Lecture: Best Practices in the Care and Handling of Ophthalmic Surgical Instruments

>> LORI PACHECO: Okay. Welcome and greetings from a very rainy day here in Boston. Thank you for joining me today. My name is Lori, I’m a nurse, I work with Orbis. Infection control is a specialty of mine. Today we’ll be talking about instrumentation is sterilization. Let me share my screen for you. So we’re going to be talking about best practices in the care and handling of ophthalmic instruments. Here we are. So we have some objectives today. We’ll talk about the environment your sterile processing department is in. We’ll talk about quality control and how you test your equipment. We’ll be going into the cleaning and decontamination process. Then we’ll start talking about sterilization, all the different methods we mostly see in ophthalmology. Then we’ll talk about storage or return to the sterile field, sterilizing instruments and bringing them right back into the operating room. So I have a couple of questions. Andy, if you would like to queue up. These questions, I’m just asking to get an idea of the audience and what you do in your practice. First, which of the following quality control methods do you perform on your steam sterilizer? Do you do bug testing, which is biological? Do you do those strips with the color change? Those are your chemical testing. Do you do both? Or do you do none? We’ll give you all a second to work on this. Oh, excellent, very good. Okay. That’s good to know, it gives me an idea of what to focus on. All right. And then we’ve got one more question. Do you have policies and procedures in your facility that tell you how to do your sterilization process, standard operating procedures or anything like that that guide you along in the process? Excellent. All right, good to hear. That’s wonderful. Okay. I’m glad to see that. All right. So let’s get into this. So let’s talk about the environment of which your sterilization department is in, and please forgive my 110-pound photo bomb behind me. Central processing really should be divided into a minimum of two but ideally three areas. Now, I know it’s not easy. You don’t have a lot of space, especially in ambulatory surgery centers. But if you can somehow separate them, even if it’s in one big room, you kind of want to separate your areas. So one area for decontamination, those are your dirty instruments. Those are the instruments that are you know coming in from the operating rooms, these are your contaminated instruments. Then you have one area for packaging, for inspecting, putting, you know, your instruments in their packages or putting instruments inside their sets, putting everything together. These are your nonsterile. Then you have your sterilization area. These are your sterilizers, you’ll be putting them in and taking them out sterile. Key for that sterilization area, it really should be controlled temperature, up to 75 degrees, which is 24 Celsius. Humidity 30 to 60%. And your sterile storage area really shouldn’t exceed 70%. Now, many of us have number 1 and number 2 in one area and number 3 in another. And that’s okay. If you don’t have separate rooms, sort of separate your room by sections. So in other words, if you look below, you can see that one area. Your dirty goes in one way, and then your clean comes out the other way. If you can have two separate entrances and exits, that is wonderful, whereas you’re bringing dirty instruments from your operating theater in one way, and then when you bring in clean instruments out, you’re bringing them out another way. You really don’t want to be passing clean and dirty. If you don’t have a barrier, so to speak, a wall between your clean and dirty, at least if you can somehow separate them into two separate areas so that your dirty is going in one way and your clean is going in another. So we’re going to go into quality control, because these are things you should be doing before you start your day. So you know your sterilizers are working properly. These are basically bug tests, this is what we call them. These are biological tests. You can see by the bottom, that’s just one example of one. They assess the sterilization process directly by killing these highly resistant microorganisms. They come in these little self-contained vials there, self-contained scores inside a vial, with a sealed growth medium. So basically what you do is you’re going to put it in the sterilizer. You’re going to expose the biological to a sterilization process. Then when it’s done, you’re going to activate it. Honestly, most of them you just push the top and then you squeeze it. Some of them give you a little device to do that. Either way, you want to crush the ampoule. And then what that’s going to do, it’s going to activate it, it’s going to allow the growth medium to create this growth environment for the bug. And now you’re going to incubate it. You’re going to put it in incubator. Some incubators, some processes allow for this bug test to give you a result in 15, 20 minutes, you know, and you can do it the morning of. Others take 24 hours, and that’s okay too. So basically your incubation produces these acid byproducts and that causes the medium to change lore. So the spores that were exposed to the sterilization process are killed, so they can’t produce that acid, so there’s no color change. But you always want to make sure you’re doing a control, which is basically a bug that didn’t go in the sterilizer but still gets activated. The bug that was not sterilized, you still activate it, you still crush it, you incubate it, and those will change color, okay? Because the sterilization, there was no sterilization process that killed the bug. You want to use a control because you need something to compare it to. You can’t look at a bug and say, okay, that’s great, that’s negative, if you don’t have a positive to compare it to. So you always want to use a control. Again, there are different incubators, different bug tests you can use. Some are for 24 hours, which is fine. Some are an hour, 15 minutes, 20 minutes, it just depends. Sometimes they come in little packs that give you a biological and a chemical together. They come in all different ways. The key is to be sure that you are doing this, because this is the way to tell your sterilizer is working. This is quality control. So chemical monitoring are those little strips. Now, chemical indicators or indicators strips, what they do is react to change in the physical conditions in the sterilizer. So it’s treated paper. And that treated paper changes color when it’s exposed to certain sterilization parameters. So what it’s doing is it’s checking on the cycle length, the cycle temperature, and exposure. These are just some examples. You can see the one above, that’s a type 1. We’ll go into that later. You want to make sure that line changes color. The one on the bottom is another example. That’s a class 5. And you want to make sure that the color goes past that white. You can see reject and accept. And that your blue, that blue line goes past a certain spot. These are just some examples, and they come in different types. And we’re going to talk about that. So you want to be sure you’re using the right type for the right sterilization process. So here are those types. Now, the classification structure is really only used to describe the characteristics and intended use of that particular indicator. The class number doesn’t mean that one class is better than another. It’s just each one of these has a very specific role. So this just gives you an idea. Class 1 is a process indicator. It’s telling you it was processed. It’s not telling you it went through the right length of time and right parameters. It’s telling you it went through a process. I’ve heard people say you can hold these over a boiling pot of water with the hot steam and it’s going to change color. So it’s going to differentiate processed items from unprocessed. In other words, if you open a sterilizer and that class 1 is on the outside of the package, you can look and automatically know that it went through a process. Example, some people, you know, they may open the sterilize and her then they get called away so they don’t bring the instruments out, they stay in. So you can come and see, okay, these have gone through a process. Or it can happen that some people will put dirty instruments into the sterilizer to be sterilized, but then they get called away. They haven’t closed the door, they haven’t started the process, somebody else comes along, they think they’re sterile. But they’re going to they’re not sterile because they’ll say that class 1 indicator showing them the color hasn’t changed and it hasn’t gone through a process. That’s all the color 1, number 1 does. Class 2 we’ll go into. Then we have class 3 through class 6. Basically the rest of them, what they are is they’re reacting, you know — one, two, three different indicators. In ASDs, typically, in most sterile processing areas, we use the classified. What a classified does, it reacts to all the critical variables, time, temperature, everything. It really is the most accurate of the indicators, because it really correlates to a biological. It’s as close as you’re going to get to a biological bug. Now, what’s important to know is that you have to use these inside every pack, every peel pouch, every container. So if you have, let’s say, a rigid container, we’ll talk about that later, and you have instruments inside the rigid container, that class 5 indicator needs to go to the bottom level of what’s inside that container. So in every case, in every package, in every instrument tray, if you’ve got three instrument trace inside of a container, they’re going to go in all three because you need to know that the steam penetrated all the way through. If you just throw it in the container, all it’s telling you is it went through one layer, it’s not telling you it went down through the other layer. You want to be sure you’re using a class 5 in every single container. So, example. 5 and 6. See the picture on top? It’s a double layer tray. So when you’re using a double layer tray, you’re going to make sure the indicator is not only on the top but on the top, otherwise you don’t know if the steam penetrated all the way through. So it’s meeting all the critical variables of the sterilization process, your temperature, time, and complete replacement of air with steam. So the determining factor in steam sterilization is ensuring penetration, that steam got through, all the way where it needs to go. That’s why you need to place it at the absolute bottom to be sure steam has penetrated all the way through. Now, type 2 is called the Bowie Dick Test. Basically with the type 2, what you’re doing is you’re evaluating the sterilization’s performance. You’re not testing whether or not instruments are sterile. What you’re doing is you’re testing the performance a pre vac cycle. Pre vac cycles require a vacuum to be drawn during the first and last phases of the cycle. So you’ve got to be sure that’s working correctly, that those — that that vacuum is going to vacuum out everything it needs to. Basically what it’s doing, it’s replacing the air inside of the chamber, and it’s pushing it out, it’s vacuuming it out. That’s what makes pre vac a very good sterilization method, because it’s suggesting all the air out of everything, out of your cannulas, out of everything. It does that through pulses, it does that through a vacuum, and you have to make sure that’s working properly. On the left is unprocessed one. In the middle, all those lines are beautiful. The last one is one that failed. This gives you an indication of a Bowie Dick Test, that’s type 2. Indicator testing really should be performed daily. If you can’t do it daily, at least minimum, weekly. You want to be sure you’re doing it at least weekly. But if you can, every day is perfect. And during critical assessment. Critical assessment is you either installed a new sterilizer, you relocated your sterilizer, or after malfunctioning or failure or any major repairs. After any of these happen, you should do critical testing. Typically, there should be three consecutive empty steam cycling run with a biological and chemical in every appropriate test package or tray. An empty steam cycle meaning not doing it with instruments, if you want to put an empty tray in there and put an indicator in there, that’s fine. Then three consecutive empty cycles run with Bowie Dick Test if you have a pre vac steam sterilizer. The sterilizing really shouldn’t be put back into use until all indicators show that it’s negative. So be sure that if you have any critical assessments, you had to have repairs done to your sterilizer, you had to move them, anything like that, you’re not just saying, okay, it’s good to go and putting them back into use. You have to test them. Do your three consecutive cycles, get your testing done to be 100% sure everything is fine and documented. We’ll go into documentation later. Now you’ve got mechanical monitoring. These are important too. These are tools that validate the autoclave process. This gives you that real time evaluation of the sterilization process. And it results in a permanent record. This can be a printout, charts, gauges. It’s measuring the time, temperature, and pressure. Your sterilizers really should have something to give you, whether it’s a printout, whether it’s a gauge, to show you real time, to show you that that process that you’re taking out those instruments, that instrument process met the correct time for sterilization, the correct temperature, the correct pressure, in a real time scenario. So you need something to show you, before you take out those instruments, that it met the correct parameters. All right. Decontamination. Cleaning your instruments. These instruments come out, no longer do we have the days of taking instruments out of the operating room and putting them right into the sterilizer and not going through a decontamination process. Those days are done. We have to be sure that all your instruments are coming out, getting cleaned and decontaminated properly. It really should begin as soon as the instruments reach the decontamination area. You can also start decontaminating your instruments at the end of the surgical procedure. Start doing it as soon as possible when the surgery is almost near done. If you’re a scrub and you’re working with your surgeon and you’re doing let’s say a cataract procedure, at the end of the case, they’re hydrating the wound, you can be there cleaning your instruments. The purpose that have is things don’t dry on your instruments, so you’re not getting viscoelastics clogged on your instruments. As they’re taking the cataract out, you’re cleaning your instruments. So cleaning and rinsing really are the first and most important steps in decontamination. As mentioned, lens matter. You’ve got nucleus inside your cannulas. Viscoelastics can harden, the instrument can end up in the garbage. Saline salt crystals, they’re terrible for instruments, it can cause pitting, blood and body fluids, it can cause deterioration of the surface of the instruments. And it’s really hard to remove. You’ve got organic material, blood, soil, debris, all these things. What they’re going to do is, if you don’t clean them and they stay on the instruments, and those instruments go in the sterilizer and get sterilized, the heat, the sterilization process is going to stick that matter, that debris, onto the instrument, onto the surface, then what that’s going to do is preventing the sterilization process, preventing the sterilization agent from actually penetrating and reaching the instrument, because now it’s blocked by viscoelastics stuck on the instrument or pieces of the cataract nucleus stuck on the instrument, soil, organic material, blood. That blood is preventing the agent, whether it’s steam, gas, what have you, it’s going to prevent it from reaching the actual instrument. So you’re basically blocking it from getting sterilized. You’ve got to do contamination immediately. So like I mentioned, start on your back table. Begin right away, during the procedure. Prevent that drying the blood. How are you going to do this? How do you know how best to clean and decontaminate your instruments? You’ve got to use the instructions for use. This is your IFUs, your manufacturer’s instructions for use. Every instrument comes with this little piece of paper or something inside that’s going to tell you exactly how you need to clean that instrument. It’s going to give you the instructions that you need. So to know what you can use to clean the instruments, whether you can use tap water, whether you need to use sterile water, if it can withstand detergent, everything is going to be in that instructions for use, they’ll tell you exactly what they need. Don’t throw away that piece of paper. You can typically find the instructions right online on the manufacturer’s website. Now, when you’re working in decontamination, all these instruments are now coming through your decontamination room. That person receiving these instruments, be sure you’re using your universal precautions, your personal protective equipment, your PPE. Utility gloves. Liquid resistant gown. Liquid resistant shoe covers. Face mask that’s fluid resistant. Eye protection. Goggles, face shield. You’re flushing cannulas. Water’s going everywhere. Make sure you’re keeping your eyes protected. And you want to keep the aerosols down. When you’re cleaning instruments in a sink, you want to be sure you’re washing under the water line. You don’t want to be up here, above the water line, and having everything splashing, so make sure you’re washing below the water line. And keep that lid on the ultrasound if you’re using an ultrasound machine. Manual cleaning, this is for instruments to just wipe clean using a moistened sponge, an instrument wipe. You can use a soft toothbrush, I say soft, be sure those metal bristles that they can sometimes use to really clean, those are very abrasive to ophthalmic instruments, make sure you’re using a soft toothbrush. Instruments with lumens need to be flushed with distilled or critical water, that just means treated, distilled or sterile water. Make sure if you’re using tap water per se to clean your instruments, you want to be sheer that the last flush, the last rinse, is with critical, distilled, or sterile water. Tap water is terrible for instruments. Make sure you’re getting all that off. And then it’s followed by compressed air. Lumens, you cannot leave water inside a cannula or inside a phaco handpiece or any instrument that’s hollow and has a hole in it. In the next procedure, when that next surgeon gets that cannula and they’re going to flush BSS in someone’s eye, you’re going to end with that sterile or distilled or even tap water left over and it’s going to shoot into somebody else’s eye and now you’re going to cause an infection. Be sure you’re using compressed air to compress everything out and make sure that lumen is as dry as can be. You also have mechanical cleaning. With mechanical cleaning, you’re using a cleaning agent, okay? These are your detergent. When you’re choosing a detergent, you want to be sure it’s low sudsing, not something that’s going to foam up. You want low foam, biodegradable, easily rinsed off, that’s important, nonabrasive. It can disperse organic soil, that’s blood. Look at the ingredients and make sure that it’s telling you that it’s nonabrasive, it’s telling you that it’s nontoxic and that it’s low foaming. And with detergent, we’ll talk a little bit about TASS. I’m sure most of you know what TASS is, toxic anterior segment syndrome. This is an acute severe intraocular inflammation of the anterior segment after intraocular surgery. There’s a lot of potential causes for it. It can be contaminated BSS, intraocular irrigating solutions with an abnormal pH, your antibiotics in the irrigation solution or intracameral antibiotics, typical ointments. It results in a buildup of your viscoelastics agents. It’s a terrible thing to see, if anyone has seen a patient with TASS, we want to do everything we can to avoid it. How do we avoid it? We want to be sure we’re following our instructions for use. The cleaning solution shouldn’t be mixed. It should be mixed and not, you know, guessed. When you’re putting detergent in your sonic machine or in your sink to clean your instruments, don’t just pump-pump and guess, you’ll end up with way more detergent than you need. Look at the instructions. You only need this much for a gallon of water. It says that for a reason. It’s telling you how much you need to make it easily rinsed off, so that you’re still cleaning effectively but you’re going to be able to rinse it off appropriately and not using more than you need. So don’t guess. Just measure the amount. We take a medicine cup and we measure it, exactly the amount the instructions are telling us to do, we set it by the sonic machine, and then when it was time, that’s what we use, we put it in and get another one ready for the next procedure. Rinse, rinse, rinse, rinse, rinse. Instruments need to be thoroughly rinsed with copious amounts of water. Copious, love that word. They say it in so many instructions for use. There really is no exact number for copious. Typically we like to see about 120 cc’s, is what most people use to flush cannulas, and compressed air to follow. Even your instruments themselves, rinse, rinse. Take the time in between cases to rinse those instruments out. If you’re using tap water, please be sure that the instructions for use say that you can use tap water. Again, tap water’s not great for instruments. But if you are, no matter what, the final rinse really should be done with distilled, sterile, or treated water. This is just an example, when we talk about instructions for use. I took this off of, you know, online, off a phaco handpiece. This is really the company telling us, this is what you need to do to clean that phaco handpiece. You can see in the middle there, push room temperature, sterile, deionized water. It’s telling us what we need to clean the instrument. Finish with a minimum of 60 cc’s of air. This is the company telling you what you need to do. Make sure your water doesn’t exceed 60 degrees Celsius, it should be warm water, not hot, hot, hot water. You’re going to ruin your instruments if it’s too hot. When you’re cleaning your instruments, make sure those instruments that come apart or have hinges, that you take them apart. Needle holders, forceps, scissors, they have to be completely open so you can get inside those jaws and expose all the parts to not only the decontamination process but the sterilizing. That’s how steam works, to penetrate. Open or disassemble the parts. The example below is the holder we use for 57 or 67 blades, there’s a little piece at the end, that’s just a screw, that’s all it is. You have to take that screw out. Unless the instrument came that way, fused together, most instruments, when you get them, you’ll see, they come in pieces. If they come in pieces and you have to put those pieces together, then you have to take those pieces out when you clean and sterilize them. Basically if it wasn’t manufactured that way, it doesn’t get sterilized that way. You’re going to take that screw out, you’re going to take apart that occult scissors. How are we doing on time? Good. No lumens in detergent. It’s such a risk for TASS. Still not to be flushing your instruments, still want to be doing your compressed air. But try not to put lumens in detergent. You can use lubricants for your hinged instruments. This is going to help these hinged instruments open and close properly. There’s nothing worse than handing an instrument to a surgeon and it’s scissors that don’t open. Lubricants, these are your scissors, needle holders, even forceps. It’s going to prevent stiff joints. It’s also going to inhibit corrosion. Usually the instruments are dipped one by one in a lubricant, not soaked. You want to be sure you’re not using a lubricant in cannulas. We spend a lot of money on instruments so we want to be sure we’re taking good care of them, the instruments are working properly. So lubricants is a wonderful way to do that. And just to make sure, after your instruments are done, whether you’re storing them, you want to be sure you’re not putting them away wet. And that is an actual instrument on the left hand side that was found in a tray, I’m sure, or in a drawer somewhere. And look at that rust. You wouldn’t want to give this instrument to a surgeon to use on a patient, okay? This is rust that happens when instruments don’t dry. If they’re put away wet or damp, they’re going to rust out. Be sure that you’re drying your instruments and that you’re not keeping instruments that look like that picture. A little bit about stains. Some of us will see some instruments come through that may have different stains or rust or pitting. Just so you know what it means when you see that. The difference really is, stain as a discoloration on an instrument service. Rust can be a red or orange discoloration on the surface of an instrument that results in oxidation. Then you have pitting, pitting is an erosion, you’re going to see the pitting on the instrument. Typically that means the instrument is done, beyond repair. You can’t use an instrument with pitting. These can be small, tiny, they could even be a large hole. Once you start seeing pitting, you’ve got to throw it away. A brown-orange color could be rust. It could be due to your water quality. It could be due to saline, if you get a dark brown/black color, that could be dried blood. Detergent can cause that. Be sure you’re using a neutral pH, your detergents will tell what you the pH is. Blue-gray, cold sterilization solutions, be sure you’re using your manufacturer’s instructions. Light and dark spots can be water spots, it’s not drying well, which can lead to rust. For stains you can use a nonabrasive cleaner or a commercial stain remover. I’ll be perfectly honest with you, if it’s a simple stain, you can use an eraser to get the stain out, it works very well. If more than 5% of your instruments are getting stained, that’s something you should look into, you can do a quality assurance study to determine what’s causing those stains. If you’re getting a lot of them, do a good investigation to see what’s happening. Sterilization, we’ll get into the nitty-gritty. I focus on the sterilization process we see in ophthalmology, which is chemical or heating. Chemical can be ethylene oxide, glutaraldehyde, heating is moist heat. Neither is better, it’s what’s more appropriate for what you’re trying to sterilize. Using chemical sterilization, this is your liquid or gas, even though steam provides the most reliable way to get rid of objects, transmissible agents, it’s not always the best sterilization process. It’s not always appropriate. Heating can cause damage to electronics, certain plastics can melt, eastern fiberoptics. I want to make sure you’re using the right sterilization process. Liquid, glutaraldehyde immerses items for a period of time. The advantages, if you’re not using sterilization often, it’s an inexpensive options. I know a facility that’s used it on their 20 diopter lenses. It can take a long time. It’s very inexpensive, you can use it safely on lensed instruments. But the thing is, it’s a toxic material. The same properties that make it a good sterilization agent make it harmful to you and I. It can release toxic fumes that have a pungent odor that can be irritating. There’s no reliable method of monitoring the sterilization process. You can’t put a bug test in there or a sterilization strip. There’s potential for contamination during rinsing and transferring. And any residual solution can be extremely toxic to intraocular and extraocular tissue. It can be a good sterilizing agent but just to give you the warning that it is toxic. Then you’ve got your gas. This is your ethylene oxide. An organic chemical, member of the ether goop. You’ve got the gas concentration, temperature, humidity, and time. These four factors. So a typical gas sterilization procedure consists of a preconditioning phase, a sterilization phase, a post sterilization, and then aeration. Now, way back when, machines weren’t — machines didn’t have an aeration process. They weren’t developed like that. Once the sterilization process was done, we would take them out when it says it was time to, and we would have to sit the instruments on a shelf to aerate for a certain period of time, from what I remember it was 24 hours, because the old machines didn’t have an aeration process. Now they do, all the new gas machines have aeration as part of the process. So it’s no longer having to sit out. Typically they have different process times for things like long tubings, because those things will take longer to dry. So you’ll see that, you know, sometimes the process will be longer if you’re using things like tubing so it gives it that time to air out. The advantages to gas is it’s very compatible with packing material. It can prolong how long you keep your instruments in packages on the shelf. It completely permeates porous material, and it’s noncorrosive. It’s good for the instruments. But it’s also expensive. The gas ampoules, all the different things you need to run a gas sterilization process can be very expensive. The cycles themselves are expensive to run. It does require aeration. It is gas, it can be harmful to the operator, it is carcinogenic and mutagenic. It can be a long, slow, complex process. It can be extremely flammable, you have to remember where you’re storing it. With all of this, I will share, I’ve been doing gas sterilization for, my gosh, it’s got to be 20, 25 years now. Never seen a problem. It’s a very good sterilization process if you follow the rules, follow the instructions. I think the only time I’ve ever seen an issue with gas sterilization, typically it has to get aerated out, there’s usually — it gets — usually there’s like a pop through the wall of some sort. I think at one point there was a bird’s nest up at the top where it goes outside, that was inhibiting it from releasing the agent. So I think in 25 years that’s the only problem I’ve ever seen with gas sterilization. It really is a great process. But it is expensive to run. You need obviously the gas, you need humidity chips, you need to put a bug test in every one, you need to put — it’s not just throwing instruments into a box, so to speak, and sterilizing with gas. There’s a lot of different items that you need to put in there as well, and they can be expensive. Now we’ve got what all of us are used to and one of the most common means for sterilizing, is saturated steam under pressure. Steam sterilization is the oldest, cheapest, and best-understood method of sterilization and it works like a pressure cooker. Moist heat kills microorganisms by causing the coagulation of protein. The vibration of every molecule of a microorganism causes a splitting of the hydrogen bonds between the proteins and the death of the microorganism is caused by irreversible damage to all of the components of that microorganism. It’s like a pressure cooker. Steam coagulates a microorganism’s cell protein similar to poaching an egg in boiling water. If you’re going to crack open an egg in boiling water, the egg white will coagulate as you’re poaching it. If you’re frying an egg using dry heat, that requires 371 degrees Celsius and can take longer. So these are your correlations between moist heat and dry heat. Boiling water, 100 degrees. Frying an egg, 371, and it takes a lot longer. Basically the more moisture that’s present, the more heat that can be carried. Steam is an effective carrier of heat. So another way to think about it, when you cook beef at home, you just throw it in the oven, it can be really tough and it’s roasted in a covered pan. Now, if you add a little water to the bottom of the pan, the meat now will become tender. The temperature is the same. The time of the roasting is the same. But the results are different because you added water. Now add pressure. By putting the same roast in a pressure cooker and reducing — it reduces the cooking time by at least three-quarters and you still get a tender product. Here you’re adding moisture and you’re adding pressure. So we talked a little bit in the beginning about prevacuum and gravity displacement. These are your two types of sterilization processes when you’re working with steam. Let’s first talk about gravity displacement. Many of the tabletop sterilizers out there run by gravity displacement. Steam is pumped into the chamber that contains the ambient air. Steam is less dense than air so it rises to the top of the chamber and eventually pushes all that air out, it displaces all that air. The steam fills the chamber, displaces all that residual air that’s forced out through a drain, typically through the tip you’ll see at the bottom of the sterilizer. By pushing that air out, it’s pushing it, it will go through that hole, by pushing all that air out, the steam is able to directly contact the load and begin to sterilize. Steam pumped in, steam rises, it’s going to push — now it’s rising, it’s going to push all that air out through a — you know, through a drain. And then that steam is going to contact that load. That’s typically gravity displacement. Then you get vacuum, pre vac is what we call it, it’s a more efficient form and it’s great for porous loads. It’s a vacuum system. It starts with a series of alternating steam pressure injections and these are little pulses. These pulses dynamically remove the air from the chamber. This allows the steam to be sucked into areas that otherwise it would have difficulty penetrating, like cannulas, things with small holes and lumens. The absence of air within the chamber allows that steam to immediately penetrate into load. And that allows for much more reliable, more efficient storm of sterilization with shorter sterilization times. So you have a vacuum system. You have these little pulses that dynamically remove the air. That allows the steam to penetrate the load. Typically, you know, with steam sterilization, we do like to see a vacuum cycle because it’s really a more efficient cycle, and it’s great for porous loads. If you’re using cannulas and, you know, things with small lumens, it’s a much better sterilization process. Now, we have immediate use sterilization, IUSS, if you’re familiar with that term. IUSS really should only be used in critical situations where there is not sufficient time to process instruments through terminal sterilization. This is usually through gravity displacement. Now, if you do want to use IUSS, typically it’s a shorter cycle. It doesn’t have a very long dry cycle, sometimes it doesn’t have a dry cycle at all, which we’ll get into later. With IUSS, it’s typically a shorter cycle. Even then, it still must be processed in the same manner, your instruments have to be cleaned and decontaminated. It will be placed in a container intended for the parameters to be used. It must be used immediately, not stored for later use. Immediate use sterilization is instruments that are not stored. You can’t use IUSS gravity displacement and try to store it later, especially if the instruments are coming out wet. Should not be used for purposes of convenience like lack of adequate supplies of instruments to meet surgical volume, in other words, you know, you’ve got too many cases to be doing pre vac and long sterilization cycles and you’ll use IUSS to shorten that cycle. That’s a no. They must be compatible with the instrument’s FIU. And really, you should be documenting. If you’re using IUSS, document it. The instrument dropped on the floor, the only one we have, surgeon really needed it. Okay, one instrument, didn’t have a hole or a lumen, you dropped a hook or you dropped a second instrument, you’re going to put it in the sterilizer using IUSS. That’s okay, that’s okay to do that. You’re doing it appropriately. But you really should be documenting it, okay? Let’s talk about those wet instruments a little bit. So when you have instruments coming out wet, there’s different reasons for that. It’s not great when instruments are coming out wet. Your instruments really should not be coming out wet, your packages should not be coming out wet. Usually when you find that packages and loads and trays are coming out with moisture in them, you need to be redoing that cycle. What can cause wet packages? Wrapping material. If you’re using reusable linen, usually the cotton thread can cause condensation on the wrapping material. If you’re loading these packages too tightly, that can cause condensation to be trapped, steam to be trapped inside, in between. So you’ve got to leave space in between the sets. Peel pouches, don’t stack them one on top of the other, you should be using some type of rack to have them vertically placed. Otherwise when you shove them in, there’s condensation happening. If you’re doing a mixed load, make sure the upper shelf is for the linen and the bottom shelf is for metal. Typically sometimes the metal — typically if you’re getting condensation, the metal will drop on your linen, it’s going to soak your linen packages. If you’re using wrapped packages and those packages are — I’m sorry, if you’re using peel pouches and those pouches are really wet when they’re coming out, that is a big source of those peel pouches to get penetrated and contaminate what’s inside, all right? Dry time. Improper dry time, or — you should never interrupt the dry cycle, okay? Selecting a drying time that doesn’t meet the instructions for use. Removing packs from the autoclave too early, that can cause condensation, these are all things that can cause packages to be wet. Remember, the process of sterilization packaging is to keep sterilized instruments away from the external environment. When packs are wet, moisture acts as a pathway for microorganisms. That’s a high risk for contamination if moisture can get inside the pack. Or instrument sets. Instrument sets should not be coming out soaking wet. Instrument sets containing moisture inside the container, consider those contaminated. Really shouldn’t be used and you shouldn’t be doing them. Moisture can cause potentially contaminated instruments increased risk of infection which then can result in poor patient outcomes, okay? Don’t bring cardboard or corrugated boxes to sterile areas of your operating theater. If your supplies are in boxes, don’t bring cardboard boxes into sterile areas. When you get instruments that come in, first thing you want to do is look at these instruments, okay? This is all under infection control. Maker sure that they’re properly aligned. Make sure the scissors open properly. Make sure there’s no corrosion. You always want to manually inspect these instruments upon delivery. But most importantly, do not take them out of their boxes and put them into the sterilizer. They need to be washed, cleaned, manually cleaned, however the instructions for use tell you. Speaking with a good friend of mine this past weekend, she was at a surgery center that was having unfortunately a span of infections. Come to find out they got new instruments and they were taking their brand-new instruments right out of the box that were just delivered and putting them right into the sterilizer. There’s your source of infection. They weren’t cleaned. Who knows what those instruments have on them coming from the facilities? So be sure that you are cleaning these instruments well, you know, really well before you put them into the sterilizer. The reason why you can’t bring cardboard boxes to a sterile area is when you get these shipments that come in these boxes, there can be bugs in them, I’ve actually seen it, taking out all the stuff that was in a corrugated box, at the bottom was a nice spider sitting on the bottom. I’ve seen silverfish, I’ve seen it all. Be sure you’re not bringing cardboard boxes into a sterile area because of the risk there could be something in that box. There’s accountability. At the end of the sterilization cycle, the operator needs to verify the correct parameters are met before the items are used. That’s where your mechanical monitoring comes in place, your printouts, your monitors, your gauges. Initial the printout. Or do you have a logbook with the cycle information and the person who removed it? Something you can track. You really should be able to go back and track every process. If a patient does get an infection, you should be able to go back and say, okay, their instruments came out of sterilizer A, you know, at whatever time, and this person took the instruments out. Did this person check that the parameters were met? Where is that print out? Can we see that everything, you know, was sterilized according to the correct parameters? Accountability, and also a way to be able to go back and track. There’s also what’s called third party testing. So, really, you could take a logbook, I hate to say it but it’s true, you could take a logbook and write down, all the way down, yes, yes, yes, I checked everything, everything’s fine. Who’s saying someone actually did that? It’s sad but it’s true, and it can happen. If you’re using third party testing, you have a person on the outside telling you whether or not your machines are working, that third party. Basically what they do is give you an spore strip and a control strip. They write down, I sterilized it for this many degrees for this period of time at this much pressure. It’s sent to an outside company for testing. The results return and tell you whether everything passed. I’ve seen some centers do this once a month. I’ve seen some do it quarterly, once a year, twice a year. A really good validation to be sure everything is working properly. How do you know your ultrasonic machine is working properly? We’ve talked about sterilizers and everything working well. How do you know your ultrasonic machine is working probably? Through cavitation, rapid creation and destruction of vacuum bubbles or cavities in a liquid. Bubbles when forced into contact with a solid surface, collapse. The surrounding liquid fills the area the bubble once occupied, that creates the intense scrubbing action. They sell commercial products for cavitation testing. On the left is one example. I’ve seen people use the frosted grass test, when you put that glass inside a sonic machine, it’s going to come out, you’ll see the frosted glass, you know, it’s been — lines and spots, you can see on it that cavitation and those bubbles and everything hit that frosted glass, it’s going to change how that frosted glass looks. You can also use a boil test, I’ve heard of people doing this as well, you see those holes in the foil, that tells you the machine is working properly and cavitation is working. The only thing is, now you have pieces of foil inside your sonic machine shareholder can accidentally get inside instruments. If you’re using a foil test, keep that in mind. Shelf life of a sterile package is determined by the date, the integrity of the package, the size of the package. Or if you have policies or procedures. Typically with sterile storage, packages are good for as long as they’re not compromised, okay? It used to be, I remember when we started, we used to redo all our packages every six months. We don’t do that that much anymore, unless your policies and procedures tell you to do that, if they do, then you’re following your policies and procedures. Wrapped instruments stay sterile as long as that rack stays intact, the integrity of that package. Wrapped packages can be peel pouches, rigid containers, wrappers. You want to be 100% sure that the sterilizer and the instruments and the container that they’re in are all compatible, okay? IFUs, look at your manufacturer’s instructions. All those three have to match. Make sure you’re selecting packages validated for the sterilization process and the cycle parameters. I’ll give you a good example as to why. Using a rigid container, instrument hit the floor. It was an instrument that the rep had brought in, it was the only one they had, really needed to use it, had no other. So they needed to stick it in under immediate use sterilization, which is perfectly fine. Cleaned it, put it in a rigid container, put it through IUSS which is gravity displacement. Got it back pretty quickly. Got it into the operating room. The outside class 1 was fine, changed color, because it went through a process. Open up the container, open up the tray inside of it, and the class 5 inside did not change. It went through the sterilization process but the color didn’t change. The reason why is because that rigid container was not validated for gravity displacement. Steam didn’t penetrate all the way through the container. Now at this point, I’ve got instruments on my back table that are not sterile. Not only did we unfortunately, you know, drop the instrument and have to take the time to sterilize it again, now we have to take the whole back table apart, everything, everything’s gone, because I had an unsterile instrument on my back table. That shows you you have to be sure you’re choosing the right sterilization parameters, your pre vac, the gravity, that matches the instrument, matches the container, everything has to match in order to be sure that your instruments are getting properly sterilized. Peel pouches, I think we’ve all seen them. These are lightweight, small, they’re meant for lightweight and small instruments. You want to be sure you’re not throwing as much as you possibly can, let’s just say you’re sterilizing cautery cords, you want to be sure you’re using the right size pouch to allow for steam penetration. Make sure you’re using tip protecters so they’re not poking through and causing contamination. These are the rigid containers I was talking about, they can be used to package surgical instruments for future use. Some of them, once they’re inside that container, if they get locked and you can put that on the shelf for as many months as the manufacturer’s use tells you. I’ve seen some of them good for 360 days, as long as that container stays intact and not compromised. Then you’ve got your wrappers, these are used for instrument trays. Double wrapped to provide the best barrier. Don’t do it too tight. Indicator tape to secure the wrapper. A lot of those indicator tapes can be latex based. Make sure you’re labeling everything. You should be labeling what sterilizer you use, if you only have one, that’s fine. If you have two or three, whether it’s sterilizer A, B, C, 1, 2, 3, doesn’t matter. Put down the cycle or load number, date of sterilization, description of the contents, and your initials. Again, accountability, and also tracking. So labeling these packages. Believe it or not, there is a pen out there that’s specifically designed, may not have been designed for this particular reason, but it is designed properly to be able to use in sterilization. It’s waterproof, it doesn’t drip or — it’s nontoxic. It’s a Sharpie, 13601, it’s black ink, it’s beautiful for being able to write on packages. And it’s just a great Sharpie to be able to use so that things don’t run. It’s not toxic, it’s heat resistant. Keep that in mind, Sharpie 13601. The shelf life of a package, as I mentioned, is event-related, okay? No longer do you have to take everything out of a package and resterilize them after a certain amount of time. The shelf life depends on the quality and the integrity of the package, the storage conditions, the amount of handling. When you go to pull a package off the shelf, is it yellow? Is it all crunched up? Then you don’t want to use it. Does the package look perfectly fine, no holes in them, the integrity looks good? Then it’s fine even if it was sterilized six months ago. What really matters is event-related. Were there any events that happened that would compromise the integrity of that package? Just make sure that you’re looking at the package well before you go and put it on your scrubs back table. Also make sure you’re looking at your quality control. Whatever you’re using, to be sure the instruments inside are sterile, usually it’s a chemical indicator, hopefully a class 5 or, you know, something to make sure it penetrates, some packages have indicators inside that they come that way from the manufacturer. If you’re the circulator opening that package, be sure that you’re looking to be sure that it passed everything it needed to pass that the instruments are sterile. Don’t crunch or bend or compress instruments or wrappers, don’t use elastic bands to secure them. Don’t stack wrapped items, undue pressure or weight can compromise it. Don’t store items on the floor or windowsill where water can get in. Make sure you’re using your tip covers. These are all examples of what you can possibly use. Make sure when you’re using tip covers, you see those holes in them, that’s really important, steam has to penetrate. If they don’t have holes, you have very little area for steam penetration just from where the instrument went in. That’s not enough. You need those holes for steam penetration. When you’re loading a tray to be sterilized, please, like I mentioned, leave room for steam penetration. Leave room so you don’t get condensation. All those instruments shoved in there like that, that’s not good. You’re not allowing steam penetration to get through these packages. So make sure, you know, these trays have these little spots for a reason, to lay your instruments exactly how they need to be with a little bit of room in between them. Sometimes I think some people go by an inch in between each one to give it room for steam penetration. In your instrument tray, make sure you’re living a gap in between your instruments, okay, for that steam penetration, and to let that moisture escape. Don’t load instruments on top of each other. Putting instruments in those little rubber mats, just make sure you’re not putting multiple instruments on top of each other. If you’re using a multilayered tray, be sure it’s used as the manufacturer designed it. In other words, don’t improvise your own way of doing double layers, in other words you have one layer, now you’re going to put a sterile towel on top, then you’ll put instruments on top that have, all of a sudden you’re layered in a way that the manufacturer did not intend for that tray, all right? Make sure that it’s designed specifically that you have multiple layers. Face all the instruments in the same direction, that’s for safety. Sharp instruments should face outward, not towards you. So when you’re setting up your instrument trays, don’t face anything sharp towards you. Try to use a separate tray for your sharps or designated area of the tray for your sharps for the person cleaning them, it’s another sense of protection. Only reuse resterilized instruments when the IFU says you can reuse it. If the IFU says one use only, it’s one use only. When you’re returning things to the sterile field, be sure they’re transported with protection, okay? These are our covered containers, all right? You really can’t, shouldn’t take instruments out of sterilizers, an open tray, walking them through, bringing them into an operating room, so many chances of contamination. Make sure they’re transported the way that prevents contamination like a covered container. When you’re on your way out, bring in anything that’s dirty. All instruments that were on a sterile field, remember, whether they were used or not, are considered contaminated even if they weren’t used on the patient. The containment should be achieved using some type of container that’s been identified to prevent the staff from coming in contact with an instrument to — you know, something like a red sticker or something, you can see here, “biohazard.” Examples can be closed carts, bins with lids, closed bags. Make sure the IFU says you can use it for bringing dirty instruments out as sort of a container. That right there is just a regular plastic Rubbermaid bin, I think it is, and that’s fine. It has a biohazard label. It’s leak proof, it’s puncture proof. We marked it with a biohazard label. There you go. Make sure, you know, you’re cleaning it, obviously, well. But this is something that you can use, and it really meets all of the specifications. Make sure you get proper education, everyone. It’s no longer see one, do one, teach one, when it comes to sterilization, okay? Really be sure that your staff is getting proper education. Don’t let anyone touch a sterilizer unless they know and they’ve been properly trained. Receive adequate training and make sure their skills are verified. Competency verification. Continuing education. And in-service training on any new instruments, devices, or equipment. Be sure that you have the right education. And that, my friends, is the end of the talk. I can stop sharing, Andy, we’re right at 10:00, and I’m happy to answer any questions that anyone may have. I see some in the Q&A. So let’s see what we can do here. Okay. So the Bowie Dick Test, I can certainly explain that. It’s a test used on sterilizers that use a pre vac cycle, okay? Not gravity displacement. So when you’re using a pre vac cycle, when I mentioned that the pulses, those dynamic pulses, those vacuums that are used, what a Bowie Dick Test is, it tests that function. It’s not telling you — it’s not like a bug test. All it’s doing is testing the function of a pre vac sterilizer. Is it proper to rinse instruments with 100 degrees? You want to use the manufacturer’s use, look at it up online, look it up on the packaging that may have come with that instrument. Every instrument is different. 100 degrees Celsius, I can’t tell you that, because I don’t know what the instrument’s instructions for use are. Some instruments can withstand heat better than others. To really know the water, if you’re cleaning them, you really should look at your manufacturer’s use. If you’re using a sonic machine, be sure it’s not too hot, I think I said 140 degrees Fahrenheit is what I believe it said. Typically you don’t want to go hotter than that in the sonic machine. But what you’re using for water, you do want to be sure the temperature matches the IFU, the instructions for use. Which is the most commonly used lubricant? There’s so many out there. You really couldn’t say a commonly used one. There are many out there. You want to use the ones right for your instruments. We’re using small, microinstruments, hinges, scissors, needle holders. So just take a look at what’s out there and see what you think is most proper for our instruments. Would it be wise to cover instruments with a sterilized towel? Can you go back, Andy, to that last question? Oh, wait, maybe I can do it here, hold on. I saw one about a sterilized towel. I’m not sure what that meant. But if you’re covering instruments with a towel, it depends on — if you’re bringing instruments out of the sterilizer — excuse me, out of the operating room, covering them with a towel is not adequate, it’s got to be a container that’s leak-proof and puncture-proof. If you’re bringing instruments out and you don’t have time at the moment to clean them, even though you really should be cleaning them right away, you just don’t have that time, a wet towel is used sometimes to keep them moist, I have seen that. Is it okay to wash instruments with clean water, to soap water then clean water then chlorine water then clean water afterwards? Clean water to soapy, chlorine, and clean. It really depends on the IFU of the instrument. I’m not sure about the chlorine water, I’ve never really seen that. You just want to be sure at the end that you’re rinsing your instruments with critical water. That should be your last phase, okay? So your cleaning water, using detergent. Just be sure that your last rinse cycle is sterile or treated water and it’s not tap water. Which sterilizer is better for heat sensitive instruments, ETO or plasma? Either. It really just depends on the instrument itself and what the IFU says. ETO is a great sterilization method for heat sensitive instruments. I don’t work with plasma. I do know the process, but I can’t speak to it. I’ve never really used it. But I can tell you that ETO is a very good process for heat sensitive. But check the IFUs and check and see what the instructions for use say in terms of what you can use for sterilization. Drum cleaning material, that’s going to be — cleaning the drum of a sterilizer. I’m assuming you mean the chamber where you’re keeping the water. That’s a very good topic, and that’s a very interesting topic. Many of these tabletop sterilizers are very difficult to clean the drum. Some of them do have tubes that come out of the chamber and allows you to drain it. But even as you are draining it, you’re still going to find moisture within those chambers. They typically don’t drain properly all the way, you know, 100%. There’s always moisture you’re going to see on the bottom of some of these drums. And that moisture can cause problems. You can get bugs that can grow in there. It is really hard to properly completely drain some of these chambers. I have actually — and I’m not by any means saying this is correct, I’m actually using it in a negative term, I’ve seen some scrubs actually pick up and literally try to dump tabletop sterilizers, which is a terrible thing to do, it’s going to hurt you or anyone. You have to be careful. I wish I had a good way to tell you how best to clean them. Check your manufacturer’s IFUs and see what they say. But I do understand they can be very difficult to get all the water out. I can’t really recommend a good autoclave machine, I apologize. They all work in different ways. They all have a different means of working. So it really just depends on your facility, what you’re sterilizing, how big your trays are, what your case volume is, things like that. It’s hard to say, you know, one sterilizer over another one. Do we need to have autoclave machine clean done periodically? Yes, you should be doing testing of your autoclave. We call this preventive maintenance. So your autoclave should be going through preventive maintenance, whatever your policies and procedures are, that say you need to have somebody come in, take it apart, make sure everything is working properly at least once a year, at least. Many facilities do this twice a year. But you should be going through preventive maintenance for your machines. Placing instruments in the tray should tips be faced up or down? Away from you. When you’re putting instruments inside of a tray, making sure that all of the tips are facing outward to the top of the tray, so to speak, and not facing this way. That’s just for safety purposes, because me as a scrub, if I’m going to grab something, I don’t want to hit a sharp that could be facing me. So everything’s faced outwards. Best lubricants? Again, it’s hard to say, I wouldn’t be able to recommend one or the other. If instruments are sterilized, put on the table and for some reason surgery postponed for two to four hours, can we use those sterilized instruments? Okay, so this is a little controversial. So typically, when instruments are sitting there for a long period of time, what happens is, you’re probably going to break scrub and you’re going to leave. If there’s no patient in the room, you’ve set everything up, and the surgery has been postponed, you’re going to break scrub. Now you’re leaving instruments on the table and everybody has left the room. You have no means of knowing if those instruments have been compromised. So typically what most people will do, we’ll put a sign on the door that says do not enter. I’ve seen some people even put tape over the door. There really is no time frame, unless your facility has a policy or procedure saying an hour, but there’s no way to validate that. They’re sitting there being exposed to the air that’s in there, you should have quality air in the operating room, but still, the instruments are sitting there. You have no way to validate if those instruments have been compromised because you’re not even in the room. There’s no time limit per se that I know of. It can be your policies and procedures. The biggest thing with instruments sitting in the room is that you don’t have any way to know if you break scrub and leave unless you literally sit there for two hours and stare at them, that those instruments aren’t compromised. We have surgeries that go two to four hours and the instruments are obviously exposed, it’s not so much as a matter of the instruments being compromised, what could have possibly come in contact with those instruments if you’re not there looking at them. I can probably take a few more questions. Let’s see. What do you say about sterilization of ophthalmic instruments morning of surgery only? I’m afraid I’m not quite sure what that means. How do you package linens? That’s going to be — there is a method to doing wrapped and packaged items, there is a very specific way to do that. I can’t recommend a specific detergent for cleaning, unfortunately, that’s something you’ll have to look for and see what’s best for your facility, just make sure you’re following all of those, you know, recommendations of it being low sudsing, nontoxic, that type of thing. But whether to say one or the other, I really can’t. How often can you use lubricant? As often as you like, it’s wonderful for the instruments, lubricant keeps them — once a week if you want, once a month you can take your instruments and use them, as long as you’re using them periodically, it’s great for the instruments. You have a separate sterilization room for ophthalmic instruments such as specialized — so if you’re in a facility that uses both ophthalmic instruments and other instruments, other subspecialties, usually not a separate room, but typically they try not to clean them, you’re not going to put ophthalmic instruments in a sonic machine with bigger instruments, you don’t want to ruin them. Typically you want to keep ophthalmic instruments separate, you want to be sure you’re keeping them separate from other, bigger instruments that could possibly ruin them. I think that’s all of our questions and answers. Thank you for joining me, I hope it was helpful to you and I hope everyone has a wonderful day or evening. Take care. [Music]