Hi everyone. First of all thank you for the opportunity for letting myself and ECRI address you all. This title of the talk we’re giving, I’m using software in a very broad definition. So here we’re talking about software systems, but also online resources, online tools, self-assessment tools and so on. And the idea here is that we actually provide you a lot of these resources free of charge. So this isn’t a sales pitch, but nevertheless I have to give you a quick introduction to ECRI, as not everyone knows ECRI.
So we’re about 50 years old as an organisation. We started off in the US. But we’ve had a European office for 20 years now. We’re not for profit, which doesn’t mean we’re not for money, but we don’t have shareholders or anything like that. And to deconstruct this sentence, independent means we don’t take commissioned work from medical device manufacturers, so our advice and our reports that we can share with you are unbiased and evidence-based. We provide our services, our information to around 5,000 healthcare organisations. So there’s 5,000 customers. They’re generally hospitals. It also includes ministries of health and interesting organisations like department of defence and insurance companies and so on. And, as I’ve said before, I’ll be providing some free of charge, evidence-based, unbiased reports for you at the end of this.
So the four types of software and online resource and materials we’re going to look at: the first one, CMMS or asset management or inventory management systems; the second is to do with IPM procedures. So they’re standardised IPM procedures. They’ve been benchmarked. There are guidance articles around delivering IPM, so it’s inspection, preventative maintenance. The third category we’re going to look at are medical device alerts and recalls. But as well as medical devices, that includes consumables and blood products and so on, but also the recalls management, so how do you actually manage that information you get, and then the fourth category medical device evaluations. And I’ll give some examples of each.
So starting with your inventory management or your CMMS, obviously knowing which assets you have and how they’re maintained is essential. And it reduces time and cost. So there’s a holistic argument here that if you can maintain your assets in a more efficient way, you can improve safety. You can optimise things like replacement strategies. So you have a direct and indirect benefit here. So the direct benefit is just helping you have a thorough preventative maintenance programme. The indirect benefit is how these efficiencies can then be realised and those extra resources redirected into improving patient safety.
So how can your CMMS system improve safety? So obviously we’ve just mentioned about saving time and resources. But also if there’s a recall you may need to quickly identify for example a medical device that needs removing from your fleet. It also promotes better evidence-based maintenance scheduling. So this is a rather thorny issue and one of the free resources will be a question about stop over-inspecting equipment for example. So we’ll look into that in more detail. But are you just going by manufacturers’ recommendations when you’re scheduling the frequency of your medical device maintenance or inspection, or what evidence are you actually using, so how comfortable you are adjusting those frequencies or the scheduling. So the very first step we’d say is at least build up a very robust evidence base before taking the next step, and this is maybe a way to do that. And there’s also options for internet of things and RFID integration.
There’s a lot of experts here on RFID, which I’m not, but there’s additional benefits you get if you can integrate RFID into your CMMS to make patients safer. So, for example, you can also, again the holistic argument save cost through RFID. So if you can build up a culture of trust between departments, and people are more likely to share medical devices between departments, and Addenbrooke’s was a great example of that from several years back, where you can trust that the medical devices can be found quickly, are maintained properly, you can then lower your total amount of inventory and make good savings there.
Also, if you want to review what you do, and you want to test what you do and improve what you do, you really need a good quality data that you can get from CMMS. And if you want to drive replacement planning, so, you know, well how do you know what do you have, what did it cost, how old it is, how reliable it’s been, all those sort of factors, it’s good to go to CMMS to do that. And of course rationalisation programmes. So by that what I mean is, it’s a good way to drive efficiency savings, where if you have a lot of medical devices that are functionally equivalent that come from many different manufacturers and you may want to reduce that number. So yeah you save on spare parts, on training, you can then procure larger volumes from fewer manufacturers so you get a better price levels and so on. If you want to do a rationalisation programme, CMMS is a good place to start as well.
So we all know the traditional features. You know, you have your inventory information, you have your work orders, your service contracts, your spare parts, purchasing of stock control on these systems. But let’s discuss a bit about the more recent developments. So our latest CMMS, and there’s other ones out there, you can now utilise portable devices and they’re cloud based. So this may make your job easier in a hospital to be able to use a phone or a tablet, but also ECRI is involved globally. So in a lot of emerging markets, in rural communities and so on, there’s a lot of areas in the world where there aren’t very good IT systems, very good computer systems, but a lot of people do have mobile phones. So if you can actually update and do the work that feeds the CMMS system and use the CMMS system with a mobile phone, even if you have to sync the data later on, that’s a big step up.
Tracking, so we may think of tracking medical devices through a hospital, but to have tracking features in your CMMS is a huge advantage also because of this big shift we’re now going to see in healthcare, so more and more people are going to be treated away from hospitals. There’s going to be big shift in fewer inpatients and so on. So you’ve now got a lot of medical devices out there that are being used in a different environment. So how do you know that you’re maintaining them or inspecting them frequently enough and how do you know where they are? And maybe also want to log somewhere about training. You know, are the users, if you like the patients, trained properly, are the nursing staff out in the field trained properly, so it’s something to consider for the future and to follow that trend.
When I talk about image rich, it’s simply using pictures and images and integrating them into CMMS can also improve safety and effectiveness. So if you have someone who’s not familiar with the device they’re trying to locate and there’s a picture of it, that has a very obvious benefit and it can speed up locating those devices. And also using images and CMMS to help with, say, maintenance and the activities you do with your medical devices. But also there’s a trend going towards augmented reality. So we’ve probably seen virtual reality in things like medical equipment planning where you can walk through your virtual hospital even before it’s built. Augmented reality, you could have software there where you’re there to say do a repair on a medical device and the software recognises the medical device and then will prompt you with what to do next. So it might prompt you with images that are overlaid on what you’re looking at. For example with a screwdriver or a measuring metre it might give you the information. And it might give you step-by-step guidance on what to do next and which tools to use and so on.
So this sounds good on one level, and it means maybe less skilled people can do more work and there’s less training required, but I’d also really think seriously about the risks of these technologies because you have less skilled people doing more of this work. So that’s something to be aware of as well, as far as what can be built in. Also, you want to build in more complementary information into your CMMS and your asset management. So IPM benchmarking, again if you want to benchmark and see well how frequently do we maintain devices? What does it cost us to do it? How long did that process take? Are you just comparing it with your historical data or are you comparing it with other people and maybe hundreds of other hospitals? So these sort of tools that you can build in at that level and then also record what you’re doing yourself are very useful.
We’re going to go on to cybersecurity, not because this a talk about cybersecurity, but cybersecurity is a growing issue, and as a part of the talk on safety and using software, we’ll touch on this and we’ll also provide some tools for you. So obviously there’s a priority to have a complete inventory list, and as ECRI we make certain recommendations to you. So for any kind of existing fleet or your legacy device assessments and so on, there’s a prerequisite there. But we’d also recommend that you fill in the gaps during your preventative maintenance, and you must include certain IT elements. And I’m going to go through a list of which data points we’d recommend that you include, not just software revisions. And I think we also need to recognise that to deal, yeah to improve patient safety by being very cyber secure, it’s a huge sort of cost and resources required. And we should be open about that and demand from our healthcare organisations that that resource is provided.
So, these are our recommended inventory points, and it would be interesting to see how what you measure on your systems compares. And if we just take one example of the WannaCry ransomware issue we had a couple of years ago, when we reviewed back as to what went wrong, you know, the Window XP updates and patches and so on, we saw there was a lot of difficulties in communicating, identifying and locating systems that needed updating. So by recording this sort of data on your CMMS it should help.
Here’s another free resource. So we have a thing called the top 10 health technology hazards. And it’s an expert group and it’s outside help, it’s not just ECRI people, and we develop a list of what top 10 areas of health technology should you focus on to really improve and make a big impact on health, on impacting patient safety. So each year I just want to make a note here that cybersecurity in recent years has been a major top 10 hazard for healthcare technology. And I’m pointing this out because these tools are free of charge. And it’s not just a list of the top 10 hazards like reprocessing endoscopes and the other hazards that we often find in this top 10 list, it’s also a bit of a toolkit and guidance on what to do to minimise the impact of these risks and to improve patient safety.
So these are available to you at any time, you can see me, and even if you wanted a previous year’s version you can. You see back in 2015 it was already an issue. In 2016, we’re talking about misuse of USB ports and how it can cause medical devices to malfunction. Software management puts patients and patient data at risk. There was a huge cyberattack in Asia recently. They took, it was tens of thousands of patient records, including the Prime Minister’s. Ransomware was our number one hazard last year and again this year. So there’s a lot of work to do there. And lots of things we can do to help minimise that risk.
So if we go to number two now, medical device IPM procedures, benchmarking guidance, this sort of information’s available, and I’d ask you, you know, when did you last compare your IPM procedures? And who did you compare with? Was it just your own historical data, did you benchmark with other people? And do they include cybersecurity processes in there? And do you also benchmark all the relevant parts to make a department more efficient, so the time taken, the frequency and the cost.
Have you considered guidance and spending more time on impacting higher risks and have you considered risk levels and developing a strategy? So the difficulty of developing a risk level strategy and risk level categories and so on, obviously the environment and medical devices used as important as the type of device, and you’re weighing impact against likelihood. So if a device fails what’s the impact of that? But also what’s the likelihood? And how do you weight those two criteria and actually come up with a meaningful classification for risk. So one of the materials I’m going to offer you is a walkthrough of how to develop a risk management strategy in that sense.
The third category medical devices and recall management. So ECRI’s the world’s largest disseminator of alerts and hazards. So we take notices and alerts and comments from our 5,000 hospitals around the world, from medical device manufacturers, but also from a lot of the national systems. So the MHRA’s in there, but also the FDA from the US, the Canadian system, the Saudi FDA, the English-speaking German alerts which are BfArM. So we take all of these and we distribute them and we add comments and guidance and so on. So a lot of these are available out there, but there’s also a question you need to ask is too much noise an issue? So would it actually help you to have more alerts that are timely from different systems or do you want to stick to the UK alerts only? And I don’t know the answer to that. It might be an interesting project to review that, but there is more information out there.
And then we get onto the point of well how do you manage those alerts? Do you have a system in place? And there’s several out there where you know who’s received the alerts and you have a dashboard. And you say well who in the hospital’s received an alert? Did it go to the right person? If a person’s away on maternity leave or has left the organisation or is off ill, has it been directed to another person? What the response was. Has it sat in someone’s inbox? Has it been replied to saying it’s not relevant to us? Has it been replied to saying yes we’ve removed, you know, there was a recall and we’ve removed that device from our systems? So it’s very good to have a system where you can actually manage those. And the big enemy is noise. You know, it’s very difficult for someone where they keep having to review these alerts and notices, and a lot of them don’t apply to your own inventory, and there are systems and methods to help filter down the amount.
Moving on to the fourth type of resource and software and so on that’s out there: in-depth evaluations and technologies, safety guidance. So when you’re, well first of all, I often ask groups of biomedical engineers in the last five years how has your work shifted? Has it shifted towards more procurement activity or are you less involved in procurement and medical technology decision making? And almost without fail, people are the same or more involved in procurement decisions than they were five years ago. And I think that’s probably a good thing to be more involved in that. And obviously a big factor of safety is to buy safe devices or safer devices in the first place if you have a choice there. So it’s not just the management of medical technologies, it’s also deciding to buy the safer technologies. So again how do you assess that? There may be a tender process, you may have discussions and meetings, but there’s also value in looking at expert evaluations of those devices. And I’d say the biggest experts of the lot are your peers who actually may already own those devices and have their own experiences. And that’s the real world. That’s not manufacturers claim, it’s the real experiences of people.
So this is an example that I took quite randomly of what the American’s call operating room, but obviously it’s a theatre table, and it’s an evaluation. And it’s just a random example of a big evaluation. I’ve just taken the safety section out. And in there there’s descriptions of features of this table, there’s a description of audible alarms and so on, but there’s also a discussion there on the base design. And the base design is flat rather than angled, that might encourage people to put medical equipment on, and then when the table’s lowered it may get damaged. Now things like that might seem quite difficult to always capture before you make a procurement decision. So it’s probably good to actually look at a lot of the safety evaluations and consider that as part of your procurement routine. And we also offer, it’s a bit like TripAdvisor, but the rate this model type of system as well. And this is the user experience system. So, as I mentioned earlier, if you can get user experience from your peers from other hospitals as to the experience of that they’ve had owning that model, that can also be very valuable before you make a decision.
So finally I’ll come on to, now, what the actual free tools are. These are available electronically and I’ll offer this for a month. And as long as you have a hospital email address you’re very welcome to these. What I’ll do is I’ll email you this list. So all the text in black are the four different categories of resource and software that we’ve discussed today and in blue are the titles of the reports that you’re welcome to have. So in there for example we have a description of the value and the advantages of benchmarking. We also have a report there and a description on how to optimise your IPM programme. And you can see there’s quite a few tools, which I hope, you can maybe either reassure yourselves that you’re doing everything perfectly, or there might be some ideas to help improve patient safety with. On medical device evaluations, what I’m offering here is if there’s a medical device type that you’re looking at procuring or you’re having issues with, come and let me know what that is, and I’ll find some materials and send those to you free of charge as well to help support that process.
I’d also like to add some other free resources. So I’ve mentioned the top 10 health technology hazards. It’s available to you every year not just an offer now so please do always request those. They’re very useful. And we also have an alert that we raised, and it was about promoting good communication between biomedical engineers and IT departments. So it’s the usual debate, and I think it was touched on earlier as well, where who takes responsibility for connected medical devices, you know, is it the IT department or is it the biomedical engineers? And we’re talking about collaboration, communication and how to recognise those issues.
Cybersecurity, risk assessment for medical devices, so this is talking, we’re talking about weighting, likelihood and impact of a failure. This is actually talking through the process of a risk assessment and how to do it. So you’re very welcome to have that example and compare it to what you do. And also the article on stopover and inspecting equipment, the contentious one where we would suggest for example if you do a visual inspection on the cable and a plug, you know, how likely is it if it looks in good condition that electrical testing will then show a fault. I know people who have spent most of their careers and have hardly ever come across that. So spending a time on higher risk, you know, reducing higher risk possibilities as maybe better for patient safety.
So see me to receive these resources, I’ll send you the list to start with and you can pick whichever free resources you’d like. We’re at stand A30. And thank you very much for the opportunity.
Philip Hodsman's presentation at the EBME Expo: Using Software to Improve the Effectiveness of Patient Safety & Maintenance Programmes.