The Compliance Divas Podcast
Our podcast covers current topics such as infection prevention and control, OSHA and HIPAA compliance for dentistry. We discuss the latest regulatory information, answer frequently asked questions and give suggestions for dental practices to make compliance easy and sustainable. The Compliance Divas are a trusted source for consistent, accurate information based upon current guidelines, standards, science, and recommendations.
The Compliance Divas Podcast
#185 Dental Burs, Diamonds & Rotary Instruments - Reusable or Disposable?
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In this episode the Divas discuss everything dental teams need to know about dental burs, diamonds, finishing burs, endo files, and implant files. The most import question to be answered is whether those items can or cannot be reused, after they are cleaned and sterilized, or are they single use items. The FDA has a lot to say about this in instructions for use and labeling. Learn what it all means.
Resources:
- CDC Summary of Infection Prevention Control in Dental Settings https://www.cdc.gov/dental-infection-control/hcp/index.html
- CDC Best Practices in Dental Infection Prevention and Control https://www.cdc.gov/dental-infection-control/hcp/dental-ipc-faqs/index.html
- FDA - Overview of Medical Device Classification and Reclassification https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification
- FDA Title 21 Subchapter H - Medical Devices - Part 801 Labeling https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=801
- FDA Labeling Symbols https://www.bsigroup.com/globalassets/meddev/localfiles/it-it/webinars/bsi-md-symbols-and-information-to-be-provided-by-the-manufacturer-webinar.pdf
Welcome. I'm Leslie Cannon. I'm Mary Gavoni. I'm Linda Harvey.
SPEAKER_01I'm Olivia Wan. And together we are the Compliance Divas. Welcome to the Compliance Divas podcast. I'm Leslie Cannum, and I'm your moderator for today's podcast, where we talk about something that most demo offices don't really think a lot about, but maybe that'll change after you hear what we have to say. We bring clarity and simplicity to compliance by navigating regulatory compliance to keep you on course. You can subscribe to the Compliance Divas podcast for your favorite podcast channel or on our website, thecompliancedivas.com. The resources we mentioned during our podcast can be found on the show notes in your podcast app. We also encourage your questions. Please send questions and comments to support at thecompliancedivas.com. Well, today it's just Mary and I who are going to be talking about burrs. Many of us don't think too much about the burrs that we use in our dental setting, but there's so much information that we probably aren't thinking of top of mind when it comes to the different types of burrs, how they're reprocessed, how they can be or should be, the instructions for use and how they're classified, and what those funny little symbols mean on the label of burrs. First, I'd like to take us over to Mary. And Mary, can you tell us how burrs and rotary instruments are actually classified?
SPEAKER_00Well, I would use the term categorized at this point because we'll talk later about how the FDA classifies them, but we have burrs that are carbide, tungsten carbide. There are still some steel burrs that are out there, but not many. We have diamond burrs. Most everybody is very familiar with them. We have finishing burrs that have many more flutes, not as much separation in the flutes, so that you get a finer finish. Then we have things like endophiles and broaches, and we have implant drills, which are very, very specialized. So when we say burrs, it's kind of a broad category, or some people call them rotary instruments. But essentially we have the carbide burrs, diamond burrs, any kind of finishing burrs. They might be polishing points or finishing discs, so forth, endo files and brooches, and implant drills.
SPEAKER_01Well, you know, Mary, I think a lot of times we don't even really give much thought to the fact that sometimes burrs have either single-use instructions or they they may have some reprocessing. But most of the time I go to a dental practice and I see burrs sitting in the ultrasonic tank or sitting in autoclave bags. And I want to, you know, spend a little time talking about that and the labeling. We'll come circle back around to that in just a few minutes. But I do want to shout out to our diva Linda, who had some information to share with all of us on how these items are actually classified as opposed to categorized. Mary listed the various different types of BRURS we encounter in a dental setting. And you might wonder how FDA, the Food and Drug Administration, who oversees medical devices, categorizes them. BRUS are actually considered to be class one medical devices, and that means that they have what they call low risk. There's no FDA approval process that is needed for a class one type of medical device, but they still have to register the device with FDA. Now, a class two, just to give you an idea of what that would be, FDA says that that's a device that provides moderate risk, and DA clearance is required for class two, as well as what they call a 510K pre-market notification to FDA. Then there's class three, which is the high risk. And of course, FDA approval is required, and pre-market approval as well. And so that's the various different categories, but it was uh surprising to both Mary and I that FDA has rated BURS as a class one or low-risk type of medical device.
SPEAKER_00Yes, that was kind of a revelation. I personally would categorize them as a higher risk type of device, especially since there are studies that show that if we do reuse BURS, it's very difficult to clean them, which then means they are most likely not sterile for reuse. But what we also want to look at, and Leslie, you alluded to this earlier in our shout out to Olivia, who couldn't be with us today, and that is what does the FDA say has to be on a label for BURS? And I gotta admit, back in my days as a clinical dental assistant, I don't remember ever seeing any labeling requirements on the BURS, but they certainly are now, and there are lots of symbols and warnings and things that we will include in the show notes some pictures of those so you can see what those labels will look like. So the Food and Drug Administration says that device labeling on any class one, two, or three device must include the following information: the attended use of the device, whether it's single use or single patient use. I'm not sure I understand the difference between the two of those, other than you use it one time on a patient, or you can use it multiple times on one patient. And you'll see a circle with a two in it and a line through it, meaning you cannot reuse it. The labeling has to advise the end user if or when to thoroughly clean the device, meaning if it's not meant to be reused, then there won't be advice about cleaning it. There's no reason to clean it if you're going to dispose of it. And it indicates also what type validated microbiocidal process would be used in order to sterilize it for the intended use of that burr. So, in other words, if I had a rubber polishing wheel or a maybe a rubber polishing cup, not to be confused with a prof, but a polishing cup. If I have that and the instructions say that it could be disinfected in a high-level disinfectant, if that's what the instructions would tell me to do, and I don't know that that's exactly what all the instructions will say about those, but that's what we would do. If it says that this burr, if it's reusable, must be cleaned and then heat sterilized, it will give the parameters for that. So then the instructions have to be technically feasible. So you have to be able to do it without damaging the device, and they have to have comprehensive instructions that the end user can understand. So, how am I going to clean this? What do I need to do for packaging and what type of disinfection or sterilization am I going to use? All that has to be put on the label, and I'm thinking, okay, there's this tiny little package of burrs. So most of this is accomplished with symbols. So then the end users need to have a chart or a graphic to help them understand what that means. And that's that really requires some training on the part of the dental assistants, I think, in particular, who are going to probably be managing these devices for their doctors. So it's a challenge.
SPEAKER_01You know, Mary, it is a challenge. And understanding the symbols and remembering what those symbols mean. I don't remember all the time. So a chart in front of me is helpful. I have a chart of symbols next to my washing machine that tells me what the tags on my clothes mean, whether I can use warm water or whether I have to dry clean only. And I have to refer to that chart frequently when I'm just not used to seeing these symbols. And I think one of the things that I will encourage our listeners to do is to take a look at the chart that we're going to put in the show notes so that they can recognize some of the symbols. And you you mentioned the single-use disposable. We're all, I think most of us are familiar with that circle with the that slashes the two that says do not reuse. But I don't know if everyone knows the difference between whether a package is sterile or whether it's non-sterile. Now, when I get delivery in my office when I was working in dentistry, I remember the objective was to get the stuff out of the box, get it on the shelf, you know, get the packing slip put away and mark it off of my list of things I needed to order. Now it's been received. And many times burrs are sent in a little bubble wrap or they're in some kind of container. They'll either be with their initial instructions from the manufacturer, along with the label and all the little symbols, or there will not be the instructions, including whether they're sterile or non-sterile. So we should certainly make it a top priority to first recognize the packaged item that says sterile. And that's going to say the word sterile. So it's not an icon, it just simply says sterile. And then there's also a triangle that says non-sterile on a packaged item. And that will help us to recognize that whether we want to sterilize it and follow the instructions before we're using it. And I think, of course, most people would be up for doing that. But if we get a delivery of burrs that we've ordered and we simply get them out of the package and put them into those little tackle boxes that are a little cleared, like jewelry boxes or like the kind that you find in a workshop that holds nuts and screws, that's a great way of organizing. But if you're now taking a sterile item that has been sent to you sterile and opening the package, it's no longer sterile. And then how do you have any of the other instructions if you take it out of its original packaging? On the pictograms, there's also one that is kind of interesting. It looks like a couch with little uh thorns on it. And that's actually the manufacturer's date on it, which may be helpful. What's probably more important on just about everything we use on dentistry is the little hourglass, which is the expiration date. And you probably can imagine that, well, you know, do burrs really expire? And I would think that the manufacturer has to have some point of saying, use this product before a certain time. We can't guarantee that something won't happen later. So if there's an expiration date on the burrs or anything else that we use, we need to be mindful of that. We also have information that is not only the circle to, as you mentioned, but there's also a picture of a person with a number one and a series of arrows going around in a circle. And you mentioned this earlier: single patient multiple use. So, how do we make something safe for the single patient multiple use? And that's where it gets to the instructions for use. And I thought I would just give an example of what a carbide burr instruction for use, what it sounds like. And so the first step is that carbide burrs must be thoroughly clean and steam sterilized prior to the first use and subsequent reuse to prevent the risk of infection or cross-contamination. And then further down, it says carbide burrs are labeled sterile. When they're labeled sterile, they require no further action before first use, but must be thoroughly cleaned and steam sterilized prior to each subsequent use to prevent the risk of infection or cross-contamination. And then further delineates this if packaging for sterile labeled devices is opened or damaged or is past its expiration date, there we go, we found one. The device must be thoroughly cleaned and steam sterilized prior to use and each subsequent reuse to prevent the risk of infection or cross-contamination. They give us further instructions on what type of sterilization. So for carbide birds, they say don't use chemical, well, chemical vapor, as we know, or dry heats to sterile to sterilize because those processes haven't been validated for use. And they said the use of these processes may be corrosive to the device and could result in premature device failure. It also states finally that proper cleaning is required after the use of the device to prevent cross-contamination. So if you're not going to remove the debris, we have seen multiple studies in our career, Mary, as dental consultants and infection control, that demonstrates that you can't fully clean a burr or an endophile. And the studies have demonstrated that there's viable oral microorganisms that still reside on those burrs and endophiles even after they've gone through the sterilization cycle. So we we it's an eye-opener on the world of burrs. And I just had one final comment to make when it comes to burrs. I know that people aren't going to want to hear this, particularly if you're the one that pays the bills in the dental practice. But so far as I know, there are currently no diamond burrs that are uh reusable and that have instructions for reuse. And I think that sometimes we think, well, you know, the manufacturer says that they can be reused, but what they're talking about is the diamond finishing burrs that are used to finish the extra, uh, they're not going to be going into invasive surfaces, they're finishing after composites or polishing. So we all need to pay a little bit more attention to what it is the manufacturer's directions are and make sure that we're following the manufacturer's directions for use. Because as we could see with dental unit water, we had a mock trial at our OSAP ADS meeting a couple years ago. And not following the manufacturer's directions for use can get a dentist in a world of trouble legally. And it would be obvious that to anyone, any jury would say, well, if you are using something on a patient and you're not following the directions for use, then clearly the operator of that device would be liable, not the manufacturer, not the patient, not the dental assistant. So dental assistants need to make sure that they understand how to recognize the labeling and how to read the instructions for reuse. And of course, dentists are always the ones that would be the at greatest risk for liability. So Mary, you had a few other thoughts on reprocessing.
SPEAKER_00Yeah, just a couple of closing comments. You mentioned that in the instructions for use for some devices, there are cleaning and reprocessing instructions. And what the FDA says is that if there are no reprocessing instructions, they can't be found, the manufacturer does not have them. Then you make the assumption that the burr or the diamond or whatever the rotary device is is single use, unless there are validated instructions for reuse of that product. And then in addition, the CDC, in its infection control guidelines, says that items that are difficult to clean, and certainly endophiles, as you mentioned before, brooches, carbide, and diamond burrs should be single use because we can't adequately clean them. It's the same thing with instruments. If we can't get them clean, whether it's in the ultrasonic or in an instrument washer, then they won't be sterile after we process them through an autoclave, a steam sterilizer. So the same, but we're not going to throw those instruments away. But the burrs are especially difficult to clean. And there are enzymatic products and there are burr cleaners, and people soak them and clean them with wire brushes. I remember doing that in my early days as a dental assistant, scratching my fingers at the same time and all kinds of craziness. But I know there have been a number of studies. The dental advisor is one group that did one under the direction of Dr. John Molinari, and the conclusion was you cannot adequately clean all the debris from burrs.
SPEAKER_01And you know, Mary, I bet it's pettywise and pound foolish to even try because of the time that it would take for someone to not only use, do go through the cleaning process and the danger of a wire brush and perhaps having an exposure incident, that you might as well be paying for the device, using it properly, discarding of it appropriately after each use. Well, with that, we hope that our listeners will take a look at the show notes and get acquainted with the various different symbols and pictograms on your burrs, recognize whether you're getting them as sterile or single-use. Remember that there's one icon that you may not be familiar with, which is a looks like a little book with a letter like a lowercase I. That means there are further instructions that are not with that packaging for that device. So if you do order a short order of BURRS and you get them, let's say, from your dental dealer wrapped up in a rubber band or in some kind of packaging that's not the manufacturer's packaging, be sure and ask for the additional instructions for you so you have those handy. At the compliance divas, we bring clarity and simplicity to compliance by navigating regulatory compliance to keep you on course. Again, we hope you will submit your questions to support at the compliance divas.com. And also, if you do listen to our podcast and enjoy us, please leave us a little review on our show notes. Just scroll down to the bottom of your app and leave us a review. Let us know what you think. And that's it till next time.