Buyer Beware: Is Your PPE Approved for Use in Healthcare Settings?

Welcome to The Dr. Phil Klein Dental Podcast.. I'm Dr. Phil Klein. Dental professionals have faced challenges throughout this pandemic, and one of those challenges involves personal protective equipment. In some cases, due to perceived shortages and increased PPE costs, dental practices resorting to unfamiliar suppliers may be buying PPE that is not NIOSH certified. or for that matter, FDA cleared for use in healthcare settings. This, of course, puts both the dental teams and patients at risk. Today, we'll be discussing the agencies that test and approve PPE for use in these settings, how to access proper resources to ensure a dental practice is using approved PPE, and what criteria to follow when making product selections for PPE. To help us put this all in perspective is our guest, Mary Govoni. Mary is an internationally recognized speaker, author, and consultant. She has a master's in business administration and is an RDH and CDA. Before we get started, I would like to mention that Mary Govoni's webinar titled Buyer Beware, How Do You Know That the PPE You Are Sourcing Is Approved for Use in the Healthcare Settings and Meets OSHA Standards is now available as an on-demand webinar on VivaLearning.com. Simply type in the search field Govoni, G-O-V-O-N-I. That's Mary's last name. And you'll see it. It's an excellent webinar for every dental team member to watch. I strongly encourage it. Mary, it's a pleasure to have you back on Dental Talk. Thank you, Phil. It's a pleasure to be here. So we're still not completely out of the pandemic. Sometimes I feel like it's over and then we get, you know, resurgence of this and we get more news about these variants. And then I'm seeing more people getting COVID locally here than I've seen throughout the entire ordeal. But of course, they're recovering fairly quickly. But it doesn't seem like this is going to be going away completely anytime soon. So that's why this topic that we're going to be talking about today is so important and so relevant to our dental practitioners. Let me ask you this question. Why is it so important for dental teams to make sure that their PPE is effective in actually preventing disease transmission, which they're designed to do while providing their routine patient care? That is such a good question, Phil, because... Many dental team members just take it for granted that a mask is a mask is a mask or a respirator is a respirator. And if we buy them, they will work. And that isn't necessarily true. And because we are seeing more cases of COVID. And as you said, I totally agree. The cases tend to not be as serious, but the virus is. can spread more easily. So we're seeing more people. Well, if a dental professional gets exposed to COVID at work, or perhaps at home, they can't be at work. So that has a whole other set of issues for a dental practice with staff outages. But there also is the potential that if a team member didn't realize that they were positive for COVID, if they didn't have effective respiratory protection in particular, that they might be spreading it to their coworkers or worse yet to their patients because they work in such close proximity. So what we want is the safest environment for the dental team members to work in and the safest environment for our patients to come and receive their oral health care. Who are the agencies involved in approval of PPE for use in dental healthcare settings? This has been sort of an interesting education, I think, for dental team members during the pandemic. Again, things we sort of took for granted. The Food and Drug Administration is responsible for approving, and the term that's used is clearing or clearance. of surgical masks as class 2 medical devices so all of our guidance from the centers for disease control and prevention says that we should be wearing surgical masks when we're doing aerosol generating procedures and medical respirators medical grade respirators so those are cleared through the fda as medical devices and respirators additionally are certified by NIOSH, the National Institute of Occupational Safety and Health, which is a part of the CDC. And so if you remember back in the early days of the pandemic when N95 respirators were in such short supply. We were allowed through an emergency use authorization from the Food and Drug Administration to use non-NIOSH approved respirators, which are the KN95s that are manufactured in other countries, don't go through our U.S. approval process. But that emergency use authorization was lifted almost a year ago, so those are not appropriate to be worn in dental health care settings. Right. So it's really incumbent upon the actual dental office to make sure that their PPE is approved, not only for the fact that they want to be safe for their employees and safe to avoid any transmission from team members to patients, but also legally. There's legal risk involved by using something that's not approved if, God forbid, there is a case where a patient gets really sick and maybe even dies from the dental practice office. I mean, so this is very, very important. So how can dental practices be sure that the PPE that they're using, such as the gloves, the face masks, and the respirators, meet the FDA and NIOSH standards for use in their practice? Well, the first step in making sure that practices are purchasing approved and cleared devices is to... purchase them from reputable suppliers so the patterson dentals the henry shines the burkhart benko all of those companies they're responsible for vetting or making sure that the products that they're selling meet certain requirements as opposed to buying from an online seller and i don't mean to pick on amazon but amazon's the largest the world's largest online retailer and they are not dedicated to making sure that any of the products that they might sell to a health care provider actually meet any particular standards. Their responsibility, according to Amazon, is to their sellers, not to the buyers. So this is sort of a buyer beware. So I know it's frustrating and I know many people spend lots of time. online and on the phone trying to make sure that they can get supplies of ppe masks gloves respirators and and so forth and the temptation to go to amazon or go to other online retailers that they don't have a lot of knowledge about perhaps is is a great one especially since they're trying to save money you know we're all hit by the gas price increases and shipping costs and supply costs in general and so Many practices are tempted to just go to any source they can and buy the least expensive PPE, but not a good idea. So stick with your tried and true suppliers that you work with and make sure then when you get your orders, you can actually look on the masks. On respirators, they'll have a special stamp on them that's got NIOSH. registration on it or NIOSH certification on it. And there should be something either on the box or a package insert about FDA clearance. And if all else fails, you can go to the NIOSH website. And if you're concerned, you can look up and see if something is actually counterfeit. You also can do that on the Food and Drug Administration website to see if something is counterfeit or actually is a cleared device. Those are all great points that you've made. But as far as the dental distributors, it's still up to the dental care provider. Like all the responsibility falls on the lap of the dental care provider. So if a dental distributor, you mentioned Patterson, Shine, Banco, Burkhardt, et cetera, they may carry really high-end quality gloves and masks. Like some of the stuff we talked about offline, like Halliard, they make a great product. But they also may carry non-FDA NIOSH standard stuff, right? they may have gloves that are imported that don't meet those levels. Is that possible or they don't carry that anymore? That is always possible, but... know from working with many of these distributors that they make every effort to protect their customers they certainly don't want any liability from supplying products that are inferior so i would say that in this day and age anything is possible but it's much less likely that you're going to get counterfeit products or substandard products from a dental supplier than you will from an online retailer that does not specialize in supplies to health care providers. And when I say online retailers, I'm really talking about the Amazons, the what's the other one, Alibaba and some of those retailers. That's a great way to look at it. So what you I think a practitioner should keep in mind is they should buy these PPE products from a reputable dental distributor and also. make sure to go the extra step to read the packaging and make sure that the description of the product on the website clearly states that the agencies that you mentioned approve them, right? I mean, they need to do both. Right. And they should ask their reps. If the rep is coming into the office, then they can ask them. And I'm sure that many of these, because they're so customer service oriented, that they would do the research for them and make sure that they meet those standards that we have to meet to be safe. Now, what about office team members that are not in the operatory? Can they use less expensive PPE, the front desk? What's your suggestion on that? They could. One of the things that I suggested to a lot of the practices that I've worked with that still have a big supply of KN95s and they don't want to waste them, they can wear those at the front desk. Or if a patient, and we are still supposed to be asking patients to... a mask on when they come into the office, even though masking in other areas, other public areas, has been lifted, you could have patients wear them. The only thing that the CDC has said, which I totally agree with, because these new variants of the Omicron virus are so much more transmissible, I wouldn't wear cloth masks at one point. During the big surge of the Omicron virus, the CDC said that even the general public ought to think about wearing a KN95 or an N95 respirator for the most protection. But if they have, for example, a level three mask, doesn't have to be a surgical mask, but a level three ASTM level three mask, those would be fine for wearing outside the treatment areas or at the front desk. Do you have any suggestions for managing supply and inventory costs regarding PPE? I do. I wish I had some really, really super $65,000 answers to these issues. But one of the things that I think a lot of practices are trying to do is stockpile and get as many masks or gloves or whatever it is as they can. Depending on how they're stored, they may reach a point where they're not effective. If there's dampness or something in the area or it's too hot in the area where they're storing them, those products can degrade. So if you're going to buy large quantities, be sure that you have cooler, dry area to store them in so they don't degrade. And consider maybe with a group of practices. Starting or organizing into a buying club, look at your state dental associations. Many of them have buying clubs where you can buy in larger quantities or you can have automatic orders. This is kind of the every port or any port in a storm situation that we're in and trying to get. these ppe disposable ppe supplies at the very best price and as i said before rather than going to an unknown retailer and getting an unknown product go through the normal channels but you know negotiate negotiate with the dental suppliers again i have several practices that i work with that have formed their own sort of buying group and they'll buy in large quantities and the doctors split the bill and they do a pretty good job, I think, of controlling the costs. All good suggestions. Any recommendations on particular types of PPE that you know have that quality control that we're all so concerned about and that you're talking about today? I do. There has been a huge issue, of course, at the height of the pandemic in especially getting face masks, respirators, and gloves. And a number of companies, Halyard Health for one, has made a concerted effort to make sure that those supplies are channeled. as much to the dental suppliers as they have been to other areas of health care like hospitals and and medical practices because we have been at the very bottom of the food chain for a long time and so again halyard and Crosstex, Hugh Freedy, some of those companies, I think, have done a really good job of trying to make sure that there are supplies available to the dental profession that haven't necessarily been in the past. Yes, and we'd like to thank our sponsor, by the way, Halliard Health. And you can go online and look at some of the products that they have. I know the company, they do a tremendous amount of R&D and quality control to make sure that you're getting PPE that fits all those tight requirements to make sure that the transmission of disease is practically eliminated if used properly. And Halliard is H-A-L-Y-A-R-D. They have a huge position in the dental PPE space. Mary, it's been really great talking to you. I think this is an ongoing fluid issue. By now, I thought it'd be pretty much... over. I don't know if you agree that we wouldn't be worrying too much about COVID, although there's always diseases and viruses. That's never going to go away. But the COVID issue I thought would be kind of not a major concern anymore, but it still is. In closing, could you comment on where we are, where you think we are with COVID? Absolutely. Well, we are still in the middle of a pandemic. The pandemic, according to many of the public health experts, is starting to wane and I know that so many health care providers are especially in dentistry are just tired of it they want it done they want it over and there's a tendency now to not be screening patients not having patients wear masks but we still need to follow CDC guidance which says we still need to be screening and wearing N95 respirators for aerosol procedures. And it's very interesting, the dental community still views CDC guidance as voluntary, but I just finished a research project which shows that 40 out of the 50 states plus the District of Columbia have some... form of mandate in the dental rules that says CDC guidance must be followed. So we need to get over our bad selves and do what the CDC tells us to do until they tell us we could do and should do something different. Yeah, and we should all be following that regularly. Thank you so much, Mary, for all the contributions you've made to Viva Learning. Your information has been invaluable from the get-go, from when this whole thing started. You're still providing us with the latest and the greatest, and we hope to have you on more of these podcasts and webinars. Thank you so much and have a great rest of your week. Thank you, Phil.