Thursday, May 21, 2020

The "Wild West" PPE Industry + A special feature on COUNTERFEIT RESPIRATORS

Written by:  Dr. Robert L. Bard & NYCRA NEWS Editorial Staff 

Months into the Coronavirus Pandemic, health responders everywhere continue to struggle to protect themselves from contamination as cases continue to pile up in hospitals across the country. Understanding viral self-protection is job #1 for companies like American Health Supply Company- a 20+ year old supplier of Personal Protective Equipment (PPE) to healthcare practices and medical centers. To help identify how PPE's work, and various options available to the healthcare worker, we interviewed chief distributor and CEO, Jayson Dauphinee.  "From masks, face shields, gowns, nitro gloves and hazmat suits, we use all our existing contacts and constantly seek out new manufacturers who carry FDA certificates. The "name of the game" is getting only certified products for our people- because anything less would be adding risk to injury for all users."

The supply chain industry, especially those coming out of China, Hong Kong, Taiwan, Korea is a mixed bag when it comes to quality.  A big part of a distributor's job is sifting through bootlegs and counterfeit items. Where human lives that are at risk, discerning who's who is in and of itself a lifesaving job.  New and seasoned manufacturers showcase in international trade shows mixing reputable with questionable ones as far as their quality and follow-through.  Dauphinee claims honorable producers usually introduce themselves by sending sample products for integrity testing and copies of their certifications.   

N95 vs KN95- WHAT'S THE DIFFERENCE?
Mayors, Governors and health officials nationwide are now suggesting anyone in public to have protective face coverings of any kind (scarves, bandanas and surgical paper masks) as a bare-bones safety solution to the contagion. This call is a desperate responses to the limited supply of FILTRATION GRADE PPE MASKS.

The most widely publicized face mask in the service field is the N-95.  Due to the high demand, healthcare people are suffering a shortage of this mask, forced to surrender to alternative (and lesser quality) products.  According to Mr. Dauphinee, the KN95 is the same product -as identified by the EPA when it comes to the 95% effectiveness of its triple micron filtration.  "N" means manufactured in the U.S.  The USP code that K and 95 is China code. Then there's an AF94 from Korea. and the FFP2 is the Euro code. They all have the same 94.6% rating with that .3 micron filtration.


















These filter masks are typically made of spun bound non-woven polyethylene built up one cylinder layer on top of another. Above that is a melt blown layer of polyethylene filtration, then on top of that is going to be another one of the spun bound polyethylene. Next is a P E wire, which is a metal free, and that kind of holds everything together. Then on top, you're going to have a cotton layer of filtration- the piece that goes across the face at the anti microbial hypoallergenic piece of cotton. This gives you a decent feel to the face- and the finishing piece on the mask.

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Credit: NIOSH/CDC  - Counterfeit Respirators
Misrepresentation of NIOSH-Approval
(Click to enlarge)
BOOTLEGGERS FREE-FOR-ALL AND HOW TO IDENTIFY THEM
According to Fortune Business Insights, Personal Protective Equipment (PPE) Market Size will Hit USD 85.72 Billion by 2026.  (Presswire link)  This market spike is greatly due to the current health Pandemic of 2020. Meanwhile, as with any booming industry, millions in counterfeit masks and other PPE arises from China and other foreign countries, taking full advantage of its high global demand.

According to the CDC and NIOSH (The National Institute for Occupational Safety and Health), Counterfeit respirators are products that are falsely marketed and sold as being NIOSH-approved and may not be capable of providing appropriate respiratory protection to workers. When NIOSH becomes aware of counterfeit respirators or those misrepresenting NIOSH approval on the market, they are posted on the CDC/NIOSH website to alert users, purchasers, and manufacturers.

How to identify a NIOSH-approved respirator:  NIOSH-approved respirators have an approval label on or within the packaging of the respirator (i.e. on the box itself and/or within the users’ instructions). Additionally, an abbreviated approval is on the FFR itself. You can verify the approval number on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page to determine if the respirator has been approved by NIOSH. NIOSH-approved FFRs will always have one the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.

For the complete coverage on Counterfeit PPE, please visit the CDC/NIOSH website: 
https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html


Addtl references: BusinessInsider.com
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The Humbling of 3M: New Industry Boom by the Pandemic
The recent explosion of today's PPE market is greatly influenced by the Coronavirus pandemic- for better and for the worse.   On one hand, the major demand has sparked a global wave of new manufacturers of all sizes. Meanwhile, there is a rampant loss of $$ from private buyers and distributors' due to delayed or lost orders as shipments from foreign countries are often seized or even destroyed.  This is either due to the major wave of bootlegging or political issues at the border.  In addition, new tarriffs, price wars, gouging and travel bans have all added to the import restrictions and challenged access to these PPE.  This opened up a floodgate of other countries now getting involved in product sourcing.  Countries like Germany have Bosch (the spark plug manufacturer) who is now manufacturing great masks.

New standards in protective gear for EMS professionals
in all New York fire departments (Elizabeth Banchitta)
Where 3M once 'ruled the game', the War Powers Resolution Act pushed every major company to get involved in producing ventilators and PPE.  This brought out the Ford's and the GM's who once paid 3M millions of dollars for masks and  are now learning to make them in house for public distribution as well as for their own protective uses. Now, if they know how to make them in house, 3M just lost that client making it hard for 3M to recover from that loss.   Due to this massive new demand escalating new price points, so many small manufacturers can finally afford to pay an American employee and earn a reason to get up and running.  Many small mom and pops throughout the country are going to get a little bit of booming. And the 3D printing industry right now has also become a huge factor because people at home can make PPE for relatives or loved ones or anything because you can put it in the program.



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COMMUNITY FOOD DRIVES:
CARING BOOTS ON THE GROUND

The definition of a "First Responder" is one who takes on the task of coming to the aid of any emergency or crisis in the community. In our current pandemic, firehouses are 'stepping up to the plate' by collecting food and staple supplies for the many lives affected by the Coronavirus issue. 

April, 2020- The King's Park Volunteer Firehouse collected over 4500 pounds of food on a one-day drive to replenish the various empty Food Pantries in their immediate area- including ones in King's Park, Bayshore and St. Joseph's church. This is just one of their many charitable initiatives on their calendar where the firehouse is poised as the central drop-off and distribution area.

"We swore an oath to take care of the people and patients in our community to support the safety and the well-being of all our neighbors. That's always instilled in you from the beginning. But the real thanks go to all the food donors in our area!" says EMT Elizabeth Banchitta (second generation first responder and daughter of Ret. FDNY FF. Sal Banchitta - see CousinSal.org).  "There are many types of FIRES to put out, and many ways to HELP... working with the fire dept. puts us at the front lines of these 'fires' to address them accordingly. This pandemic really puts our whole country upside down economically-- and getting food to those who need is one of our major challenges..."