By Graziella DiNuzzo
Annie created an official division – Annie Medical PPE But it wasn’t easy. Steven Miller, Executive Director of Sales and Operations explained the challenging process, “There were countless obstacles that we faced through the whole process. COVID-19 really showcased how unprepared the world is when it comes to each country being able to sustain itself with essential products.”
Testing to meet National Institute for Occupational Safety and Health (NIOSH) Standards “We had to start the long process and invest 10s of thousands of dollars to have our products tested at Nelson Labs, a globally recognized lab. Many of our products have FDA, CE and ISO certifications among others but we quickly learned that many doctors and insurance companies require NIOSH certification, formed by the CDC. When the world is in crisis and needs immediate PPE there should be a process to streamline this testing. In the meantime doctors, nurses and other healthcare workers had to resort to not wearing PPE, wearing the same PPE or wearing a homemade PPE, while we have medical and surgical grade PPE’s ready and willing to donate and/or sell. Obtaining KN95 Approval in USA “The standard in the US is the N95 mask. The N95 is made in America, the KN95 is made in China and the KF94 is made in Korea. These three masks are the most common and widely used medical grade masks in the world. Because N95 masks were not readily available in America the last two options were the KF94 and KN95. Fortunately China still allowed KN95 masks and surgical masks to be exported to other countries, and they soon were allowed in America. Japan, Australia, Mexico, UK, Europe and America all started immediately getting supplies from China as there was/is no other source.”
Customs Delays “Shipments were being held in customs for long lengths of times due to the extreme high volume of PPE and because of changing regulations.” Missing Product from Shipment “When dealing with a healthcare system, national chain store, major distributor or union this shortage can be dealt with. When dealing with a government contract this shortage is an issue when you come up short.” High Demand, High Freight Costs, Not enough Planes “Standard air freight went from around $2/KG up to $26/KG. This is outrageous. The main freight carriers such as DHL, UPS and FedEx would only accept shipments up to a certain weight. Large shipments had to rely on airlines, which either stopped flying into and/or carrying freight from China. As the airlines dropped off one by one over the weeks companies were fighting for space on planes, driving up cost. At one point Amazon, being the largest airline customers, took all of the flights out of China for 1-3 weeks while our product sat waiting.” Cash Up Front “Ten to twenty year relationships with factories didn’t matter. If you have/had terms with a factory those terms were not applicable when it came to PPE. The global supply chain for PPE’s became and still is cash based market. You must wire 50% of the cash at time of placing a PO and then the remaining 50% at completion of production before shipment. Some factories were requiring 100% upfront before production. Large National Retailers, Governments and militaries from countries all around the world, and major medical systems are and were not prepared.
“We have been providing the Mexican Government in Mexico City with millions of masks per shipment to support their healthcare system due to COVID-19. The Mexican Government had to also meet the new “playing rules” and wire the money in advance before receiving the product. When the product arrived police and military escort then took it to the social security procurement. We have done this with many countries such as Jamaica, Dominican Republic, South Africa, UK, and France.”
“We have always been in the business of PPE products, just not to the level of what the country and world needs now,” Miller emphasized. And while Miller calls the global PPE market “the wild wild west,” he admits the challenges are worth it to save lives.
9 Comments
M T
6/20/2020 04:36:28 pm
I appreciate that Annie Inc has worked hard to bring their masks to market.
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8/4/2020 04:22:18 pm
NIOSH testing is performed by a globally recognized lab called Nelson Labs. Nelson Labs tests products and certifies if those products meet not just NIOSH but EN149, EN 14683 standards, COFEPRIS and many other global standards. The Nelson Labs test results for Annie masks are published on the Annie Inc website and available to download. To speak to the statement of the CDC finding many KN95 masks were fake, you are correct! This was and still is the case all over the world. Many people around the world are just wearing face coverings or cloth masks which at best only filter 25%. It is better than no mask but most viruses pass right through cloth masks. Cloth masks really just dampen the projecting of saliva when someone speaks, coughs and sneezes, It is always much safer to wear a true medical quality mask that has a 90% or greater filtration rate. Annie Medical PPE is available everyday to answer and questions, concerns or provide you with any information that you are looking for to help you make an educated decision in the protection that you select.
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Kechia
7/17/2020 01:14:35 pm
I need to know if your manufacturer in China is on the FDA EUA approved list or have they been removed? Please answer promptly by suppling the name of your manufacturer.
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8/4/2020 04:41:24 pm
The published list is very outdated and not properly maintained as there are manufacturing facilities all over the world that do meet all of the levels of certification. The published list is a good list but do not limit yourself to only locate masks from these manufacturers otherwise your odds of locating them are slim. The key is to ask for lab test results and to match those results to the product you are purchasing, You also need to make sure it is a reputable lab.
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1/20/2022 09:24:13 am
Very much appreciated. Thank you for this excellent article. Keep posting!
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3/1/2022 07:52:10 pm
I very much appreciate it. Thank you for this excellent article. Keep posting!
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7/31/2024 11:53:24 pm
I was impressed by the depth of research and clear explanation in this article. It gave me a new perspective on your topic.
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