Factors to Consider when Purchasing Respirators From Another Country

Factors to Consider when Purchasing Respirators From Another Country

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Hello. And thank you for attending today's webinar discussing. Factors to consider when planning to purchase respirators, from another country including, k95, respirators, from China a few. Housekeeping notes before we begin due. To the volume of attendees your microphones. Will remain muted however, if you need to reach out to us there are two ways you can do so please. Use the chat feature on your screen if you have any zoom related, technical questions. The. Q&A, feature can. Be used to ask questions, about the presentations, themselves though. Please note we will address all questions after, the final presentation. Today. A link to today's webinar will, be posted on the NIOSH and BB TL website and with. That I'd like to introduce our first speaker dr. Mary Ann D'Allesandro, director. Of the CDC's, National, Institute for Occupational Safety and Health national. Personal protective technology, laboratory. Good. Afternoon everyone and thank, you for joining us today in our webinar today we're, briefly going to discuss CDC, optimization. Strategies. For. Respirators. And discuss, the NIOSH and FDA roles concerning. International respirators. And here. Are some from some of our stakeholders on, some best practices, and guidelines from. These two user groups. Next. Slide. CDC. Recommends, a series. Of strategies to optimize supplies. Of disposable, n95, respirators, in healthcare settings when there is limited supply, so to get started today with the issues being observed with international. Respirators, I first, want to remind everyone that before, you move to purchasing. And using international. Respirators. It is very important, that you make every effort to consider, both, he conventional, and the contingency. Capacity. Strategies, described, in the posted CDC, covered, 19 guidance, these. Strategies include the implementation. Of effective administrative. And engineering controls and the, use of NIOSH, approved, respirators, including, filtering, facepiece respirators. Elastomeric. Respirators. And the, peppers that you see on the left-hand side of the slide additional. Strategies, include. Approved, respirators, that are beyond the manufacturers. Designated, shelf-life or, extending, the use of your respirator. Next. Slide. Users. Can be confident, that NIOSH, approved respirators, will provide the expected, level of protection there, are hundreds, of NIOSH approved filtering, facepiece respirators. In the market and users. Can be confident, in these products, regardless, of their country, of origin you. Can tell if your respirator is NIOSH approved, by locating, the approval, number which is indicated, by the letters T C followed, by a T for a for, these filtering, facepiece respirators. And a, series of numbers as you can see in the picture since. 2008. NIOSH, has required, the approval number, to be placed on the respirator itself, or on the straps it's. Important, to closely. Inspect, your respirator, in the packaging, and as, designated, in the picture on the right make sure the NIOSH label, is identified. And that the model, number is clear as well you. Can be certain that these devices are authentic, if you are purchasing, directly, from a manufacturer. Or, one of the reputable, distributors. You. Should be very cautious about random web searches, though in an eBay for example, there. Are some. Nonprofits. Out there who, have very good intentions but, are collecting, respirators, from donors, and distributing, them to healthcare, organizations. Who, may have respirators, shortages, while. I applaud, these organizations. For helping our frontline workers, be, sure that you check the authenticity of, these products, if you have not purchased them yourself, from, manufacturers. Or a reputable. Distributor, if you, are unable to ascertain. The authenticity of, the respirator you may have to use it as a mask or a for source control.

So. NIOSH has posted information, on our counterfeit, website that shows pictures of the products we found that are counterfeit, and these, products, have one or more deficiencies. And sometimes, it is difficult to, tell if the product is actually, counterfeit. So, if you go to those website, that website you can learn, more about that information, and see those products, that to date we have identified, as counterfeit, a recent. Science blog identified. Here, also, provides additional information about, some of these tips. Next. Slide. If. You, are unable to obtain a, not approved, respirator, and have no choice but to purchase, a respirator conforming. To an international, standard, we. Are very clear, in the CDC guidelines about. Which standards, are considered nearly equivalent to. Now n95, respirators, these. Include standards, from Australia, Brazil. China. Europe. Japan Korea. And Mexico. The. First point to note when. It comes to considering, the use of these respirators. From other countries, is the, fact that there are not approval, holders or manufacturers. Of NIOSH, approved respirators, who also produce respirators. Conforming, to the standards, in these, other countries and regions so. If you're implementing, this crisis, strategy, and are able to obtain a product, from a manufacturer. Who is announcer, approval holder we have confidence, that the respirator will meet the requirements, that they claim to meet the. Niosh-certified, equipment. List you could see at the bottom of this slide can be checked to determine, if a manufacturer, is a NIOSH approval, holder if. The, manufacturer, is not an approval holder you should follow several, more steps before making, a decision to purchase, as will be discussed throughout the rest of this webinar and you will hear from several other speakers. Many. Other steps are needed to provide the confidence, that you're obtaining a quality, product. CDC. Describes, these points, in our guidance and OSHA, describes, them in the, information, in their April, third enforcement. Guidance for use of respiratory protection equipment.

Certified, Under standards. Of, other countries or, jurisdictions. During the Cova nineteen pandemic, and another. Important, factor when considering respirators, from other countries, is that. Those respirators, have been issued in emergency, use authorization by. The Food and Drug Administration, if. The product is not on the FDA eua list it should not be considered for a purchase in healthcare, organizations. Until, a further discussion, with FDA takes place. And that, particular respirator, is considered, for, an EU a I would. Like to now turn it, over to dr., Suzanne Schwartz who is with the Food and Drug Administration, - the deputy director of the, office of strategic partnerships and technology, innovation, Suzanne. Thank. You very much Marianne. FDA. Shares, with CDC, NIOSH, an ongoing commitment. To address, the personal protective needs of health care personnel during the close of 19 pandemic, we, continue, to keep a strong focus on increasing availability of. Medical. Products, along, with conducting. Surveillance of the global supply chain, because. The, need for respirators. Has outpaced, supply FDA, is doing everything, under its authorities, to increase the availability, of these devices and, one, way that we do this is by issuing, emergency. Use authorization zouri. UAE's for. NIOSH, approved, respirators. As well. As certain non NIOSH, approved, respirators. That meet comparable. Standards, that can be used in healthcare settings. Today. We. Have reissued. The eua. For. Non NIOSH. Approved. Disposable. Filtering, facepiece respirators. Made in China this. Ei was initially. Issued on April 3rd in. The next few minutes I'm going, to summarize the changes. To this eua our. Rationale. For doing so and, additional. Public Health actions, that FDA is taking, working. In partnership. With NIOSH. We've. Had concerns, about the potential, for fraudulent products. Or, products, not performing, up to the standards, necessary for, respiratory protection. Identified. On the market, as K, n95. Respirators. And for, this reason we did not originally. Include, respirators. Manufactured. In China in the. EA that, we had issued in late March entitled. Imported, non NIOSH, approved, respirators. At. The time we also encouraged, importers, and distributors, to. Do their own due diligence and, take the appropriate steps to verify the, products, often to prior to importing. Particularly. Those, products, not authorized, by the FDA. However. In response to, continued, concerns, expressed over, respirator, shortages. Supply. Chain disruptions. And hearing. From health care facilities, who have been seeking, access to these products, we, issued, a separate, eua for, non NIOSH, approved respirators. Manufactured, in China on April 3rd at the, same time recognizing, the, importance, of putting in place additional, safeguards. Under. The April 3rd eua respirators. Manufactured. In China such as KN 95, which. Has to have met at least. One, of three, criteria to, be authorised. Criteria. One is the manufacturer, is a NIOSH approval, holder and FDA. Can. Verify the NIOSH, approval, numbers for the manufacturers. Other NIOSH, approved respirators. Criterion. 2 is. That the product, has a regulatory authorization. Under a jurisdiction. Other than China that, can be authenticated. And verified, by FDA or. Criterion. 3 that, the product, was tested by an independent. Test laboratory. Accredited. To, international. Standards and the, test report, demonstrated.

That Applicable, performance, standards, have been met. Working. Together with NIOSH, we've come to learn that a growing number of respirators. Listed. On FDA's, appendix. A that. Were authorized, under, this third, criterion. Failed. To meet the expected, performance standard. Of greater than 95%. Particulate. Filtration efficiency. When. Subjected to NIOSH. Testing, under its modified, version, of nauseous, standard, test procedure and this. Was despite, submitting. Passing. Test report results to the FDA in. Light. Of these findings today, the FDA has reissued. The EA, for. Non NIOSH, approved, respirators, manufactured. In China. Removing. Criterion. 3 of the April 3rd EA and, thus. Removing. All firms, from Appendix, A of the e way, that, were authorized, based, on submission, of an independent, test report. All. Manufacturers. And/or, importers. Impacted. By this change have. Been notified. Now. We recognize that many of these respirators. May, still, meet expected performance. But. Out of an abundance of, caution we. Are taking, this action. Some. Respirators, have already, undergone, additional, NIOSH testing, they've, demonstrated that. They meet the expected, performance standard. Of 95, percent filtration, efficiency and, they, are posted, as such on the CDC NIOSH, website, in these, circumstances the, FDA has added, the, respirator, back to, the new appendix, a. Firms. That have had their, authorisation. Rescinded. Because. They've provided test, report documentation. Criterion. 3 of the April 30 way but. They have as yet not been tested by, CDC, NIOSH, can. Consider, resubmitting. A new request, for emergency, authorization. To FDA, within. 45. Days of the, reissuance, of today's, revised. UA and, after. The product has undergone, testing by, senior. Yash and its, performance, results, are posted, on the CDC, NIOSH website, if. The product passes, a minimum. Of 95%. Filtration efficiency and, there. Are no other authenticity, concerns. The FDA will authorize the product, and listed, in Appendix. A. Additional. Changes, to the reissued, a way include, that. Submissions. Of new requests, for authorization can, only be made by manufacturers. Themselves and. Manufacturers. Should list in their request who, they're authorized, importers. Are and. Finally. Criterion. 2 of April, 3rd EA has, been changed, to reflect the, addition. Of Chinese. National, medical products, Association. Registration. Certification. Once. It has been authenticated, by. The FDA. The. FDA in, collaboration. With CDC, NIOSH is increasing. Surveillance, and sampling. Of all respirators. Imported, from China to further ensure that. Products, are performing, as they should. Respirator. Shipments, from China that come into the u.s. will, be subject, to random sampling. By FDA and, testing. By CDC, NIOSH to, determine, whether the respirator, meets the. Appropriate, filtration. Standard. Also. The, FDA is detaining, shipments. Of products, that CDC NIOSH, has listed, on its website as, not, meeting, their labeled performance, standard, the. Continued, surveillance and sampling, will, number, one inform. The FDA's decision to, allow entry of products, that meet the performance standard. Number. Two refused. Products, that do not, and number. Three identify. Situations where, relabeling. The products, for use as face. Masks, only, in, other words as source control, is appropriate. Those. Respirators, that fail to consistently. Meet a 95%. Filtration. Efficiency performance. Standard, as reported, on CDC. NIOSH a--'s webpage, can, no longer be marketed, or distributed, in the US as respirators. However. Again, they may be relabeled, as face masks, by the manufacturer. We. Also want to emphasize that a product, sales testing. It will not be allowed to be distributed, in the US as a respirator. Regardless. Of whether, it is in Appendix, A or not as. Part. Of FDA's, activities, we've released today a letter to health care providers, to make, these considerations, clear. For all healthcare facilities, that have these respirators, and their inventory, we've. Also posted, a, frequently. Asked questions, or FAQ, that walk through the considerations. And actions, I've discussed, today, next. Slide please. This. Slide includes. Links, to the reissued, eua the. Letter to health care providers the.

FAQ, S as well. As the, FDA, 24/7. Call center, that we have stood up for. Coping 19 response, I thank. You for your attention and I will now turn the, presentation over. To John powers who will discuss, NIOSH, testing. Thanks. Suzanne. Go. Ahead and advance, to the next slide please so. I, would like to start today by covering some basics. For evaluating, international. Products. The. First step, as we. Just heard is to verify that the, product you are considering, is listed, on the FDA emergency. Use authorization. When. Possible you. Should ask for samples, of the product prior to finalizing, the purchase. For. Legitimate. Companies, suppliers, distributors, this. Should not be an issue to, receive samples. The. Results, of the international, products that knowledge has been assessing are available, on a results, page I will, discuss the results page a little bit more on my next slide, NIOSH. Also recommends, that you purchase respirators, that, have traditional. Head strap designs, most. Of the filtering facepiece respirators. Being imported, have ear loops it is. Difficult to achieve a proper fit, with, ear loops. OSHA. Regulation. 19, 10.1, 34, requires. Employers, to develop and implement a respiratory protection program. When. Respirators, are necessary, to protect the health of the employees or, whenever. Respirators. Are required by the employer, the. Regulation. Provides information on, the proper selection of respirators, medical, evaluations, of employees, and training, just to name a few the, regulation. Also provides, guidance on fit test procedures. Appendix. A of this regulation contains. The fit test procedures, which. Lays out the eight exercises, that, must be performed, during the fit test. During. The Cova 19 pandemic, OSHA issued, a memorandum, temporarily. Suspending. The, annual, fit test requirement, as long, as the employee, continues, to use the same model style. And size. Respirator. That the initial, fit test was conducted for, if, a. Different respirator, is used by. The employee. The, initial, fit test requirement, still exists, and should, be conducted, by the employer, this. Would include switching, from a respirator with head straps to, a respirator, with ear loops.

Preliminary. NIOSH, assessments. Indicate, that it is difficult to achieve an, adequate fit, when, wearing respirators, with ear loops, several. Agencies have, attempted a fit test with air loop designs and how. Anecdotally. Told us that they could not get a passing fit factor. NIOSH. Strongly, recommends, that users do not purchase a respirator with ear loops without first, conducting, a fit test using, multiple people with. Varied, facial, structures. Following. The requirements. Of the. Approved respirator, protection program. Next. Slide please. Since. The beginning of April NP, PTO has evaluated over, 90 international. Products. Approximately. 40% of the products, achieved. A filtration efficiency more. Than 95%. This. Leaves 60. Percent that have filtration, efficiency of, less than 95, percent. So. I'll elaborate a little bit more now, on our results page the. Results page is an alphabetical order by manufacturer. The. Model information is, listed along with the international, standard, and the, maximum and minimum filtration. Efficiency a. Copy. Of the report that was issued is also available. The. Maximum, and minimum filtration. Numbers on the webpage are for the ten samples that were tested. The. Reports, show the results for all ten samples and, also includes pictures of the packaging, and of. The respirator that was submitted I, encourage. Everyone to not just focus on the filtration, efficiency numbers. But. To really look at the reports. Next slide please I. Would. Like to end my portion of the presentation by, pointing out a couple of ways you can evaluate, the respirator, manufacturer. Every. Effort should be made to purchase NIOSH, approved respirators, there, are numerous manufacturers. That. Make NIOSH, approved respirators, including, several in other countries, these. Can be found by using the resources available on, our website, the. Niosh-certified, equipment. List is searchable using many different terms for instance. You can select n95. Which. Will return every manufacturer, that makes NIOSH, approved and 95s. International. Manufacturers. Like to include test reports with their products, as we we just heard from Suzanne, every. Effort should be made to, verify, the testing. Laboratory that is shown on these reports you should, check, to see if the laboratory is accredited to ISO, 17025. Which. Is an internationally. Recognized, standard, for calibration, and testing labs, in fact. Our NPPL, Laboratories, are accredited to this standard. Another. Resource to check is the China national. Accreditation, service. For, conformity assessment better. Known as Cena's. There. Are several, several, respectable. Laboratories in China that are seen as accredited, you. Can also check the European, Union Commission website to, find accredited, laboratories. While. Documents, are a crucial part of verifying, manufacturers. It, can be difficult to know which, documents are real and which have been fabricated. Documents. Are very easy to falsify. One. Final resource I would also like to mention is our. MP, PTO webpage for counterfeit, respirators, and. Misrepresentation. Of the NIOSH approval. When. We receive a notification of, potential counterfeit products we.

Always Contact, the manufacturer, to have them verify, and validate the, information that we have receipts. Extras. That. We have added to to, this counterfeit, page, we. Always provide pictures to aid users, and spotting, these products, I. Would. Now like to turn the presentation over, to Christina Baxter. Christina. You're on mute. Sorry. I was talking to myself guys on you. So. I wanted to first. Thank John for passing, the baton over to me and then. Talk. To you guys a little bit about some of the experiences we've been having, in the field of the, problems, with trying, to validate, some. Of the masks that are coming in as you, can imagine there. Are a, lot, of different ones coming in for verification and it's not as simple as what, we're used to which is go to the NIOSH website, look. Up the mask and it's, there so, let's go the next slide and I'll walk you through some of the things that I'm finding for the different types so. This, first case is, masks. That are certified, to the European, Union standards, and so the standard that we'll be looking for here you, can see in the bottom in that teal block and that, is en1. 49. 2001. With. The update, from 2009. So. A couple of the things that you want to look for here and John. Brought this up earlier is first. Thing we want to do is verify the notifying. Body so. In Europe they use what are called notifying, bodies, that are similar to test laboratories, so if, you want to look at it in a u.s., context. For, respiratory protection that, would really be, nice. For, us but. If we're looking at some of the other PPE it might be underwriters, laboratory, it might be inter tech there's different, facilities. That we approve for different things same. Thing in the UK and in the rest of Europe so, what you do here and I always find the best way to find this website is just to, go into a google search that. Says European. Union Nando. Na, n do, and that. Is their website for, notifying bodies so. Then you can go in and there's multiple different ways to search you can search just by the name of the entity so if you have the name of the test lab just look that up or, the country, or you can look up by its number so when you see a mask that is marked. With a see e mark, it. Should have a number four digit number right next that is the notifying, bodies number, and you, can just look up that number and it'll tell you whether they are approved to. Certify. Against PPE so. Some of the things that we see. Most. The time I've seen lately is that sometimes, that seee mark that we're used to isn't. A CD mark at all and it's actually, what's called it's a fake mark called China export, so, if you look at the bottom right you'll see that, a c e mark, is a. Trade, mark that is specific. To the European Union but, what it does is the way it's always no matter how you spread, it out however you change its dimensions, the, inside. Of that see if you firm, if you made a perfect circle would. Actually hit the outside of the e if those, letters, are squished, together closer, then. You know that it's not the actual trade mark from the European, Union and, one. Thing that we want to do is make. Sure that we look for that C e with, four numbers after it that's a common pitfall that people have if they. Have a mask and it does not have that on there then it is not meeting the, labeling, requirements from the European Union things. To look for make sure that notifying, body is approved. For, doing. Personal, protective equipment so. Verify. The EU, type examination. Certificate, and I'm going to get to this one a little bit more and then, verify, that. They're on the FDA exhibit, one which is for the other, types, of masks that are not China that's under Appendix. A so.

Let's Go to the next slide and I'll, show you what an examination, certificate, looks like so, in this case one. Of the things that I'm seeing more often than not is. Something. Called a certificate, of compliance, and, everybody. Seems to be providing these with their masks, but they actually mean nothing there is no legal authority, to a certificate, of compliance so. It does not mean. That it is an EU type, examination. Certificate, and that is what you're looking for in terms of. How. Do you prove that it's real so, you want to get the EU type examination. Certificate, you, want to be able to go to that, agency that did the search vacation, search. For them make, sure that they are a notifying, body for the EU regulation. 425. Which covers all PPE, and, then. You go further in and make sure that they can certify for respiratory. Protection equipment. And the. Biggest thing I see with all of the European Union, products coming in is this. Fake certificates, and these certificate, of compliance is which are well. Nice to have mean, absolutely, nothing so. Let's go on to the K + 95 experience, of the next slide. So. In terms of K + 95 s John brought this up but, there's a website for the China national, accreditation service, for conformity, assessment and, if, you look up see Nass just. CNAs. You. Will find this website the. Nice thing about the website is I have. A picture of it there in the top left if you. Focus, in you'll see on the top right there is a column, that helps you find an accredited, body very. Similar, to the experience, you would have with the European Union it lists. All of the people who are accredited to. Verify, PPE, for them, and this, is where you're going to find a lot of your mistakes that, people are making fake certificates. And they're not finding, an accredited laboratory, now. Right now because, of so much problem, in this area see, Nass has made it really easy for us so that second red circle you see when you go to the website that is, a direct, link where they have packaged, up a list of, every. Accredited, body in the. Cns Network in China that. Can do any of the PPE assessment, so that list is divided out by, respiratory, protection. Gowns. Gloves. Goggles. So. A section, for each one of those things so it's a fantastic, one-stop. Shop for you to go and look and say. Does. It pass, that first sniff test so. Now one. Other thing you're going to do is once you find out that you have the mask and you find out the basic information, about it one of the hardest, things actually to find is the manufacturer, name so. Find that then. You're going to go to that FDA, appendix. Which was updated today, as Suzanne told us earlier and bear. With us all of that was occurring just, today, this morning prior to this call so, we did not have enough, time to make any detailed, information for you but, you'll be able to find all of that on the FDA website, one. Thing that I want to remind everybody of too is, you'll. See certificates, saying FDA, registration. Now. One thing we want to everybody remember, is that an FDA, registration. Does. Not mean it's an FDA clearance, and, it definitely does not mean, that it's allowed for use under this you a UA that they have out so. You have to make sure that if it's, a KN 95, and it, is not made by a NIOSH. Maker. So like 3m, some, of the other ones that make products. They. Don't have a standard, FDA clearance which means they'd show up on the NIOSH, website, then. They, have to be on this Appendix A for, us to use and that just. Gives us the assurance that, NIOSH. Or some an FDA, have done their due diligence as well to. Help us make sure that we're, gonna have the safety we expect, with the product and one. Thing that we are seeing left and right are fake certificates, and this is pretty. Much when, I review, these I would. Say right now at about 90%. No. Success, rate meaning that at least 90% of, the masks, that I am asked to evaluate have. Been fraudulent. Information, can't. Say that that means they don't work but.

I Can say that it means. We. Can't tell you because. We don't have the data now. One, thing I also want you remember there, are gonna be three different markings. You're gonna look for for in the Chinese realm of for, filtering, facepiece respirators. The, first is the GB one, nine zero eight, three -. 2010. I want. You to imagine that to be something like an FDA. Cleared. NIOSH, approved, mask okay, that one's made for the medical, community. Where, if you were to get. Body. Fluids flashed at you it would have resistance, to those body fluids then. You have the gb2, six to six which. Was updated, in 2006. That's most, common, and that is more of an industrial respirator. May. Not repel. The body fluids some. Of a might and. Then you have the G B to six to six the 2019. Version, which is just coming online right, now so. You'll see some 2006. In some 2019. Depending. Upon when they were tested, so. Let's go to the next slide and. Here. I'm gonna talk a little bit about. The. Forgery experience. And there's, one thing that can. Help us here. And that, is verifying. The Chinese business, license, and I'm not going to steal, the thunder of Luke and Danny coming up because they've done some fabulous work on the. Validation. Of the Chinese businesses, and things but, the way I do is I go to this website and the. Website allows, us it's called the national enterprise credit, information publicity. System, and it's. A website in China that allows you to look up business. Licenses, and a couple of things that I like to go through and then. Look. At here is the Chinese company, name so, just. Make sure that the name on your products, and the registered address match, what you've been given okay, look at the incorporation, date if something was incorporated. Just in 2020, I'm, not sure that they've had enough time to build a process, that is going to be ISIL accredited, like, Jon told, you about for terms of the quality assurance make. Sure they're registered business, scope is in line with what you're looking for the, ones I was just reviewing earlier. Today the. Registered, business scope is for a tool manufacturer. And so I'm not sure that they really have the scope or the capability, to make respiratory, protection and, then, a really, important thing is look at their registered, capital how, much money do they bring, through that location and are they able to front enough money to be able to make and procure, the appropriate, materials, to make the masks, because, you surely don't want to give them all your money upfront so. Some of the common forgeries, that we see is that the company names not even a registered name in China the. Establishment. Eight's don't, match that you see it as an establishment, date might say. 1996. But were in 2020. And they've. Just forgotten their business license and then a lot of folks will change their capital, to make it look like they, have the ability to procure the starting materials, when in fact maybe they don't so. Let's go to the next slide. And. This. Will bring us over to the Australian, New Zealand ones and I didn't cover all the different types of masks, I just covered the ones I've seen the most and in, this case it's. Almost like we're back to our NIOSH experience, where we have one-stop shop we one place to look in life is pretty good in this, case you just go, to the. Australia, New Zealand standard, is 1716, it was, updated in 2012. And it's, soon gonna be replaced by the ISO 16 900, but, the thing that we can do here is go, in and verify the five Tech's standard, mark so we're, in the US we go and we approve, make. Sure the NIOSH markings, are correct in this, case we go to this Web site in Australia, which is sa I global. And verify. The product, certification. One. Thing that we do see a lot is that the product labeling, is a. Problem. But. On their. Requirements. It can be either on, the packaging, or on, the filtering facepiece respirator. And then, I'm also seeing quite a few fake certificates, coming from there as well so. Let's go to the next slide and. What. I want to remind you in this final slide is. That. This is a continuous, process so. As we start assessing, the. Issues, that we're having we. Need to assess that level of risk and make sure that the people that we're procuring, the, materials. For have. The risk assessment. Which then associates, it to an appropriate level of respiratory protection, then. We need to go through and verify that the chosen product, is certified to meet that necessary, level of protection if you, can't verify it through your standard, searches, as well, as they're not a NIOSH. Holder. I would recommend, that you then go and see, if you can get ten example, products, and provide them to NIOSH, and have them test them for you that will give you the level of protection, that it's, going to provide and then, you can follow that up with a fit test to ensure that you're going to get the protection you need one, thing that we are seeing quite often is that most other countries allow, an ear loop design that.

We Don't allow in the US which, tends to not give us as good as a fit especially. If that face, design was, not made for the average American. Sized face and then. Remember, operate, following the best practices, and keep. Doing that assessment product, as you go and the one thing that's really important, to remember and I think really comes home when you look at that NIOSH, website. That is about. International. Mass that they've checked, just. Because it's a fake mask meaning, it's fraudulent in its markings, or it has stolen somebody else's numbers doesn't. Necessarily, mean it's not protective. But. The problem, is that it does bring up is that we have no idea if it is or if it's not until, it's actually been tested so, just keep those things in mind as you move forward and I'm, gonna pass this over to Luke. And have, him start talking about the great work they're doing over at his place. Hi. My, name is Luke, Basso, I'm the chief of staff of the Indiana Economic Development Corporation. Here. In Indiana and seven. Weeks ago governor. Holcomb tasked. Us with, buying. PPE. For. The entire. State during the kovat crisis also. Be joined here in a few minutes by Danny Chan Danny, is a consultant. Who does, a lot of work with, Hong Kong and China who. Has helped us develop some best practices, when. It comes to buying respirator, masks, next. Slide please. So. In Indiana one, thing that we've learned and I think some we've heard today buying. Respirator, masks is not an exact science. In. Fact you. Know it's as you all know it's a very difficult thing so we established early. Some very baseline. Guiding. Principles, that we would use, when. Searching for respirator. Masks the, first one being you know a bad deal is a bad deal if. You wouldn't have done it prior to Coba 19 why would you do it now you. Know I'm sure like everybody else we get a lot of sure to, make deals to put money up front if, you don't buy now the mass go away well, you know. During. This admit during this time with this immense amount of pressure to buy you, also have to realize that bad, deals are bad deals, in. Dealing. With in. Manufacturers. In China or groups in China you also must be willing to walk away at the last minute we. Always sell ourselves the deal isn't done until the sort of document is signed we've. Walked away from deals at the very last moment because, something, has felt off about the deal and it's turned out to be right. We, asked a a enormous. Amount of questions and, then we ask more questions and, they're the same questions, we, have a minimum three. Contact, rule in Indiana before we can make a deal. You. We must must. Hear the same answers they must be. They. Must be right for us and if they're not we walk away from the deal we. Also speak. Directly to the manufacturer, and we make sure we're, speaking, directly to the manufacturer, they have to call. Us directly from their facility, we. Do not or, we, have to be able to call from them and they have to verify that, their, facility. Is. Who they are and who they say they are and. So they also wanted to bring up third-party. Vendors or, as we call them third-party scams there, are some people out there that the third-party vendors that are legitimate and helping, out but a majority or not this. Is not a world where you can hop in today and go. Out and buy a lot of masks in fact these, third-party vendors and third-party scammers, are the ones who are really hurting all. Of us as we go through this so I can't stress enough today that, in order to really defeat the this type of scam and these type of people we have to come. Together as a group and stop accepting, third. Party scammers, and, buy a mask from them I'm. Sure we've all had these phone calls we've all had these emails, you.

Know Again. Ask yourself if they're part of a multi-million, dollar. Medical. Organization. Why are they emailing you from a gmail account if. They. Have, access to medical supplies, why. Won't they put the money upfront to buy themselves rights. Mostly because they've never done with this group and they've heard it from somebody else and said hey I'm gonna try this today next. Slide please. So. On. Every, mask. We have we. Take samples. So, one of our sorry I forgot to mention one of our other guiding. Principles, is we, don't buy masks with ear loops, now. We've, dealt with a lot of people who said they'll they'll send those masks that go behind the head or the respirator excuse me that go behind the head but, as soon as we get those respirators, we realize that they are over. The years but we. But. So we do, not purchase respirators. That go over the years but, we do ask for samples and, if, they aren't willing to send the sample we will not do business with them and. Once we have the sample we do our own fit test. It's. Partly, why we think that we've, developed such a great process because we do the the fit test with, the smell of smelling salt that makes. You cough when. It's not a real respirator, or real fabric we, let our doctors take a look at the respirators. We. Have. Them compare. It to stuff they use in the emergency room every day and, then we also evaluate, the boxes, but this is becoming harder and harder and, harder as the boxes. Are becoming the next level of the the counterfeit, world but. You can still see minor differences, and you. Must be willing to take the time to evaluate all this, if. You don't you will get caught with some counterfeit masks I'm now gonna turn it over Danny Chan who will explain the rest of our process. Next. Slide please great. Thank you very much, my name is Danny Chan I've been helping the state of Indiana for about six weeks previously. I lived, in China for over a dozen years working. In private equity spending, a lot of time on due diligence evaluations. Of Chinese companies for. The past six weeks I've been spending about, 11:00 p.m. to, 5:00 or 6:00 in the morning speaking, to Chinese manufacturers, and Chinese sellers one. Of the first, things I want to talk about is as you guys go through this process of dealing with companies in China it, would help to kind of have, a philosophical change, so, it could feel like whack-a-mole where, you're trying to go through a checklist of a thousand items but. It's very important, to understand, philosophically. That when you deal with Chinese businesses, that they just have a different, set of rules. Of engagement, so, looking. At documents asking, for those things great all these things are great but those are more us, centric business practices, from, a philosophical standpoint, you need to treat or I would recommend, you treat every seller from China as a no, and having, them work up to get you to say it yes because if you going up front and say here's the doctor the things, that's, exactly, what they know we look for so they'll always have what we look for so you need to spend a little bit of time, philosophically. Going, into every deal going it's a no and you have to prove to me that it's a yes and so, for Luke and I buying for the state where. The first line of defense and very likely the last line of defense so. All the upfront work that you're going to do is going to mean a lot ensuring, that you get the legitimate. PP that you're looking for and, it's conducting, a lot of due diligence making. Sure your counterparty, is going. To be correct asking. For documentation, and standard operating procedure, we ask for documents, not, that the documents, mean a lot but you do it because you go through that process you ask for samples and I, should go through this course Luke touched on these third-party, sellers. Some of them are American medical companies suppliers, they're, very aggressive they're, very smart they, use high-pressure, sales tactics and, sales methods that get you to commit and all, of us helping the states and other organizations, we're all doing. Our best to get the PP gear and sellers. Know that so they're using a lot of sales tactics, so you need to be disciplined and kind of filter out that noise to. Not think about those things, regardless. Of these sources I often, often, actually I shouldn't say often but we 100%, have to speak to the company so, the manufacturer, in China we will not do anything unless we can speak to them that's, going to help you eliminate some, of the sellers because some of these sellers are buying or sourcing.

Gear As not, even the second or third middleman, it could be the fourth or fifth so, they have no access to the actual factory or company in which case asking. To speak to them is going to have a good, effect of eliminating some people now. For, Luke and I we had an experience with n95. See CDC. NIOSH seller and so, we asked to speak to the company the person we spoke to at the, end of it I asked her a business card it was a digital business card with no company. Email no company phone number and more. Than like that person didn't work for the company so, having somebody pretend, to work for a legitimate company is something that could happen and, so this is again why we have a lot of precautions, in there to, make sure that we're actually talking to the right person at the company that we're talking to and you, know as you go through and make these transactions. With Chinese companies know that the, repercussions, of a bad deal there's, probably not much you can do and so. Again, asking. A ton of questions the, people are gonna say you're being too diligent you know don't you trust me the. Answer is no we don't trust you but you need to earn our trust so, American. Side we don't deal like that but when you deal with the Chinese companies you have to make them earn your trust the, trust is not built in and they understand our rules of engagement, I think it's very important as American, looking. For PPE gear that we need to understand, more about China's. Rules of engagement, the businesses, and the companies as. You go through the. First group I want to talk about real quick are the n95, makers, so the CDC NIOSH list I think, those eight or nine companies are the gold standard the. Difficulty, is a lot of people are running around saying they have access to those and the answer most likely that they don't and so, you have to figure out how to get direct access to speak to the manufacturers, I find, it very unlikely, and difficult, that, they will let you or have access speak, to them so if they cannot then, you shouldn't buy you should just move on to the next there, are anecdotal. Evidence of people being able to obtain n95, from China and reselling them but usually those people are, connected. In some way to the company and it's. The they're not easy to find and they're not out there calling people to sell because there's a network of people that know how to get a hold of them so if they're n95, from China you just want to be really. Sure that you can actually talk to the company because if you don't talk to the company then, you have no idea if it's real or not and it's going to sound too good to be true and you just want to be really, really careful about that list and then, shifting, gears. Really quick to the K. N95 next. Slide please. The. Cans right now are the wild wild west the, cost of the fabric that goes into the KN 95 to create the respiration it's, gone up from 6,000. RMB a ton to 780, thousand, RMB a ton so, that's about fifty-two dollars a pound up from about 70 cents so the cost of the actual Muriel has gone up significantly and, so. If you get pricing, that's way too low there's. Something wrong if you get pricing way too high doesn't, mean that it's real it just means they're making a lot of money probably more than they should but, pricing will give you some indication on, how real it is because if the deal is too good then, you know there's a problem because there's a market price for this material and when. You look at the cans the, most difficult part of the cans are you. Could have a mass that passes the fermentation test, so if you take the mask you send it to the CDC, they test it it's, 97, percent that's, great the men you put on your ears you, do a fit test it, doesn't work so Indiana we've done these fit. Tests and if they're on the ears you will or at least the tests that we do you'll start coughing and you'll, start choking off at the fit test so that's, one of the things we do here and it's important that you guys do that as well I don't know as John, Powers mentioned earlier I don't know how you can have your loot. Legitimate. K95, fabric, mask that passes the fit test and so, that's something to be aware of is that even if the fabric is, good with, the ear loops you're, not you're more than likely not going to pass the fit test there's.

Been A couple companies in China that are moving to doing head straps the, problem that I understand, is the head straps require different machines from the year loose and that those machines are not in high demand and so, people are trying to get them right now because they understand that American, buyers are, starting, a request head loots which is good but, at the same time there's going to be a delay from when they can have it so, you just want to be really really careful that you. Know you're getting things I can pass the fit test because even if it's good material if the fit test doesn't pass then you have to ask yourself you know where are these masts going to and you. Know what where is it going to where is it going to go you just have to be really really careful about that and then. Some, of the other things that to, kind of anecdotally. Ask is. Companies. In China when they change from one industry to another they, have to do a change on their company registration, so there, was examples, of a few companies that used to sell iPhone, phone. Cords they switched into making respirator, mass about 60 days ago so, you should ask them provide, documentation, of your. Company registration, when, did you change did you just change to make people year when did you do that have. You sold to US companies show me company that you sold to gives. Me custom, documents, that you've actually shipped from China and that land into the u.s. who. Are some of your American customers, let me talk to them and these, are things that I would ask the Chinese company, as a post in the middlemen because the middlemen more than likely will have every, answer that you want so, it's important that you get a hold of the actual seller because many of these sellers don't. Think there's any repercussion. If they sell bad, things to America so for them you, know many of these factories in China right now they're switching to PPE gear are having, problems in their main business so they're moving a PPE gear as a means of survival and, if they're trying to survive they're, trying to make a profit they're. Probably not going to care about quality control they're, probably not going to care about what, any, American buyers gonna do to them six months or a year from now so it's very very important, that. As you look at these Chinese companies that. You look for ones that have financial strength, and the register, capital, system in China is different from the US you, set up a US company its par value you. Have a company that you create, four thousand dollars and you raise money or you put up your own money in China, the system is different on registered capital what, register capital means shows, how big your company is from the beginning it affects your ability to borrow from the banks it affects how people abused your company so it's a very good reflection if, you have a company, with a small amount of registered capital let's say a million US and you, put in a 2 million dollar order for masks they're, gonna need to put up about 1.7. 1.8 million dollars worth of cash to buy the fabric, because the fabric right now you have to pay upfront and this, is exactly why they're asking the buyers to front half the money so, they take half the money go. Buy fabric, or put a order for it and then they end up getting the other half so you're basically fronting, the entire transaction, but. What happens that the price of the fabric goes up which it has are, they gonna go in their pocket and put. Up the money that is the difference to get you legitimate, masks are will, they blend legitimate. Fabric with fabric that's not so legitimate, so, that your permutations, going to be lower all these things you have to ask yourself, as you go through this process because, if the company you're buying from doesn't have financial strength then. If any change in the price of the fabric goes you're, gonna be out of luck and there's, not much you're gonna be able to do so it's, very important, that you look at the counterparty, and ask, yourself is this the kind of company that you want to do business with for what you're trying to buy I think it's very very important you look at that and what I first mentioned the call is philosophically.

You Have to be, very distrusting. And have. Them prove to you that this is somebody you want to work with we. Also always, ask for the Chinese, companies owners, ID, and passport the. Reason we do that is once they give you the ID and pass for it they know that, you know who they are and so it just adds a little bit of a layer of nervousness. For them because right now a lot of the middlemen are insulating. The Chinese sellers going hey listen I'll take care of it just give me the masks you need to take the control out of the middleman and deal direct with the Chinese manufacturer, I know that's not easy because you're gonna need a Mandarin. Speaker and somebody. Who's Mandarin speaking that has done business in China just speaking the language is gonna be fine but a lot, of these factories they know that if you have someone on the phone who just speaks Mandarin but does not in do business there they, relish that so, I just caution that you know you don't want to just get anyone you want to just you know if they speak Mandarin it's helpful but just have that mentality of they, need to prove to you the. Buyer that they're, gonna be a legitimate, counterparty, or the chances of them being a legitimate counterparty, is higher and this. Is why we don't do upfront payments, we don't do escrows, we, make sure that they have the financial strength to pay for the fabric and that we're more than happy to pay once, we know the products fine but we don't front money for people to go do the. Purchasing, of the fabric because that means they don't have the financial strength which. Makes it very very, nervous. From a buyer standpoint, and, so. That's. All I have, there's other best practices, that we're working on but it's important, when you deal with the k95, to, ask questions, to, ask again to. Not get pressured, into it and just. Make sure that you know you, really think about it and really, really think you know is this the company that's going to come through for and also, the middlemen company you, want to make them on the hook so if the middlemen is coming in you, should say if I buy and something goes around you the middlemen are financially, responsible as well as the Chinese factory so you'll not see if you can get them into some sort of three party agreement where all you, know the other two sides are responsible, something goes wrong and again you. Want to make it so that you're such a hassle that if they're up to no good that they go you know what I'm gonna go find another buyer that's. Basically the philosophy. That you want to have is you want to have them go this is too much work I'd rather go find another sucker and if you do that then you, get to move on to the next seller, which is hopefully the legitimate. That one that you're looking for, thank. You guys very much. Thank. You Danny. So the. Last slide here is talking about the fact that NIOSH, will continue, to prioritize the, testing, that we have been doing, according.

To The scheme that you see on the right hand side, we. Will continue to work with FDA that is the first priority in our testing, because, this testing, will help the FDA and making decisions, and putting. Information on, to the EU A's it is not the only decision, but. It is an input into FDA's, decision in, making those EU. A's, priority. Two is working, with other federal government, agencies, as we. Are seeing these products, that are not conforming. To the standards, they claim to meet, we, are providing. That information to. Agencies. Such as the FBI the, Department of Justice, and US. Attorney general's offices, and FEMA and, DHS, and those, agencies are looking at what actions, need to take place next so, we are very involved in those, with, those organizations. As well we. Will continue, to provide, this service to state government, agencies as, well looking. At products, that not previously evaluated. By NIOSH and those products, previously evaluated. By NIOSH and finally. Our, fourth priority, will be to continue. To provide FFR users, this. Service as long as that product, is listed, on an FDA eua, I, want. To mention as John, did earlier that every, product, that we evaluate, is listed. On our website the results, in the test report and the, pictures that we do receive from, those submitters. Next. Slide. Here. Are some additional resources that. You can. Reach. Out to if you have additional information all. Of the FDA e UAS that Suzanne mentioned earlier, and then, we have some additional resources as. Well recently. CDC. Posted, the. Information. On factors. To consider when selecting an, International respirator a lot, of the contents, of the webinar, today is listed, on that product. That's on the website and there are some other products. As well that you see here. Now. I would like to go, to the, Q&A, s and reach. Out to the. Individual, speakers, to, answer, some of the questions we've, received online. So. The first one I want to go to is looking at Danny. Or Luke, if you, could talk about a, little bit more about how. You verify, you're working with a manufacturer, since, it is typically. Typical. In China that they were that, there are other agents, and they don't have their own sales force at the factory how do you know you're working with a manufacturer. Um. When. I guess for the IDS, what, I can do is in some different provinces. In China you can pull their shareholders, from company, records similar to how we have the secretary of state system so, we grab the shareholder list and then we look at the ID they send and make sure it's the same person and so, that's one way to check and then when we talk to them we, spend a lot of time talking and letting them understand, and then additional, checks we could do is we can call the local government, in China and say, this is what we're doing can you let me know what this company looks like and again this is not easy for most people to do but it's. Possible, if you have the resources to do that but. Um the, ID coupled, with the company registration, that helps that, helps and then again it's just asking just. Asking questions you know again you're being investigative. And how you're approaching this so you don't want to go, in there with okay, I think they're real let me check you want to go in there with the mentality, that this is not real and you have to prove to me and again, just, by having that attitude a lot of people a lot of the sellers just go away because they don't want to deal with it and so if they're not willing to deal with it then you're asking yourself do you want to buy from a company that won't even spend, the time to prove that they are who they are. Thank. You Danny the, next question is for John powers John. The. Question is what action will not take, to protect niosh-certified. Products. If we, identify a counterfeit, product and we advise NIOSH, NIOSH must take action to stop the sale of these goods.

You. Oh as. I said before, the. First action, we take once, we get a notification is. To. Contact, the manufacturer, so. As you can imagine with. The time difference between the US and China everything's, delayed, by a day so. We, will send the information we have to the manufacturer, we will ask for confirmation. They. Typically. Check and get back to us within a day or two if. They. Tell. Us that they believe it's counterfeit, then we post it. We, also, you. Know we have we. Have some manufacturers, that have sent us a. Lot. Of pictures of what the what, the actual product should look like little, nuances, of the box little. Things to look for. That's. The information we've been working with the. FBI and. Department of Justice and, those folks on to, try to find, these products, that are out there and being sold, but. We if we do find a non conformance. To the NIOSH approval, we, will then. Work. With that manufacturer. Through internal processes, that we have, that's. Within the guidelines of our regulation. To. Have, that manufacturer. Correct, those issues. Thanks. John you can stay off mute because, the, next two questions are for you as well can you explain the private, label, field. In the, NIOSH approval, I. Will. Try my best, so. So. The example. This is going to be a manufacturer. That, makes, their. Own product. We'll call it product, a. And. Then they're approached by another company, and they, say hey we love product, a would you make that and put our name on it so. They say sure they, submit it to NIOSH we, look at it we. Issue a, concurrence. To, that private label, and. Now you have product, B, and. Then that continues, so they're they're approached by another company, approached by another company and so, basically it's, a very similar product. With. Different. Labeling. I kind, of think of it as a brand name you see a lot of the so I have a lot of the international, products that we get requests for people. Say the manufacturer, is X and you, look at the pictures and you notice right away that X is a brand name it is not the manufacturer, of that product so to, to me I think it's similar to what you would see as a brand name on the respirator. So. Hopefully, that answered that one yep. Okay thank you and, MIT, has recently published results, of a test performed, on a number of KN 95, is this a reputable, study. This. Is a reputable, study and I, actually, had. About, an hour phone call with MIT. Two, days ago. So, they they, not, only have, they, been. Performing, these tests, for the, state of Massachusetts. They. Did tell me that they. Tested. Five products. That we had on our webpage, and. Verified. And validated that. They got the same results, that we got, which. Was very good news we. Are working, with MIT we, are going to try to. Link. From, our page to, their, results, once. They get something up they. Were still working, working. Through, their. University. System, to figure. Out the best way to get their, results posted and. Once they do that we, can link to them and, they've agreed to link back to us so that'll be another source. Where. People can go and check results, for other international. Products. Thank. You John this. Next question is for, John. Cristina Dani and Luke and I'll ask you each one at a time to respond, so the question is are all K n95.

Respirators. Ear looped and I'd, ask you all based on what you all have seen in your testing, and evaluation, so John first. So. We. Do. See. Very. Few I don't. Have the numbers in front of me but. Are some, with. Head, straps. At. This time on our results page it's, not easily, visible. To. See that we've talked about maybe updating our table, and. Putting. You know heads track or ear loop but, it is in the report, so. Unfortunately right now you'd have to click through all the reports and see if it says it's an ear strap, head, strap design or an ear loop design, there, are only a handful, out of the, 90, Plus that we've done. Thanks. John Cristina. I'm. Seeing the same thing very few, that are using two head straps almost, everybody, using the ear loops and. The. Fits are just atrocious, with most of the ear loop designs so it's still holding up true that the ear loops are something we're trying to avoid thanks. Thanks. Christina, and Danny, or Luke I. The. Answer is yes like from what, I've seen most of the 1095. Our lips, and it's. Very. Very very few our head straps I mention, a little bit earlier a lot of the people in China are trying to buy the machines, to, make the KN 95 head straps, there's, a it's, very difficult to get those machines because, the. Can they're just ear loops so for them to switch I think we're gonna see a delay I don't know how long that delay is gonna be but at some point maybe. They're able to get, the ear loops on and catch up but for now it's a lot of manufacture they're working on trying to do that but it's very difficult, to get the machines to. Make that you're the head straps and to make sure they're strong enough so when you put them on it doesn't pop off. Thank. You Danny. Yeah. That was Danny oh. Thank. You Danny I agree, with the other three. Okay. Thank you. So. Other question here is it is not on the FDA list which is real short now but NIOSH tested, it and it's greater than 95%, can. We use the.

Respirator, As long as it fits. This. Is Mary Ann now answer that question, so if it's not on the FDA list, and it, cannot be used in health care environments. However. OSHA. Does, have these, products, listed, in their, regulatory. Memo. So. It is possible, to use them in other, industries. However. OSHA, now is just saying if they authorize them to be used in other industries, but as, of this time OSHA. Is only having, their guidance out there for, health care is my understanding. Another. Question, here. How. Do they get away and then Christina I don't know if you have any information, about this. Not. Sure if someone from the US could answer this but how do they get away with having, a logo, that is so identical to the European conformity, logo can there be legal, action taken, for. Masks that are labeled with a fake ze logos. So. This. Comes into the trademark, process, in a, trademark is what the Cee logo, is and, when. You submit. For a trademark you actually submit the exact, spacing, of your letters the colors the, looks and, what. They've done is, they've just changed one thing which, is the, distance between the C and the e and, that, means that it's not a trademark, infringement anymore because they have changed that size they've. Made it look as close as possible but, in terms of a trademark, infringement would be the. Process they'd have to go after and there's, really nothing. They could do there because that's it's not infringing. On their trademark it's slightly, different, in terms. Of them going after mislabeled. Products. They. Can they, will they, have different, websites, that lists all the ones that they find so as we find them we try to send email saying hey this. Is what I found and they start updating it more and more and I. Think. They're just doing the best they can at, this point in time because reality. Is, it was a non-issue, in. 2019. It's. A huge issue in early, 2020, and at, this point everybody's, trying to just, make sure the right product, gets to the right people, versus. Worrying. About how, do we go after the people with the wrong products but rest assured, everybody's. Planning for the future of going after and making sure that this doesn't happen again Thanks. Thank. You Christina this, next question is for, Suzanne. And it, goes along with what I said earlier about the fact, that NIOSH, testing, is one step in your process but. The. Question is now Josh tested.

2020-05-19 21:13

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