CATER Mask Decisions

January 21, 2021

Mask Webinar Contained Lots of Discussion but not Much Disagreement

More Efficient and Comfortable Masks Needed for Everyone says Brigham and Women’s MD

Biden Mask Mandate Expands Beyond Federal Property to Public Transportation

France Advises Against Wearing Cloth Masks

McIlvaine Provides  Guidance for Mask, Media, and Service Companies

Lemu Group has New Mask Making Machine Design

Australia Distributed Defective Masks

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Mask Webinar Contained Lots of Discussion but not Much Disagreement

Association presidents, E.R. doctors, researchers and suppliers discussed the potential to quickly fit everyone with tight fitting and efficient masks. There was general agreement that more efficient masks would make a huge difference in stopping COVID. There was surprising little disagreement on the availability of  media and mask manufacturing.

There were, however, many views on how and if the regulatory, political, and social barriers could be breached. Dave Rousse of INDA explained how his non wovens association group had understood as early as March that some standard would be advisable for public masks. The initial discussion with NIST was around an N80 as opposed to an N95 mask. Subsequently INDA  started working with  ASTM. The result is a standard soon to be released which sets two efficiency levels. One is 20% or higher. The other is 50% and higher. When you consider that the virus is generally in larger particles or drops than used for the efficiency rating and that the effectiveness is the combined efficiency of masks on emitters and recipients these standards will greatly reduce COVID spread.

Eric Couch, consultant, believes the new administration can be persuaded to champion the new ASTM standards. His concept is to keep it simple and to first persuade a small group of experts with influence who would then persuade the decision makers.

Eric recommends the use of multiple mask designs including one with flat filters and external braces. This design lends itself to quick scale up. Sabrina and Katherine Paseman of Fix the Mask, have designed an external brace which is comfortable and tight fitting. It gives surgical masks the tight fit and efficiency of N95 masks.

Keith Dellagrotta and Jesse Chang of M^3D.ai have a program where a mask purchaser can use his mobile phone and select a mask which will provide a good fit

McIlvaine introduced a five step program starting with mask manufacturing quality control, distribution quality control, an ASTM  or governmental minimum, a tested quality seal, and fit check

You can view this at: https://youtu.be/CEFinop1rus

More Efficient and Comfortable Masks Needed for Everyone says Brigham and Women’s MD

Abraar Karan, MD, has been treating COVID-19 patients for 10 months. In that time, he hasn't gotten the virus, and he credits his N95 mask for protecting him.

"I've seen more COVID patients than I can count since March, and I get tested regularly, and I've not tested positive. I want others to have that kind of protection, too," says Karan, an internal medicine doctor at Brigham and Women's Hospital and Harvard Medical School.

But N95 masks are in short supply, and Karan says he's frustrated that high-filtration, or hi-fi, masks aren't available for the public nearly one year into the coronavirus pandemic. Karan recently co-authored an op-ed highlighting his concerns and calling for a national initiative to make masks with higher filtration easier to get — even having the government send them to people's homes.

The issue is as relevant today as it was a year ago when the first cases of the coronavirus were identified in the United States.

A study released Tuesday in The Lancet found that a 10% increase in mask-wearing makes it three times as likely that the coronavirus spread slows.

He says the U.S. needs a more coordinated effort to do two things: protect those wearing masks from getting the virus and prevent those who have the virus from emitting the droplets and aerosols that spread COVID-19, especially when they're asymptomatic and don't know they're infected.

"We've been saying wear a mask, wear a mask. Well, we're now 10 months into this, and we are still just telling people to wear masks that are OK, but they're not the best protection that we can get. We already know that N95-level protection is out there and it is the best," Karan says. "There is a supply issue — so fix it."

Karan says many other countries are taking steps to get better masks to their citizens. In Austria, the government says it will distribute free FFP2 masks (their equivalent of N95s) this month to people over the age of 65. Karan isn't the only one with this idea. Researchers recently raised the question in The Atlantic, too — pointing out that cloth masks were supposed to be a "stopgap measure" in the US and that other countries have done far more to get better masks into the hands of their people. Examples include Hong Kong giving lab-tested six-layer masks to the public, Taiwan boosting its mask production to get more high-quality masks to people on a weekly basis, and Germany now requiring people to wear higher-grade masks.

"We are 10 months into this. We should have more comfortable designs that have a higher filtration efficacy," Karan says. "I've talked to some companies that are working on different mask designs now, trying to get more filters into cloth masks that can provide some electrostatic charge that can stop small particles."

Biden Mask Mandate Expands Beyond Federal Property to Public Transportation

The U.S. mask order for travel being implemented by Biden will apply to airports and planes, ships, intercity buses, trains and public transportation. Travelers from abroad must furnish a negative COVID-19 test before departing for the U.S. and quarantine upon arrival. Biden has already mandated masks on federal property.

Although airlines, Amtrak and other transport providers now require masks, Biden’s order makes it a federal mandate, leaving little wiggle room for passengers tempted to argue about their rights. It marks a sharp break with the culture of President Donald Trump’s administration, under which masks were optional, and Trump made a point of going mask less and hosting big gatherings of like-minded supporters. Science has shown that masks, properly worn, cut down on coronavirus transmission.

France Advises Against Wearing Cloth Masks

The French government is now recommending that people wear surgical masks in public because they offer better protection from COVID-19 transmission than fabric face coverings, Health Minister Olivier Veran said on Thursday.

France already requires masks to be worn in public places, but until now has not made recommendations about the type of masks. French authorities are worried they could be hit by new, more contagious variants of the virus

“The recommendation that I make to the French people is to no longer use fabric masks,” Veran told French broadcaster TF1.

Veran also said it was very unlikely that restrictions on ski resorts — a hotspot for the virus at the start of the pandemic — would be lifted next month.

That effectively rules out a return to skiing in time for the February school holidays, normally the last peak skiing period of the season.

Veran said that the government could not rule out a tightening of coronavirus restrictions if the situation with virus transmission deteriorates.

“We could be forced to take tougher measures than those that the French people dealt with this autumn. That could go as far as a lockdown if the situation were to require it,” he said.

France has reported over 71,000 coronavirus-related deaths since the pandemic began. It is now at 35% of its peak infection rate, according to Reuters data, well below its neighbor, Britain, which is at 70%. French schools are still open, and non-essential shops are allowed to trade.

Mcilvaine Provides Guidance for Mask, Media, and Service Companies

Due to the rapid changes in the market suppliers need to focus initially on the low hanging fruit and later on the whole market.

The sales of public masks are going to be determined less by individuals and more by various types of venues where masks will be used. Suppliers need to be apprised of the influence of the following venues in each country.

For more information on World Mask Market click here: http://home.mcilvainecompany.com/images/Mask_Market_Revised_2021-01-21.pdf

Lemu Group has New Mask Making Machine Design

Lemu Group, a global converting equipment manufacturer, has engineered a machine to help produce facemasks in the continued fight against the COVID-19 pandemic. This product development provides an opportunity for converters to expand into new areas of potential growth. Lemu Group has used its technical know-how to launch this mask manufacturing line. The equipment was developed by Teyman, a  Lemu Group company whose factory is located in Valencia, Spain.

 “Given the shortage of masks in Europe, Lemu Group decided to do what it does best – build robust machines with stable production,” explains Andre Beaudoin, leader of Lemu Group USA's sales and marketing team. “We wanted to help curb this disease, which spreads so fast. In record time, we were able to develop a surgical production line from scratch.”

 Market research has revealed concerns with low quality and inefficiency with many existing mask-making machines. Lemu Group’s latest launch, a 100%-made European machine, delivers enhanced productivity and full automation while adhering to all of the European safety standards. Plus, this machine can be operated primarily from a PLC, with the ability to provide quick and seamless job changes.

 “While there are many machines out in the international market, we believe we are offering something different,” notes Beaudoin. “The majority of foreign machines on the market lack the automation and quality that Lemu Group provides, and they are clearly not operating within the same safety standards.”Lemu Group also boasts local technical service.

The Lemu Group mask-making machine is equipped with four unwinders, which enable the production of masks with three and four layers. Each reel also has its own independent tension control.

 “We can work with different materials, and the adjustments are always simple,” states Beaudoin. “With just a few manual adjustments, the machine works properly and efficiently. This is critical because the materials used in mask production frequently change in terms of quality.”

The machine features two welding groups, as well. The first welding group joins the different mask layers, while the second welds the mask’s ear loops. Lemu Group has partnered with Weber Ultrasonics to produce these German-made welding groups.

 “We have worked diligently to ensure the welding point of the mask’s ear loop can be adjustable,” explains Beaudoin. “Depending on the quality of the ear loop and mask material, this welding point can vary quite a bit, so it is very important to have the material well-guided. The positioning of the masks in the welding system are servo-made, which guarantees that the position of the mask is accurate and eliminates positioning errors.”

 The machine is also equipped with a system to place the ear loops inside the mask, and the mask grouping system in each welding line is independent.

 “We group the masks and we use one pneumatic pusher in order to make sure that the masks will be together during transportation,” says Beaudoin. “At the entrance of the packaging system, the machine is equipped with one selection system so that the Flow Pack packaging unit can have constant feeding and the mask forming unit never stops.”

Australia Distributed Defective Masks

Some of the masks distributed to hospitals and aged care homes at the height of the pandemic as part of the federal government's national medical stockpile have been judged defective by the Therapeutic Goods Administration.

Laboratory testing by Australia’s medical regulator identified a range of issues with some disposable surgical masks branded Softmed and imported by M House.

The issues include quality control, lack of proper labelling, and inconsistent fluid resistance between batches. Fluid resistance is vital for medical masks, as fluid droplets generated by coughing and sneezing have been found to spread COVID-19.

A Kirby Institute study, published in November, estimated Australian healthcare workers were nearly three times more likely to become infected with coronavirus than other Australians. More than 3560 healthcare workers have been infected with COVID-19 in Victoria. Nearly three-quarters of them caught the virus at work.

At the peak of the state's second wave of infections in early August, so many staff were off sick or isolating from the Royal Melbourne Hospital that the facility was forced to temporarily close four of its wards.

The TGA's product defect alert does not cover all Softmed-branded masks supplied to the stockpile, or masks from other suppliers.

In a statement, M House accused Australia's medical watchdog of incompetence or bad faith and said it had serious concerns about the regulator's lab testing.

"Based on the results of internal and external accredited laboratory testing, M House is very confident that its products supplied during the height of the pandemic do not pose a risk to frontline workers but in fact protect them," the spokeswoman said.

“M House genuinely believes that, at best, the TGA has conducted itself incompetently in relation to the testing of the device and, at worst, has acted and continues to act in bad faith towards M House, in respect of which M House has reserved its rights and, if necessary, will prosecute them to the full extent necessary, including to obtain the removal of the alert notice which it genuinely believes is unjustified.”

The TGA issued a product defect alert for the disposable surgical masks in November and the Health Department has since written to aged care homes, healthcare networks, the National Disability Insurance Scheme and state and territory health authorities, warning about the defective batches.

The TGA has been running its own lab tests on masks, with priority given to the millions of masks on Australia’s national medical stockpile. Of the first 25 results released, seven had problems identified.

A spokeswoman for the TGA said: "A strong precautionary approach was taken by issuing a Product Defect Alert notice on 14 November 2020 for the relevant Softmed branded surgical masks, sponsored by M House, to ensure customers who purchase or are supplied with these masks safeguard healthcare workers if the masks are being used in high-risk settings,"

Andrew Hewat, Victorian Allied Health Professionals Association assistant secretary, said: “Any concerns in terms of the level of safety, the standards that are being applied, raises concerns for our members.

"[Masks are] the baseline protection for the wearer and anyone they interact with."

Safety experts have called for an overhaul of Australia's "trust-based" mask regulations.

Australia's summer of bushfires, the COVID-19 pandemic and government-mandated mask rules led to a flood of masks entering the country in 2020. In May The Age revealed serious concerns that many of these masks were counterfeit or did not meet the standards claimed – and that some of these products ended up in hospitals.

At the time, the Health Department told The Age it was satisfied with the quality of all masks it had purchased.

A post-market review by the TGA has now led to the watchdog cancelling the registration of 90 different face masks, with sponsors voluntarily cancelling another 647.

Several masks were cancelled for making "false or misleading" statements in their application or because "the safety and performance of the kind of device is unacceptable".

Kate Cole, president-elect of the Australian Institute of Occupational Hygienists, said: "It's really demonstrated the lack of mask regulation in Australia.

"The harm that can happen is a healthcare worker, in good faith, uses an N95 respirator and that respirator does not actually provide N95 protection, and exposes them to COVID."

The TGA also issued four product defect alerts, including three for masks that had "insufficient evidence to support claims for bacterial filtration efficiency, differential pressure or splash resistance".

Two of those three were apparently sponsored by a home nursing service.

"What it shows is there needs to be that front-end quality check and assurance process built into our importing market," said Naomi Kemp, chairwoman of the Australian Institute of Health and Safety.

Australia's medical regulations allow companies to register "low-risk" items, such as masks, on the Australian Register of Therapeutic Goods – allowing them to be used in healthcare – by simply stating they have evidence to back up claims about meeting certain standards.

That evidence is often not checked before the mask is registered, a regime Monash University associate professor Ken Harvey has labelled “trust-based”.

The TGA defended its mask regulation system and decision to treat masks as low risk.

"The impact of COVID-19 has highlighted that while risks are low if all regulatory requirements are met, some manufacturers and sponsors were not aware or were not meeting regulatory requirements," a spokeswoman said.

The Australian Institute of Occupational Hygienists, along with the Australian Institute of Health and Safety, the Indoor Air Quality Association Australia and the Australian Council of Trade Unions, has called for the federal government to set up a national register of approved respirators.