Infection Control Expert · American Dental Assistants Association
American Dental Assistants Association · American Dental Hygienists Association · American Dental Association Council on Dental Practice · Organization for Safety Asepsis and Prevention · Academy of Dental Management Consultants · Dental Compliance Institute
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Mary Govoni is an internationally recognized speaker, author and consultant on clinical efficiency, ergonomics, OSHA & HIPAA compliance, infection control and team communication.
Mary is a past president and a life member of the American Dental Assistants Association, a member of the American Dental Hygienists Association, a consultant to the American Dental Association Council on Dental Practice, a member of the Organization for Safety Asepsis and Prevention, the National Speakers Association, and the Academy of Dental Management Consultants and the Speaking and Consulting Network. She is featured speaker on the ADA Continuing Education and Lifelong Learning seminar series and the infection control columnist for Dental Economics magazine.
As a nationally recognized healthcare risk management and compliance expert, Linda Harvey assists dentists and teams navigate regulatory requirements. She is the founder and Chief Knowledge Officer for the Dental Compliance Institute.
During the height of the COVID crisis, Linda and her team spent countless hours coaching clients through all the updates, questions, and concerns. She also draws from real-world experience, having worked with offices that have undergone HIPAA, OSHA, and Infection Control audits.
Are you compromising patient safety and your career longevity by purchasing dental PPE based solely on price? The rise of online retailers and lesser-known suppliers has created a minefield of counterfeit and substandard medical devices that could expose your practice to significant liability.
Join Dr. Phil Klein as he explores the complex world of dental PPE procurement with two of dentistry's most respected infection control authorities: Mary Govoni, internationally recognized speaker and past president of the American Dental Assistants Association with expertise in clinical efficiency, ergonomics, and infection control, and Linda Harvey, founder and Chief Knowledge Officer of the Dental Compliance Institute and nationally recognized healthcare risk management expert. Both are members of multiple professional organizations including the Organization for Safety Asepsis and Prevention and have guided countless practices through regulatory compliance challenges.
This episode examines the hidden dangers of purchasing PPE from unvetted online sources and provides actionable strategies for maintaining quality while managing costs. The discussion reveals how gray market products, counterfeit devices, and improperly stored supplies create serious risks for patient safety, employee protection, and practice liability. The experts explain why FDA clearance matters, how ergonomic design impacts career longevity, and what happens when recalls occur on products purchased from questionable sources.
Episode Highlights:
Gray market PPE products may appear identical to legitimate brands but lack proper FDA clearance and quality control, potentially exposing practices to product liability claims when patients are injured. Counterfeit packaging has become increasingly sophisticated, making identification of fake products extremely difficult without proper vendor verification.
Ergonomic glove design significantly impacts practitioner comfort and career sustainability, with quality manufacturers using flexed-hand mandrels during production to reduce hand strain and pressure points at the thumb base. Purchasing decisions based solely on price often compromise long-term physical health and practice efficiency.
Large practices can negotiate directly with trusted distributors rather than abandoning established relationships for lower-priced alternatives, while implementing buying groups through state dental organizations provides another cost-effective option when vendors are properly vetted.
Two-ply sterilization wraps eliminate the need for double wrapping procedures, providing both cost savings and workflow efficiency compared to single-layer products that require additional materials and labor time to achieve proper sterile packaging.
Infection control coordinators rather than accounting staff should drive PPE purchasing decisions to ensure appropriate product selection, regulatory compliance, and patient safety standards while still maintaining cost consciousness and vendor accountability.
Perfect for: Practice owners, office managers, infection control coordinators, and dental team members responsible for supply purchasing decisions who need to balance cost management with patient safety and regulatory compliance.
Discover how to protect your practice from counterfeit PPE while implementing strategic cost-saving measures that don't compromise quality or safety.
Transcript
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This transcript was automatically generated and may contain errors or inaccuracies. It is provided for reference and accessibility purposes and may not represent the exact words spoken.
You're listening to the Phil Klein Dental Podcast.
When it comes to buying your dental supplies, everyone is looking to save money. Everybody wants a
good deal. But when you're shopping for a medical device like a dental glove or mask, you have to
be extremely cautious about whom you're actually buying from. Do you completely trust your vendor?
And are you sure you're actually getting PPE that has gone through the rigorous quality control
that's part and parcel with an FDA approved and medical grade device? And for those large
practices, it's certainly very tempting to order PPE from a distributor like eBay or Amazon that
offers the lowest prices. But in the long run, is it really a good deal? How good are those gloves?
Were they stored improperly for long periods of time, causing them to deteriorate more quickly?
Are they uncomfortable to wear and lack ergonomic design? And also, what are the liabilities that
you may face if you order PPE that is not actually medical grade and someone gets ill in yourmary
practice through the transmission of a bloodborne pathogen? To help us better understand how to
manage the cost and quality of our PPE are two incredibly knowledgeable people,
Linda Harvey and Mary Govoni. They are arguably among the best educators, authors,
and speakers on the topic of infection prevention and control. Linda, Mary,
thanks for joining us on our show. Phil, thanks for having us. Great to be here, Phil. Thank you as
well. Yeah, to have the two rock star infection control experts on the same show, it's an honor to
me. So we're really very happy to have you both. So Linda, let me start with you. What is driving
the cost increases? I find it at this point hard to believe that PPE prices continue to be high as
a result of the unprecedented supply shortages caused by the COVID pandemic. I mean, that's now
over for several years, but prices are still high. So what's actually going on in the background?
As you mentioned, who doesn't remember that supply chain shortage and the associated cost increase?
There was a lot of interruption that we saw back during the time of the pandemic. And one of the
things that came out of that during the peak of the pandemic and the public health emergency was
that there were things that the CDC approved, as well as the Food and Drug Administration, for us
to use and kind of bridge the gap. For example, we had a temporary approval to use KN95 masks
because of the cost and the lack of. N95 masks in this country, and that was made available through
the Food and Drug Administration's Emergency Use Authorization. So what we're seeing now is that
there is still some, every now and then you see different shortages in different parts of the
country, but I think it's different brands in different areas. They may not be able to get their
particular brand this week, but it's not that there's the same crisis that we felt during COVID.
But we do know that there are things that can happen outside of our country that impact our prices.
For example, China tariffs, they may play a factor in pricing for some of those products that are
made overseas. And I can remember for a while, Phil, that receiving newsletters from glove
manufacturers talking about sanctions that the U.S. would place on other markets, such as
Indonesia, for example, because of their labor practices. And when that would happen, then there
would be an interruption in our supply chain as well. So we're seeing a few of those things, not as
many as before, but I think there's some increase in costs. is starting to level out a little bit.
Yeah. And unfortunately, when you say level out, that means kind of stay where they are. It doesn't
mean they come back down to what they were pre-COVID. And this is exactly what's happening in the
grocery store. We have an inflationary period and food prices go up. The Fed tries to do everything
they can to rein that in by raising interest rates. But the reality is the prices in the grocery
store are going to still stay high. They've reached this new level. And as long as consumers are
paying for it, the manufacturers, vendors, and distributors will continue to maintain that price
until, of course, competition forces them to lower it a bit. I think that's kind of the same
situation we're in now with PPE. Although COVID as a pandemic is in the rearview mirror,
we're still at a higher price target. I think that's a valid statement, Phil. I certainly do. I
think there's not going to be a change in the immediate future. Mary, your thoughts on this? I
completely agree with Linda.
And I think Linda would agree with me that we see is some of this is perception on the part in
terms of supply shortage or some practices will say when we're doing compliance training or
compliance evaluations, well, I can't use those N95 respirators if I'm supposed to because I can't
get them. Or the perception is that they cost so much more and there still is the misperception
that you can reuse them. So there's a lot. of little nuances there. So let me ask you this,
Mary, you know, as we all know, getting supplies to the office requires a distributor.
And, you know, for the longest time, we had three major distributors, I guess we can call the
legacy distributors. And then there were some smaller dealers that you could order your supplies
from. So what's happening? in that space? What's the trend right now? And how does that change the
playing field as far as getting access to PPE supplies from different sources?
We've heard and we've seen some reports that some of the legacy suppliers are seeing a downward
trend in sales, not major, but I think that they're aware that they're losing some of their sales
to other smaller vendors we also see the trend in sometimes the name brand of supplies gloves for
example so instead of a halyard brand glove someone's looking for something that maybe is a private
labeled brand or a lesser known brand that they'll use because they are less expensive they're
looking at decreasing their costs but they don't necessarily always get the same quality if they
like a particular type of glove and it's the one that really fits them best and and doesn't you
know they don't experience punctures and those types of things then in the past many of our
practitioners out there were willing to stick with that brand and it wasn't until the cost went up
so much that they said oh well I guess I just have to do away with that and now go to a lesser kind
of a brand. And one of the things that Linda and I have both noticed is that there is just a
plethora of new online dental suppliers that they seem to be just coming out of nowhere.
Now, it doesn't mean that they're not. credible that they're not good businesses to work with.
But I think for someone from a dental practice who's trying to really keep their PPE costs down,
if they're strictly buying on price and they don't really know,
is that an offshore company? Is it a U.S. company? What would happen to them if they had to return
the goods? Do they have to pay for shipping? So the price may be lower. than what I might pay at
one of the big three, as you say. But I might also, as a preferred customer with one of the big
three, get reduced or maybe even free shipping on my goods. So again,
there's all those little nuances that are happening out there. But it's a little scary to see all
these little suppliers out there selling products that we don't know are necessarily
legit, FDA cleared that they may not be a gray market copycat kind of product.
Yeah. And one of the things, and I'm going to get to you in a second, Linda. But one of the things
that's really important for dental practice to understand is that sometimes the packaging of these,
for instance, let's use gloves, for example. The box comes, looks exactly the same, but that
manufacturer is sending these empty boxes out for bid to 12 different companies in China,
for instance, or other countries to pack those boxes up. to the best specifications that they can
to meet what the manufacturer is looking for. But of course, the quality control as compared to the
better brands may not be as good and often is not as good. Some boxes come back to the dental
practice and they're pretty good. And then others are not. So it does take a little bit of time for
that practice to realize that the quality of their PPE is not consistent.
And I think that's what Halyard and other companies like Halyard and quality distributors, who you
can trust, bring to the table. Linda, did you want to mention something? Phil, I want to say the
quality and going further into the comfort is the ergonomics. So are you compromising your physical
health and your long-term career in our profession over inexpensive gloves that aren't legitimate?
So Mary, what do quality manufacturers like Halyard do to ensure that,
of course, the glove serves as a excellent barrier protecting the operator from bloodborne
pathogens and so forth and maintains its integrity during the procedures, but also is comfortable
and ergonomic, which is so important for the operator to practice dentistry. That depends on the
manufacturer. And I know that Halliard and a couple of others are very dedicated to making sure
that when those gloves are manufactured, they use the type of form or a mandrel that they put that
material on that forms the glove has actually the hand in a flexed position.
So if the hand that the model or the mandrel that they use has the hand perfectly flat,
then there's really very little flex that can happen in the glove without causing pressure,
especially at the base of the thumb. So if it's in a little more flex, not quite a claw-like
position, then you've got the flex already built in. And that's what...
don't even realize that that's there, that that's built into the glove, if you will. But they can
tell immediately when they put them on, oh, wow, this fits good. It doesn't constrain my hand.
Linda, talk to us about the online retailers that sell dental supplies. And I know Mary mentioned
the legacy. the large, you know, multi-billion dollar distributors that we're also used to over
the last number of decades. And now Amazon and eBay are now selling dental products. And not that
long ago, some of the legacy distributors were concerned about Amazon really, really eating their
lunch. That didn't really materialize where that's a big deal. And part of it is service. The major
dealers provide service for the practices. How do these Ebays and Amazons of the world fit into the
equation of buying PPE for dental practice? Phil, this is a huge concern of mine.
And the fact that any online retailer, non-dental retailer can sell,
supposedly sell, I would say allegedly sell dental supplies. We don't know if they're legitimate or
not. And once again, the packaging may look the same, the boxes may look the same. And if we can
use the analogy of... down the street in New York City and there's folks on the corner selling
Louis Vuitton handbags and other brand names. You can't hardly tell the difference, perhaps, if you
don't really know the product. So are the lot numbers legitimate? You know, are these really
credible products? And so we really should not be trusting sources like that to purchase PPE or,
in my humble opinion, other dental supplies. When you think about, I looked up something the other
day on Amazon just to kind of get an example of what was there. And I saw some. one of the top name
brand cassettes being sold there. I know it's not PPE for the sake of our conversation, but as just
a general example, I'm thinking it doesn't even list the manufacturer. Who are you actually buying
this from? So why would you choose to buy something that looks like the real thing when you really
don't know and there's no warranty behind it? So you go back to the original manufacturer that you
think made that product, that PPE, that cassette or whatever the product is, and there's not going
to be anything behind it. So if you have a product liability issue with the patient, and the
patient's injured or claims injury, or there's some allergies or some unknown outcome, then you
won't have a credible leg to stand on. And that's what I call lack of defensible documentation.
Yeah. And I think this is a good point because we all have to realize that Amazon, a hugely
successful operation, primarily their fiduciary responsibility is to the vendor,
not the consumer. And people don't realize that. They're out there listing these items by the
gazillions. And they're out there to make the vendor money and incentivize vendors to participate
in their program. And of course, it's consumer beware, as far as I'm concerned, when you buy from
Amazon. But for the most part, the things we're buying on Amazon are safe to buy. And you can
return them and no harm done. But when you're talking about a medical grade product,
that's a whole different ballgame. Because like you said, Linda and Mary. There is liability
involved. And for you not to be able to prove that this is not a gray market item is going to be
difficult. I'm not sure how prevalent gray market or fake items are. We talk about it a lot.
Does anybody know the pervasiveness of these kinds of products that are actually marked 3M,
for instance, but 3M had nothing to do with it? I don't think we have, again, any quantifiable
evidence, but I do know that I've talked with several manufacturers in the last couple of weeks
that have said, like Linda said, they found their products out on eBay and Amazon,
but they don't know how they got them. There are a couple of them that have actually ordered
restorative materials that came. And they were packaged in,
again, the legit package. And it's sort of like the analogy that you used earlier with the gloves.
They had the legit packaging, but then they opened up the packages and it was not their restorative
material. Or it's in another language. They cannot read the instructions.
There are just all kinds of... things that are happening. And when we don't know where these
products are sourced from, that becomes a huge liability. And what also is concerning is if there's
a recall on a medical grade product, like a glove or a mask, for whatever reason,
if you purchase it from a reputable distributor, you obviously will be notified in a very timely
fashion. They'll take it back. I'm not sure how that would work on a non-dental online entity.
Amazon's pretty good about that, but with these kinds of medical-grade products, I'm not sure.
There's no guarantees that the buyer will be notified that these products have a defect in them and
they have to be recalled. So tell us more, Mary, about the concerns on the infection control level
when you're using PPE products specifically that have not undergone quality control measures.
up to the level that reputable companies provide. If these products have not been FDA cleared and,
or they may have an FDA clearance for use in another setting, in another type of setting,
you then are not using. what is appropriate, what you are legally required to use in conjunction
with patient care, that it is FDA cleared as a medical device. So a mask,
gloves, those types of things or pouches. That's another thing that, you know,
folks are just. going to all different kind of retailers and shopping on price on pouches not
understanding that perhaps the indicators that are built into the pouches may not be effective or
they may not be even, again, FDA cleared or they may not even function.
And so they buy these things in big quantities because they got such a good price. And then they
find out maybe even that the products are expired. They're no longer effective. So there's all
kinds of issues, liability issues related to that, that I think many practices,
if they're only shopping on price are not thinking about, is this authorized?
If I bought a sterilizer, for example, from eBay, how do I know that it's been FDA cleared?
How do I know? And I certainly am not going to get any kind of a warranty when I buy it. And I'm
not necessarily going to take a chance on something like that. I wouldn't. Many practices do. But
even things like handpieces.
a management consultant a while ago who was in a client office wanting to know if I could contact a
manufacturer that I work with and ask why this ultrasonic scalar tip kept bending when they were
using it. It was brand new. They took it right out of the packaging that looked like it came from a
manufacturer. However, it was purchased. on amazon and it was truly a fake it was made to look like
a name brand product but it was not so this is truly a buyer beware situation um and i would
question you know if you bought this PPE or again, in this big quantity, how much aggravation are
you going to have to go through now to return it? Are they going to take it back? And how much
money are you out waiting to get a refund if you're even going to get one for buying all of those
products? And I also want to bring up efficiency. When you're buying a premium product, you are...
able to take advantage of the product where it actually brings you efficiency in your practice.
For instance, the cassette wraps that are made by Halliard, for instance, I think they're the only
ones available. They are double lined and they're not much more expensive than anything you would
get anywhere else if you were buying on price. So that wrap that goes around the cassette, you only
have to wrap at one time. So if that product is the same price or even less expensive than some of
the other products available that you think you're getting a great deal on, you have to use twice
as much. So there's efficiency factors involved when making these purchasing decisions as well.
It is a Halyard product and the price differential is not that great.
And in many cases, there are practices that don't know, they don't research to see.
First of all, they don't know that they need to have either two-ply or two separate wraps, and so
they may only be using one, so then they're using it incorrectly. They're not necessarily
protecting the sterility of their instruments when they go into storage, but that's a huge
advantage with that halyard wrap that it is two-ply and I can wrap once and I'm done.
Those are things that you have to start looking at when you're talking about quality products and
return on investment, especially for the larger practices that go through tons of this PPE. But for
many large practices, the incentive is to buy on price because they use so much PPE. So what are
some of the strategies, Linda, that large practices can utilize in order to keep their costs down
and also continue to use premium PPE products? So one of the things these large group practices can
do, and even our individual practices, is sit down and negotiate with your current supplier, your
favorite supplier, the one you've been working with for a long time, or maybe it's that supplier
that helped you open your practice and they've been a trusted resource for you for a long time.
Don't just walk away because of price. Sit down and have that conversation. It might be difficult,
but you never know what kind of flexibility there can be there when that happens. So sticking with
the brand names is very important. If they're going to buy online, make sure that they have...
vetted the support, the online supplier. Don't just rely on third-party endorsements.
Do your own research. I'm a really big fan of that. Do your own research. Make sure that even if
they're backed by an organization or association that you trust, you just never know. I know they
try to do their due diligence, but I want to take us back to a time during the peak of the pandemic
when even the Washington State Hospital Association got fooled. They thought they were buying a
quality, N95 masks in bulk. They thought they had vetted the distributor. They took possession of
the product and found out they were all fake. Now, here's a big hospital association saying there
were tens of thousands of masks for all their hospitals who so critically needed N95 masks.
So that's a huge example. So you have to be very, very careful. Always research,
always research. Don't just buy on prices. Mary and I have been talking about. Make sure you
understand that the gray market is not a safe market. Yeah, I think the CDC during COVID, correct
me if I'm wrong, had some website listing legitimate mask numbers or something.
They had some NIOSH approved list. They did. Yeah, that some people didn't look at.
But it said, listen, if your mask doesn't have these numbers on it, they're fake. Is that what was
going on back then? They did have that. And they had a list of FDA.
approved KN95 mask under the EUA. And when the Food and Drug Administration first published that
list, it was a very long list. I'm going to say nine pages are longer, Mary might remember exactly.
And then all of a sudden, when they went back and started doing more research on these companies,
that list shrunk tremendously because they realized that those products, many of them were fake.
They didn't meet any requirements at all. So they had to go back and retract. So there was a lot of
things that were happening at once that were very confusing. So in the five minutes that we have
left, let's start with you, Linda. Give us a verbal cheat sheet for some of the things we can do to
get quality products, quality PPE, and not overpay. So right off the bat,
there's two things that I would suggest. And that is create a short list of your trusted brands.
Shop for those at different places if you need to, like the halyards of the world. And second tip
is... The dental knowledge. Who's driving the expenditures in the practice? Is it someone that
truly understands what infection control is all about? Or maybe is it your CPA who's saying,
oh, your supply costs, this is where you need to cut money? Or is it somebody who you've trusted in
your practice who's brand new to dentistry and doesn't have the background? So know who's driving
the expenditures in the practice. Mary, your thoughts on this? Well, I always tell practices,
don't look at cutting infection control costs first if you're looking at cutting supply costs.
Look at other things. Can we cut back on office supplies?
Do we need to do so much printing and use so much ink? There's a great way to cut back on some
supplies. But infection control shouldn't be where we start because that's the backbone of...
patient safety that we provide, but it's also the backbone for our safety to continue to be able to
provide that oral care, oral health care to patients. Many of the state dental organizations and
other groups out there are establishing buying groups. And so if that's something to look at,
but then does the buying group vet the vendors? And so there's there's a little bit of risk there.
So you have to vet the buying groups and vet the vendors, but just...
on price. It doesn't matter. There are some people that think a glove is a glove is a glove.
And I agree with what you said earlier, Linda, that they may not be the appropriate person.
Maybe it's the infection control coordinator or the OSHA coordinator who takes charge of the PPE
orders so that we know we get appropriate things and that maybe they're incentivized in some way,
if that makes sense for. the hard work that they do to research and vet and find the best prices on
the products that we like. It seems to me that there needs to be someone held to account,
like the ICC, the Infection Control Coordinator, to make these decisions because,
like you said, if you put an accountant up to it or an office manager, nothing disparaging against
an office manager, but if their goal is to save the office money, if that's their incentive on
buying supplies, they're going to be looking strictly on price. But if the ICC is involved,
like you just mentioned, and they're held to account on the quality of the supplies for PPE,
they're going to be looking at price. But they'll also say we can't cross this red line because
there's too much risk. We're treating patients. We have employees. We must focus on patient safety,
employee safety, and minimize the risk of bloodborne pathogens. There's too much at stake. So
excellent discussion. I think you covered a lot of great points and really do appreciate both of
you coming on together to do this. It's a very important topic. Thank you so much. Thank you, Phil.
Thank you, Phil.
Clinical Keywords
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