John AmooreLadies and Gentlemen. What motivates us as clinical engineers? You've just had lunch, you're not going to be allowed to sleep, you've got to think! You've got to be there ready for the questions ready that I'm going to pose. That's my first one, but it's actually quite serious: what motivates us as clinical engineers?

A colleague that I worked with for many years was motivated by his mother dying, and experiencing his mother dying and promising on her deathbed that he would help to look after patients as best he could, although he was, as he put it, merely a technician. The dedication and motivation that he had, right up until his retirement, was wonderful to see.

I suspect among the answers to that question will be the desire to support healthcare, and now we don't talk just about healthcare but wellbeing, through the application of medical devices. In this 20 minutes I just want to look at some of the ways, some of the processes involved in supporting healthcare. We need to ask ourselves this as we go through them: how can we as clinical engineers support this? How can we add value? We heard the word 'value' used this morning. Our programme has a subtitle under it, or a title, 'innovations'. We need to think how we can innovate; how can we do things better? Because we all hear about this 'plan, do, check, act' cycle, which implies a regular review.

Really that's what I want to look at. I want to first start with a few definitions just to clarify some terms. We hear a lot about the word 'governance', and when I look for definitions I see various ones. But I'm looking at it in the sense of those processes, those organisational operational policies that are put in place to ensure effective and safe care.

I do not believe it is sufficient that when we look at governance that we are talking just about safe care. The Institute of Healthcare Improvement, which is a US organisation, and does a lot of work and a lot of focus on safety, brought out a white paper, a document describing their approach. It was entitled, 'A framework for safe, reliable and effective care'. It's not sufficient for us just to concentrate on safety. Obviously we have to, but it needs to be effective as well. To be that, it must be appropriate for the patient; the application must be safe, and the application should add value to the patient's care.

Right, you saw in my introductory slide there was a picture in the middle of a nurse, a patient and lots of equipment. I'm going to have that same picture running right through it. I want, in drawing attention to that, to say although that picture is very much an acute hospital setting in an intensive care environment, what I am saying is applicable to care in the community, to somebody at home on a palliative care device, to somebody at home actually using a thermometer to measure their child's temperature to see if they should go to school. The emphasis there is that we're not just talking about the physical constraints of a hospital; it's healthcare without boundaries.

 

 

governing medical devices

I'm going to present a model, a very simple model, to summarise what we call the A-Z of medical device governance.
Essentially it's got three circles, or three ovals as you see them in this diagram, looking at processes at three levels around the patient case in point of care.

One is immediately surrounding the point of care. One of those processes within the institution – and we heard the term 'medical device committee' this morning, and I'll comment on that again – and then there are national and international processes, standards, regulations, that all go to support this application of the medical device to support care.


This important question that I want you to consider right throughout: how can clinical engineers be involved? Just some examples at this point of care level immediately surrounding it, is the appropriate device available? I think we heard that from somebody this morning. And is it safe and effective? Were staff competent in its use? At the institutional level, within your healthcare organisation, what processes support effective medical device management? Do you have a medical device policy? How do you plan for the purchase of equipment? At national level, how can we support national groups such as the MHRA and the standard body? I'll look through some of these in more detail as we look at those three areas.

 

 


At Care LevelFirst we want to look at surrounding the point of care. It might seem obvious, but I've got things like, is the equipment clean and contaminant-free?

It starts with an A, and this level is an A-H. But it starts with something that I think is very, very important. Is the appropriate device available? Have we got the appropriate devices for that patient? That includes are the appropriate accessories and consumables around? Are they available when needed? The clinicians, the carers; do they have the equipment at hand? Safe and functioning?

Paul talked about the equipment support plans this morning, and that's something that we're all much more familiar with: the routine tests. Are there competent staff? That is increasingly recognised; it has been for some time. Clean and contaminant-free? Have we got links with our infection control people? Is the equipment properly mounted and installed, and is it commissioned for use?

 

 

Just looking at the A and the H – and I'm going to look at some of them in the next slide – I can't stress again, I think, enough, the importance of having the appropriate equipment in the patient care. Nor can we stress enough the importance of commissioning the equipment correctly. That includes things like configuration of the equipment, getting the staff trained, and those aspects, so we don't just put the equipment into use.

 

How can we add value?

Just looking at some details, at some examples at this care level, and looking at asking ourselves the question: how can we, as clinical engineers, be involved? How can we innovate? How can we add value? We all say staff need to be competent and fully trained to use it, but how can we, as clinical engineers; how can we support formally and informally clinician training in the use of the medical devices?
We might feel that we're not in charge of the department, that it's not up to us, but I think it is up to every single person in departments to actually do what they can. You're sitting on the bench, and you find that the same kind of faults coming back from a particular area; that should suggest training needs. It's being open and perceptive to what's going on, not working with blinkers on our eyes, narrowly focused, but thinking of the wider picture. Yes, there's a time for narrowly focusing, but we need to think broadly.

 

Cleaning medical devices.

I have a terrible memory. I was called out one weekend, and fortunately my son was at home, and I was called out by a coronary care unit. It was the old days when monitors weren't light, and it was mounted up and it was a big hefty CRT monitor. I said to my son, "Can you come and help me pull it down?" I knew I had a spare one, so I could put that in. It was an open coronary care unit; somebody in the bed next to it. My son, who was like most teenage lads at the time; not necessarily observant about things, cleanliness; he said, "Dad, there's a lot of dirt around." "Shh, shh!" There was no one responsible for cleaning. We clinical engineers felt this was not something we should be doing; the nursing staff felt this wasn't something they should be doing, and you know, one needs to have that dialogue with housekeeping staff; who is responsible for keeping medical devices clean?
What links do we have in EBME departments, clinical engineer departments, with our infection control colleagues? One of the things that I will emphasise as I come to the end of this talk is we are not talking about the solution to these questions, but doing it all ourselves. It's a combined team effort. Keeping the equipment clean is certainly a team effort, bringing in infection control, talking to ward managers, talking to hospital hotel services, whatever they're called in your organisation.


Commissioning medical devices I've mentioned already, but as configuration and equipment is so important, and alarm configurations are particularly important. It has been a thing on the ECRI top ten list for several years; alarm fatigue, and sometimes we get it right, sometimes we don't. I can remember going into a theatre one morning, for I forget what reason, and the theatre's sister was switching all the patient monitors, and configuring the alarms and the colours of all the displays. I said to her, "Jenny, why are you doing this?" "Well," she said, "I have to." I said, "But we can pre-configure that." What we didn't do is have that dialogue beforehand, before it was installed, and discuss what their optimal one does."
There's a lot we can do. I make no apologies for looking at practices in the past where I could have improved, because I think we all need to look and see how we can improve, recognising that, yes, we do a lot of things well, but there are certain things that we can do better.

Institution level 

Right, at the institution, we've got away from the immediate patient environment, the hospital as an institution has an important role in ensuring medical device governance. I think right at the start of it is the institution must have a strategic plan, a medical device policy. I know that some of your institutions do have medical device policies, and actually you can get a lot of them from the web, and there are some very nice ones out there. But that sets a vision; that sets a strategic framework in which medical devices can be governed.

The working through of that is very useful to have some collective group of people multi-disciplinary, which is often terms a medical device committee. I think that was a term I first came across from an MHRA or an MDA document several years ago, when it was the MDA rather than the MHRA. But it's a multidisciplinary group who are concerned with the application of medical devices. We need strategic device planning, careful selection, the device support plans, operational guidelines. I'll talk about cyberattack and data confidentiality in the next slide. We need a review process. We need to be involved in those people looking at adverse events. We may be called upon to be centrally involved, or there may be a risk management department. But we need to know how we can help support that, and obviously the management of safety warnings.

One hospital that I worked at thought it was totally unnecessary to have a medical device policy. "John, we're so small, we don't need it. We know everybody." I think that was wrong. I think we need one, because we mustn't rely on just individuals. The individual's in place, excellent, but eventually like me they will get older and they will retire, so it's important to have one. It's a strategic framework. It gets a link through to the chief executive, who after all has an important legal responsibility for medical equipment, and it gives that chief executive, him or her, a framework with which to work, in which to ensure that the governance is being taken care of.
I think it's something very important, and I think all of us practicing clinical engineers need to understand the approach that we've got in our institution. Remember this is not an academic exercise just to listen to this afternoon, but I really want you to think, how can you innovate and improve the governance of the medical devices; add value to it?
Selection of medical devices for purchase; one can talk on and on and on about that. Is it done in a true multidisciplinary way? How were the specifications written? What are the selection criteria? I can think of examples in my career where I've got it wonderfully right. I can think of one example where fortunately I got it right, but it shamed me that in intensive care monitors I hadn't even spoken to the charge nurse. The selection was done at an anaesthetist level and we didn't speak to the nursing staff. She berated me very friendlily afterwards, and we had very happy relations, but that was a lesson early in my career. I thought, "No, it's got to be properly multi-disciplinary."


Cyber protection

I want to do a little bit on cyber protection. Fortunately, it is still very much a theoretical threat. I do not know of any real threats, and some of you may know real cyberattacks on medical equipment. I've heard that people have done it in a scenario setting and shown that they can get in, and if it's network medical devices they can get in and hack into an infusion device in such-and-such a bed, and change the rate. It is real. It is very, very real, and following on Justin's talk, there's an ISO standard on it. There's a lot of good work being done on it.
One of the difficulties we face in the profession is a silo approach to things; that we don't communicate properly with our IT colleagues. We really need to recognise their responsibilities, their strengths, help them to understand our responsibilities and our strengths, and work together to ensure that the medical devices that are networked are properly protected.

 

National Level

National levelAt national level, which is the third of these three levels, I've started again with the identification of the need right up at the top, manufacturers, when they're developing new equipment, need to consider carefully what is needed. I worked for a year in industry, and there was a red herring put into the company to put some device in that was never really going to be needed. I think it was one reason why the company collapsed.
We've heard about the standards, good manufacturing practice. Human factor design, regulatory devices like the HMRA, post-market surveillance and professional organisations.


You might say to me, "John, why are you mentioning this national, international level? It's got nothing to do with me working in the workshop." It has everything, everything to do with you. When you're working as a clinical engineer, you can influence the salespeople, people from companies, about the human factors design of the equipment. When you talk to them you can give them feedback.


The MHRA wants people to work with them. In England you've got the medical device liaison officers; get involved. There are wonderful opportunities. In post-market surveillance, which is very important, reporting problems back to suppliers, and to the MHRA. At this national level, outside the hospital institution, there are roles for each one of us.


In conclusion, I want to say there are a lot of processes, and we've grouped them into 26 A-Z processes, that combined together can ensure effective and safe application. We as clinical engineers have roles in all the processes. But it's not just clinical engineers. Teamwork is essential.


Any questions?
(Applause)

 

John Amoore's presentation from the 2017 EBME Seminar may be downloaded here:
http://www.ebme.co.uk/downloads/summary/18-2017-seminar/198-medical-device-governance-for-effective-and-safe-care

 

 

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