AAMI and IAHCSMM Town Hall: Sterilization and COVID-19
April 1, 2020
In this March 30 town hall sterile processing professionals shared their insights, experiences, and questions about the COVID-19 virus and its implications for the healthcare delivery environment. The town hall addresses the challenges and questions about processing instruments and medical devices that have been exposed to COVID-19 as well as providing guidance in relevant sterile processing standards for these unprecedented times.
This event was hosted by AAMI and the International Association of Healthcare Central Service Materiel Management (IAHCSMM). As of this town hall, there were more than 732,000 cases worldwide and more than 143,000 cases in the United States.
- Amanda Benedict, director of AAMI's sterilization standards program (host and moderator)
- Damien Berg, immediate past president of IAHCSMM and the regional manager for UC Health and direct manager for Medical Center of the Rockies and Poudre Valley Hospitals in Northern Colorado. Berg has spoken at sterile processing conferences around the world and has written several articles on sterile processing leadership.
- Sue Klacik, IAHCSMM clinical educator, has served as IAHCSMM's representative to AAMI for nearly 20 years and has authored articles, lesson plans, and textbook chapters, as well as presented educational sessions for IAHCSMM.
What has been the sterile processing experience in your hospital during the COVID-19 pandemic? (02:38)
Damien Berg: Twenty-one years in the military, I've seen a lot of things, been to a lot of places. And as most of us remember, dealing with events that shaped and changed our world like 9/11 still doesn't compare to this, not that it's any better or any worse, it's just so different than what we've ever seen before.
What I'm going to share with you is a day in the life of the day it started in my system, the day it started in my hospital, and the day it started in my department. I'm going to go into very specific details of what we did here, but Sue's going to tie it into the regulatory questions, the standards questions. We're going to talk about the what ifs. What if they're telling us to do this? We're going to hopefully answer some of those, but more importantly, we don't want it to come from Sue or Damien that we are the know-all, be-all, end-all for the questions. What we're really going to do is direct you to the resources.
I've received thousands—and I'm not kidding you—thousands of emails, messengers, LinkedIn questions from people around the world. I'll give a shout out to my people in the Philippines. They reached out to me this weekend on some very innovative questions, because they're hurting big time. We're going to give you resources so that hopefully it will help you all to be able to look for where to find the information you need, but to understand that we're all going through the same thing. That's what I'm here to share with you today.
The Beginning (04:34)
Damien Berg: My journey on this COVID thing started like everybody else. I think we saw it coming in China, and then we saw it coming in Italy. We saw it hitting the other areas, and we kind of looked at it from a distance. We kind of said, "Is this coming our way? It's going to come our way. How bad is it going to be?" But until it got here and is doing what it's doing, it didn't really hit home. My home state of Colorado, being where we're at, we didn't get it nearly as bad or have not received it as bad as states like New York or Washington or the city of New Orleans, but we're now getting that. We have patients, we have concerns, we have the same questions everybody has.
The day that it started with me was actually a Saturday phone call, an emergency phone call from my operation center in the hospital saying all leadership needs to jump on a meeting. So 5:30 at night, I believe it was, I jumped on a phone call with the leaders of my system in my region saying that effectively Monday, we are suspending all elective surgeries for our healthcare system. To give you a perspective of my three facilities—two large hospitals and one surgery center—we did roughly 30 to 40 surgeries at each place, and then another 20 or so surgeries at the surgery center each day. A good chunk of those were elective, so we had to essentially shut down our surgery center and reallocate not only staff, but processes and equipment and supplies and figure out what are we going to do now that the elective surgeries have stopped?
So reached out to my leadership, reached out to my teams on Monday morning and kind of regrouped. That's the one thing I did is like, "Okay, what do we have? What do we know?" Our first day of surgeries was six at one hospital, five at another, and none at the other. When you go from the volume we had to that, it's a shock to the system. Again, these are emergent and urgent surgeries, not elective surgeries. Again, we haven't been hit at this time with COVID patients or anything really in the state of Colorado. It was more of a preemptive “Let's start conserving supplies. Let's start going through processes.” Because if we don't conserve supplies by delaying elective surgeries and we don't start looking at our processes when this does hit—not if–when this does hit our hospitals and our healthcare systems, we want to be ready for it. We had the luxury. We still have the luxury of seeing other systems and other countries get hit before us, so we're able to adapt to that.
Be Prepared (07:05)
Damien Berg: The first thing I did when the volume dropped was to look at my staffing model. I looked at the staffing model to my leadership here, and it happened to be spring break here in Colorado for the majority of this stuff. It was a weird week altogether, because we have docs off. We had staff off already. Volume was going to take a dip, but not to this extreme. I said, "Do I have the right staffing here?” The staff, I could not be more humbled and impressed with my staff pulling together, and with the unknown that we were facing, they just said, "Okay, what do you need me to do, Damien? What can we do?" They cleaned beyond ... I've never seen sterile processing department as clean as it's been multiple times a day. They wiped down door knobs, they wiped down phones. They wiped down every possible thing if it had a chance. We restocked. We took inventory.
That's the one thing I can honestly say that helped us and is still helping us now. We took inventory not only of our PPE, which was asked of my healthcare system, but we took inventory of our other supplies, our sterilants for our low-temperature sterilizers, our disinfectant spray, our biologicals, our wrap. We took inventory, and I issued, I don't want to say an order, but I issued a guidance and said, "I want to have three weeks on hand of all my supplies, if I can get it." I know this is a shock to the supply system, but I reached out to my vendor friends and said, "Hey, guys. If and when the spigot ever stops and I get no more supplies, what can I survive off of?" I took one week of our busiest week in the past six months and I had my team go, "Okay Damien, this is the most supplies we used in one week based off of surgical volume, the normal operating." They doubled at times three to give me three weeks on hand, so that I have three weeks on hand of supplies if the worst case scenario happens based off our busiest week. Again, we can't predict what's going to hit us, but at least it gave me some type of starting point.
That was really kind of the initial stages we started going on. And right off the bat, the other thing I reached out to was my vendors. You can imagine doing, oh my gosh, 10 to 20 total hips and total knees a day, and we're doing none now because those are elective. Maybe in a revision here too, but what do we do with our vendors? Well, my trauma vendors, my elective vendors, I reached out to all of them and said, "Hey, if you're in my facility ..." If any vendor knows me, knows that I'm pretty tough on them, but what I said is, "Give me your stuff to process. I will take anything and everything you have and run it through my sterilizers and have it on hold, because I don't know what's hitting my door. If it's sitting in a hallway, if it's in a loaner room ready to pick up, if it's in your car, bring it to me. I will take it all."
Two reasons why is I wanted to be prepared, and number two is I want to keep my staff busy like there's a relative normalcy to what we're doing and keep our skills honed at what we're doing, so that you're not just out there trying to figure it out on your own. More importantly, playing the productivity model as well too, because we've always got to make sure we're balancing all that fun stuff at the same time. Those are what I deal with when the volume dropped and the staffing level. I'll talk about staffing a little bit more towards the end, because I want to share some of that.
The next question that came up right off the bat was how do you clean COVID? Sue's got a great part of her presentation. We'll talk about cleaning COVID off the surgical instruments or surfaces or equipment, and I'll tie in on that too. I don't want to get into that, but I really dug in and did a lot of research on viruses and different bugs and different stuff, and I worked with my IP teams. That's what I can't stress for you guys enough. I worked collaboratively with my OR, my IP, my safety, my environment of care. I worked with all these people because I really wanted to make sure my knowledge base and my experience was not wrong, because a lot of times we go off of, "I've been doing this 27 years, so I must know it all." Absolutely not. It's not about Damien. It's not about what I think I know. It's about what the standards are and what I can prove. That's really what I dug into when we talk about cleaning COVID, which we'll dig into in more detail.
The next thing obviously was a big question we have. I'm talking thousands of questions, probably, we got about masks and PPE. I can't tell you the number of questions I've seen online. I can't tell you the number of questions I've gotten, but they're pretty much all the same. “How do we handle masks and PPE? Do we reuse them? Do we need N95s in decontam? When we're walking to the cafeteria, do we need a mask?” All this fun stuff that nobody ever thinks of because you never thought about it before, but the funny thing is we've had a lot of nasty bugs in our world, whether it be TB, HIV, hepatitis, CRE. We've had them out there, and we know how handle these, and we can handle them. It's just a different unknown for us, and there's a lot of fear factor in there. We're going to really talk about masks and the confusion, but the big thing about confusion is when people were coming to me asking me some varied questions that I've never had the answer for or had to answer. I had to take a pause.
Again, like you heard me say before, it's not about Damien and Damien's background experience. It’s, “What can I prove?” Because the one thing I don't want to do is add to the confusion or create a level of false safety or security. I don't want people thinking that because I'm doing something in my department and we're sterile processing department that they're safe, because if it's not based off of evidence, if it's not based off of standards or manufacturer's recommendations, I don't want two, three months, a year from now, someone to come back to me and say, "Damien, you jeopardized all these people because you said it was right or good." I removed that confusion right off the bat and said, "It's not the Damien show. It's not the sterile processing show. It's about what available facts we can find," and we're going to really dig into that a lot here in the near future.
I attended the AAMI's first webinar a week ago or so on biomeds, and there was a biomedical engineer from Italy who spoke. Which kind of got me really thinking about a lot of things, and if we were going to do this presentation, what would it look like? That's where I tied onto it. One of the things that he talked about and that we talked about here is anesthesia machines, ventilators, PAPRs. How do we clean those? Again, I'm teasing it up a little bit for the question and answer session, but again, we have the resources. The first thing I understood is, what are the reprocessable parts of the anesthesia machines, the ventilators, and the PAPRs? What are the disposable parts? What are the parts that never leave the patient room and should be cleaned in that area?
I differentiated those in those three categories, because if they are the reprocessed will parts that can be taken apart off the machines and sent a sterile processing, then I can look up the IFUs, which we did. There are certain things that absolutely should never come to serial processing. They can be wiped in the room. There's certain things that are disposable, and there are certain things that are reprocessable. I divvied them up in those three categories, and then that helped me prioritize what I needed to do. I took pictures. We did YouTube videos with the anesthesia techs, disassembling the anesthesia machines with my biomed, dissembling the ventilators and sending the parts to sterile processing. Then my sterile processing techs can see all the parts and how they came apart. Then they had colored copies of the IFUs and directions of these are the steps you need to do.
Our cleaning chemistry's [inaudible 00:14:13] and our disinfection machines and our sterilization technology, this is not a hard bug to kill. It's been very well stated on that, so all the processes we have in our area were able to meet our anesthesia machines, ventilators and PAPRs, and I'll talk more about that in the questions and answers—there are some good questions and answers. But the big thing I want to talk about is segregating the myth from what we can do versus what we can't do versus what we shouldn't do. That's the first thing I did.
The other area I want to touch on briefly is working with other departments like our environmental services, our facilities, our biomed. I can tell you right now, we see, and I've even posted some stuff on Facebook this weekend, amazing chalk art that citizens and fellow healthcare workers put on the ground as you're walking in that said, "Not all superheroes wear capes. They wear scrubs.” And not all superheroes wear scrubs. Some of them wear facilities uniforms. Some of them wear EVS uniforms. Some of them are street clothes and our biomedical guys and girls. It's amazing to see these unsung heroes from other departments, just like sterile processing, learning, living, and supporting the clinicians because the clinicians are up there dealing with the patients. They're up there dealing with the stress. They have to go home to their families afterwards and say, “I was working on a COVID floor.”
And it's no different than any of us. We are exposed. I worked at a front door and I had patients cough on me and things like that. It is something that we haven't done before. But I wanted to single out working with your other departments. And more importantly than that is, as we know when the surgery's drop, because most COVID patients aren't surgical candidates, they might be surgical candidates that get COVID, but COVID doesn't necessarily mean you get a ride to the OR. So, all OR volumes drop. What do I do with all my staff?
So, what I did is I reached out to my counterparts in these other departments and I said, “Hey, what do you got? Can my staff help you out? Do you need help stocking shelves? Do you need help wrapping sandwiches? Do you need help delivering goods? It doesn't matter what it is, what can we do?” So, we're still working on that plan, but we've had some good collaborative working relationships with my counterparts in other departments, which I find very nice because sterile processing has a seat at the table in our command center. We're not just a department who... and forgive me, some people know this term, but I absolutely hate it, but washes dishes and cooking things. I never thought I would say that because we don't do that. We decontam. We inspect. We sterilize. And now, other departments of the hospital are seeing what we do on a real basis because we are the experts in what we do. But it's by engaging with those other departments and making us part of them and them part of us, which has been successful in our healthcare system in my hospitals.
One of the last things I want to talk about is preparing for the waking. And what I mean by that is the ORs will wake up, guys. The ORs will start doing surgeries again. And will we be ready for that? So, that's where my brain is always thinking, a month from now, two months, whenever the ORs... three weeks from now. I don't know. We don't know. But, when the ORs wake back up, let's be ready as a sterile processing department. These surgeries that stopped their hernias, the total knees, the shoulders, robotic, whatever they might be, they're going to need those surgeries. They didn't go anywhere. So, they're going to be wanting to get those surgeries. The doctors are going to want to get them in. And we're all going to want to get back to some normalcy. Let's not have sterile processing be the ones that cannot wake back up when the OR wakes back up.
And that means being ready, having your supplies, having your training ready, having your staff mentally ready for the waking up, is what I'm calling it. Because our hospital, our state, our country, and the world will wake up from this COVID and we will get back to normal. And that's what I want to make sure we're prepared for. So, I, as a manager, as a sterile processing tech, want to just let you all know that we're in this together. But again, we operate now but I'm thinking towards the future.
Lessons Learned (18:11)
Damien Berg: And the last thing I want to share with you is lessons learned. It's been humbling for me, to say the least, because I've never been through this and my staff has been amazing. My team leads, my supervisors, my educators, my frontline staff, it doesn't matter, all shifts, they're all dealing with their own personal issues. But the three things that I said I can promise them—and this is what I can promise anybody—I will be clear and transparent with you when it comes to what I know and what I don't know. I'll be clear and transparent with you when it comes to what your schedule is, what you're going to work. Because we've had to down-staff people. We've had to tell people, you've got to go home. We don't have the surgical volume. And that's a very tough thing for me to do.
So, it's tough because I care about these people. And I don't like sending people home because there's other work in the hospital that can be done to take care of these patients. So, that's what's tough for me because I just want to see everybody work and work to their full potential. And sending people home, impacting their pay and their life, that hurts me. But the second thing I did—a lesson learned—is provide opportunity. By reaching out to my counterparts, by using my healthcare system, by using my contacts, I provided opportunity to my techs to take jobs in other areas of the hospitals so that they can have income for their family if they choose.
And the last lesson I want to share with you is stay positive. That's one thing that I've done. It's not been easy. But, if the leader, or the head of an organization, or even the entry-level tech, don't care where you are, are not positive, that impacts everybody else. So my job is to stay positive. My job is to be the cheerleader for my staff, to listen to my team, to listen to my peers, to listen to the doctors. It doesn't matter. And the community as a whole… you imagine how many questions I'm getting, you're getting them too… but being positive about the situation we're in and not negative. Yes, are we short some certain things? Absolutely. Do we have workarounds? Absolutely. Can we get this done? 100%. But by staying positive is really the strength in what we do to get over this.
So, with that, I just want to say thank you to my healthcare system. I want to say thank you to my hospital. I want to say thank you to my sterile processing teams for doing the work they do, because they truly are the ones making it happen. I get to be on a webinar. I get to do a lot of things, but they're the amazing teams that take care of our instruments and our equipment so our providers can take care of our patients during these tough times. So, I want to thank them.
And, before we go to questions, I am honored to turn us over to Sue Klacik, not only a mentor of mine because I've known her for many years and learned a lot from her, but she's a friend. And she's got a wealth of knowledge. And I'm excited to hear her next portion on tying this together from what happens in the real world to now standards and practices in education. So, with that, Sue, I'll pass it on to you.
Standards and Regulatory Guidance (21:02)
Susan Klacik: Thank you so much, Damien. It's wonderful to have a leader like you on this webinar. I love your positive, your very, very positive message, basing things on science, being the leader with a cool head to lead us through this pandemic, and not basing your answers and your decisions on panic, but rather on science. So, we haven't lived through a pandemic such as this. And it's very important that we do follow the standards as set by FDA, and CDC, and AAMI. Currently, FDA and CDC are working very hard to come out with new guidance for this type of an epidemic, this pandemic actually, that we're dealing with.
FDA Emergency Use Authorization (21:47)
Susan Klacik: Just recently, many people may have heard that the FDA has just come out with a new FDA emergency use authorization in regard to some of the N95 masks. So, what that means is, when it is an FDA emergency use authorization, that authorization is not as detailed as the typical 510(k) clearance that we are familiar with. They have reviewed the information and it is being permitted. As users, there's a few things that we need to know before going forward with the FDA emergency use authorization.
When a manufacturer has that authorization, as users, we need to look very, very closely at the wording that the company has obtained and has been permitted from the FDA. We should get a letter from the company, from the FDA, and in this letter it's going to tell us if that device can be decontaminated. Which, if that's the case, and we're talking about a mask here, would have to go back to the same person. Is the mask undergoing high-level disinfection or sterilization? And also, it may also contain how many uses the mask may have. We're used to doing this with some of our other products. Each time it's used, it's marked.
And so, again, when we're looking at this FDA emergency use authorization specifically for the N95 masks, we need to make sure that we're following what the letter says. Is the item undergoing decontamination—so it would go back to the same person–high-level disinfection, or sterilization. When we're looking at COVID-19 for the N95 masks, there's a few things that we need to check into with the manufacturer. When looking at disinfecting and sterilizing N95 masks, we need to make sure that the disinfectant method is effective against the target organism, such as the virus which causes COVID-19. We have to make sure that, if this is being processed, it does not affect the respirator's fit. It must be safe for the person wearing the respirator, such as there was no off-gassing of the chemicals into the breathing zone. And also, the filtration of the mask cannot be damaged.
These are new times that we're going into. Damien, you did a wonderful job talking about this being a new time. This pandemic is so new to us and there are a lot of questions. And so, each facility is going to need to perform a risk assessment. And, when performing a risk assessment for various activities, take into consideration all of the science and all the information that you already have available.
Decontamination, Disinfection, Sterilization (24:39)
Susan Klacik: We need to follow the current standards that we currently have. With COVID-19 being so new, a friend of mine reminded me that this is sort of like when we're going down the freeway and we may be doing 70 miles per hour and the speed limit is 65. And, when you see the police it's like, oh my gosh, I've got to go back to doing the 65. It's the same thing here. We have had the standards in place, the AAMI ST79 standard, the steam sterilization standards have been in place for many years. So, we need to go back. We need to look at those standards and make sure that we're following them. We follow the standards for this type of a pandemic just as with anything else, which of course hand hygiene is very important. We've heard that over, and over, and over again.
So, looking at the standards, the ST79 comprehensive guide to steam sterilization and quality assurance in healthcare facilities, I'm going to talk briefly about the containment for transport, our PPE, and processing in decontam. And, when processing in the decontamination room, we're doing it for two main purposes. We need to protect our staff, making them safe for handling. And we also need to make the equipment safe for patients. For equipment disinfection, there's also the AAMI TIR68, which is the low- and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing surfaces. This technical information document discusses disinfectant classifications and general applications to disinfectants.
So, first I'll talk briefly about a review of ST79. And in ST79 it reinforces the OSHA Bloodborne Pathogen Regulation, which is universal precautions. We treat all items coming into the decontamination room as contaminated. Everything that comes in the decontam room is considered contaminated. So, that being the case, when transporting items to the decontam, the person must wear the appropriate PPE. And the container, when transporting the items to decontam, they need to be closed and it needs to be labeled with the biohazard insignia or a red container. And if it's sharp, it has to be puncture resistant and leakproof.
Personal Protective Equipment for Sterile Processing (27:08)
Susan Klacik: Once in decontam, we need to put on our PPE. Staff will already have on the sterile processing–recommended scrub, but now, working in decontam, we have to wear the appropriate PPE. And so, as a review, the gloves are not going to be the same gloves that they use in surgery, but rather thick utility gloves. And these gloves are fitted at the wrist, preventing the wearer's skin coming in contact with contaminated water. And they also have cuffs. We take the gloves up over the cuffs of the gown so that we don't get water onto the person's hands. Also, the gown has to be liquid-resistant covering with sleeves. A backless protective gown is fine, a jumpsuit, or even a surgical gown. But it's important that it is liquid resistant. Shoe covers are also recommended. They have to be liquid-resistant shoe covers, because there is a potential for shoes to become contaminated with blood or other body fluids.
Now the face mask, that's what we hear so much about now. We must wear face mask and eye protection if there is any anticipation of blood splatter, which in the decontam there is. However, in the decontamination room, the N95 is not the recommended mask. It is a fluid resistant mask. That is what is specifically recommended in the OSHA Bloodborne Pathogen Regulation and also the AAMI ST79 standard. And the reason for that is we don't have aerosols in the decontam room. We have work practices in the decontam room that prevent aerosols from forming. The eye protection, we have to use goggles, a full-length face shield, or other devices to prevent splash from all angles. And so, our regular eyeglasses just don't fit the bill there. It has to be, again, a full face shield or face mask. But the eyeglasses do not fit the bill.
Instructions for Use and Universal Precautions (29:16)
Susan Klacik: So, talking about work practices in the decontam room, again we have to keep our personnel safe and the products must be safe and effective for patients. So, we're following universal precautions. And the other thing is we need to follow the instructions for use, for the instrumentation that we're processing, and also the equipment that we're using, and even the PPE. So again, it's we need to follow all validated instructions for use. And everything gets cleaned. We're still going to totally disassemble all items. Everything gets brushed with the correct size and type of brush. We will use fresh cleaning implements and fresh water each time. And so, we need to prevent aerosols from forming. And to do that, according to best work practices when we clean instruments, it has to be under the surface of the water, and the reason for that is to prevent aerosols from forming. Again, we don't wear the N95s in the decontam room. We need to save those for the direct patient care providers. We need to follow good work practices, which means brushing under the surface of the water to prevent aerosols. We also need to keep the lid on our sonic washers closed while it is in operation, and that also prevents aerosols from getting into our work environment.
To keep the entire environment safe, we need to keep all doors and the pass-through windows closed. All windows should be closed. Sometimes we forget to close the pass-through window or even the door, but we have specific environmental practices for both rooms. And so in the decontam room we have air pressure that removes the air from the room and then on the clean side, we have a positive pressure bringing the air constantly in. We do not want to take the work environment from the decontam room and put that onto the clean side because on the clean side personnel do not have PPE on. So it is important to keep all doors and windows closed in the decontam room.
And so, upon thoroughly processing all of our instrumentation, so again, we're going to use clean implements and clean water, follow all of the protocols. The items should then be safe to handle. This is what we've been doing for many years and we have to follow our standard precautions. In ST79, there are whole sections that talk about safely cleaning medical devices to protect the staff and also to make them safe for patient care. The next step is after the items had been thoroughly decontaminated, the items can … be sterilized or disinfected. Again, we're going to use the medical device’s IFU to see where we go from there.
Disinfectant Selection for COVID-19 (32:18)
Susan Klacik: During the COVID-19 pandemic. One issue that has come up quite often is on a disinfectant and Amy does have a disinfectant TIR for that. As I said earlier, it is TIR 68, and I'll go through that real quickly. And, of course, items that are undergoing disinfection, and this is low- to intermediate-level disinfection, they are according to the Spaulding classification. And so this document will walk us through exactly how to perform low- to intermediate-level disinfection. And I'm going to start off with the selection criteria. How do we select the correct disinfectant? So again, we're going to go back to the Spaulding classification, and many pieces of equipment that we're talking about today do not require sterilization. So we need to look at how the product is used and then we look at the disinfectant itself: Is there a dosage? And by that I mean, will the will the disinfectant need to be diluted in water? So we look at, once again, the instructions for use from the disinfectant. In health care facilities, we need to make sure that the product has an EPA registration number. And in healthcare facilities, we only use EPA-registered hospital-grade disinfectants. A disinfected product with an EPA registration will have been extensively reviewed and approved for safety and the effectiveness of labeled claims. Since any claim requires submission of data, they are both evidence based and tied to the specific product formation written instructions for use. So the question then comes up, what about COVID-19? What is the spectrum of activity product claim? We're going to look at that for gram-positive negative bacteria, fungi, viruses, and micro bacterium.
For COVID-19 being such a new virus, such pathogens are often unavailable commercially for lab testing, as is in this case. There are some resources we can go to. The EPA and ECRI have both done some testing on these products. On their websites, they have listed disinfectants that they have tested for the coronavirus. You can review both of these lists by checking either the IAHCSMM[ or the AAMI coronavirus websites. They will lead you right directly to these charts. I caution you that as you use the charts, please check and make sure you're reading all the instructions on how to use the charts. On the charts, they do have the EPA registration number. Some have the product name and also what it is effective against. So again, this information is available. It can be accessed through either IAHCSMM or AAMI through our websites. We have coronavirus website links there that will let you know is the disinfectant you're using effective against the coronavirus? We also need to look at what is the contact time, the wet time required for the activity, and these charts also have that kind of information available.
Also, some other things that we're looking at for this selection is what is the compatibility of the materials of construction of the device or equipment? What is the organic load tolerance—which is the ability of a product to work with the presence of soil—may provide a more consistent result if the organic load of the item may be disinfected as inherently low, then this tolerance may not matter. But again, before anything undergoes disinfection, we're going to clean it first.
Is there a flammability concern with the disinfectant? The other issue is there a potential residue and how easy is it to rinse? The amount of residue in a no-rinse application and/or difficulty in rinsing in an application requiring rinsing can both negatively impact the usability of a disinfectant product or could be a positive. We also may need to track how many uses. So the FDA has reviewed the information on the products that we use. The EPA looks at our disinfectants. … We currently have many standards and recommended practices that are applicable to COVID-19. We need to be mindful and follow our standards and recommended practices. They are there, we need to be mindful of them.
During this time, as Damien said earlier, this is a pandemic and manufacturers are working with manufacturers, the government agencies such as the FDA is also working with manufacturers. They're working with each other. There's a lot of work going on right now, and it's so important to keep our healthcare workers and our patients safe. This is a very, very tough time. I, too, applaud all health care workers. You are the true, true heroes of today, and for many, many years to come and forever the healthcare workers will be the ones that we have identified as being the true heroes of battling this COVID-19. And with that, Amanda, we can start our questions and answers.
Q & A (38:15)
Amanda Benedict: Thanks, Damien for your remarks about your experiences and thank you, Sue, for cross-walking us to the guidance that's out there and what's coming up. I want to start off with a question to Sue.
Are there any specific and/or different protocols in processing for cleaning—both manual and mechanical—disinfecting, and sterilizing reusable surgical equipment and instrumentation with regard to COVID-19? (38:39)
Susan Klacik: They are all the same. These standards that we have in place now, they have been in there for many years. These consensus standards are based on scientific evidence. We've done an awful lot of work with these standards looking at a multitude of pathogens and medical devices, and the standards that we have in place today from AAMI, the ST79 steam sterilization standard specifically, if we follow those we are definitely protecting ourselves and our patients from COVID-19. So they are in place. We just ... Maybe we need to dust off the manual but they are there and we need to follow those standards.
Damien, how do you treat surgical instruments that have been or potentially have been exposed to COVID-19? (39:21)
Damien Berg: Great question. Thank you. I think Sue answered it very well. I had, Initially when this hit my facility, the OR, or the end user where the product was at, was trying to do their due diligence and in the closed case carts and the required transportation bins, they were marking COVID on them. Which, I get what they were trying to do—they were trying to inform my staff that this is a COVID patient. But again, remember COVID is a respiratory disease/droplet form. There's a whole lot of stuff to consider and that's where I look into the CDC guidelines and all the regulatory agencies’ guidance. But we don't look at what the patient is. In decontam, I don't really care if it's a one-year-old, a ninety-year-old, whether they have hepatitis, they have HIV, they have CRE, they have COVID-19. What's important to me is that we follow those universal practices.
We follow good processes, we use the correct chemistries and the EPA-approved [list] that Sue discussed. Because all our practices that we’re trained by, all our practices as documented by, are the proper ones to proper decontam, whether it's a surgical instrument, whether it's part of an anesthesia machine, whether it's a flexible scope. It's our current knowledge and everything guides us down that way. So we don't need to ... I heard someone say, "We're going to go to all disposable instruments." No, we don't need to do that. So let's just take a pause, take a breath. Follow guidelines, follow standards and what we're trained to do and cleaning and disinfecting surgical instruments can be accomplished like we do all the time, prior or not.
Only thing I can say is, and we'll talk about in a future question, is it just raises a sense of awareness. I can tell you traveling around the country and even my facilities, sometimes I'll walk back into a decontam area and also see people not brushing underneath the water, or I'll see people doing things that probably aren't the best for universal precaution. So whether you're COVID or not, follow those. So the one thing I can say about COVID is the staff are acutely more aware now than ever. So I think following them now is highlighted more so than ever because of COVID. Which I think is a good thing, but I think we need to do it all the time. And like I said to you, when the ORs wake back up, it doesn't mean our precautions and the way we practice goes away.
Damien, I have another question for you. And that's about processing of ventilators and anesthesia machines. We've gotten a lot of questions at AAMI about that. So what do you have to share about that? (41:43)
Damien Berg: Yeah, thank you Amanda and I kind of mentioned previously and I kind of answered this question a little bit already, but I'll dig into a little bit more. The big thing that I found besides the three areas I asked you guys to bucket them into is understanding that IFUs really are out there now. The IFUs for ... This is where I leaned on my biomeds a lot and my anesthesia techs because the IFUs for anesthesia machines and ventilators and other equipment like that are not like what we're used to reading. They're very much book form. They're very interesting and a lot of parts and pieces, but they go through your standard decontamination process, your standard washer-disinfectors. The big difference is most of them require what they call an open or naked sterilization steam cycle.
So, meaning that, again, following IFUs, depending on what they are, because there's different manufacturers. In my one facility in Loveland, we actually have three different types of anesthesia machines, with three different IFUs. So I had to crosswalk all my IFUs and make sure that my staff aren't thinking they're doing the right thing by one and doing it wrong on the other. So no matter what you do, make sure you have that out. And again, whether you're using an online database resource for IFUs, whether you're using the old hard copy papers, the staff have to have access to those, the staff have to understand them. And I think this is that opportunity to actually provide some really good training, get the manufacturer in here and provide some really good cross training with the biomeds, with the anesthesia techs, and with sterile processing techs. Because they need to be disassembled, then we do our part, then they need to be reassembled properly, or they don't do any good. That's mainly with the anesthesia machines.
With the ventilators, again, there's really two types. I'm pretty blessed in my current situation because all the current parts that they use that touch a patient or would be contaminated by the patient are disposable. Now, they do have reusable pieces that if we run out of disposables, we go down that path and again, the same process. I looked at the IFUs I'm like, "What can we do?" Again, most of our modern washing equipment has anesthesia cycles on them for processing anesthesia equipment, so circuits and other things like that. So there are resources and processes out there. Hopefully the IFUs will guide you, if not phone a friend, and the friends are your manufacturer of that product. Your phone-a-friends are your biomeds, your phone-a-friends are your anesthesia techs, and your other resources out there. We have a nation of sterile processing techs, a world of sterile processing techs. So reach out to your counterparts, use the social media for help that way versus some other things.
Damien, you touched on transportation just briefly. Another question for you: How should transport bins, counters, sinks, and reusable cleaning equipment/supplies (faucets and pump handles, brushes) be cleaned and disinfected to prevent cross-contamination and personnel exposure? (44:29)
Damien Berg: Thank you, Amanda. And this was a question sent to us by a great friend of ours and a true expert and passion for what we do. I appreciate this because, again, we talked about cleaning of instruments, we talked about cleaning of anesthesia machines, and we talked about cleaning of items that we sterilize and reprocess. But I really want people to focus on: make sure your faucets are clean, your pump handles, your brushes. Again, a lot of brushes. It depends on your policy, but do you put them through a washer-disinfector and a sterilizer according to their IFUs? Once a shift, when they're dirty, once a day? Do you dispose of them?
I think it's time to review that and make sure whatever your countertops, all your other supplies, because again, it's not that in decontam, as Sue stated, COVID is in the air if we're practicing our proper protocol and our proper processes. But if you're touching instruments or a laryngoscope blade for instance, that has been used on a COVID patient or suspected COVID patient, then you touch that handle turning off the water. Then later on, you change gloves, you touch that handle to do something else. Did you disinfect that handle? And then you're touching your door knob and then you're ruffling around for brushes. I mean, think about everything you touch in relation to then, I need to clean and disinfect that prior to the next person comes in. We know this, but I think our heightened sense of awareness is more important now than ever.
Have the standards changed for transportation of instruments from surgical COVID-19 patients? (46:09)
Susan Klacik: It absolutely has not. I think Damien touched on that quite a bit very, very well, thank you. It's the same as it is for any other item that is used on a patient. It's considered as a contaminated item. It's placed in a transport bin. It should be labeled or identified as contaminated—that's either the biohazard insignia or it's red. If it's a sharp item, it needs to be in a leak-proof and puncture-resistant container and sent to the decontamination room, where all items are considered as contaminated. And when transporting, we need to make sure that the person doing that also has the correct PPE on.
Damien Berg: Absolutely. And I'll tag onto that real quick, Sue. Again, we know that we focused on transportation a lot, especially the last couple of years because of Joint Commission and other survey readiness. And again, a lot of people said, "Oh, Joint Commission is making me do this," or "It's a waste to have this biohazard sticker because I know it's in a closed-case cart that's here."
But I think now we're seeing more so of here's the “why.” The why is I don't think anybody in the healthcare system who's transporting medical devices or decontaminating medical devices wants to do something bad, wants to come across as, “I'm going to cut a corner.” But what I call it in the real world, I call it the Good Samaritan rule. We have people that might be Good Samaritans and take a product that was contaminated and they know it's contaminated. "Hey, I'm going to take this and put this in the soiled utility room to be transported," or "I'm going to take this by the elevator." But it's not marked. It's not labeled.
Then another Good Samaritan comes along and goes, "Oh, I found this here." And they don't know it's dirty or contaminated because they can't visibly see the contaminant, the COVID. The COVID is not the color of blood, it's not the color of anything. So, that's why we put these universal precautions and that's why we say when you're transporting anything contaminated, follow these processes so that you avoid the human factor and the Good Samaritan law out there that is key to ensuring that the items are safe but also get to where they need to be for proper processing and not contaminating anybody else.
Susan Klacik: Yeah, and one more thing on that Damien, that we do in healthcare facilities, is identifying what is patient ready from what is not. And so especially with scopes, after we've processed a flexible endoscope, we label it when it was processed, the date, the person who processed it so that we can easily identify equipment, whether it is an IV pump or a flexible endoscope, whatever it is that has undergone the process and is now patient ready so that we don't mix up what is patient ready from what needs to undergo decontamination.
Damien Berg: Absolutely, Sue. Thank you for clarifying that. Before we move on, I want to just add one more thing to the decontamination process that I thought. But in our decontam area, we talked about our automatic washers, we talked about the sinks, we talked about other things. There's also units out there that have pasteurizing devices, especially for anesthesia-type equipment or those type of devices. A pasteurizer or pasteurizer device is in a lot of the sterile processing departments around the country, around the world. So please keep in mind that that also can be accomplished, but you really need to brush up on the instructions for that and make sure that it's adequate for the processing that we need.
Damien, what's the most important thing that technicians can do to ensure their safety when they're removing PPE? We get a lot of questions that are related to PPE, and how can they help maintain safety when they're taking it off? (49:57)
Damien Berg: Ah, that's a great question. So we all know, anybody who's spent time in decontam, I actually like decontam. Number one, I don't have a computer. I don't have a phone. I usually have some good tunes going on in there and I can zen out and do my job. And I actually love it when I can get in there. But the more important thing about decontam is when you're done, you're hot, you're sweaty, you're tired potentially, and you want to get out of that PPE as fast as possible. That's not the time to do it. And again, relative to COVID or not, that's not the time. Donning and doffing PPE appropriately has been something that's been studied. That's something that's well-documented. I can tell you when we had the recent outbreak of Ebola, they really, really focused on the donning and doffing of PPE. So there are amazing PowerPoints out there, there's amazing presentations. But again, I don't want all this work we talked about—by disinfecting surfaces, getting your equipment clean, all this stuff—and then by simple fact of you not taking your gown off in the correct way, you can possibly transfer something onto your scrubs or your bare skin. It's a shame.
We put a lot of training and a lot of stuff into technology and to chemistries and to science. And then a simple thing of not removing your gown, your gloves, your booties, the correct way can really cause detriment to the end user, which is my passion. So please read up on how to don and doff. There are so many resources and again, as stated, we'll be sending these resources out to the end users in the community. So again, it's not the Damien and Sue and Amanda show. It is really truly about here's what the experts say on how to do things.
The other topic we've heard a lot about is masks. And I want to shift into questions related to that and start us off with for either one of you, Sue or Damien, on the subject of alternatives to manufactured masks. What are your thoughts about alternate methods for making masks, such as using wrap material or cloth masks? (51:47)
Susan Klacik: Well, when looking at masks, masks are a Class II FDA regulated device and so there are specific parameters for our masks. And when looking at masks, we need to look at what is the filtration and what is the fit. If making a mask, you need to contact the FDA and they can help. They can provide you the guidance for what is needed for a mask. But there are definitely specific criteria that is needed for face masks. And again that's the filtration, it's our fit, where we're going to be breathing. So it is so complex to make a face mask, you should really contact the FDA for some guidance.
Damien Berg: Yeah. And I'll tag on to that Sue because again, I've seen it across the board. Again, the ingenuity and the drive and the passion of our citizens and our technicians is amazing. That's what makes us great. We find a challenge and we hear people suffering and we're going to try to overcome it.
The challenge I have, like Sue said, is we don't know what these do and what they don't do and I don't want two, three months from now we thought we were being protected by a mask or we thought we were protected by some PPE and it turns out we weren't protecting the people at all. That's my biggest fear. So, while I think there's applications for it, we want to make sure we validate it and in our healthcare system, again, we are not using those at this current point, but if worse comes to worst, and again I've been contacted from people around the world going, "Damien, we're out of everything. What do we do?" Well then, that's where you sit down and you do that risk analysis and risk assessment with your hospital leadership and yourself and you weigh in and go, "Okay, what is the best option for what I have?" But if you have clear PPE to use that meet the standards…AAMI standards and CDC and all the other FDA, please use those because that's really what we're trying to do. We want to make people safe. We don't want to inadvertently not do that by trying to do something that's really good.
We’re getting a lot of questions about reprocessing of the N95 masks. And I know you've both touched on this a little bit, but what message do you want to really communicate with the audience today? (54:19)
Susan Klacik: Well, you need to go back to the manufacturer of the mask and get their recommendations for use of the mask and reprocessing of the masks. They are the experts. They know the material, they know the structure, the engineering, the chemistry, they know everything there is to know about that mask. So, if that is something you're interested in doing, you should contact the manufacturer.
Damien Berg: The one thing I want to say is again, as anything in life, but I can tell you when we announced the webinar last Wednesday, I believe it was to today, even up to a few hours ago, the industry is changing. Whether it be a mask manufacturer, a distributor, the FDA, a sterilizer manufacturer, they are all trying to help us. There is not one person or one company out there that I think wants to sandbag or hold back or not try to help us solve this problem of not having enough masks or solve this problem of getting to the new normalcy of what we're doing. So, before you do anything, reach out to that, like Sue said, that mask manufacturer. Reach out to that sterilizer manufacturer, reach out to that distributors so they can do X, Y, Z. Follow FDA guidelines. They are changing daily.
A lot of the red tape, and I don't mean that in a bad way, but a lot of the paperwork and processes that delay technology and good things happening are being removed from the FDA so that ingenuity and adaptive technology can come forward, which is what we want to embrace and see. But we never want to go against manufacturers’ instructions because, again, that leaves us as liable for that and for the safety and wellbeing of our technicians. So please, resource those three different people that we said. We can't say “Damien and Sue said do this,” but we can guide you to the most appropriate, but it literally changes daily so you’ve got to stay up on it. Please do.
Closing Remarks (56:33)
Amanda Benedict: Sue and Damien, I want to express our gratitude to you for being with us today, sharing your experiences and helping to get all of us to the right resources to address questions about sterile processing and sterility assurance during the COVID-19 pandemic. And many thanks to all of you who were able to join us today. We again want to express also our sincere appreciation to those who are in the healthcare facilities and hospitals directly supporting patient care during the pandemic. We do want to remind you that AAMI and IAHCSMM are here to support and assist the sterile processing community.
If you asked the question that we weren't able to address today, we will follow up with you. And as Damien mentioned, we'll also be sending out an email to registrants for today's webinar with links to the resources we've compiled, which includes publicly available standards, technical information reports, and other guidance.
For Coronavirus updates from AAMI, including important resources, visit www.aami.org/Coronavirus.