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
#80 Does Single-use Really Mean Single Use?
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With increased supply costs, it may be tempting to reuse certain items that are indicated for single use only. However, there can be serious repercussions if single use items are reused, such as disease transmission from one patient to another. Check out this week's podcast for tips and strategies when using single use items in your practice.
Resources:
- CDC Division of Oral Health - Single Use Devices https://www.cdc.gov/oralhealth/infectioncontrol/faqs/single-use-devices.html
- FDA FAQs about the Reprocessing and Reuse of Single-Use Devices https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-reprocessing-and-reuse-single-use-devices-third-party-and-hospital-0
- RDH Magazine - Single-Use (Disposable) Devices https://www.rdhmag.com/infection-control/disinfection/article/16405788/singleuse-disposable-devices
Welcome. I'm Leslie Cannon. I'm Mary Gavoni.
SPEAKER_02I'm Linda Harvey. I'm Olivia Wan. And together we are the Compliance Divas.
SPEAKER_01Welcome to the Compliance Divas Podcast. This is Linda Harvey. I will be your moderator for today. We 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, the compliancedivas.com. Any resources that we mentioned during this podcast can also be found on our website. And we invite you to submit questions to support at the compliancedeivas.com. Today's topic is single-use devices. Is something that's labeled single use really single use? The concept of single-use items or devices is not new in dentistry. Yet there was a time when some items that are now disposable were reusable. For example, profiangles. Long ago, profiangles were metal and were hot oil sterilized. And it was only the rubber cups and brushes that were disposable. Since that time, the increase of single-use devices has grown so much so that the majority of offices no longer use cold sterile baths. Yet with the increased cost and supply chain interruptions that we've seen due to the pandemic, it may be tempting to use items or devices that are labeled single-use for more than one time, or perhaps even be unaware that an item is designed for single use. So in this episode, the Divas will discuss the rationale behind single-use devices and how to manage single-use devices in your practice or organization. Mary, I'd like to call on you first. Could you please define for our listeners what is a single-use device and share with us are there any guidelines or regulations that govern single-use devices?
SPEAKER_00Absolutely, Linda. Single use devices are defined by the Food and Drug Administration as disposable devices intended for use on one patient during a single procedure. They're not intended to be reprocessed, meaning cleaned, disinfected, or sterilized, and used on another patient. The labeling may or may not identify the device as single use or disposable and does not include instructions for reprocessing. So this is a really, really important thing. If a device is single use or disposable, it will typically say on the package, or you'll see a symbol circle with a letter two in it and a line through it, meaning you don't use it twice, you don't use it again. If an item, and the biggest controversy I think we have over this in dentistry, are burrs. If you buy burrs and they do not come with reprocessing instructions, they are considered by the Food and Drug Administration to be single-use devices. Now, if manufacturers do submit to the FDA for reprocessing of items like BURRS, and those instructions are um cleared by the FDA, then BURS could be reused. And there actually are a couple of manufacturers, or at least one that I know of, that has reprocessing instructions for BURS. So it's something that a lot of people who are trying to save money on supplies, which is understandable, will sort of abuse, if you will. There are many items that are heat tolerant that are classified as disposable. For example, if you use surgical suction tips, they are um plastic. Some are actually reusable, they're not labeled as disposable, but even the ones that are labeled as disposable are heat tolerant. But that is so you can sterilize them before you do a surgical procedure, and they can go through a sterilization cycle. But if it is labeled as disposable, it's not to be reused. Masks, um, gloves, of course, are common items. Impression trays, those types of things, plastic impression trays, impression trays in many cases are disposable.
SPEAKER_01Thank you, Mary. That gives us a good idea about where this comes from as far as the exact definition of a single-use device and what the CDC and Food and Drug Administration have to say about this. And as we have acknowledged in the past, many, many states have adopted the CDC guidelines as law. And even if it's not as overtly written into a state dental practice act, there are laws in every state about having a safe and sanitary practice and following the standards for patient safety. Olivia, can you help us understand why single-use devices are important in healthcare just in general? Um, maybe there's some things going back that you can refresh our memory on of how we got to where we are with so many single-use items.
SPEAKER_02Sure. Linda, there's a couple of things that I wanted to highlight. One is that when we use single-use items and we only use it on one patient the way it was intended, then this helps reduce the risk of patient-to-patient contamination. So that's one aspect that we really appreciate is that it promotes safe dental care. The other issue that I don't think is brought up enough is saving staff time. Sometimes I have to remind dentists that when employees are doing what I would call busy work, it costs the practice money. So if there's something that we could replace with a single-use item, it is saving money in the long run, even those single-use items might be costly, appear costly. Years ago, I worked with a dentist who was cited because the assistant was disinfecting the saliva ejectors. And when asked about why she was reusing them to the auditor, she said, Well, these things are expensive. And the dentist said, Well, you're not paying for them. He had no idea that she was reusing them. So it was quite embarrassing. So we see that you know, single-use items, as Mary pointed out beautifully, should not be reprocessed. They are not heat tolerant, they cannot be reliably cleaned or disinfected. And obviously, it is the standard of care. Now, another situation came up within the last few years where the allegation of reusing burrs was made against a practice. And so in this situation, it was the Department of Health that came in. And, you know, this unfortunately, discipline can be looked up through the state dental board, and all of that information is public. And unfortunately, this practice did have to pay a civil fine and also notify three years of patients that they may have been subjected to HIV, hepatitis B, or C and encourage them to be tested. So we want to stick to the standard of care. When it's possible that we can use a single-use device, that is the best practice and it helps minimize the risk of cross-contamination. So, Linda, I see that it's a win-win to remind people of the value of single-use items.
SPEAKER_01Olivia, that was so well said. Thank you. It's just a good reminder when we think about the standard of care. It's not what's what is it that we nice that's nice to know, but it's what we need to do. And I love the fact that you remind us that busy work, reprocessing items that are meant to be single use or can be purchased as single use creates busy work and it really drains staff time and it drives up the cost to a practice, which is something everyone's trying to be mindful of now, their bottom line. Leslie, could I call on you for a moment and let's talk about common disposable items that we see and how do we know or identify something as single use?
SPEAKER_03Well, Linda, this is something that comes up over and over again when I visit dental practices. I do see single-use disposable items being reused. And clearly, if there are no instructions for reprocessing that uh item by the manufacturer, then it's intended as single use. Now, of course, we all know about the common things that are single use: gloves, cotton rolls, gauze, uh, things that are uh obviously disposable. But there are other things that sometimes are look like they could be reprocessed, like nitrous oxide hoods. Uh, and sometimes, as Mary mentioned, saliva, not saliva ejectors, but evacuator tips. I've seen some very nice, uh comfortable evacuator tips with a really nice rubbery type of cushion. And uh it apparently does uh the same good job as a regular evacuator tip, but is more comfortable in the patient's mouth. And because it looks like it's a more expensive evacuator, I have uh asked the dental assistant in the practice where I noticed this uh why she was reprocessing them when they're supposed to be thrown away after each patient. And she said that uh, well, it's not necessarily cost, but they look so sturdy. And I said, Well, why don't we get on the phone with the manufacturer and find out what their reprocessing instructions are? And they told her that they are single-use disposable items, and that's why there are no reprocessing instructions with that item. There's other things that uh should be thrown out after use. For example, sterile water in their sterile water has been opened as a bottle. Uh, you know, how long has that been on the shelf? Um, Mary mentioned and also Olivia mentioned about burrs, uh, bib chains are uh available and re and disposable rather than spending the time to reuse them. Um, I've uh also want to make sure that auto clave bags, uh, note that there are some that can be reprocessed, but it would be, I guess, uh, as Olivia pointed out, time consuming for a person to be able to count the number of times that they can be reprocessed. They're made out of a cloth material. Now, my position is I would rather uh be certain of my infection control uh and maybe spend a little bit more money on the things that are plastic and the things that that are barrier protecting some of the high-tech equipment rather than take a chance on infection transmission. And uh when we talk about barriers, they need to be changed after every single patient as well. So that's again where we would find the information is from the manufacturer's instructions for use. If there are no instructions for reprocessing, it is a single-use disposable item.
SPEAKER_01Thank you, Leslie. That was a wonderful recap of the variety of items that we see in our practice that are single use. And one of my pet peeves, as you mentioned, is the sterile water. I know that there's been different shortages because of manufacturing and different issues and healthcare supplies and emergency medical drugs and so forth. And so an office may have to buy a larger volume of sterile water, say in a container, 500 milliliters versus 100. And they typically forget that the front of the container does say single use. And when I mention it to staff, they just they seem like it's okay to, I'm just drawing out water from there. I'm not putting anything in, but it doesn't matter. Once the seal is broken, it's no longer considered sterile. And I would liken it to something that you would buy in the grocery store, maybe a container of milk or anything that has the double seals. If you got home and found those were broken, you wouldn't use them. Doesn't matter that somebody else had poured milk out or whatever the substance was, you wouldn't use it. Mary, do you have a good story you can share?
SPEAKER_00Well, it's actually not a story, it's just sort of a clarification of um something that I talked about at the beginning, and that is the FDA um control, the regulations about um single-use devices. These devices are tested for approval or clearance through the FDA used only once. They are not tested for efficacy for another use or after reprocessing. And so there's liability on the practice if you're using reusing disposable devices. How in the world would you go through a testing protocol to be able to prove that it is safe for reuse? But that actually falls on to the user, which many people do not know. They think it's just like not a really big deal, but it certainly could be.
SPEAKER_01That is such an important risk management point, Mary, because the practice is assuming that liability. And let's say the patient has an allegation about some type of disease transmission after procedure, whether it's surgical or not, and the practice has no defense because when they when they're interviewed and they're investigated and the processes are not matching the standard care and they're not following the manufacturer's instructions for use, there is no defense. Olivia, speaking of defense, what would you have that you could offer to us?
SPEAKER_02Well, the the defense of saying it's expensive and my practice can't afford to do that is not a defense. And so when I run into dentists that give me that explanation, I encourage them to look at their fee schedules and to work with a qualified consultant that can evaluate their fee schedules and also negotiate higher compensation with the insurance plans that they're working from. So it has to come from somewhere. And if it can't come from a proper budgeting of the practice, they really need to work with some experts. And we have plenty of experts that we work with with the associations that we belong with, such as uh ADMC.
SPEAKER_01Very true, Olivia. Very true. Our good friends at the Academy of Dental Management Consultants can certainly help our practice negotiate their fee schedules and be able to comfortably afford, if you will, to follow the manufacturer's instructions for use and maintain standard of care. Leslie, I bet you've seen some interesting stories over the years.
SPEAKER_03Well, actually, I had a couple that became violations both with State Dental Board and OSHA, where the single-use disposable barriers, which were placed on keyboards and mice, were being disinfected rather than changed after each use. So that's something I want to remind everyone. Once a patient leaves a treatment room, we've got to consider everything contaminated. And remember that those barriers that were placed on equipment, such as maybe an X-ray head or perhaps some high-tech piece of equipment that you have in your treatment room, may have become aerosolized on. So the barriers need to come become off and certainly never disinfected. And uh another story that came to mind is uh when I heard about an OSHA citation that was issued to a dentist. He didn't know this, but his dental assistants were opening up the sharps containers that were the small ones in the treatment rooms and pouring the sharps into the larger big container that gets picked up so that they could reuse something that is a single-use disposable item, the sharps container. So disposable meaning uh picked up or disposed of properly according to your state and uh and local regulations. So that and then uh just a quick tip for everyone. When I see a dental office that's using cold sterile, and I ask them, what are you using the cold sterile for? Uh I'm usually shocked when I find out that there are single-use irrigating syringes. Uh, they're using those for maybe sodium hypochlorid for irrigating or maybe chlorohexidine. And single-use uh irrigating syringes are darn cheap, really, when you think about the cost of cold sterile and the time that somebody has to take to reprocess. And of course, what a liability it would be if you're reusing something that would might be used uh post-surgery or during to irrigate um a sterile area of the patient's mouth and it's been used on another patient. So, gee, go figure. One more thing that I see in the cold sterile when I open up the lid and look is uh the disposable impression trays. And I understand the point uh that the dental assistants make to me is that well, we tried in that tray and it didn't fit. So we didn't use it on the patient, but it went in their mouth. Well, a single use is single use, no matter whether you used it for a second in the patient's mouth or you used it for an actual impression. So the suggestion to get around that was to use a metal tray, a regular metal impression tray for your try-in, and then get the disposable tray that matches that size, and you've got a clear fit. Linda?
SPEAKER_01Leslie, those are some great tips and reminders. Thank you for sharing your stories. Uh, Divas, this has been such an important topic today because single-use devices is really the heart of the matter when it comes to quality care, safe care, and following the standards of care. I would like to close out this podcast with one saying, one sentence, if you will, from the CDC guidelines. And that is single-use devices for one patient only and dispose of them properly. That should be, if you will, the gospel truth and be followed in every single practice to the best ability. I'd like to thank everybody for joining us today. We 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, thecompliancedivas.com. Any resources that we mentioned today during our podcast will also be found on the compliance divas website. And we invite you to submit questions to support at the compliancedivas.com. And we look forward to seeing you next week.