CPAP Recall | Vaccine Administration | Top 10 Health Technology Hazards

Paul Anderson: Hello and welcome to the first episode of ECRI Now. A show about healthcare insights from the experts. I'm your host, Paul Anderson. Today we'll talk about strategies for ensuring safe vaccine administration and take a look at emerging tech hazards in healthcare. But first, we'll take a trip to our lab and have a talk with Ismael Cordero ‎, a senior project officer with a device evaluation team here at ECRI. His work is always focused on assuring the safety of patients who rely on devices he's evaluating in the case of a recent nationwide recall. He also happens to be one of those patients. Here in the ECRI Labs. Ismael Cordero ‎ is evaluating subglottic aspiration devices, which are getting renewed attention during the COVID- 19 pandemic as more patients require ventilation. Ismael is also a patient who uses a continuous positive airway pressure or CPAP machine, which have been the subject of a recent nationwide recall. You recently, you had some interviews with a couple different media outlets around some recalls for continuous positive airway pressure devices. What happened that led you down the road to talking to some of those media outlets?

Ismael Cordero‎: Sure. So working for ECRI, I have an advantage that I get to see all the alerts we put out, the messages we sent to our clients, telling them about potential hazards with medical devices. I happened to see one on the Philips CPAP recall, and I noticed that one of the models listed of the affected models was one that I was using because I'm a CPAP user myself. Because I had it for like 20 to 30 years now, and the device I had was about 12 years old. So, one of the older units, but it was listed in the list of affected devices and that's how I discovered it.

Paul Anderson: But highlights sort of a problem, is that as these devices are moving out of the healthcare environment and into personal use settings, home settings, are we seeing a similar breakdown now where that recall information isn't getting to the home user, the consumer user?

Ismael Cordero‎: Absolutely. Big manufacturers are used to dealing with big distributors or hospitals, big hospital systems. They're not used to dealing with patients directly. And the number of patients directly that they would have to deal with is 100 times what they deal with.

Paul Anderson: Sure.

Ismael Cordero‎: More care is moving towards the home environment. That's going to become the reality where the manufacturer needs to know who's using their devices and who to inform in case there's a recall or a field note notification of a potential problem. So, that's a move manufacturer are going to have to make in the coming years as to how do they communicate to their individual users about these sort of problems. Because going through hospitals and durable medical equipment providers obviously did not work. A lot of patients did not know, or they found out too late or were afraid to stop using their device because they could stop breathing during the middle of the night.

Paul Anderson: What does that feel like when you're not using your CPAP? If you ever find yourself in that situation, what does that feel like?

Ismael Cordero‎: ECRI did an alert on these CPAP recalls for its members, and as part of that investigation, I brought in my own CPAP machine and was testing it and fiddling with it. And in the process, I managed to break it. So, I went a few weeks without a CPAP machine, and I can tell you it's like the worst sleep I've ever had in 20 years. You wake up multiple times in the middle of the night, you can't breathe, you don't feel well rested. The next day you can fall asleep at a stop sign or a red light. So, for me, it's pretty severe, so.

Paul Anderson: Yeah.

Ismael Cordero‎: And I'm lucky that I... previous ECRI, I worked with maintenance and repair of medical devices, so I was comfortable opening my own CPAP device and removing the foam that was supposed to disintegrate over time and get into your lungs. That was the cost of the recall, the disintegrating foam. So, I just tore mine apart and took the foam out and put it back together and kept using it. But your average patient is not going to be able to do that. The manufacturers aren't going to let every single home CPAP user tear apart their devices and make modifications. That would be-

Paul Anderson: That'd be a bad idea.

Ismael Cordero‎: That would be a bad idea. Yes. Yes.

Paul Anderson: You look at all different kinds of technologies. What did it feel like to all of a sudden be thinking about one that had a much more personal connection for you? This is one I use now, not just a theoretical.

Ismael Cordero‎: It's good. It really puts things into perspective. It makes it real. It's not theoretical, academic, ivory tower kind of stuff.

Paul Anderson: Yeah.

Ismael Cordero‎: It's real to you. It affects you personally. And it actually got me thinking about what future devices I may be on later on in my life at home. Could be a dialysis machine, could be a ventilator. So, that got me thinking into.

Paul Anderson: That's interesting.

Ismael Cordero‎: How am I going to approach if I ever get connected to those devices at home?

Paul Anderson: Interesting.

Ismael Cordero‎: I'm probably going to think about them a lot and do a lot of research and ask a lot of questions and always be looking for certain things. Yeah. And I think every patient should do that, but they're just not used to doing that.

Paul Anderson: To learn more about what the device evaluation team is up to, check out ECRI Lab webcast. Of course, CPAP recalls aren't the only healthcare story in the news, for almost three years now, the dominant healthcare headline has been around COVID-19, and you can't think about COVID- 19 without thinking about vaccines. We sat down with Michael Gaunt, pharmacist with the Institute for Safe Medication Practices to talk about vaccine administration and how providers can make their process safer. Vaccines are widely available to help prevent infectious diseases, but just having them available isn't enough. You have to be administered safely too. ECRI and the ISMP PSO has been reviewing data and developing recommendations to support just that. I'm here with Michael Gaunt, a pharmacist with the Institute for Safe Medication Practices to talk about some of what they've learned. Mike, I think it's probably pretty common knowledge. Vaccines are important, but it can't hurt to reiterate that a little bit. Right. So, can you tell us a little bit about just why vaccines are so important as part of the broader public health program?

Michael Gaunt: Yeah, it's really probably considered one of the most successful kind of healthcare interventions we know. WHO, the World Health Organization has estimated that upwards of 5 million deaths are prevented each year from immunization. So certainly, they provide the opportunity and us the armament to prevent disease, prevent disability from things like polio and COVID and prevent deaths. And so now, we have probably vaccines that address more than 20 different illnesses. And so certainly, over time that continues to grow.

Paul Anderson: It's one thing to have the vaccines, it's another thing to administer them safely. So, what are some things that can go wrong in the vaccine administration process?

Michael Gaunt: Right, sure. So, as you mentioned, we've been looking at this data as part of the PSO and prior to that ISMP is operator reporting program as well for the past decade or so collecting errors. And so, we do see errors happening at different stages, whether it's the prescribing stage, when the doctor's ordering it, whether it's how something's stored in the refrigerator in the physician's office or the pharmacy, and even at the point of administration. So, when that nurse or pharmacist or medical assistant is administering the vaccines, different things can go wrong.

Paul Anderson: And how about scenarios where the wrong vaccine is administered? I show up for a flu vaccine and they give me, I don't know, the COVID shot or something like that. What are some of the consequences of that potentially at least?

Michael Gaunt: Right. I mean, likely for the most part with immunizations, there's not a tremendous risk of serious harm. I mean, there are some cases if you're allergic to one or things like that, and you could have a severe allergic reaction, but in that scenario, you're probably less of a risk from getting the wrong vaccine. You might have some side effects like COVID. Most of us who've gotten the COVID vaccine have had those you kind of annoying effects like feeling fatigued and fever and things like that. So, for the most part, that's most of the risk you would have. On the flip side is if it's not recognized, you're obviously not receiving the vaccine you should be.

Paul Anderson: Right.

Michael Gaunt: And so, then you're less protected potentially for the illness that you're trying to get protected for because you didn't receive the right vaccine.

Paul Anderson: Another important aspect of the sprint is that we've got members, participants talking to each other. How important is that collaboration?

Michael Gaunt: I think it's really important. I mean, I think we try to do this for a number of different topics, but certainly in the vaccines, we're reaching out to hospitals, we're reaching out to physician practices, and I think at times and pharmacies, and I think at times we work kind of in silos, very much separated from each other. And so certainly one practice site and one pharmacy, one hospital experiencing one thing, come up with strategies to fix that one thing, but there's no easy way of really sharing that with other sites. And so, having those safe tables and those collaborations and avenues and venues to get people together to talk and share learnings that they've had in their own practice with others is immeasurable, I think. I know at ISMP, one of the big things we always see with vaccine or prevention, or medication error prevention is right, really taking advantage of trying to learn from others, learn from external sources of information, whether it's ECRI, the PSO, ISMP or other organizations. So yeah, I think that's probably one of the key takeaways and key opportunities with the sprint.

Paul Anderson: Mike, thanks so much for joining us today.

Michael Gaunt: Yeah, no problem. My pleasure. Thank you.

Paul Anderson: To learn more about ECRI and the ISMP PSO, go to ecri.org/ pso. Healthcare faces more risks than just COVID- 19, and many of those concerns are related to technology. For the past 15 years, we've published a list of the top technology related hazards facing healthcare providers. I sat down with Rob Schluth, a project officer with our device evaluation team who oversees the list each year. We discussed why the list is needed, how it's evolved over the years, and how it's been affected by COVID. Healthcare today. Faces many emerging challenges often related to technology, with the rate at which it changes, it's hard for the healthcare industry to keep up. That's why I sat down with Rob Schluth, a project officer with our device evaluation team to discuss our annual top 10 technology hazards list, which calls attention to some of the biggest tech challenges for the coming year. Rob, why do we produce every year a top 10 technology hazards report? Don't people already know what their problems are?

Rob Schluth: Sure. I would say yes and no. Some problems device users are aware of, but they may not be aware that there's a solution to that problem. They may just find workarounds and keep doing things and never take the time or the information never may get to people who can actually do something to fix that problem. So, they may just accept that there's a risk and keep doing that. There are also situations where problems can be under the radar, so things that are escaping, observation or emerging issues. So, with new technologies and practices, there could be hazards that are starting to emerge that escape notice. Most healthcare workers, for example, they're going to be very focused on what they're doing day to day. They're going to be worried about the patient, who's right in front of them. So, they may not be able to step back and see some of these things. So at ECRI, we can kind of take the 30, 000- foot view and maybe observe things that otherwise could be escaping notice. So at ECRI, since we were founded, we would serve as a clearinghouse for medical device problems. So, people in the healthcare community could report an issue to us. We log it into our database. Sometimes we'll investigate the issue to try and determine what the cause could be. So, we're always collecting that information. When we first produce the top 10 hazards list we had in our mind, we keep seeing some of these same things over and over again. There's got to be a way to get the word out to get more people to address these. So, we created the list for that purpose. The whole reason for doing it was to prevent problems before they occur. So, this kind of future looking thing, and that idea really kind of resonated. So, the list started out being somewhat retrospective where we were focusing on the reports to us, and now it's a little more predictive, I would say. So, we look at other sources and we bring in more voices as we're selecting topics, so that we can really try to identify things that are emerging, all with the goal of preventing harm before it happens. So, in the current environment, post COVID and middle of COVID kind of thing, staff they're overworked, they're understaffed, and that certainly affects clinical care, but it also can affect the way technology is used. So, in that sort of environment, I think you have a better chance for device use errors to occur or for there to be oversights. So, when we're producing this list this year, we're really keeping in mind the highly stressed environment in which caregivers are working, and we're trying to focus the solutions to be a little more useful in that environment. So, what I mean by that is if industry can design away a risk, that's going to be much more effective than trying to tell staff, you need to remember to do X, Y, and Z. So, we're really trying to push for those sorts of engineering solutions. So, an engineering control that eliminates a problem is going to be much better than, say a training solution where you're just reminding staff, you need to do this, this and this. They're stretched the limit. That's not going to be an effective way to deal with the issue.

Paul Anderson: You mentioned COVID there. This will be our third report coming out in the... I'll say in the COVID era.

Rob Schluth: Sure.

Paul Anderson: How is that changed? How we either approach the process or how we write about these things?

Rob Schluth: Yeah, the past two lists, we certainly have had COVID focused topics on there, things related to PPE and supply chain shortages. Infecting control with COVID is obviously a big issue. And like I mentioned before, that's something that we've always kind of considered on our list, so we still do that as well. But yeah, so the environment, healthcare environment now has changed because of COVID. If manufacturers and industry can do more to support caregivers, design out some of these risks, we're all going to be better off. And it's also the pandemic has accelerated trends like moving healthcare away from a hospital or into the home setting. So, we look at those sorts of settings as well. What sort of technologies are used there? What sort of problems can crop up?

Paul Anderson: A lot of the audience for this list, I think of as folks who are responsible for, I'll say purchasing or managing or even using the devices in the healthcare environment. But another audience sometimes is the patient. If I'm a patient and we're all patients, how can I think about what's on this list?

Rob Schluth: Yeah. You're exactly right. We're all patients, either ourselves or our loved ones, people we care for. So, we all have a vested interest in making healthcare safer, so reducing the possibilities for harm. So, in our list, we're focusing on the role that healthcare technologies maybe play in leading to patient harm. So, as a patient, I'm going to hope my providers have that same goal of reducing the risk of medical errors, and I'm going to hope they have the tools that their disposal to do it. So, our list is one tool that healthcare providers, organizations, device users can use to hopefully minimize these risks.

Paul Anderson: If you'd like to see this year's top 10 Technology Hazards report, visit our website at ecri. org. Thanks for watching our first episode of ECRI Now. To find future episodes, go to eory.org and look under our about page or go right to ecri.org/ now. Until next time, I've been your host, Paul Anderson.