture in the environment causes a controlled release of the copper and silver through a proprietary ionic exchange.

The silver-copper zeolite antimicrobial agent is embedded throughout the fabric of the mask. As humidity in the environment naturally interacts with the silver-copper zeolites, an ion is omitted which interacts with the cells of the microorganism and interrupts its ability to function or reproduce. This safe and nontoxic release of the ions are continuous and remain active over long periods of time.


In many applications, the antimicrobial compound has been shown to provide antimicrobial efficacy in just a few minutes while maintaining optimal killing and inhibitory performance for months.

Sciessent says that unlike the premeditated work with Nexera to develop a mask following the SARS outbreak nearly two decades ago,  work with Hanesbrands required that the team leverage existing knowledge and experience to quickly fill-in various information gaps. Instead of developing a product from the ground up, Hanesbrands was repurposing its knitted cotton fabrics treated with Agion Antimicrobial to develop its masks.

Sciessent supported Hanesbrands in their interactions with FDA. Given the urgent need to address the PPE shortage, it appeared communication was far more open and frequent with the agency under the EUA directive. The correspondence and exchange of information between Hanesbrands and FDA moved quickly. In this circumstance, the FDA did not clear specific efficacy claims; in fact, the agency said no efficacy claims could be made.


Nexera Guardian FFP 2 Mask Lasts Fourteen Days and Costs $10 Dollars

With the next generation microbe-fighting technology, the SpectraShield™ GUARDIAN is the first ever REUSABLE antimicrobial protected FFP2 respirator mask. It is creatively engineered to be reused for up to 14 days. Its patented, safe, natural, and effective Fosshield® antimicrobial technology penetrates the microbe’s cell wall, attacks its metabolism and disrupts reproduction. Approved under E.U. classification EN149:2001 + A1:2009 Features and Benefits:

• Regulatory: EU FFP2 and Reusability certified • Superior Performance: – Proven highly effective against the following viruses: - Influenza A (Swine Flu or H1N1) - Avian Flu (H5N1) - Rhinovirus - Adenovirus - Coronavirus – Begins microbe prevention immediately and eliminates 99.99% of the following tested bacteria after one hour of contact with the surface of the respirator: - Methycillin Resistant Staphylococcus Aureus (MRSA) - Streptococcus Pyogenese - Haemophilus Influenzae - Legionella Pnuemophila

• Protection: – Shields from blood, other bodily fluids, and a wide spectrum of airborne respiratory threats – Meets CDC and WHO guidelines for tuberculosis and other infectious disease exposure control – Filters out viruses, fungi, bacteria, pollen and other airborne irritants; including non-oil containing fumes, mists and dust – Hypoallergenic

 • Design: – Reusable wear for up to 14 days – Unique construction naturally contours to facial features for a guaranteed proper fit – PVC and latex-free – Uses same safe and effective Fosshield® antimicrobial technology incorporated in Nexera’s FDA 510(k) cleared surgical respirator mask


The Pandemic Could be Over in Weeks with High Efficiency Masks

Devabhaktuni Srikrishna will be a presenter in the webinar on the 2lst where we will be       discussing the impact of more efficient masks. He has used the Wells-Riley model on infection risk to show the impact of higher efficiency masks.  His findings are consistent with what has been reported in the Alert. Here is a summary of his new paper.

Abstract

Background Recently the US CDC acknowledged that the COVID-19 crisis is facilitated at least in part by aerosolized virus exhaled by symptomatic, asymptomatic, or pre-symptomatic infected individuals. Disposable N95 masks remain in short supply due to their use in healthcare settings during the Coronavirus pandemic, whereas NIOSH-approved elastomeric N95 (eN95) masks remain immediately available for use by essential workers and the general public. New reusable N95 mask options with symmetric filtration efficiency can be anticipated to be NIOSH approved in the coming months, today’s eN95 masks have asymmetric filtration efficiency upon inhalation (95%) and exhalation (well under 95%) but are available now during the Fall and Winter when Coronavirus cases are expected to peak.

 

Methods Based on the Wells-Riley model of infection risk, we examine how the rate of transmission of the virus from one infected person in a closed, congested room with poor ventilation to several other susceptible individuals is impacted by the filtration efficiency of the masks they are wearing. Three scenarios are modeled – a room (6 people, 12’ × 20’ × 10’), a bar (18 people, 20’ × 40’ × 10’), and a classroom (26 people, 20’ × 30’ × 10’) with one infectious individual and remaining susceptibles.

 

By dynamically estimating the accumulation of virus in aerosols exhaled by the infected person in these congested spaces for four hours using a “box model,” we compare the transmission risk (probability) when susceptible people based on a realistic hypothesis of face mask protection during inhaling and exhaling e.g. using cloth masks or N95 respirators.

Results Across all three scenarios, cloth masks modeled with 30% symmetric filtration efficiency alone were insufficient to stop the spread (18% to 40% infection risk), whereas eN95 masks (modeled as 95% filtration efficiency on inhalation, 30% on exhalation) reduced the infection risk to 1.5% to 3.6%. Symmetric filtration of 80% reduces the risk to 1.7% to 4.1% and symmetric filtration of 95% would further reduce the risk to 0.11% to 0.26%.

 

Conclusion This modeling of mask filtration efficiency suggests that the pandemic could be readily controlled within several weeks if (in conjunction with sensible hygiene) a sufficiently large majority of people wear asymmetric but higher-filtration masks (e.g. eN95) that also block aerosols whenever exposed to anyone else outside their household in order to completely stop inter-household spread.

https://www.medrxiv.org/content/10.1101/2020.11.10.20227710v1