Coronavirus Technology Solutions
October 15, 2020

Experts say Masks are More Important Now than Vaccines but Fail to Qualify the Term to Mean “Efficient and Tight Fitting”

FDA will No Longer Review Chinese Masks for Addition to the Approved List

Qualitative vs Quantitative Fit Tests

Polymer Face Masks Developed at Ag School and Being Tested at Meat-Processing Plants

How Efficient are Masks Once Leakage is Included?

OSHA will Levy Fines for Failure to Have Appropriate Mask Fit Testing

Vogmask is a Lightweight Mask with a Good Fit

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Experts say Masks are More Important Now than Vaccines but Fail to Qualify the Term to Mean “Efficient and Tight Fitting”

McIlvaine agrees with the recent comments that masks are the most important weapon in the fight against COVID.  But using the term “mask” is  like using the term “pill”.  If you have malaria the quinine pill is a solution but aspirin is not. A squirt gun is nominally a gun but not the weapon of choice against a deadly enemy.

To fight COVID the tight fitting efficient mask is the solution. A loose fitting cloth mask is no better a solution than an aspirin.  Some are expressing concern that people over estimate the protection given by poorly fitting inefficient masks. Here are recent comments by those who do not define the term “mask”

While there has been a lot of talk and hope that an effective Covid-19 vaccine will be available soon, top experts say an affordable tool that already exists is just as important in the fight against the pandemic: masks.

Dr. Christina Brennan, vice president of clinical research at Northwell Health’s Feinstein Institutes for Medical Research, told “60 Minutes” on Sunday that if she had to choose between a mask or a vaccine, a mask is more important.

“With our social distancing, wearing of the mask, the data’s already showing that it’s been effective. It’s, you know, cost savings, and it’s effective. And it can go a long way,” said Brennan, who oversees multiple clinical trials using drugs such as Remdesivir, which President Donald Trump received on Oct. 2, to treat Covid-19.

Dr. David Ho, a world renowned virologist working on developing monoclonal antibody therapies for Covid-19 at Columbia University, who also appeared on “60 Minutes,” emphasizes the importance of masks too. He tells CNBC Make It that “masks are key right now.” But “we need as many tools in our tool box as we can have in dealing with this pandemic,” says Ho, and “vaccines and therapies would make a huge difference as well.”

Dr. Kevin Tracey, who spoke to “60 Minutes” and heads the Feinstein Institutes for Medical Research at Northwell Health, says masks are key in tackling Covid-19 now.

“The reality is we know the masks work,” Tracey, who is doing clinical trials and research around Covid-19 treatments, tells Make It. But also, “we know we need to make therapies and vaccines.”

It is puzzling that so little information is being published about mask leakage and mask efficiency. Distinguished professionals are using the term mask to indicate some product much more specific than just a “pill” but the public needs to be made aware of the big differences in mask quality.

FDA will No Longer Review Chinese Masks for Addition to the Approved List

Today, October 15, the U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH). 

Under the June 6, 2020 version of this EUA, a respirator was authorized if it met any of three predetermined eligibility criteria. Effective immediately, the reissued EUA no longer includes the three eligibility criteria, meaning the FDA will no longer review requests nor add to the list of authorized respirators–known as Appendix A—of this EUA based on those criteria.

The FDA recognizes there is still a shortage of FFRs, and to provide additional capacity as needed, the agency is continuing the emergency use authorization of respirator models that are already included in Appendix A of this reissued EUA.

“Since the beginning of the COVID-19 public health emergency, we have taken appropriate actions to support the personal protective equipment needs of our health care personnel by issuing EUAs. As part of our continuing work to meet the demands of this public health emergency, we undertook and completed a shortage assessment and concluded that reissuing this EUA was appropriate to reflect the current U.S. demand for these products,” said Suzanne Schwartz, M.D. M.B.A., Director of the FDA’s Office of Strategic Partnerships and Technology Innovation in the Center for Devices and Radiological Health.

To further inform the EUAs, the FDA completed a respirator shortage assessment to understand current product availability for both NIOSH-approved N95s and KN95 respirators and use practices for each. The assessment shows that the KN95 respirator models authorized by this EUA meet the demand for these respirators. As part of this assessment, the agency heard directly from health care personnel that the KN95 design has limited adoption in health care settings; from distributors that imported, non-NIOSH-approved product from China is sitting in warehouses unused; and from manufacturers that NIOSH-approved N95 production is increasing. Additionally, CDC/NIOSH continues to issue more N95 approvals.

The FDA is reissuing this EUA to authorize only those respirators the FDA had already authorized and that are presently listed in Appendix A. As outlined in the reissued EUA, FDA has removed the previous eligibility criteria and, therefore, no additional respirator models will be added to Appendix A under those criteria. As such, the FDA is no longer reviewing requests submitted based on the June 6, 2020 EUA’s criteria.

As a result of this EUA’s reissuance, FDA expects that staff and agency resources that were devoted to reviewing those submissions can instead focus on other critical needs during the COVID-19 public health emergency, including continuing to work with CDC/NIOSH to help facilitate the availability of respiratory protection that meets the applicable standards and demands of health care personnel. The FDA is committed to refining our policies and approaches as appropriate to further facilitate the development and availability of these devices for health care personnel.

Qualitative vs Quantitative Fit Tests

According to OSHA, “a ‘fit test’ tests the seal between the N95 mask’s, or respirator's, facepiece and your face.” It typically takes 15-20 minutes to complete and should be performed when this type of mask is first used and then at least annually. The purpose of the fit test is to assure that the mask fits and seals properly so potentially contaminated air cannot leak into the mask and so hazardous substances are kept out. The fit test must be conducted using the same make, model and size of mask that the worker will use on the job. Fit testing with a different type of mask than the one that will be used does not assure proper protection. If the model of mask used for the fit test does not properly fit, another make, model, style, or size of mask must be tested until one that fits properly has been identified. Employers need to provide staff with a reasonable selection of sizes and models to try. Once the fit test is completed and the wearer knows which mask fits best, he/she should always use the one shown to be the right ‘fit’ or ‘size.’ That way, it can be replaced with another mask with appropriate fit. Fit tests can be qualitative or quantitative. In dentistry, the qualitative test is most often used.

Qualitative fit testing is normally used for half-mask respirators like the N95, which cover only the user’s mouth and nose. Qualitative fit tests operate on a pass/fail method and do not measure the actual amount of leakage. They rely on the user’s sense of taste or smell, or the person’s reaction to an irritant, to detect leakage. The mask fails the test if the wearer can detect any leakage of the test substance. OSHA has accepted four qualitative fit test methods:

1. Isoamyl acetate, which smells like bananas;

2. Saccharin, which leaves a sweet taste in your mouth;

3. Bitrex, which leaves a bitter taste in your mouth;

4. Irritant smoke, which causes coughing.

Information on quantitative fit testing can be found on OSHA’s website. The agency’s resource, Appendix A to §1910.134—Fit Testing Procedures (Mandatory): Part I. OSHA-Accepted Fit Test Protocols: A. Fit Testing Procedures—General Requirements, offers helpful guidance. Mask fit should be reevaluated any time the wearer experiences changes in his/her physical condition that could affect the fit. These include: a significant change in weight (either loss or gain); major dental work, such as new dentures; facial surgery that changes the shape of the face; or significant scarring in the area around the seal. Employers must ensure that the fit testing and recordkeeping requirements of OSHA's respiratory protection standard are met before staff can use a N95 mask for protection against hazardous exposures at work. Employers may allow personnel to use their own respirators but cannot require them to do so.

Polymer Face Masks Developed at Ag School and Being Tested at Meat-Processing Plants

While many people are encouraged and even mandated to wear face masks to prevent the spread of COVID-19, some complaints have become common: The mask doesn’t fit correctly. It’s uncomfortable. It’s too hot, or it’s hard to breathe through.

A material scientist at The Ohio State University (OSU) College of Food, Agricultural, and Environmental Sciences (CFAES) is working to change that.

Judit Puskas is in the final stages of developing a polymer face mask she expects will be more effective in the fight against COVID-19. Puskas, who is a distinguished professor in polymer science in the CFAES Department of Food, Agricultural and Biological Engineering, has a provisional patent application pending for the mask she is developing.

She’s working with the Mayo Clinic to create and test the mask to meet the same safety and efficacy standards of an N95 mask, but with more comfort and usability for the wearers. Puskas’ mask is made of a nonwoven fabric composed of biocompatible rubber composite formed into a fiber mat that can be used to create personal protective equipment, including face masks.

The goal, she says, is to offer alternatives to the current market of N95 masks that can be used by workers in a wider variety of conditions and situations.

“The current N95 masks protect against the virus, but most people say the masks aren’t comfortable and aren’t easily breathable,” Puskas says. “There are other polymer fiber mats used in N95-equivalent masks, but they are based on rigid plastics and don’t offer much flexibility.

“The material I’ve developed is a flexible, breathable rubber, that can be made into comfortable-fitting masks. Additionally, it’s water-repellant, doesn’t allow sneeze particles through, nor will it let moisture build up on the mask from breathing. This rubber can also be used in hot, humid conditions as well as in a freezer, can be easily sterilized in water-based solutions, and is recyclable for multiple reuse.”

It’s for those reasons that Puskas’ masks, once completed, will be tested by more than 100 workers in five meat-processing plants across Ohio to gauge the masks’ effectiveness for ag workers in hot, humid conditions.

CFAES researchers, including Lyda Garcia, an assistant professor of meat science; Mary Rodriguez, assistant professor of community leadership; and Joy Rumble, assistant professor of agricultural communication, are working with meat processors statewide to determine the barriers workers face when considering masks as personal protective equipment to reduce the potential spread of COVID-19.

The team is also researching workers’ perceptions about wearing personal protective equipment to better understand why some choose not to wear it. The team’s goal is to develop strategies to get more workers to change their perception of masks and to choose to wear them, Rodriguez says.

According to the Centers for Disease Control and Prevention (CDC), the meat and poultry processing industry, which is an essential component of the U.S. food infrastructure, employs approximately 500,000 people nationwide, many of whom work in close proximity to other workers, often in hot, humid conditions.

Ohio meat processors reached out to Garcia, who is also an Ohio State University Extension meat science specialist, and her team for help in determining solutions for personal protective equipment, including understanding what works and how to encourage workers to wear personal protective equipment such as face masks, Garcia says. OSU Extension is the outreach arm of CFAES.

Garcia says the conversations with meat processors helped her team realize that understanding employee behavior and attitudes about wearing personal protective equipment such as masks would be valuable in helping Puskas modify and adjust her mask design.

“Understanding employee behavior, attitudes and leadership is critical when designing personal protective equipment,” she says. “The most common complaint among workers is that masks are uncomfortable, tend to move and slip off, and they have to keep adjusting them.

“Another drawback is that workers say it’s difficult to breathe in masks in hot, humid conditions while constantly moving, and they don’t like breathing in their own carbon dioxide that is trapped in the masks in those conditions.”

Additionally, Garcia says, with the fans and the air conditioning noise in the plants, workers say wearing masks makes it harder to communicate with each other, which could be a safety issue considering the sharp knives and tools they use.

“Also, these workers are on their feet 8 hours a day, wearing hair nets, safety glasses, with some men having long beards, then you add a mask and you can see where things can become more complicated fast on top of just wearing the mask,” she says. “At the end of the day, it’s about working with employees to encourage them to wear personal protective equipment.

“Not only will it serve to protect the food, but it will help keep the employees safe and healthy, and, in turn, will keep them working to provide a wholesome, sound, high-quality product.”

That’s one of many reasons why Puskas was compelled to develop a mask using the biocompatible rubber composite fiber mat she created as a way to add comfort, flexibility and breathability to the N95 mask market.

http://www.angusbeefbulletin.com/extra/2020/08aug20/0820fp_B_FaceMasks.html

How Efficient are Masks Once Leakage is Included?

It is interesting that McIlvaine found better information on leakage for masks worn by the public in air pollution  research rather than COVID. There is a good analysis on the Smart Air website dating back three years.

Thomas Talhelm

Thomas is an Associate Professor of Behavior Science at the University of Chicago Booth School of Business and the founder of Smart Air, a social enterprise to help people across the world breathe clean air without shelling out thousands of dollars for expensive purifiers.

In addressing the mask leakage Talhelm said “This question is tougher to answer because you have to measure the mask while you’re actually wearing it. For that, you need a really expensive fit test machine. Fortunately, I begged and begged 3M until they let me use their lab in Beijing.

The blue tube is sampling air outside the mask, while the white tube is sampling air from inside the mask.

Smart Air co-founder Anna Guo and Beijing-based Dr. Richard Saint Cyr also tested masks, so I combined all of our data.

The 3M masks consistently performed the best in these tests. The Vogmask performed fairly well, capturing 95% of pollutants. Big-name masks like the Respro and Totobobo masks both captured less than 85% of pollutants.

It’s important to make clear: masks that fit my face well might not fit other people’s faces well. However, there is evidence from a broader population that masks fit most people well. A scientific study of 3M models on 22 Chinese people found a median fit score of 99.5%–essentially the same as the top results from Dr. Saint Cyr and me.

Best yet, effective masks don’t cost a lot of money.

The branded masks – Vogmask, Respro, I Can Breathe and Totobobo – all cost the most. However these masks consistently performed worse than cheaper 3M masks. Only the Vogmask was able to capture over 95% of particulates (meeting the N95 criteria).

OSHA will Levy Fines for Failure to Have Appropriate Mask Fit Testing

Guy Burdick asks and answers the following question.

Will workplace safety and health inspectors show up at your facility if workers contract coronavirus disease 2019 (COVID-19) and one of them files a complaint? Yes; in fact, it’s already happened.

Although there are no federal standards for coronavirus exposure or airborne infectious disease, COVID-19 has become a recognized workplace health hazard since the pandemic was declared in March. You can be cited for failing to protect your employees from the coronavirus under the General Duty Clause of the Occupational Safety and Health (OSH) Act of 1970.

Section 5(a)(1) of the OSH Act reads: “Each employer shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.”

The federal Occupational Safety and Health Administration (OSHA) has cited several employers under the General Duty Clause for failing to protect their employees from the coronavirus.

OSHA cited JBS Foods Inc. of Greeley, Colorado—operating as the Swift Beef Company—for failing to protect employees from exposure to the coronavirus. The agency cited JBS Foods with a violation of the General Duty Clause for failing to provide a workplace free from recognized hazards that can cause death or serious harm and proposed penalties of $15,615, the maximum allowed by law.

The agency conducted a coronavirus-related inspection and also cited the company for failing to provide an authorized employee representative with injury and illness logs in a timely manner following OSHA’s inspection.

The agency cited Smithfield Packaged Meats Corp. in Sioux Falls, South Dakota, for a General Duty Clause violation for failing to protect employees from exposure to the coronavirus. OSHA proposed a penalty of $13,494. At least 1,294 Smithfield workers contracted the coronavirus, according to the agency, and 4 employees died from the virus in spring 2020.

In addition to the General Duty Clause, the agency also is enforcing all federal standards, including the respiratory protection standard despite ongoing shortages of N95 filtering facepiece respirators.

OSHA cited Bergen New Bridge Medical Center for respiratory protection violations at its Paramus, New Jersey, location. The hospital failed to fit test tight-fitting facepiece respirators on employees who were required to use them, train employees on proper respirator use, and ensure employees understood when to wear a respirator, according to OSHA. The agency proposed penalties of $9,639.

OSHA cited Georgetown Dental LLC in Georgetown, Massachusetts, for respiratory protection violations, proposing penalties of $9,500. The agency cited the dental practice for failing to provide medical evaluations and initial fit testing for employees required to wear N95 respirators as protection against the coronavirus; a lack of written programs for bloodborne pathogens (BBP), hazard communication, and respiratory protection; and insufficient bloodborne pathogen training and controls and inadequate eyewash stations.

OSHA cited Hackensack Meridian Health for a serious violation for failure to provide respirators to resident-care employees at its North Bergen, New Jersey, location in March. Employees without respirators were caring for residents who were exhibiting symptoms of coronavirus infection, according to the agency. OSHA proposed penalties totaling $28,070. Other violations included failure to conduct respirator fit testing, effective training, and compliant medical evaluations for the period after the employer began providing respirators to the employees and requiring their use.

The agency cited Ohio-based healthcare provider OHNH EMP LLC for violations of the respiratory protection standard after the company reported the coronavirus-related hospitalization of seven employees. The agency proposed penalties totaling $40,482. The agency also issued the company a Hazard Alert Letter regarding the company’s practice of allowing N95 respirator use for up to seven days or until damaged or soiled. The company also had instructed employees to wear surgical masks issued each day over their respirators. Wearing a surgical mask over a respirator could interfere with the respirator’s inhalation and exhalation resistance—factors the National Institute for Occupational Safety and Health (NIOSH) tests respirators for in addition to particle filtration when certifying respirators.

The agency cited three of the company’s locations for serious violations of the respiratory protection standard’s requirements, including lack of a comprehensive written respiratory protection program and medical evaluations of employees provided with and instructed to wear respirators.

State workplace safety and health agencies also have cited employers for inadequate COVID-19 protections. Governors in Nevada and Oregon have ordered their workplace safety agencies to ensure employers’ compliance with their states’ COVID-19 restrictions in addition to enforcing their states’ occupational safety and health laws. California and Michigan have cited several employers for coronavirus-related violations.

The California Division of Occupational Safety and Health (Cal/OSHA) announced it had cited 11 employers in agriculture, food processing, health care, meatpacking, and retail for not protecting employees from coronavirus exposure.

Cal/OSHA conducted a complaint-initiated inspection of DL Poultry, Inc., of Monterey Park and proposed penalties of $51,190 for COVID-19 and other violations. The agency proposed penalties of $9,000 following a complaint-initiated inspection of Olson Meat Company, a meatpacking facility in Orland, finding the employer did not physically distance employees at least 6 feet apart in processing areas or install plexiglass or other barriers between workers.

The agency cited a frozen food manufacturer and a temporary employment agency for failing to protect hundreds of employees from COVID-19 at two frozen food plants. The employers did not implement procedures to have employees work at least 6 feet away from each other or install barriers and did not investigate employees’ COVID-19 infections that included more than 20 illnesses and 1 death.

The agency has cited agricultural labor firms with COVID-19 and other violations, including:

• Michel Labor Services Inc. for COVID-19 and heat illness prevention violations and proposed penalties of $11,700 following an inspection of a Dixon worksite; and
• Serve Max Farm Labor Contractor with both COVID-19 and heat illness prevention violations after an enforcement task force inspection of a Vacaville agricultural worksite, seeking penalties of $11,250.

California also has an airborne transmissible disease (ATD) standard that applies to healthcare facilities, as well as correctional facilities, diagnostic laboratories, and police and public health services. Under the ATD standard, California employers must protect workers at healthcare facilities and other services and operations from airborne diseases like COVID-19 and tuberculosis (TB), influenza, and pertussis (whooping cough).

Since the pandemic began, Cal/OSHA has cited several employers under the ATD standard, including:

• Gateway Care & Rehabilitation Center, a skilled nursing facility in Hayward, for exposing nurses and housekeeping workers to COVID-19 when it failed to provide necessary personal protective equipment (PPE);
• Santa Rosa Police Department for failing to implement required screening and referral procedures for persons exhibiting COVID-19 symptoms and failing to report to Cal/OSHA multiple serious illnesses suffered by employees who contracted COVID-19; and
• Sutter Bay Hospitals’ CPMC Davies Campus for not ensuring its healthcare workers in administrative medical offices and security guards in the emergency department wore respiratory protection, as well as medical staff without N95 masks or other proper protection while performing a medical procedure in the operating room on a suspected COVID-19 patient.

The Michigan Occupational Safety and Health Administration (MIOSHA) cited 19 businesses with serious “general duty” violations for failing to protect employees from coronavirus exposures. Violations cited under the state’s reopening guidelines included:

• Lack of a preparedness and response plan and failure to designate a COVID-19 workplace supervisor;
• Failure to require face coverings when social distance could not be maintained;
• Failure to train employees on COVID-19 guidelines;
• Failure to conduct a daily health screening protocol and maintain/retain documentation for training, entry screening, and contact tracing; and
• Failure to post signs, markings, and barriers at the time clock and provide cleaning supplies for high-touch surfaces.

https://ehsdailyadvisor.blr.com/2020/10/covid-19-enforcement-a-guide-for-ehs-professionals/

Vogmask is a Lightweight Mask with a Good Fit

Ethan Brooke is the person behind BreatheSafeAir.com. He has addressed mask fit in his blog and had the following observations about the fit with Vogmask

It’s important to note that the filter standards (N95, KF94, KN95, etc.) are irrelevant if the mask isn’t fitted correctly. If there are gaps in the seal, particles can simply enter through these gaps rather than through the filter. 

For this reason, the fit of a mask is vital. For the best fit, professional fit testing is required. However, this is not accessible for most people.

3M recently found that even without professional fit testing that some level of protection can be achieved if methods are followed to create a good fit (3M). If you are wondering how to don a respirator properly, please refer to this guide by the CCOHS.

It is vital that a mask fits as well as possible and that a seal can be made between your mask and your face. 

Vogmask offers five different sizes, each meant for different people. The mask sizing is meant to be easily accessible and is therefore based on the height of the wearer. However, if you have strong facial features, you may find achieving a fit hard. This is especially true if you have a big or small nose.

Vogmask uses ear-straps, and although common on respirators, this is one of Brooke’s biggest issues with the product. Ear-straps are less sturdy than a head-band style of strap and mean that the mask is more loosely fitting. Further, these ear straps (as with all ear-straps) become very painful after long periods.

Luckily, a headband accessory is available. If you are purchasing a Vogmask and expect to be wearing it for long periods of time, Brooke can’t recommend this headband enough. Your ears will thank you for it!

The mask features a wire-nosepiece for adjustments around the nose. Although easily adjustable, it’s important to try to retain the structural integrity of the product when storing it. This means, if possible, don’t share the mask and don’t store it in the sun, or somewhere where it can be crushed. 

Another aspect that I noticed when first trying Vogmask is that the mask is very light. It is lighter than the Cambridge Pro Mask that I Brooke usually uses, and it also feels significantly lighter than most other reusable masks that I use.

This is great for long-term wear. Although the weight doesn’t seem to make a big difference initially or in theory, in practice after long periods of wear it will be a lot more comfortable.