Mike Giles presentation at the EBME Expo -- Medical Device Management & Procurement InnovationsJust by way of introduction and to give some context to my talk this morning, I first met John back at the end of 2014/15 when we were reviewing how we were going to go forward with biomedical device management, not only around maintenance but actually around procurement as well. And so my presentation this morning is in that context. We began the journey back in 2014 and I’m going to bring you forward to where we are now. I appreciate that some of you, you may be where we were back in 2014 and some of you may be well ahead of where we are now and perhaps some are in the middle, but hopefully for all of you there will be something you can take out of what we’ve embraced at the RNOH.

So, very briefly, I’m responsible to our executive directorate for the oversight of outsourced services, and that includes clinical engineering, pathology and a number of other clinical supplementary services, like vascular surgery and cardiology. I oversee the capital and revenue budgets for medical device replacement, and I also oversee the revenue budget for ongoing maintenance and planned periodic maintenance periods. So we are the largest hospital in the UK. That’s the Royal National Orthopaedic Hospital. We are the largest orthopaedic hospital in the UK. We are regarded as a leader in the field of orthopaedics, and we train approximately 20% of the UK’s orthopaedic surgeons. So it is our thing for want of a better term.

So I’m aware in some of these sessions objectives can drift a bit so what I’m going to hopefully give you something to focus on, target on and work with me through. So one of the first objectives here is to share the core evaluation principles and governance structures we’ve found effective in managing medical devices, with particular emphasis on our annual replacement programme. I’ve spoken to a number of trusts over the last three or four years and I’m aware that probably only about 25% to 50% have actually got a replacement programme running, most of the work is reactive in terms of replacement. And also just to share our experience of how using, basically a simple mathematical model to give us a first cut of the risks that are on our asset register combined with intelligent discussions with the clinical leads actually can give us a lot of confidence at a clinician management and executive level.

So, as I already explained, I’ve been asked to come here really to cover the journey that John’s actually seen us go through here. So, back in the end of 2014/15, we had limited clinical engineering personnel. We had one excellent engineer, actually sitting here this morning, with various levels of ad hoc agency support, so it could be two, one or it could just be him again. It would not be inaccurate to say that he’s not only regarded as the engineer at our trust but with affection. There was a lack of confidence in medical device database accuracy, so we audited, we actually asked for an auditor to come in; unfortunately we didn’t scope it very well or it wasn’t scoped very well, so we got every single component of every single device audited. So we had serial numbers, say an x-ray room that you may have, end up we have 20 different parts for what basically is a 1.5T. So the audit actually proved to be pretty useless for us and we spent £30,000 doing it.

We had a disparate, non-centralised procurement and maintenance management. So for instance our manager of imaging would be responsible for organising his own maintenance contracts, calling out for any faults he had. When it came to procurement, he’d have to sit at the table with everybody else to argue about why his new scanner or his new ultrasound device was more important than another area. And our planned periodic maintenance levels at that point were 55% of known devices, and I’ll speak a little bit more about known devices in a minute. At that point the CQC were expecting about 80% of devices to be within their planned periodic maintenance period. We also had a CQC inspection at the end of 2014 and it came back very poorly around this area.

There was a lack of actual confident risk-based medical device management planning, it was reactive, like a lot of you guys, or I’m guessing at least half of you guys have got here. There was no robust medical device procurement approval process. That’s year-on-year something’s broken, improve a service or add additional devices. There was no contingency funding. If we had catastrophic or uneconomical repair incidents there was a lack of robust assurance for a medical device whole life management for the finance department and corporate. So they tended to drill down into every request almost to get confidence as to whether we actually did need this or not and whether it was the right piece of kit; obviously not really the right people to be asking us questions. Lack of clinical and corporate confidence in training compliance, as few records were kept and many of those were out of date, and it wouldn’t be inaccurate to say probably at that point we probably could identify 2% of all of our clinical staff having training records that were in date at that point. And there was limited and unstructured device sharing between clinical areas. So, most of you will be familiar with infusion pumps being hidden under beds, locked in cupboards or even taken home maybe.

The good news is that this was recognised as not a sustainable position for us to be in, so we brought in a consultant, a clinical engineering procurement consultant, to review and provide suitable options to increase confidence at the trust. Around the same time I was also brought in as a consultant to create a risk assessment model to actually prioritise all the equipment in the trust. There’s a fairly simple mathematical model using age of equipment, number of failures and the risk to the patient. The options paper resulted in recommending we should outsource clinical engineering, and we went for actually, noting the previous speaker, we went for effectively MES minus, the confidence that our trust then in outsourcing was nervous I think would be fair to say, and the MES, one step too far, they didn’t like the idea of a third-party owning the equipment, but they did like everything else that MES offered. So we went with basically handing over all the maintenance responsibility to TBS as they were, but left the actual retainership of the equipment to ourselves. In 2015 TBS GB or Althea as they are now, UK and Ireland, were awarded the contract and began operations.

So the first thing, perhaps unsurprising, that they did was they did a survey across the whole trust about an audit of all our assets. And interestingly enough they were unable to find 600 devices that were on our database but found 600 that weren’t. Which was quite a surprise to us at the time and a bit unnerving as well as you can imagine. We were advised then that we should expect to find 80% of the 600 that they hadn’t found over the two years. And actually that’s borne out to be about correct actually. TBS actually had their own model for assessing risk. Theirs was probably a broader model then than what we had, which is the one I developed was very local, so we integrated both models together, which gives an overall confidence to TBS and to my trust.

Our medical equipment group, obviously you’ll have different names for your groups at your trusts, but we divided it into two. We felt that at exec level you didn’t really want to be talking about how many infusion pumps were available at any one period of time, that’s more of an operational function, and the operational staff didn’t really want to be talking about budgets being across the whole trust, which wasn’t relevant to them. We were challenged a little bit about the beginning, but it has really worked very well so we can have those executive conversations we need to have and the operation have got theirs. In fact, as you’ll see in a minute, we actually developed another med group actually. We also reviewed the management and training policies, which had been written very well, but they were written I think in 2010, so they were well out of date. And I think, I recognised, because I actually commissioned TBS’s services at the RNOH, we recognised very quickly that what was badly missing and probably is in a lot of trusts is that there was no credible infrastructure where people felt safe, that if they needed this what the process was. So there was a big piece of work to do in terms of incorporating an infrastructure.

So, some people say I’ve gone a bit acronym mad at my trust but anyway I’m going to press on here. So, I’ve spoken about an executive, a med exec. So I’ll quickly run through this, I don’t think we need to perhaps labour it too long. As you’d expect we’ve got a chief operating officer in there, the director of finance, director of nursing, director of imaging, head of clinical governance, head of procurement, a med ops, the imaging manager and aesthetic consultants, head of theatres. And then more latterly we’ve introduced med train. With the appalling training statistics I shared with you a minute ago, about 2% back then, we found that the number of conversations with clinical educators needed to happen was just bleeding so much into our ops meetings that it was actually overriding everything there.

So we separated it out. I was a bit concerned in the beginning that it may not have sufficient engagement, but actually it’s found to do very well. The clinical educators love it because it’s a legitimate place for them to be involved with the medical devices and the training programmes we’re running out. And just as a quick point now, actually we’ve been working on training now for the last two or three years, specifically, and we went from that 2%, we’re up around 75% now across the whole trust of all clinical staff being trained, which I think for a lot of trusts that would be worthy to have. So we spoke about the model that TBS and I have developed. As part of that, we wanted to introduce a replacement process. And with the various versions of the model, if we took the approach that the manufacturers’ lifespan, normally seven years for most equipment as you appreciate, the actual ongoing rolling budget was just going to bury all the capital and revenue in the trust pretty much every year. We realised it just wasn’t sustainable and not sensible.

So I did quite a bit of work with TBS’s analysts and we looked at financially where we could maintain that line, a good line, but at the same time give clinical confidence internally that equipment was safe and reliable. So we worked on this for a while, TBS analysts, I don’t think she’s with them anymore but she was very patient with me as we went on, and we came to a point where we looked at the number of errors we were having and the funding costs, and we, as you can probably see from the slide, we chose to take the OEM period plus four years as a standard line. We had quite a lot of discussions in the trust as you’ll probably appreciate around that and eventually our director of finance then just said actually we have to start somewhere, because obviously you can go on and on and on with these things.

So, simply, if a piece of kit is designed to last seven years, we say it’s 11 years, that’s it’s actual lifespan with us, and as most of you probably do is we’re sweating for four years, as is known in that way. This gives us a risk priority list as it suggests. And then that informs our ideal medical device replacement programme budget requirements. I say ideal because there’s always a ‘but’ isn’t there when it comes to funding. Just before I move on to the next slide and I’ve probably made the point one way or another this morning but the audit is critical in confidence to underpin this, because if you don’t know how many devices you’ve got, even with what we didn’t know, we knew what we didn’t know, if that makes sense.

So, this is the last time I’m going to say medical device replacement programme, from now on it’s going to be MDRP. We haven’t got that much time and I know you’ve got coffee coming up shortly. So our budget requirements at any given year are ratified by head of clinical engineering and myself, and then presented to our capital planning group. They will then look at our requirements in the context of the trust broad capital requirements and then give us an actual budget figure, which invariably isn’t the ideal. So we draw a line on both the revenue capital budgets and we know what’s underneath that line. We then go back to all the clinical areas under that line represents to get confidence that the devices that we’re not replacing that year are safe and will last another year, which we then take back to both med ops and med exec to report back to them that even though we’re not going to replace them, that it’s safe. We record those devices, not individually but as capital or revenue somewhere on our risk register to remind us as it were.

As I’ve said, we had the risk assessment model, it is, I’m going to use the term simple, it’s not an intelligent, obviously it doesn’t know exactly what we need, it’s just telling us what we’ve got and where it is in its lifespan and the number of errors we’ve had. So the thing that has worked very well for us is our clinical engineering manager will then discuss what’s on that list and above the budget line with all the clinical leads or heads of department to actually look for how many devices do we actually need, upgrade opportunities and requirement for clinical trials. Because we’ve got a process, people are not clinging onto devices, if they need three but they had five, we’re far more likely to get actually we only need three, that’s fine, that’s what we need. It works really well. It’s brought a lot of confidence in the trust. I don’t think anybody where we are would be concerned about what’s happening on medical devices. And part of that is device standardisation, and we maintain that as much as we can throughout all replacement programmes.

So part of my speech this morning is around procurement routes. I’m not quite sure this is procurement routes but this is what I’m going to focus on now. So we’ve looked at how we managed the budgets around medical devices and divided into four areas. So we’ve got our MDRP. You remember replacement programme from a minute ago. It’s planned. It’s got a budget or two budgets, one for capital and one for revenue, and then we’ve got emergency, which is unplanned procurement devices or uneconomical to repair or have catastrophic failures. And all we’ve simply done with this is rather than try and squeeze more money out of the budget for something we’re not sure we’re going to spend, we divided both budgets very simply into four quarters. And we don’t spend anything from what I’m going to say is the fourth quarter, until we get to the fourth quarter. So we retain that. And it’s available throughout the first three quarters of the year. It worked very well for us. I think in our first year we had a mini c arm fail on us, which I think was around £55,000. Ordinarily it would have been people running around panicking, having to stop other things, we just took it out of Q4. And then a few more things dropped below the line. But we used the same principle as I’ve already explained. We check the commissions, is it safe to drop those things out? If it is, then great, because we have a greater need.

We also have planned service improvements. So these are the things that you’d go through business planning every year, which could be an increase in the number of devices or the introduction of new devices for new services. And that’s, as you’ll appreciate, for all of you, you’ll have an agreed budget coming from that, or not as the case may be, and then we’ve got service improvements unplanned, which is mid-year requests that we all see for devices, for additional devices or for new services. We’ve been quite strict with this now because we’ve found that people were buying stuff around us all over the place, and this was not working for the level of governance and conformance we wanted. So basically if it’s under £250, as long as it’s one of our standard devices, they can buy it on the revenue budgets locally. So the ward needs a new set of scales or something, they haven’t got to go through a big process, but above £250 they go through business planning. Not a big business planning process for the lower cost items, but still they go through business planning.

I hesitated to put this one up and the one you’re going to see straight after this, but I am going to just speak briefly to this. I think sometimes we find policies and governance can be a hindrance to progressing what we want to do. But what it’s done for us, it’s provided a more consistent and unified approach, and has encouraged sheer professional ownership of the broader trust-wide risk and responsibilities. So we don’t get the bun fights at the table with finance. People can see what we need across the whole trust and they’re far more happy to work collaboratively for the needs of the whole trust, not just their individual area. It provides confidence at exec level, that there are clear and robust processes in place for managing the whole lifecycle of medical devices, and it holds all parties accountable to agreed bases of procurement and training. And ultimately it provides clear assurance for executives and the CQC that we have relevant and robust governance around device management. In fact we had a CQC inspection at the end of last year and our clinical engineering, actually our device management full stop came back completely transformed from where we were back at the end of 2014.

Again, hesitated to put this here, but I have repeatedly found this a very useful reminder to me. I’m guessing most of you will be running risk registers where you are. It is critical to recognise risks, as we all know, and ensure they’re recorded and understood and mitigated and tracked. Every time I come to our risk register on a monthly basis I am always amazed at how much elapsed time has passed since the risk is originally established. Horrified actually and I think I’m actually quite keen on governance and quite diligent, and I’m still shocked to see I’ve got risks that have been there for nine months, maybe longer. It is an actual honest reminder of risk progress. It helps keep us honest and focused. And it clearly defines who owns the risk and who is overseeing the risk, because otherwise these things as you all know can drift around I thought Shirley was doing, I thought Tom was doing that.

So the benefits, if they’re not already obvious, I hope they are but if they’re not here they are, is the increase in clinical morale. Genuinely this is a real thing for us. People are not having to beg or lobby for replacement devices; the MDRP is seen as a very fair and credible way of doing our replacement. It provides improved patient confidence. I work very closely with the head of clinical engineering. I’m definitely not a stand-off hands-off contract manager. Anybody who knows me well enough will know that. And we work to make sure the patients feel assured when they come to us. If they have newer devices, haven’t got things peeling off them or labels peeling off them, we want to give that assurance. And that can often be done cheaply actually. And there’s a significant increase in finance’s confidence and assessment robustness, and greater confidence and assurance at director level of sustained and managed replacement governance for planned and unplanned procurements.

Standardisation is a real and achievable aspiration, to a high level, first of all bulk-purchasing of equipment and consumables, obvious gains there, and perhaps the more subtle gain, by doing standardisation, we are only having to train our clinicians, and particularly nurses actually because they are obviously in such shortage at the moment, on one device per modality, rather than having maybe five different infusion pump manufacturers, where the nurses then have to be released ideally to be trained on five, they’ve been released to train on one, and that’s been a huge benefit as we’ve rolled out our training.

It also provides greater assurance to our charity of real issues. And most of you I’m sure will be connected with charities, and sometimes trying to explain to them the real needs and win them over can be quite hard. As a result of this process that we’ve set up, we got nearly complete funding in the first year for our equipment library, which we didn’t have before, which has stopped of course hiding most of the infusion pumps under beds or in cupboards. And ultimately we are far better assured of optimal patient care and safety.

So, in summary, this has been a significant journey for us as I hope you can see or hear this morning, and it’s acknowledged as a significant improvement and a success for the trust providing confidence at all levels. And actually other trusts have taken an interest in our journey. I’ve been asked to present this similar presentation to two large other London trusts, and there’s more interest as well in that. We continue to refine our process to better suit clinical requirements and improve our intelligence for the algorithm. And improvements, and I hope you’ll bear with me with this because we’ve just heard Althea speak actually but the improvements have been attributable to TBS GB’s experience, empathy, engagement and shared vision with the RNOH, and our leadership actually and vision for this as well. And I think it’s been a partnership.

When we started, we were in a very poor place. Obviously we didn’t know what devices we had. The PPMs were low, training was very low. When we chose TBS at that point, against their competitors, we felt that we needed to be with an organisation that were empathetic to where we were; we didn’t want somebody come in with a million dollar solution when we couldn’t afford it. Like trying to put a Rolls Royce engine in a Model T Ford, we needed somebody who understand how to upgrade the Model T Ford, and that partnership between them and us has been an ongoing success for us more latterly TBS. Just before I come to the end and give you a chance to ask questions, I’ve laid a lot of this work. I did the commissioning and I did a lot of the governance and infrastructure, but it would be really wrong of me not to recognise two of the clinical engineering managers I’ve had onsite, who have been exemplary in their commitment to all that we’ve done. And I can honestly say, hand on heart, this has been a 50/50 venture. I can come up with the vision and I can come up with all of the infrastructure and governance but without their commitment to doing the feet on the ground work, the asset database, all the real detailed stuff, this would not have happened. So I’d just like to indulge me for a minute actually and just recognise Mr Yorick Catre who is actually sitting in the second row back there and Mr Maneeb Shamin, yes, thank you both. This has been very much a joint process.

OK, thank you very much. I hope it’s been helpful and informative.


Mike Giles' presentation at the EBME Expo Medical Device Management & Procurement Innovations



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