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
#76 When Work Arounds Don't Work and Instead Create Hazards
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What happens when a piece of equipment isn't working properly or you don't follow the proper steps for troubleshooting or using the device? What you do next is critical because you just may end up unintentionally creating a hazardous situation in your practice. Listen in as the Divas help you avoid potentially unsafe and dangerous situations in your office.
Resources:
- Research Collective: Human Factors and the FDA Medical Device Instructions for Use https://research-collective.com/fda-medical-device-ifu/
- Federal Register: FDA Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications https://www.govinfo.gov/content/pkg/FR-2017-06-09/pdf/2017-12007.pdf
Welcome. I'm Leslie Cannon. I'm Mary Gavoni.
SPEAKER_01I'm Linda Harvey. I'm Olivia Juan, and together we are the Compliance Divas.
SPEAKER_03Welcome to the Compliance Divas Podcast. My name is Linda Harvey, and I will be your moderator for this episode. The Compliance Divas bring clarity and simplicity to compliance by navigating the regulatory world to keep you on course. Please subscribe to the Compliance Divas Podcast through your favorite podcast channel or on our website at the ComplianceDevas.com. Any resources that we mentioned during today's podcast can be found on the Compliance Divas website as well as in today's show notes. We also invite you to submit any questions to support at the ComplianceDivas.com. Today's podcast topic is workarounds. And I think workarounds is something that we're all familiar with, but maybe we didn't know what it was called. Sometimes a workaround becomes a treasured tip in a practice and it makes your life easier. And other times it's simply a temporary fix and it's creating more hazard than you realize. So think of a workaround as a way of dealing with the situation that you come up with in your practice to see if you can do something a little bit differently. You're working around the normal way that you would follow something or the normal process that you would follow, or maybe you're even working around and not following the manufacturer's instructions for use, but maybe you're not aware. So we've got some ideas and questions related to this to help you have a safer workday. So Leslie, if I can call on you first. When it comes to using the ultrasonic, have you ever noticed any workarounds that teams did that were simply unsafe or maybe ineffective?
SPEAKER_00You know, Linda, I have. And the first thing that I've noticed is that team members want to overload the ultrasonic tank because thinking that, well, it's going to be 15 or 20 minutes that the instruments are in that tank, I'm going to get as many in there as I can. That pretty much renders the ultrasonic ineffective because there's so much weight of the instruments compressing down on one another that it doesn't allow the cavitation to explode and implode against the instruments. Now, the manufacturer's directions usually state to have a layer of instruments and you use a basket so you have plenty of room for the cavitation to be developed. Something else that I've seen is the use of the basket as a dish drainer sitting outside of the ultrasonic tank where the instruments are on the floor of the tank. Talk about not being able to have cavitation, that creates uh sort of a barrier and it's there's no room for the cavitation to be developed. And if you've ever wondered why there's a little bit of space between the ultrasonic tank and the bottom of the the ultrasonic basket and the bottom of the tank is to allow that cavitation to develop. The other thing that I've seen is, well, of course, if you don't have the basket, that means you have to reach into the tank. That's like reaching into a sharp container, and you could easily be poked with an unseen sharp instrument. So workarounds there that seem like they might allow you to have greater quantity do not yield better quality. It actually makes it more dangerous. And one more thing, Linda, that I've seen is uh sometimes the ultrasonic tank is overloaded where some of the instruments are not even submerged in the solution. So a lot of times when I visit a dental practice, I'll walk over to the sterilization area and lift the lid of the ultrasonic tank. Of course, not when it's running, because we don't want to be inhaling all those aerosols from the tank, but uh just to see how it's loaded and what's in there. And uh, a lot of times I will see that conundrum of overloaded instruments. So team members really should uh have a method of making sure or some kind of uh communication with each other, not to put instruments on top of instruments that are already in there, allow the instruments that are the small number of instruments, uh the appropriate number to go through the cycle and to be removed from the tank before the next person throws their tray of instruments or their cassette of instruments onto that same load and then start allow it to go through that same cycle. Lyndon?
SPEAKER_03Leslie, I have seen all those items happen in practices, and they are not such good workarounds. So to just to your comments about cassettes being on the bottom of the ultrasonic, I've seen that happen and them take the basket out because the cassette doesn't fit in the ultrasonic otherwise. So that workaround is problematic because the office doesn't have the proper equipment and perhaps the doctor doesn't even know this. And then secondarily, when reaching into any ultrasonic, that is something that violates the OSHA's bloodborne pathogen standard. That standard specifically states that healthcare workers should not are not allowed to put their hands inside of any type of container that has contaminated sharps. And thus we know that's the ultrasonic. Uh Mary, what can you contribute to this?
SPEAKER_02The other workaround that I see many practices do is um leaving the cover off when they're running the machine, because when they put the cover on, if the instruments are kind of sticking up, it rattles and makes noise. So they then are potentially aerosolizing any of the contaminants in the solution. So the manufacturer's instructions clearly say do not run without the lid on the unit.
SPEAKER_03Oh, well, thank you both. Those are some important workarounds that our listeners should be aware of so that they don't fall into those bad habits. Olivia, what can you tell us about um offices that say have an instrument washer? Uh, what workarounds have you seen there, maybe when the device isn't working properly?
SPEAKER_01Well, one, they may resort to wiping the instruments with a disinfectant. But Linda, I think what I've seen that's even worse is that they go to Lowe's and they buy a residential dishwasher and they use it thinking that it's the same concept, but failing to recognize that a residential dishwasher is not medical equipment approved by the FDA for that use. And I think another thing, Linda, to mention is that these workarounds might be something that we can reduce. In other words, keeping our equipment from going on the blinks if we're following the manufacturer's instructions for maintenance. Maintenance is critical. So whether that's your vehicle or it's a piece of dental equipment, whatever the case may be, if we follow those maintenance instructions, we're going to get more longevity out of the equipment and avoid some of these workarounds that we so commonly see in dental practices.
SPEAKER_03Thank you, Olivia. And I too have seen offices uh resort to wiping down their instruments with a disinfectant wipe when their automatic uh official dental instrument washer was not working. And likewise, it does need to be um an FDA-approved device. So it's so important because when we think about staff shortages, and this because it's a whole different conversation, and we've certainly talked about this topic with Kevin Henry recently, that impacts what's happening in the sterilization area. Does somebody even know that their manufacturer's instructions for use during the practice? And where are they? And is a team member being trained on that? So, Mary, let's let's jump over and talk about now, if we can, just what happens to the sterilizers. We've taken our instruments through an ultrasonic or perhaps an instrument washer. So, what kind of workarounds happen with those autoclave?
SPEAKER_02The workaround that I see that happens most frequently is not using the dry cycle. The perhaps the practice doesn't have a large enough inventory of instruments. So they're trying to rush them through reprocessing and they're taking them out of the sterilizer. Maybe they don't even understand what the drying cycle is. There is a specific part of that sterilization cycle that is meant to vent the steam out of the sterilizer. The door may pop open automatically, or you have to manually open it. And you only keep the door open about an inch. You follow the manufacturer's instructions, and then the residual heat that's in the sterilizer, or perhaps there's continuing um heat being produced that dries the packages. So many times team members think that, well, they'll just dry when I take them out and put them into storage. You've now compromised the potential sterility of those instruments because they packages can tear, they can wick in contaminants from the air. So know what the manufacturer's instructions are for the dry cycle, how long it is. It's usually around 10 minutes. Um how far to prop the door open. And if you're still getting wet instruments, then there needs to be some troubleshooting. Are they placed in the proper way, paper side up, paper side down, depending on what the manufacturer recommends? Um, are they um does their sterilizer maybe even need to be serviced if the dry cycle isn't working for them? And not overloading that sterilizer, because if you overload it, then there isn't room for the not only the steam to circulate and penetrate into the packages, there isn't a way for the hot air to circulate as well and dry those packages. So um skipping the dry cycle is a bad thing, but it's probably the most common workaround that I see.
SPEAKER_03I couldn't agree more with you, Mary. And I I always encourage dental teens to have that conversation with their doctor because that's a good conversation to have. It's a conversation that reflects growth of the practice and growth anywhere. So volume of patients also impacts other areas such as sterilization and needing to accommodate for that. So we have some great tips so far, or as for what some of the workarounds are, pardon me, but let's talk about what some tips are. So let's leave our listeners with some great tips of how they can minimize their workarounds or choose a workaround that would be within the guidelines and not be fraught with risk. Um Leslie, can I ask you to start?
SPEAKER_00Well, yes, I failed to mention one of the workarounds that I saw was on organizing instruments. And uh I've seen those rubber bands that look like ponytail holders that we used to wear when we were kids. And they've used those to wrap around the instruments to organize them into sets. And of course, that prevents the instruments from being able to be exposed to the cavitation activity of the ultrasonic pane at all the points of the instruments, the handles and other critical surfaces. Plus, to me, it seems like an awful danger to wrap a rubber band that's sort of tight like a bungee cord around a group of instruments. So a better way would be obviously cassettes work well to organize instruments, but then also the little band that you mark the instruments with to identify them with. There's either the tape or there's the silicone band that can be placed on an instrument to keep them in groups.
SPEAKER_03Thank you, Leslie. Those are two, some great tips there. Olivia, what can you share with our listeners for a takeaway tip?
SPEAKER_01One of the things that we have been encouraging clients to do rather than spend so much time writing out standard operating procedures, is to just make short videos on their phone. And maybe that has to do with maintaining the equipment. So someone would look at the operator's manual or the instructions for use and go to the maintenance section. And that's something that could be recited in a short video using their phone, and then start cataloging or indexing these videos so that they can serve as SOPs. And people love to look at videos rather than reading these daunting documents.
SPEAKER_03Oh, Olivia, that is a great idea. And we use our phones so much anyway in our daily lives. So taking a quick video, putting it maybe on a hidden spot on their website or on their server where they can be cataloged, as you mentioned, and be used in training, just not just for new team members, but for updates. That's great. Mary, what tip can you share for our listeners today?
SPEAKER_02Well, I'm still so excited about Olivia's tip. I can't, I'm speechless. Um, it's great because now you also then have training for onboarding new employees. That is a fabulous, fabulous idea. One of the things that we stress all the time in our podcast is follow manufacturers' instructions for use. So have the manuals close by, or with your phone, take a picture of that particular section that's so important. Like which way do we place the instruments paper side up or paper side down? Take a little photo of that, maybe add that into the video or post it somewhere so that you've got it very readily available. The most commonly asked questions or the most common issues that we see that come up. So keep those in manufacturer's instructions handy. Um, I love the idea of maybe incorporating that as a photo inside that video. And here's what what um the sterilizer manufacturer says about what to do, and just keep it there so everybody can refer to it, and then it doesn't become the telephone tree. Mary told me, and I told Linda, and Linda told Leslie, and then it comes around to Olivia, and then it's like, okay, something got lost in the translation.
SPEAKER_03We definitely want to avoid that, Mary. So thank you. That's that's a beautiful tip. So my tip would be to be sure you add safety and compliance to your team agenda. So there's a chance throughout, say, the year at the monthly meetings to discuss items like this. And today's podcast is probably short and sweet enough that you can listen to it at your next team meeting. So to recap our tips to takeaway are follow the manufacturer's instructions for use, having written protocols and especially the videos, and to be sure that you follow um all those manufacturers' instructions for use, which I just mentioned. But those are some really important things so that your practice doesn't end up using these temporary fixes and sort of workarounds that have dangers and they're fraught with risk, and you take away the treasure tips from today. Thank you for joining us with this episode of the Compliance Divas. We bring clarity and simplicity to compliance by navigating the regulatory world and to keep you on course. Please subscribe to the Compliance Divas podcast through your favorite podcast channel or on our website at the compliancedevas.com. Resources mentioned during our podcast can be found at the compliancedevas.com website. And we always invite you to submit questions to support at the compliancedevas.com. And we look forward to our next podcast with you.