During this live webinar, best practices in processing ophthalmic surgical instruments with considerations in decontamination, sterilization, storage and quality control will be demonstrated.
Lecturer: Lori Pacheco, RN, CRNO, Orbis International, USA
The first thing I want to share with you is that I have no financial disclosure or any conflicts or any interest with any of the things I’m going to show you today. There’s going to be a lot of equipment, a lot of different supplies. I have no financial interest in any of them, this is really just an example to give you.
These are our objectives today. We’re going to talk a little bit about the environment, just a few slides. The environment of which you have your sterile processing area in. We’re going to talk a little bit about cleaning and decontamination, we’ll go into sterilization. We’re going to talk about quality control and how you’re testing your equipment. And we’re going to finish with storage and return to the sterile field.
Let’s talk a little bit about your environment first. Typically when it comes to sterile processing area, you’re going to have your dirty area, your area where you’re cleaning your instruments, the area where your instruments are coming in. They’ve just come from your operating rooms, any of your procedure rooms, this is your dirty area. In a perfect world, you want to have a dirty area and a clean area. So you need that delineation. It would be great if you had one room for each. You’ve got your dirty area then you have a room for your clean, where you’re going to be sterilizing, your sterile instruments are coming out.
That’s not always the case, it doesn’t always happen that way. Sometimes you just have one big room for everything. If that’s the case, you want to somehow separate that room, however you can, so that you are bringing your dirty instruments in one way, your clean instruments in another. You really shouldn’t have one passageway where clean and dirty are passing by each other. Somehow separate that area. If you have one part of the room that’s your dirty room where you can come in with all of your dirty instruments. And then another part of the room where you have your clean area where you’re doing your sterilization, that’s best if you don’t have two separate rooms.
The temperature in your sterilization room, it can go as high as 75 degrees Fahrenheit, 24 is Celsius, you don’t want to go any higher than that. Don’t forget, bugs like warm, moist environments. You want to keep your humidity in all your work areas from 30-60%. Keep that humidity low. And if you have a sterile storage area, try not to let that exceed over 70% humidity. Again, you want to keep that humidity low.
And let’s talk a little bit about decontamination. Why do we decontaminate? Why can’t we just bring our instruments from the operating room, they’re eye instruments, we can clean them on the back table then put them right into the sterilizer. Because we need to decontaminate to remove all that organic material. That blood, you’ve got your nucleus fragments, you’re doing hydrodissection, you’ve got fragments that can get stuck on your instruments. You have your inorganic material, you’ve got your viscoelastic. You certainly have your saline salt crystals. And that collects on the surface of your instruments.
It can get in the grooves, it can get into lumens, it can get stuck on your hinges. And what that’s doing is that’s actually blocking the sterilizing agent so it could be steam or gas. And the steam sterilizes, the steam is what’s sterilizing your instruments. If you have blood, if you’ve got body fluids, you’ve got salt crystals, and viscoelastic, stuff on your instruments, the steam can’t penetrate that and it can’t sterilize that instrument. It can’t make complete contact with the surface of that instrument. You really have to make sure that you’re cleaning those instruments, you’re decontaminating them prior to getting them back into the sterilizer.
When do you start decontamination? You want to start it right away, immediately, on your back table. Don’t let these items sit there and dry out. Decontamination really has to start immediately during the surgical procedure. You want to prevent that blood from drying, prevent that debris from sitting on your instruments, sitting inside your lumen. And how are you going to decontaminate them on your back table? You’re going to use your Instructions for Use. You’re going to hear me say this over and over again during the talk, is that your IFUs or your manufacturer’s instructions. Every instrument, every piece of equipment tells you, comes with that little pamphlet that tells you exactly how to clean, wash, sterilize, every instrument. You want to make sure what you’re cleaning it with, what you’re using is compatible for that instrument. Check your manufacturer’s instructions, that’s going to tell you exactly what you need to do in order to clean things properly.
Little bit about universal precautions, your personal protective equipment, and COVID-19, it seems to be a common question, of course, during these times. And really, nothing has changed in terms of your sterile processing department. You’re still using everything that you should have been using, which is your utility gloves, your gowns, your shoe covers, your face mask, make sure it’s fluid resistant. Your eye protection, make sure you’ve got your goggles or your face shield.
But what’s really important is that when you’re washing your instruments, especially when you’re washing them in the water, you want to keep them underneath the water line. You don’t want to be washing them like you’re doing your washing the dishes and you’re spraying everything down and spray’s going everywhere. You want to make sure that you’re washing things underneath the water line. Or keep your lid on your ultrasound machine. Don’t let aerosols spray in the air. Otherwise, even as far as COVID-19 goes, you’re still wearing your gloves, you’re still wearing your mask, you’re still wearing your goggles. You’re doing everything that you’ve been doing.
There’s different types of cleaning, there’s manual and using sonic machines, mechanical. When you’re using manual cleaning, just wipe them down using your instrument wipe or some type of moistened sponge. Make sure you’re using something that is lint-free, don’t use your 4x4s because little pieces of 4×4, little piece of lint can come up and get on your instruments and certainly get inside the eye so you don’t want to do that. Just use an instrument wipe or something that has no lint. You can use a soft toothbrush in your sterile processing department. And I say soft because they do sell them with those really harsh metal bristles, you don’t want that. You’re just going to use something soft, a regular nice soft toothbrush is fine.
And instruments with lumens, with any types of instruments with holes you want to make sure that you’re flushing them. And I’m using the word critical water, that’s the new term. And all that is is treated water. That’s distilled or sterile water or if you have any type of filtration device. Make sure you’re flushing, flushing, flushing. And you want to follow that with compressed air. You don’t want to leave fluid in those lumens because then the fluid’s going to get sterilized, brought to the next patient and the instrument set and that fluid’s going to get squirted out. This is how we have issues. You want to make sure that things are flushed really well and then you want to follow that up with some type of compressed air. Whether it’s mechanical or just using a syringe, that’s fine.
Then you have your mechanical. This is your sonic machine, you could have a regular table top sonic machine, you could have a large washer/dryer. Any of those is fine, just make sure when you’re choosing a detergent and your cleaning agent that it has low sudsing, low foaming, it’s biodegradable, it can be easily rinsed off, non-abrasive, make sure that it can disperse organic oil and make sure that it’s non-toxic. Check the manufacturer’s instructions on them, check those bottles and especially make sure it’s very low sudsing and low foaming.
And here’s your Instructions for Use. Make sure that cleaning solution is mixed with a measured amount of water, please, this isn’t the place that you want to guess. This is where you have to be very specific. And those Instructions for Use are going to tell you exactly how many gallons per detergent that you need for your machines. Make sure that you’re using the measured amounts that it’s telling you. Rinse, rinse, rinse when you’re done cleaning these instruments detergent needs to come off of these instruments. Rinse, rinse, rinse. They must be thoroughly rinsed with copious amounts of water. You can use tap water for rinsing as long as it’s compatible with the Instructions for Use for the detergent and the equipment. Just make sure your final rinse is with critical water, don’t leave tap water on those instruments. Make sure your final, final rinse is with critical water that’s your sterile or your distilled water.
Your water temperature, check your IFUs, check your manufacturer’s instructions. Check the detergent, it’s going to tell you exactly how hot it needs to be. Because if it’s too hot, you’re going to have coagulation of protein. And if it’s too cold it may not even activate the detergent. And you’re just having instruments just splashing around in a bin of water. Just really make sure what those Instructions for Use are telling you in that you have the right water temperature.
As far as detergents go, let’s talk a little bit about TASS, that nasty word, toxic anterior segment syndrome, I think we all know. It’s that acute, severe, intraocular inflammation, it can happen after anterior segment surgery. There are so many causes to this. You can see the list here. You can have irrigating solutions that have an abnormal pH to them, you have viscoelastic, certainly things with preservatives in them, but those last two inadequate sterilization of surgical instruments, especially tubing and things with lumen. Inadequate flushing of instruments in between cases which result in the build-up of viscoelastic sitting on those instruments. We really have to make sure that we’re doing a good job with cleaning these instruments and flushing these instruments, getting that detergent off there, getting these lumens cleaned out. This is where TASS can become a problem. Please make sure that you’re taking the time that you need to rinse, rinse, rinse and clean these instruments properly.
All right, all of your little instruments that can come apart, that have these hinges. You have to really make sure that you disassembling them, you’re opening them up. Your needle holders, your forceps, your scissors, they have to be completely open when you’re cleaning them, when you’re sterilizing them, especially when you’re cleaning them. You’ve got to get in there, you’ve got to get inside those jaws. Something to remember is that if an instrument comes to you disassembled and you have to put it together in order to use it, it has to be taken apart in order to clean it. You cannot leave instruments together if they’re not meant to be that way.
In other words, you have a new I/A and your I/A tips, your gently curved or your 45 degree angle tips, they come off so you can put a new tip on, should you need it. Don’t leave that tip on that I/A device in the sterilizer. If it came to you in pieces, it gets taken apart in pieces to be cleaned. It’s not meant to be cleaned and it’s not meant to be sterilized with that on there. The manufacturer’s instructions are going to say you have to take them apart. It’s not helping you by saving you any time by keeping things together. If it didn’t come that way, it doesn’t get cleaned or sterilized that way. Make sure you disassemble all of your parts before you clean them and before you sterilize them, really important.
No lumens in detergent, you don’t want to get detergent in these lumens. I know we’re flushing them, we’re flushing them with copious amounts of water, but you don’t want to risk getting soap, detergent, any type of cleaning agent inside of those lumens to have the potential of coming off in another patient or coming out and causing serious problems like TASS. Make sure you’re not putting your lumens in detergent, make sure you’re just flushing them, flushing them, flushing them, get that viscoelastic out of there. But please don’t put them in detergent.
We also have lubricants which is great for our instruments. They keep your instruments healthy. You spend a lot of money on instruments, instruments aren’t cheap. You want to keep them working properly, you want to make sure you’re giving your surgeons instruments that are working well. Your scissors, your needle holders, and forceps, if you’re using lubricants, they’re going to open and close really nicely. The last thing you want to do is give a surgeon an instrument that they can’t open and close. The lubricant prevents the development of stiff joints and also inhibits corrosion. And typically, you can check your manufacturer’s for use, typically they’re dipped, one by one, into the lubricant, they’re not really meant to be soaked. You don’t want to just leave them there. But just make sure you dip them one by one into the lubricant. Then please don’t put cannulas in lubricant. Don’t risk getting lubricant inside of your cannulas.
Dry. Dry, dry, dry. Instruments must be dried before being stored. I know I’ve seen it, I’m sure many of you have seen instruments that looked like this, that is rust. That happens when instruments are put away wet or damp, it’s going to rust out. Eventually you’re going to find this type of rust. Make sure that after you’ve cleaned everything, if you’re going to be wrapping or you’re going to be storing things for a long period of time, you’ve got to make sure that your instruments are dry before you wrap them, before you put them out for storage, before you do anything to them that’s going to keep them sitting there for awhile. Please make sure that they are dried out.
I’m sure we’ve all seen stains on our instruments. I’m going to talk a little bit about stains to give you an idea of what they mean and the difference between stains and rust and pitting. Stain is a discoloration on the instrument’s surface, that’s really all it is. But that’s different from rust. Rust can be a red/orange color on the surface of an instrument that results from oxidation. And then you have your pitting. You have erosion of an instrument’s outer surface. And that really can render an instrument beyond repair. Because these are small holes, they’re deep holes, there are visible small dots that are happening on your instruments that can be caused by various reasons. Know the difference between a regular stain, what’s rust, and what’s pitting.
And you can do that sometimes by the color. If you’ve got that brown-orangey color, that’s possibly rust. That’s when the instrument loses its finish. Instruments have that nice, beautiful chrome or nickel finish on them. But they become susceptible to rust after they’ve been used over and over and they’ve been around a long time. It can also happen from abnormal pH, neutral pH is usually 6-8. And your water quality. That’s why we rinse our instruments with critical water at the end. The last rinse is with critical water, you’re not leaving that saline on it.
That dark brown color, that can be dried blood and that can also be happening from high acidic detergent. And you have that blue-gray, that’s typically you’re going to find that on cold sterilization solutions, so check your manufacturer’s recommendation for that. And then you’ve got your light and dark spots. These are your water spots from inadequate drying. That’s why I’m saying you really, really have to dry things really well because it can lead to rust.
How do we get these stains off? You can use a non-abrasive cleaner, you can use a commercial stain remover. But honestly, many stains that you have, an eraser works just fine. Just take that eraser and you can literally just erase some of these stains out. Just remember if you have more than 5% of your instruments are stained, that’s a problem. And you really should be doing a quality assurance study to see what’s causing it. That’s a great study to do. If you’re finding that you have more than 5% of these instruments are getting stained and you’re finding rust on them, then do that quality assurance study and see what’s causing it so you can have a corrective action plan.
And then we get into sterilization. I focused on just the sterilization we see mostly here in ophthalmology. Our chemical which could be liquid or gas. You could use glutaraldehyde or your ethylene oxide. Or you have your heating which most of are very familiar with. And this is our moist heat.
Let’s talk a little bit about chemical first. This is your liquid or your gas. Heating really is the most reliable, it’s always the most best understood method to sterilize instruments. but you can’t always use heating because it can damage fiber optics, it can damage electronics, and it can certainly melt plastic. Not all plastics can be put in a steam sterilizer. That’s where you have these alternative sterilization methods.
Your liquid sterilants, this is your glutaraldehyde. And it works as a high-level disinfectant and sterilizing agent. And it works just by completely immersing your items in a solution for an extended period of time.
It’s advantages, if you’re not using sterilization often, if you have a low volume center, it can be a really inexpensive option. It’s really actually great for lensed instruments. I know a lot of clinics, I have friends that work in clinics that use glutaraldehyde for their lensed instruments.
But it also comes with a lot of disadvantages as well. The same properties that make it a great sterilizing agent can also make it harmful to you and I. It has toxic fumes, especially when it’s heated. It has this really strong odor. There really is no reliable method for monitoring the sterilization process when it comes to glutaraldehyde. You definitely have the potential for contamination during rinsing and transferring. And you really risk that residual solution that can be left on your instruments which can be extremely toxic to your intraocular and extraocular tissue.
And then you have gas. This is your ethylene oxide. This is your gas concentration is part of the ether group. You’ve got the gas concentration, you have your temperature, your humidity and time, these are your four really important factors when it comes to gas sterilization. The concentration of gas, the temperature, the humidity, and how long it’s being sterilized for.
Typical gas load process with a preconditioning phase, it goes into the sterilization run, it goes into your post sterilization, and then you have your aeration. Most of the newer machines and your gas machines, they do the aeration for you. That’s built into the process. Some of the older machines may not have the aeration process and then you’re going to have to aerate those instruments yourself, especially the tubing. If you have a gas sterilizer that does not have an aeration process, you need to be taking those instruments out when they’re done and you need to be putting them aside for a specific amount of time. The manufacturer’s instructions should tell you that, for how long they need to sit there and aerate. Especially your tubing, you don’t want to leave residual gas inside any tubing or on your instruments.
The advantages to gas is that it is very compatible with packing material and it can really prolong storage life. It completely permeates porous materials. And it’s very noncorrosive, it doesn’t damage items.
But it also comes with disadvantages as well. It is very expensive to run. Typically, when you’re running a gas load you need, obviously, your gas ampule, you need a humidifying chip, you need your bug tests for each load, you need a dosimeter. It’s not just run a gas load, there’s a lot of pieces to it and there’s a lot of supplies and things that you need to run just one load. So it can be expensive. It does require aeration. Gas is obviously, it’s a harmful substance, it can be carcinogenic and mutagenic. It’s got a long, slow, complex process. It takes a long time, anywhere from 12 to 24 hours. Usually it’s 12 hours without heavy loads or tubing, it can be up for 24 hours if you’re using tubing. In its pure form it can be extremely flammable. But it’s also a great sterilization method. I’ve used it for years. God, going on 30 years now. Never had a problem, I’ve never had a problem with gas sterilization. If it’s used properly, it is a great method for sterilization, especially when you’re using it on instrumentation that you want to store for later use. Don’t be afraid of it, just make sure you’re using it properly.
And now we’ve got what everyone knows well and that’s moist heat. This is your saturated steam under pressure. Steam sterilization really is the oldest, it’s the cheapest, it’s the most understood method of sterilization. And basically how it works, it’s a pressure cooker. Most heat kills microorganisms by causing the coagulation of protein. And that vibration of every molecule of these bugs or these microorganisms, that causes the splitting of the hydrogen bonds between the protein. And then you have death caused by irreversible damage to that organism, to these bugs.
Think about moist heat versus dry heat. This is why moist heat is such a great sterilization process. Steam coagulates a microorganism’s protein similar to poaching an egg. You’re going to put an egg in boiling water. Egg whites coagulate when you poach it in boiling water at 100 degrees Celsius. If you fry an egg using dry heat, that usually requires about 371 degrees Celsius and takes a lot longer. The more moisture you have present, the more heat is carried and that’s what makes steam a really effective carrier of heat.
Same thing, think about the kitchen. When you cook beef at home, it can become really tough when you put it in a covered pan. Now, add a little water to the bottom of that pan and that meat’s going to become tender. The temperature’s the same, the time of the roasting is the same, but the results are different because you used water. Now add pressure to that. By putting the same roast in a pressure cooker, you reduce that cooking time by ¾ and you still get a very tender product. Think of it in that sense.
How does it work? We have different processing cycles for saturated steam. You have gravity displacement and you have pre-vac, so we’ll start with gravity displacement. Steam is pumped into a chamber containing the ambient air. Steam is less dense than air so it rises to the top of the chamber and eventually just displaces the air. Then the steam fills the chamber, displacing that residual air which is then forced out through the drain at the bottom of the sterilizer. And by pushing that air out, the steam can come in contact with the load and begin to sterilize. You have steam pumped in, steam rises, displaces the air, and then the steam contacts the load. That’s a gravity displacement cycle.
Now you’ve got a vacuum cycle or what we call pre-vac. It’s a very efficient form of sterilization. It really is a preferred method for a porous load, things with lumens and holes and I’ll tell you why. It’s equipped with a vacuum system. It starts with a series of alternating steam pressure injections and vacuum draws, these pulses, and that dynamically removes the air from the chamber. This allows the steam to be sucked into all those little crevices, all those lumens and holes that would normally be difficult to penetrate. That absence of air in the chamber allows the steam to immediately penetrate the load and that’s what makes it a more reliable form of sterilization. You have the vacuum system, you have these pulses that remove the air, and then you have the steam that penetrates the load. That’s your vacuum.
And we have our immediate use sterilization. That nasty word as well. IUSS. Really IUSS, the definition is the shortest possible time from the item being removed from the sterilizer to the aseptic transfer on the sterile field. IUSS is not a bad thing, per se, it’s a bad thing if you use it all the time. You can’t use IUSS all the time. But it has its purpose. It really can only be used in critical situations when there is not sufficient time to process instruments though the full terminal sterilization dry time and all of that. Example, a specific instrument is needed in an emergency. You had your rep come in and brought this one instrument that you needed for surgery, you got it, and you dropped it on the floor. It happens, it happens to all of us. That non-replaceable instrument that’s been contaminated and needs to be replaced immediately. These are really the only reasons why we should be using IUSS.
If you need to use it, it still has to be processed in the same manner that you’re doing any other type of decontamination. It needs to be placed in a container intended for the cycle parameters. I’m going to give you a great example of that a little bit later in our talk. Use immediately. You cannot sterilize instruments in IUSS and then store them. It cannot be used for purposes of convenience such as lack of adequate supply of instruments to meet your volume or just to push things along and hurry up and do as many cases as you can. And they have to be, IUSS has to be compatible with the instrument’s IFU. When you’re using immediate use sterilization, you’re using a very specific sterilization process, typically gravity displacement. Or whatever your sterilizer’s cycle has, for immediate use sterilization it has to be compatible with your instruments, and it has to be compatible with the container you’re putting them in. Make sure if you’re using IUSS that you document it. They’re actually documenting why you’re using it so you know if there’s ever an issue and you have to go back, you’ll know that those instruments were sterilized through immediate use sterilization.
I’m going to show you a little video. This is just going to recap what we just discussed. Please keep in mind you’re going to see a lot of equipment, a lot of things. Again, I have no interest in any of them, this is just one facility and I’m not saying you have to do it like this facility, but this is just to give you an idea. Sometimes it’s best to actually watch and see the process. There’s a lot of ambient noise in the background because this is a working sterile processing area, so you may need to turn your volume up a little bit.
Hi everyone. I just want to recap a little bit on this first section. We’re going to start with the environment, talk a little bit about what a sterile processing area should look like. Ideally you want two separate rooms. You want a clean area and a dirty area. I understand that may not always be feasible. And if you have one large room just make sure you somehow separate it, that you have some time of delineation between clean and dirty. So you’re bringing in your dirrty instruments in one area and you’re bringing out clean instruments in the other.
Right now we’re going to pretend that these are our dirty instruments. I am not gowned and have proper PPE, just for the sake of speaking with you, and these are not contaminated instruments. But if they were, I would have my gown, I have my eye protection, and I also have utility gloves. If you can use utility gloves in the sterile processing area, that’s wonderful, less chance of breakthrough and getting any type of needle stick injuries. If not, as long as you’ve got your gloves on, you have proper PPE.
Your instruments are going to come out, before you do anything I want to really make sure that you understand that everything in this tray is going to get decontaminated. No longer are we using the this section was used, this section wasn’t used, we’re only going to clean what was used. Everything on this tray gets decontaminated whether it was used or not. You want to make sure that all of your jaws, all of your instruments that have multiple pieces get separated. Going to open our needle holders, we’re going to make sure we open our speculums, any of our scissors, we’re going to open them up. Make sure that all of our jaws, all of our scissors are properly opened.
Anything that you have that has lumen, your phaco machine, any of your cannulas, you’re going to flushing those. Copious amounts of fluids. Flush, flush, flush. These cannulas have viscoelastic in them, they could have nucleus material in them. We want to make sure we’re flushing really well. You could use a machine, if you don’t have a machine that’s perfectly fine. You can use a syringe. Just make sure that you’re flushing as well as air. Whatever you’re flushing, make sure you’re following with air and you’re not leaving any fluid in there. And make sure your final rinse is with treated water.
Some facilities have a large washer/dryer. If not, you just have sonic machines, that’s fine as well. Your instruments are going to go into your sonic machine, just make sure that you’re using sterile treated water and that your detergent is by the IFU, Instructions for Use. And just make sure that it’s measured and you’re not just pouring detergent in there. How many gallons of water per how much detergent that you need. This particular one, you can see it has a line here exactly how much is needed. After your instruments have gone in your sonic machine, you’re going to go to another area, rinse, rinse, rinse, make sure you’re getting all that detergent out and you’re going to rinse properly. And then we’re going to go over and we’re going to put everything together.
All right, that’s just a recap of that first section. We’ll talk a bit about quality control. How do we know that our machines are working properly? How do we know that they’re actually sterilizing our instruments? You can’t see microorganisms with a naked eye, you can’t see the bugs. You can’t look at an instrument and know that it’s sterile. With quality control, it’s a method to effectively monitor the parameters needed for effective sterilization. And there’s three different types. You have your mechanical, your physical monitoring, you have your chemical monitoring, and you also have your biological monitoring.
We’ll start with mechanical. These are your printouts, your gauges, your TARP, this is a real-time evaluation of the conditions in that sterilizer resulting in a permanent record. And you’re measuring the time, the temperature, pressure.
Now, accountability. When you’re sterilizing your instruments and they’re ready to take out and you’re looking at these gauges, you’re looking at these printouts, whatever you have that’s giving you that mechanical means, you need accountability. That person taking those instruments out needs to be initially or signing or something, a logbook, something that’s going to tell you that that person is the one that took them out. That’s the person verifying that the correct parameters were met before these items are used. Initial the printout, you could have a logbook with the cycle information, the person who removed the items. You just need something to be able to track, you want accountability.
You have your chemical indicator. This is where I think we’re all used to these. These are your treated paper, these change color when exposed to a certain sterile parameters. And they have to be used in all containers and packages, inside. Just because you may have a chemical indicator in the sterilizer showing that it went through a process, how do we know that the steam or that sterilizing agent penetrated through your container, penetrated through your package? You have to place, all packages have to have some type of indicator inside. And we’re going to go through the different types. Internal chemical indicators are used to verify that the sterilizing agent reached the contents of that package. And there’s different types of chemical indicators, typically Type 5 and Type 6 is what we use inside of our containers.
The determining factor in the end is steam sterilization. We need to determine and ensure that heat/steam penetrated those instruments. That color is going to migrate along a path, you can see here, oops, sorry. So you can see here that you’re going along that path and that blue went all the way to the accepting. And this is just one chemical indicator. But you’re going to see where that color went all the way through telling you that it is accepted and it has gone through that process.
There are six types of chemical indicators. And one type is not better than the other. All the six types mean is they all each have a duty, they all have a job. The classification structure is just to note the characteristics and its intended use.
You have your Type 1. These are just process indicators that react just only one critical process variable, typically steam. It’s not enough to indicate sterility on its own. It’s just telling you those instruments went through a steam sterilization process. I think you can literally probably hold these Type 1s over a pot of boiling water with that steam coming up and it would change color. It’s just telling you that it’s been exposed to a steam process. It has its use, but note that it’s only react to one critical process variable and it’s only going to tell you that it’s been through a steam process.
Type 2 is a very specific test. This is your Bowie Dick Test, this is your daily air removal. And this is what’s used in pre-vacuum sterilizers because pre-vacuum uses those pulses to dynamically remove air, we have to make sure that that’s working properly and that’s where the Bowie Dick Test comes along. It needs to verify the air removal from the autoclave chamber is working properly. It should be run as the first cycle of the day that the sterilizer’s being used before any of the instruments have set a process.
Giving an example, you see here this could be a Bowie Dick Test, one of the many that are out there. Pre-vacuum sterilizers require that vacuum to be drawn, but the Bowie Dick Test is going to test that. And you can see on the left you have an unprocessed slide and that slide has all those lines on it. You get through a process load with a Bowie Dick Test and those uniform lines, you have a beautiful uniform lines there. If you end up with lines that are squiggly, that are different colors, that show something different or you have that big block in the middle, that’s a fail. That means that your pulses, those vacuum draws, are not working properly and that’s when you’re going to need to have the machine looked at.
Type 3, that’s usually one critical parameter and it’s typically not meant for steam, it’s typically used in things like hydrogen peroxide gas plasma. And then you get into Type 4. That’s getting a little bit tighter variables and that’s two or more critical variables. You get into Type 5, this is what we typically see. And what we do here in ophthalmology, and these are your integrating indicators and it reacts to all critical process variables. Your time, your temperature, and your saturated steam. And you have Type 6 which has tighter tolerance and that reacts to all critical process variables. Typically we see 5 or 6s, I more often see 5s than anything else.
Then we get into our bug tests, these are our biological monitors. These are our self-contained spores that are inside those little vials. They’re sealed in there with a growth medium. And how they work is that you expose the vial to a sterilization process, you throw it into the sterilization process. It’s thrown in the sterilizer, you could put it somewhere that’s going to give it a good challenge, some people even put them inside of a container, put it somewhere in the sterilizer that it’s going to challenge it. You’re going to activate it when it’s done by crushing the ampule, you’re going to allow the growth medium to create this growth environment for this bug and then you’re going to incubate it. By incubating it it allows the growth of the microorganism.
The incubation produces these acid byproducts that causes the medium to change color. If you sterilize it, the spores that were exposed to the sterilization process are killed so it’s not going to produce that acid, so there’s going to be no color change. Please be sure that when you’re doing biological monitoring that you’re always using a control because how do you know the color change if you don’t know what the color was to begin with? You need to have something to show that, you need a control to compare it to. You’re going to actually not sterilize it, you’re going to take a bug that was not sterilized. You’re going to activate it, incubate it, and it’s going to change color, you need something to show that color change. You’re going to see what it would actually be if it was a positive test. Make sure you’re always using a control and something to verify it with.
You have times when you really need, besides every load or besides doing a daily monitoring, that you really have to be using your biological monitoring and doing really important checking of your machines. And all of these are sterilizer installation, relocation, when you have a malfunction, or you have any major repairs, this is when you have to be doing your bug test. You can’t put your machines back into use until you’re doing, not only your bug test, but you’re also doing chemical indicators as well. Really, when you have any of these important processes that are happening, any major repair, someone comes in and does a major repair. Well, great, the machine’s working. But before you can put that machine back into use you really should be doing three consecutive empty steam cycles, run with a biological monitor and a chemical indicator in a good test package or tray. Give it a good challenge. And you should be doing three consecutive empty cycles with a Bowie Dick Test if you’re using a pre-vac sterilizer.
If your sterilizer does both pre-vac and gravity displacement and you use both different types of cycles, you need to be testing each one. Do the pre-vac and do a cycle with gravity. The sterilizer really should not be put back into use until all biological indicators are negative and the chemical indicators show a correct end response.
Talk a little bit about outside testing or third party testing. These provide results from an outside source. I talk a little bit about this in the video I’m going to show you in a moment. But basically third party testing is somebody else that’s going to tell you that your sterilization process and your bug tests came back negative. We’re going to talk a little bit about that soon with record keeping as well.
Sterilization records are maintained according to your policies and procedures in your facility. But you really should be documenting the contents of each load and be able to identify the load. Sterilizer A, load number. The cycle’s parameters, the operator’s name or initials, and the results of your physical, your chemical, and your biological monitoring. And this is where accountability comes in. Your print outs, your gauges, things like that that you’re initialing.
Example of record keeping. You’ve got Patient Pacheco, surgery was done on January 4 of 2022. Her instruments that she’s using were sterilized in sterilizer B, load number 22. Those records should be retrievable. If you have an issue down the line and you have endophthalmitis or you have TASS, you should be able to go back and track that Lori’s case used these instruments. You should be able to see the printout or some machines have a USB drive, OT drive that contains all of the loads that are in there, and they have load numbers, load 123, or however they do it. Our facility does it by the date and the load so it will say 010422 A14, or anything like that. Whatever you have, just make sure that you’re able to track and go back.
Let’s talk a little bit about that here. With quality control comes documentation. You need to verify what you’re doing. Remember, if it’s not written, it didn’t happen. All these tests and everything that you’re doing, we need to keep our documentation, we need to keep our paperwork so we can go back and we can show that we can validate it. This is just one example, there are very many out there, you could have just a logbook that shows the date and the tests and the results.
This particular one is an envelope and it keeps everything in it. Inside we’re going to have our printouts. These are our printouts for the day. This is showing each and every load that was done in the sterilizers for the day. There are dates on here and it’s going to coincide with the patient and that patient’s records so that we can always go back and say, okay, this particular load B14 at this time, and we can look at the time, we can look at the pressure, we can look at everything that’s what to do about that load. We’re going to keep these and it’s going to go inside this envelope, as well as our Bowie Dick Test is going to go inside this envelope, everything is kept together. We can go back and we can look and we can say on this day, this is everything that was run for quality control and these are the results.
And don’t forget about your outside testing or third party testing. Because you have a logbook that has every date and every test that you did. But when you’re using something like that, who’s to say you actually did it? Really, in all honesty, you could just open a piece of paper and keep writing everything in it. Yep, I did it. All the way this week, check, check, check, everything’s done. Third party testing is somebody on the outside actually telling you that your equipment is working properly. Really what they do is they send you the tests. You’re going to put it in the sterilizer, you’re going to run a load, you’re going to give them all the information that they need and then you’re going to send it out to them. And then they’re going to run it and then they’re going to send you back the results saying that yes, we ran the test, yes it ran properly and your equipment is working properly. This gives just another tool for validation. This is somebody else besides you saying that your equipment is working well.
Before I move on, I’m just going to show you real quick you see some incubators there, they may look familiar. The one on my right is a large white one with blue on it. That’s an actual incubator for bug tests that gives you back your results in I think it’s 20 minutes, less than 30 minutes. And it’s done every day. Minimum, minimum of biological testing should be once a week. If you can every day, that’s great. But you would need, obviously, an incubator that’s going to give you those results quickly. We use challenge packs and inside of it has a bug test, it has a chemical indicator, that challenge test goes right into the sterilizer and it comes back with everything.
You also see another small one there that is another incubator, that one is basically the bug tests that go in there are for 24 hours. You get your results the next day. Just to give you an example of different times.
And then you have your ultrasound machine. That’s another piece of equipment that has to be working properly. How do you know that your ultrasonic cleaner is actually working and that it’s vibrating well enough and giving you that motion that’s going to be cleaning your instruments? And that’s where we get into cavitation testing.
This is your ultrasonic cavitation testing. All cavitation is, is the rapid creation and destruction of these vacuum bubbles or these cavities that are inside a liquid. And these microscopic bubbles, when they’re forced into contact with a solid surface they collapse. And the surrounding liquid around it, once the liquid fills the areas that the bubble once occupied, it creates this scrubbing action and that’s your ultrasonic action.
There’s different kinds of doing them, you certainly can use a manufacturer’s one, that’s just one example, your SonoCheck, those are your vials that you put in there and it’s going to change color on you, it’s going to tell you that it’s working. There’s also what’s called a frosted glass. And you put the frosted side inside your sonic machine and basically all you do is you get it wet first, you put, with a pencil a big X on the frosted side, you put it in the sonic machine. And if your sonic machine is working well enough, the X actually goes away. And you’ve got a foil test. Basically it’s just that. It’s a piece of foil that you’re going to put inside the sonic machine and if those bubble’s scrubbing action is working well enough it’s going to shoot these holes right through your foil. It’s going to poke holes right through it, you can see in the top right there.
I don’t have a preference to any of them, I can say that the foil test, there is quite a few complaints and concern that after it pokes those holes through the foil, those little piece that are now floating around inside of your sonic machine can end up in your instruments and your instrument trays. Just be careful with that. But this just gives you an example of all the different cavitation testing that you can use.
Let’s talk about storage. Your wrapping and packaging sterilized instruments for later use. You’re going to go put them away to use at a later time. Peel pouches, rigid containers, wrapopers. Please be sure that the sterilizer, the instruments, and the containers are all compatible.
I’m going to give you a quick example of some things that I’ve seen happen that’s a really great teaching tool, especially with immediate use sterilization. Instrument hits the floor, the rep brought the instrument in, the only one they had, gets in the sterilization room, the patient is on the table, instrument hits the floor. Now it has to be run by immediate use sterilization. Okay, no problem, it gets cleaned and processed and it gets put into a rigid container, we’re going to go through that, and then that rigid container is going to go through immediate use sterilization cycle. This is a gravity displacement cycle.
Goes in, does its thing, now it has a class one indicator on the outside, when it’s done and it takes out, that class one indicator changed, that color changed because it went through a steam cycle so the load was, it did go through a steam process. Instruments were brought into the room, with the container open the scrub goes in, takes the instruments out, puts it on the back table, opens it and the Class 5 indicator, this is why it’s so important to put it inside, Class 5 indicator inside that instrument did not change. That color didn’t go anywhere, it looks the exact same as it did when they put it in. Those instruments are not sterile. Why?
The reason why is because that rigid container that went in for immediate use sterilization is not validated for a gravity displacement cycle. Steam did not penetrate it. It’s only validated for a pre-vac cycle. That’s why you have to make sure that everything matches. That’s your instruments, your containers, your packaging, your cycles, everything has to be compatible. That’s where your manufacturer’s for use are going to come into play. Not only do we not now have instruments that aren’t sterile, that we obviously can’t use, but it’s on our back table as well. Here we are rushing to get an instrument into the room that we need, we had to take everything down, everything gets taken down because you have unsterile instruments sitting on, an unsterile instrument sitting on your back table. Everything had to go. That’s a good teaching moment. Make sure that your containers, your instruments, everything is validated for the cycle that you’re going to use. Make sure you’re selecting your packaging according to your instruments for use.
You have your peel packages, these are small, light, these are for small, lightweight instruments. you need to make sure you’re choosing the appropriate size, do not shove as many instruments as you can inside. Lost my earplug. Inside these packages. You need to allow for appropriate size to allow for circulation of steam. Tip protectors should be used to prevent. Lawrence, can you still hear me?
[Lawrence] Yes, I can hear you.
[Lori] Okay, thank you. Sorry, my ear plug fell out for a moment. Tip protectors really should be used to prevent compromising the package. You have to make sure all of your sharps have tip protectors on them and that they’re steam permeable and they fit really loosely. Make sure that you’re using the appropriate size of the packaging for what you’re putting in there.
And you have your rigid containers, I’ve been talking a little bit about that. These can be used as a way of packaging surgical instruments for future use. I suggest check your IFUs. Rigid containers come in all shapes and sizes and different manufacturers. Just like I said, confirm which sterilization process and cycle the rigid container is validated for. You want to match it up with the sterilization process. But these are also a great means for storing instruments. The validation sometimes is up to 360 plus days that instruments can stay sterile inside of them. It’s just according to the manufacturer’s use. There’s all different kinds, you want to make sure and check and see what the Instructions for Use say.
And, of course, you have your wrappers, your blue wrappers. They’re used basically for wrapping instrument trays, make sure you double wrap to provide the best barrier. Keep it snug, not too tight or if it’s too tight you can allow for strike through. Make sure you’re using your indicator tape to secure the wrapping. Just be careful, a lot of the indicator tape that’s out there can be latex based for your latex allergy patients.
Labeling. So important! Your packages should be labeled for accurate identification and for tracking. You want to be labeling it with the sterilizer number. If you’re using more than one sterilizer, make sure that you have a sterilizer number. If you’re using more than one sterilizer, it could be anything. You could have a sterilizer A and a sterilizer B. As long as you can track it. The cycle or load number, the date of sterilization, what’s in there, and then the initials of the person that is putting it together and processing it.
When you’re labeling it, to be visible, you need to use something that has non-toxic ink. No chemical with toxic stuff cannot be released during its use. Make sure you’re using some type of marker that’s not going to let off a toxic substance. Immediately dry, waterproof, heat-resistant, acid-resistant. I give an example here. This is actually a Sharpie, it’s 13601. This is actually a great sterilization marker. If you’re here in the U.S., and you get surveyed by Medicare or by accreditation and you’ve got a really, really good surveyor, they’re going to ask you how do you know that the ink that you’re using to mark these pouches are appropriate for sterilization? And these are. So it was actually a certified sterile processing teacher that I had once that told us that these markers are great for sterilization. They don’t run, they’re heat-resistant. This is just an example for you. It’s a Sharpie 13601 that’s great for sterilizing.
And then you’ve got your storage. I did see in some of the questions that came in, which by the way were wonderful. I got great questions and I’m hoping I’m answering all of your questions as we’re going through and we’ll talk a little bit more at the end. But one of the questions was how long can something stay sterile inside of a package for. And basically it’s event related. What that means is that once it’s in there, it’s gone through a sterilization process, all of your chemical indicators showing appropriate sterilization, it can stay there for as long as it needs to, as long as that packaging has not been compromised. There’s no holes in it, it’s not crumbled up, and it’s yellow. If that package stays intact, the instruments inside haven’t been touched, they’re still sterile. Really, shelf life of a packaged item depends on the quality and the integrity of the package, the storage conditions, and the amount of handling.
Prior to opening up a package when you have to grab a sterile package, just make sure that you’re looking at it. Visually inspect it. First you’re going to visually inspect and make sure that all of your indicators have changed, but you’ve got to look at that package, make sure you don’t have strike through. Sometimes packages that have been sitting there for quite some time are yellow. If it’s yellow, you want to throw that thing out. But really, shelf life just depends on the quality of the packaging. You could have a package sit there for three months, six months, as long as it hasn’t been tampered with and the integrity is good, you’re all set.
Don’t use elastic bands. Don’t do anything that can compromise the integrity of these packages. Don’t crunch, or bend, puncture them, don’t use paperclips. Don’t stack things really tight on top of one other. Stacking can result in damage of your wrapping. Do not place items on the floor, don’t put them on windowsills, windowsills leak. Or any other place other than a designated shelf or counter. Be really cognizant of where you’re putting your sterile packaging.
Again, talk about the tip covers. Make sure they have holes in them. I have seen many times people use tip covers that have no holes on the top of them. Steam, that sterilizing agent or gas, has to penetrate, has to get through to those tips. They have to have holes in them. Your packaging that you see here, some of them that they sell out there are great to keep your instruments safe and secure inside. You see those on the bottom, safe and secure inside your packaging. They also have indicators on them, you’ll see some of the orange and the blue, depending on steam or gas. And that’s another great indicator inside your packaging to show you that it changed color. That it’s gone through a sterilization process. These are great to use as well.
Please leave room for steam penetration. Look at all those things, they’re shoved in there as many as possible. And I’m going to go through this in the next video to watch. But steam is your sterilizing agent or gas. You need enough room for it to penetrate. You need enough room for it to get in there and do its job. When you place as many as you can just to get a load in to save time, you’re not saving time because you’re going to find that those process indicators inside of them may not even change because that sterilizing agent didn’t make it all the way through because everything’s so squished in there. Please leave room for steam penetration. All right, let’s talk about that for a little bit.
Let’s talk a little bit about wrapping. There is a technique here to using these wrappers. The biggest thing is you want to make sure that you’re closing these wrappers so that they’re flat and no air can get in. Sometimes the trick is really to start in the middle and bring your hand out, flat as can be. Because if you’ve got bubbles in here and air can get in these packages, what’s inside is no longer sterile. Example is something like this. If you can see our little bubbles here, all these little bubbles, all these creases, air can get in there and then what’s inside is no longer sterile. Just want to make sure that you’re flattening it, making it nice and flat.
And here’s an example of one that’s been done. You have your indicator inside, showing that what is inside has been sterilized, not just on the outside. Some of these wrappers also come with dots that are inside that changes color when it’s been exposed to steam or gas, so you can always check for that color change as well. And what’s written here is the name of the item, the date it was sterilized, the sterilizer that was sterilized in to be able to go back and track, and the person’s initials. The operator’s initials, make sure you have all of those so that we can always go back and track in case there was ever an issue.
And you have your regular blue wrappers here. There’s also a trick to doing these as well. You can see that they’re wrapped nicely so that when you open it, you can open it in the means that each piece can be opened without touching and contaminating the instrument. And then you can see also that we have the tape and this tape changed color when it’s exposed to a sterilization as well. You’ve got indicator tape, you have your wrap.
I wanted to show you this. These are all wrapped items, let’s just say getting ready to be sterilized. Put them inside of our little tray, what is wrong with this picture? Look at all this stuff. There is a lot of instruments in here, there is a lot of wrappers in here, there is no room for steam to penetrate. Steam is what is sterilizing these instruments. Steam has to be able to get to these instruments. They have to be able to get in here, you need room, you need airflow. This is way too many. Please don’t throw as many as you can in here because you don’t want to run multiple loads. It’s not about time, it’s about doing it correctly. Way too many. These particular cases have slots for a reason. Make sure you’re not overdoing it and you’re allowing steam penetration to get through.
And we talked a little bit about rigid containers and many of them are validated for long periods of time. This has sterile instruments inside of it, this rigid container can sit on a shelf, it is locked. The key has an indicator showing it’s been through the process. It has an indicator on the outside showing the operator the date it was sterilized. The sterilization number is telling us what’s in here, this is a phaco set. And this can sit on the shelf for Instructions for Use for however length of time the Instructions for Use tell us to. This is another means for storage. Little things to keep in mind that are really important. Locks to make sure that nobody is contaminating the instruments, making sure that you have enough space when you’re sterilizing things, and flow can go through and steam can get through. Making sure that your wrappers are wrapped properly, all these things make a large difference to be sure that you’re doing things correctly, efficiently, and effectively. Thank you.
All right. Let’s get into transportation. This is the last piece, I’m sorry I’m going a little bit over time and we’re certainly going to take some time for questions at the end as well. This is just such an important topic that I want to be sure that we cover everything. When you’re transporting instruments to the sterile field, from your sterile processing area to the sterile field, they really should be transported in the means that provide adequate protection to avoid contamination like a covered container like the one you just saw. One of the rigid containers. Doesn’t have to be that, it can be something that is covered, filtered is best. Those containers have little filters on them. You don’t want to be walking back and forth, in and out, dirty instruments coming in and clean instruments coming in passing each other. That goes back to your environment and making sure that you have a good process that those two things aren’t literally walking past each other. But you need to be having some type of transportation flow so that your instruments, when they’re coming out you have that flow going through and you also are keeping your instruments covered to keep them protected from contamination.
Example, that top one, obviously that one on the right is completely open. You don’t want to be carrying that through the halls and into your room, it’s totally open, anything can happen. And the one on the left, you would say, oh, that’s a covered one. But obviously it has holes, it has holes for steam penetration to get through there. With those holes that’s not a covered container. That too can certainly be exposed to any type of contamination. On the bottom there’s some examples of rigid containers. These are covered containers. You need something to keep your instruments covered when you transport them.
And when you’re coming from the sterile field, and you’re bringing dirty instruments, remember whether they’re used or not, they’re still considered contaminated, everything that was on that sterile field during surgery is contaminated. You need to contain those instruments in some type of container that can identify that it’s contaminated. Any staff that comes into contact with it understands and knows for personal protective equipment on, gloves, everything, and knows that those instruments that are in there are dirty and contaminated.
Give you some example. Transport in a way to prevent contamination, spillage, damage. Container should be leak proof, it should be puncture-resistant, and marked with a biohazard label. There’s your label, that’s what’s going to tell your staff that what’s in there is dirty. All this is is a storage bin. I think it’s a Rubbermaid bin of some sort. That’s all this is. And it works fine, you don’t need anything fancy, you don’t have to go out and buy expensive containers. A storage bin, this is covered, it’s leak proof, it’s puncture-proof, and there’s a biohazard symbol on it. Works perfectly. And that’s how Iis are brought out from the room to the sterile processing area.
You’ve got closed carts as well, you use any kind of bins with lids. Impermeable bags you can use, red biohazard bags, but please remember if you’re just using the bag, you’re sticking instruments, let’s say those instruments up there on the top left, top right, you’re placing that whole bin inside of a red biohazard bag. That’s not puncture-proof. Those instruments can absolutely stick up and poke right through a biohazard bag. And if that biohazard bag’s not closed, and you’re just putting it in there, it’s not leakproof as well.
Just please be sure that you’re using something that is puncture-proof and leak proof. Some people use rigid sterilization containers. The ones that come in with the sterile instruments, they may want to use the same ones to bring the dirty ones out. Just make sure that the manufacturer’s instructions say you can do that. Because these rigid containers have to be cleaned as well and if you’re putting dirty instruments in them, now you’re going to think how am I going to clean them? Those rigid containers, some of them are huge, they’re not going to fit in your sonic machine. They’re not probably going to fit into a washer/dryer. Just really be sure that you’re following manufacturer’s instructions and that is validated to use for dirty instruments.
Lastly, education. Please, this isn’t the place where you can do see one, teach one, do one. These instruments are going to be used on patients in surgery, they need to be clean, they need to be sterile. Every patient deserves sterile instruments. And the person that’s doing this, the person that’s running this sterile processing department that’s working in there really needs to be educated well. They need to know and understand infection control. It can’t be okay, just come in, just put the instruments in, press this button and you’re good. They need to have adequate training and make sure their skills are verified. Competency training, competency verification related to the sterilization process. Continuing education to review and update knowledge. There’s so, so many things out there. This talk is one of them, this is great, I’m so glad that you’re here today to be listening and learning. There’s so many things out there where you can learn sterilization processes. And make sure you’re always having in-service training on any kind of new instrument or any kind of new devices that you know how to use them properly.
And that is my talk. I am sorry that I went a little bit over, but I’m going to make sure that I can get through all of our questions and answers.
I just want to throw it out there to everybody, the questions that I got prior to here when you registered were fantastic. They were excellent. And as I’m reading through them, I really hope that you can reach out when you have a question, that is my hope is that I hear from you. That when you have these questions and you’re not sure who to ask, Cybersight, Orbis Cybersight has a great mentoring program. And it’s not just for ophthalmologists it’s for nurses as well. And it’s a great means for you to reach out to me and ask these questions. And you can do that through our mentoring program.
I think Lawrence is going to put up the link on the chat so everyone can see it. You just have to go in and register with Cybersight, it’s free, just register with them. And then through there you can get into our mentoring program and you can ask me these questions. You can say, hey, Lori, how do I do this, or this came about and I’m not sure about this. I would love to hear from you. If you have any questions at all, please sign up for the mentoring program and I would love to help you. Especially when you’re writing policies and procedures and infection control programs, things like that.
Let’s go through this. Do you recommend sterilization of intraocular lenses? If yes, which procedure? IOLs, that’s a tough one. I, myself personally, have no experience in sterilizing IOLs. That is manufacturer’s Instructions for Use. IOLs is an implant. When we’re talking about implants, there is a very, very specific process for sterilizing implants. I have not seen IOLs reprocessed typically. You really have to check manufacturer’s Instructions for Use if you’re going to try sterilizing something like IOL because that is an implant that’s going to stay in someone’s eye, so you have to be really cautious with that.
What are the most important measures do you perform for TASS prevention? Rinse, rinse, rinse, rinse, rinse of your instruments. Making sure that decontamination is key to preventing TASS. Detergent. Detergent left on instruments, viscoelastic left on instruments, things that are left on your instruments so that the sterilization process, that sterilizing agent can’t reach that sterilizer or you’re not rinsing your lumens well enough. And then those instruments get into the next patient and as soon as the surgeon hits that plunger or steps their foot on that phaco handpiece, that phaco device, and fluid comes out. Or something comes out, viscoelastic or something, detergent that wasn’t rinsed properly comes out. The best way to prevent TASS is to be sure that you are rinsing and properly decontaminating your instruments.
Can we use chemicals like Sterillium to sterilize instruments for outpatient minor surgeries like. Only if the manufacturer’s instructions tell you to do so. Sterillium, I’m not familiar with. I’m not sure if Sterillium is the stuff that we use for surgical scrubbing. But you don’t use any, do not use any chemicals in your sterilization process unless the instructions say to do so. Specific reasons for that. A, you’re going to ruin the instrument, or B, you could cause harm to the patient if it’s not being used properly. I wouldn’t use any type of chemical unless the manufacturer’s instructions say so.
How do you label individual instruments and does that interfere with sterilization? You’re labeling the packaging is really what you’re doing. Not necessarily labeling the individual instruments. When you’re packaging your instruments and you’re putting them in those peel pouches, or you’re putting them in the wrappers, or you’re putting them in some type of container, what you’re labeling is that container and you’re labeling that package. And if you’re using the proper ink, like I was showing you, a proper marker, it is safe to use a sterilization. So that it’s going to run, it’s not going to have any chemicals. Just really please be sure that you’re using the proper marker to be able to sterilize, to be able to be on your pouches to put in the sterilizer that’s not running.
Do you have any experience of formalin used for sterilization and do you recommend it at all? I have no experience in formalin used for sterilization. I’ve actually never heard of that. Again, we go back to manufacturer’s of use. If you’re using anything for sterilization you have to be sure that your manufacturer is validating it. But I have not seen that done.
What is the longest time you can recommend for storage of packaging? Okay. Great question. And that goes back to event related. Your packaged instruments are sterile as long as those packages remain intact and the integrity is solid. When you’re storing packaged instruments you’re looking inside making sure that the indicator has changed, you are storing it somewhere safe, you’re not putting it on windowsills, you’re not putting it on the floor, you’re not stacking things. And the integrity of that package stays well. In other words, it doesn’t have holes in them, it’s not crumpled up, there’s no bubbles in there, and everything inside is staying nice and safe in there. Really the longest time, there really is no longest time. Many, many years ago when I started this, I think every six months we took everything off the shelf and resterilized them. And you look back and think, why did we do that? Those instruments were perfectly sterile in there. It’s really event related, making sure that your packages, making sure that everything in there is sterile if your packaging stays intact.
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Is jewelry, rings, nail polish allowed in surgery? And you saw me with jewelry and rings only because I wasn’t working in a sterile environment. Typically, no. Here are the rules. Rings, no. Jewelry, no. What rings and things do is they harbor microorganisms. They have bugs on them. So when you’re opening things on your back table, let’s say the circulator is opening things on the back table. When you’re got jewelry and things and bracelets, those things can harbor microorganisms and it can, those things can fall on your back table. Rings is typically a no no, especially bracelets. Sometimes earrings, it depends. Big hoops like I have on today, no. Too big. Some facilities may allow you to wear just studs, that’s okay.
Nail polish, the rules of nail polish is yes, you can use nail polish. If it is simple nail polish, these aren’t fake nails, these are not artificial nails because the glue and the things that can get underneath artificial nails are bad. Those can harbor microorganisms. They have to be simple nail polish. And it’s not chipped. Nail polish has to be intact. If your nail polish is starting to chip, those chips are going to end up on your patients, they’re going to end up in the patient’s eye, they’re going to end up on the back table when you’re opening things.
And I’m talking about circulators. When it comes to scrubs, no jewelry, nothing, nothing on your hands, nothing on your wrists. You can’t scrub jewelry. When you’re scrubbing in surgery, you can’t scrub jewelry. Jewelry cannot be rid of those microorganisms like you’re using your scrub. Scrubs definitely not, never any jewelry for scrubs. Yep, rings can puncture too.
Minimum form of sterilization recommended for tubes. Again, gas sterilization isn’t found everywhere. It really depends on the type of tubing that you’re using. Again, that tubing whatever you’ve got is going to have some type of instructions of how to sterilize it. If it is meant for sterilization. A lot of things aren’t meant to resterilize. These are called one time use only. Especially here in the U.S. we have very strict rules on reprocessing things. If that type of product like a tube or a cannula, if you purchase that and the manufacturer’s instructions say one time use only, you can only use them one time use, you can’t reprocess them. Your Instructions for Use is saying that you can only use it once. You really have to check your manufacturer’s instructions because that’s going to tell you whether or not you can use that tubing and reprocess the tubings. Just check it.
There really isn’t a standard minimum form of sterilization or minimum time for tubing. Just make sure you’re not using immediate use sterilization or gravity displacement. I only say that because you shouldn’t be using immediate use sterilization for things that have lumens or holes in them because it’s just not a long enough process to penetrate instruments that have lumens and holes. When you’re doing immediate use sterilization, they should be simple instruments, one simple, solid instrument, two simple, solid instruments. You can’t use it for a tray of instruments. You can’t use it on a tray that’s stacked. And you shouldn’t be using it on instruments that have holes and lumens in them because it’s not a good process for that. If you are sterilizing tubes, please check with the manufacturer as to the sterilization process what your cycle should be, what the temperature should be, what your pressure should be, what type of cycle that you should use.
And I think, did I answer, nope, hold on. Where’s my tubing? What else did we have here? Enzymatic sprays? Yep, enzymatic cleaning solution and sprays can be used for cleaning? Enzymatic cleaning solutions and sprays. Some of these sprays, what they’re not necessarily for cleaning, so to speak, but it is used as part of the cleaning process. Enzymatic sprays are typically used to keep instruments moist when they’re going to be sitting for a while and you can’t get to them right away. The instruments are coming out of the operating room and you may have blood on them, you may have debris on them. And that sterile processing department just is not going to be able to get to them right away and they’re going to sit there for a little while. That’s where these sprays come in handy. They keep things moist, they’re going to keep those instruments moist so things don’t cake on them. Use your manufacturer’s instructions of how you’re supposed to be using them. But typically sprays are great. Those sprays are really good for keeping your instruments moist.
We talked about IOLs, let’s see what else do we have here? How do you handle instruments that were used in a case of mitomycin C. Fantastic question. Mitomycin C is a toxic chemical, it is an anti-neoplastic agent. This is a chemotherapy agent. There are a lot of rules and I would love to talk more, but this is actually a whole talk all on its own on how to handle toxic chemicals in the operating room. Typically to give you the basics, when you’re using mitomycin or any type of anti-neoplastic agent, such as mitomycin C, you want to be sure that you’re separating your instruments out so that the person in the sterile processing area knows that those instruments were used with mitomycin C. The forceps that are getting used in your sponges, or anything like that.
The key is though if you’re using sponges that’s a little easier to do, you can just put them aside. You don’t want to mix your instruments that were used on mitomycin with other instruments, especially during surgery. When you’re actually doing the procedure and that surgeon’s going to use that sponge, and they’re going to put that mitomycin in, you want to be sure that after you get that back it gets put aside and it’s not mixed with any of the instruments that are going to be used during the surgery. You really have to be separated.
When it’s going to come out to the sterile processing area, make sure that they know that somehow, you can put it in a separate tray, that they know that it was used with a chemical. A, to make them aware that it was used in mitomycin C. And B, really the process is going to be the same but they may want to sterilize, they may want to decontaminate those separately. They may want to just separate them out from the rest of the instruments. It’s not that the process is going to be different, they’re not going to be cleaning them any more, it’s just that they are going to be cleaning them separately. They’re not going to be put in together.
Some doctors are injecting mitomycin C. And honestly, in that case, when you’re injecting mitomycin C into the conjunctiva, pretty much everything now you’re using now in that conjunctiva’s going to be contaminated with mitomycin C. It’s not just the forceps, not just you know, anything that touches them. Really, everything on that table. You really just want to make sure you’re telling your sterile processing department that these instruments were used in mitomycin C. Make sure that you are bagging them correctly, that they’re putting them in the correct biohazard because this is an anti-neoplastic agent that you have the right biohazard container for that.
Sterilizing tubes, please repeat sterilizing tubing other than gas. Oh, sorry, no problem. When you’re sterilizing tubing, just make sure that you’re using the Instructions for Use on that tubing. Not all tubing is compatible. Make sure that you’re able to reprocess it, not all instruments, not all supplies can be reprocessed. If it’s a single use only, it’s single use only. Really, when you’re sterilizing tubing I can’t tell you a specific temperature or a specific means for doing it. It depends on the manufacturer’s instructions. Make sure you’re checking the instructions for that tubing and it’s going to tell you you can sterilize this at this temperature and under gravity displacement or under pre-vac and it’s going to give you everything that you need to know. Make sure you’re not throwing tubing into the sterilizer and just putting it under any cycle. You want to make sure that you’re doing it properly.
Is it all right to use cut BSS tubing as a protector? Yeah, okay. Yes, I can say I’ve seen that many times. One of the means for using as protectors, it really is a great means, unfortunately we can’t do this here. They used to years ago in the U.S. but unless that tubing says it validated for it. But I can tell you that IV tubing, BSS tubing, things like that. If they’re made of a plastic that is able to withstand a steam sterilization process, so check your instructions and make sure because you don’t want it to melt in there, but really it is a good means. You could take a tubing and cut it up into small pieces so you’re going to put it on your forceps, you’re going to put it on your scissors, the top is going to be open because you’re cutting the tubing, the top is open, it’s going to allow for steam. And it really does make for a good protector. You just want to really make sure that that tubing is able to withstand a process, either gas or steam. But if it can, yeah, it really does make a good instrument protector.
I think I’ve got to most of these. And I know it’s getting a little late, so I don’t want to take up all of your time. I’m glad I was here with you today. Thank you so much for joining me. If I didn’t get to your question, again like I mentioned, I’m always here and I’d love to hear from you. If you have questions, you’d like to be part of our mentoring program, please reach out. And thank you again, everybody, I hope you have a wonderful day, a wonderful evening. Please stay safe and be well. Bye bye.
January 7, 2022
2 thoughts on “Lecture: Sterile Processing of Ophthalmic Surgical Instruments”
Fantastic education video!
✨ Thank you Lori Pacheco