My name is John Sandham. I’m doing a presentation on device management policy and why device management policy is important. It may seem like a dry subject, but device management policy is important for a number of reasons, the two core reasons being risk and cost.

In 2011, the Department of Trade and Industry issued a document called ‘Strength and Opportunity’. In ‘Strength and Opportunity’ it stated that the medical technology market is going to grow internationally at 10% a year for the next five years. That’s growth in terms of product range as well as suppliers, especially from countries like India and China, where there are more and more manufacturers becoming prevalent. It’s important for us to understand that that’s an opportunity with regard to buying products, but it’s also a risk with regard to variance in product.

Painting the policy picture: policy needs to guide practitioners’ conduct in an accepted way that not only meets the needs of the organisational requirements and the regulators but primarily must ensure the well-being of patients. That’s quite an interesting statement, "Policy needs to guide practitioners," because in my experience it often doesn’t guide practitioners.

I’m going to paint the picture over the last 15 years of research and guidance that has been issued and see where we are now compared to 15 years ago, because I don’t believe we’ve moved fast enough in the right direction.

Just for a show of hands, can I have a show of hands for those of you who work in hospitals if you have a medical devices management policy? Put your hands up, please. That’s about half the audience. Can I have a show of hands of those of you who just put up your hands if you can say the policy is reviewed regularly? That would be, I would say, at least once every two years, preferably once a year. That’s about 50% of the 50%, so that’s about 25% - and I think I’m being generous.

Now of the 25% that just put up your hands, can you honestly say that the stakeholders who are responsible for applying that policy are aware of the policy and are using the policy? Can you put up your hands if you believe that’s true? I’ve got three hands, so we’re down to about 1.5% of the audience. Of that 3%, do you believe they really understand and apply their policy? Can I have a show of hands? One, so we have less than half a per cent of the audience is saying that medical devices policies are applied in their organisation. That’s a scary fact.

I’m going to just give you a little bit of background. In 1999, the UK National Audit Office said that their survey showed that 12% of trusts had a documented policy. Now it’s gone up to 20%, according to our audience, which is quite good, so there’s been an improvement.

Furthermore, 70% of trusts that had a purchasing advisory committee, only half of them had responsibility for formation of policy on medical equipment standardisation. That was 1999, so we’re talking 15 years ago; I think things have improved, slightly.

In 2004, the National Patient Safety Agency did a piece of research across five NHS Trusts specifically looking at infusion devices. They painted a picture of uncontrolled purchasing and uncontrolled device management in the absence of competency-based training, and these were contributing factors in causing incidents.

Again in 2004, the National Patient Safety Agency said that 93 Trusts expressed an interest in taking part in that study, which also tells us that those Trusts need help to understand policy and understand how to apply policy.

Further to that point, the UK Medicines and Healthcare Products Regulatory Agency produced a document in 2006, MDA DB2006 (05). Can I have a show of hands, people who have read that document? That’s quite good; I’d say about 30% of the audience.

It’s a guidance document that says how we should manage devices and a lot of what they say is directly linked to the National Audit Office advice; you can see correlation there. It talks about device management policy, acquisition, training, decontamination, maintenance, record-keeping, and a number of other areas. It’s well worth a read; it’s quite a long document but well worth a read and recently been updated.

The World Health Organisation issued a resolution in 2007 stating that healthcare providers should establish priorities in the selection and management of healthcare technologies. One of the issues in doing this is that there are very few experts in management of healthcare technology, people like us. That’s a big issue, because when it comes to actually applying the recommendations and the guidance, there are not enough people out there that can do that. We need to get that message across and make sure that we do something about it.

We need to expand expertise in the field of healthcare technology and healthcare technology policy. We need to ensure improved access quality and use of medical products and technologies. We need to do that. We’re in the organisations; we’re responsible, as part of that team, to make sure those devices are used safely and it’s done in a cost-efficient way.

In 2011, the World Health Organisation stated that a number of studies have shown that between 39% and 46% of adverse incidents resulted from the misuse of medical devices. They were specifically looking at operating rooms, but in most of the studies the cause indicated was device operation related, i.e. the users weren’t using the equipment correctly.

I think a key issue around using equipment correctly is standardisation. We all understand what standardisation is, I’m not going to preach standardisation, but I go and visit many, many different organisations, in the UK and abroad, and variation is an issue.

If you look at one technology group - I’ve mentioned infusion devices because the NPSA did a good piece of research on that - we’ve just looked at one organisation where they had 36 different types of infusion pump all doing the same thing. There’s no need for that and it causes issues. If you take into account that that organisation has 400 technology groups and if the variation across each technology group is similar, then that creates a huge risk in terms of cost, utilisation, and safety for patients.

Again, the World Health Organisation said, "Variation in medical devices between hospitals, and even within the same hospital, is one of the causes of these accidents." Three facts emerged that the devices are often not well designed, so sometimes buying cheap is not the best thing you can do; you need to buy what is effective, what is easy to use, what is easy to decontaminate. You need to be choosing your devices in a way which is safe for the patient and has the right economic advantage for the organisation.

The user is not often trained properly. Variation creates difficulties in training. If you’ve got 400 technology groups in a hospital and then you’ve got variation of 30, even if it’s 10, across each of the technology groups, suddenly you’ve got 4,000 different devices that you may need to train on because of variation in model of devices that do the same job, which makes it, I would say, impossible.

One of the other things is if you do want to train your staff, I did a piece of research which indicated that actually, even if you did standardise on every single technology group, you would still have to invest a huge amount of money in backing nurses to go on training courses. One of the issues I get from nurses is saying, "We can’t come on the training course because we’re too busy," and that’s the truth.

The third fact: new procedures often result in long learning curves. We can go and we can put a new policy in with new procedures, "This is how we’re going to buy, this is how we’re going to train, this is how we’re going to do our maintenance," and wrapped up inside a regulatory framework that’s dictated by the Government. We can say all of that, but do we actually do it?

The World Health Organisation also stated that the effective medical equipment management could avoid 30 to 50% of additional cost for extra spare parts and extra maintenance workload. What they’re actually saying is if you utilise equipment, if you standardise, if you buy right, then that reduces the size of your asset, which means that you can also then get economies of scale.

Twenty to forty per cent of equipment remains underutilised or unused. In the work that I’ve done, I would say it’s more than that; I would say it’s over 50%. When I walk around a hospital, I look at equipment that’s in use and equipment that’s out of use and I would say 70% of equipment is out of use. That doesn’t mean that 70% of equipment is not needed, because some equipment is only used infrequently, but I would agree that 40%, the higher end of this figure, in NHS hospitals is true.

Ten to thirty per cent extra modifications or additions required for equipment - this could be because it has not been bought right in the first place and you haven’t bought the right software to go with the device, you haven’t bought the right durables or consumables to go with the device. It could be a number of different additions that could be required.

Ten to thirty per cent of additional unplanned costs - if you’re not doing the management correctly, if your policy isn’t being applied then it introduces unplanned costs - and 30 to 80% loss of potential lifetime of equipment. Loss of lifetime doesn’t mean that you scrap it after 20% of its life, but it could mean that it’s sitting in your department for two-and-a-half years because you can’t buy the spare parts, because you haven’t got the money or you haven’t got the technicians to repair it.

I’ve actually seen this in three different hospitals, where I’ve gone in and our team have audited and found equipment over a value of £1 million in one particular NHS acute hospital that had been sitting there for more than two years. If the life of a piece of equipment is 7 to 10 years - let’s say it’s 10 years - that’s 20% of its life it’s been sitting in the EBME department. When they do eventually repair that piece of equipment, when it breaks down next time is it going to sit there for another two years? That’s inefficient management of devices on the maintenance side.

Twenty-five to thirty-five per cent of equipment out of service - if we don’t have an efficient policy, if we don’t look after the way that we manage devices, things can be out of service for a number of reasons, not just because we haven’t fixed them but also because nurses or doctors don’t know how to use them, or there’s a risk that they will try to use them and then there’s an incident and the device has to be quarantined and put out of use because somebody’s not trained.

In 2013, from the Robert Francis inquiry into failures at Mid Staffordshire, there were no routine follow-ups of compliance. The hospital wasn’t going and checking on its own policies. Even when it was found out, it still didn’t go out and follow up, unless the information suggested non-compliance, so when it was found out that there were areas of weakness, it didn’t then say, "Are there areas of weakness in other areas?" It only addressed where the finger was pointed. "We’ll go and look in that area because that’s the area that the CQC have picked up." We need to have policies in place which pick up all of the areas.

The CQC attributed this to them not having relevant expertise. I spoke to a Chief Executive of a hospital recently and she said to me, "I haven’t read the medical devices policy, because there are too many policies in this organisation and the number of policies is dictated by the regulators’ external forces, such as the CQC and the NHSLA. I have to rely on my operational staff to make sure those policies are abided by."

I said to her, "No, it’s your responsibility. You’re the Chief Exec; you need to make sure that you do understand the policies, because these are the risks." When I explained, she said, "Oh dear. You’re right; I do need to understand what’s in my policy." It’s a scary fact that people don’t read policies and they do impact on patients dying and being seriously harmed. Poor practice is harmful and expensive, and best practice guided by policy is safer and cheaper.

Research shows that if you don’t have a good policy guiding practice, it does lead to higher risk to patients. Patients being harmed may lead to litigation and therefore ultimately higher litigation costs and loss of reputation, as happened to Mid Staffs.

It has happened to a lot of other Trusts; if you look in the news, I looked over the last two years, and there are hundreds of news stories about medical equipment, and 99% is around the use of equipment. Very few are actually round maintenance and I know that most of us here are more involved in maintenance than training, but I’m sure that there are a lot of people here who are also involved in training.

Poor governance leads to non-compliance of regulation, and potentially now we recently had an issue at one hospital where the Care Quality Commission threatened to close down their theatres because so much of their equipment had not been maintained; it was out of date. It’s a serious issue.

One of the areas that I think is an issue is lack of teamwork. I regularly speak to people and they say, "Everybody is working in silos, so they don’t understand my problems." Teamwork is important; we need to understand who we need to be working with and why we have policies in place.

I asked myself this question: how can we impact on medical devices management policy to ensure stakeholders meet the needs of the regulators -  external demands, the organisation -  internal demands, and the patient, thereby leading to regulatory and best practice improvements? There needs to be regulatory compliance, because if you haven’t got that the CQC can close you down, and best practice means that your nurses and doctors are using the equipment, or maintainers are maintaining the equipment and everything is being done properly.

There’s an argument that I sometimes get: "This is going to be too expensive," but actually all the research shows that it’s cheaper - if you do it properly. As I mentioned, the external demands on policy come from many different areas; I’ve got four mentioned here: NHSLA - National Health Service Litigation Authority; the MHRA - the Medicines and Healthcare Regulatory Agency; CQC - the Care Quality Commission under regulation 16, outcome 11, and also under regulation 12, decontamination; and the European Union - lots of regulations from them.

Then there are internal demands for medical devices policymakers, so you need to have that consideration: what is the Government saying? What is Europe saying? That needs to be inclusive, but also you need to be saying, "How do we buy?" because it’s important, "How do we use it?" because it’s important, "How do we maintain it?" because it’s important. That needs to be wrapped up in a management framework which includes the policy but also includes audits and compliance checks, because, as you saw from the Mid Staffs inquiry, they weren’t doing that and it led to a lot of issues. Medical equipment management is mentioned in all three volumes of the Mid Staffs report.

We need to bring these together; the external demands and the internal demands need to be brought together into policy. In that way, we should be able to then at least have a policy which is correct.

The overall aims of the policy are underpinning the buying of devices, using of devices, and maintaining of devices, and managing policy compliance with governance. People need to be aware, practitioners need to be aware that the policy is there to guide their practice, whether they’re a nurse, a doctor, a technician, a buyer, whoever they are; there are many different stakeholders that these policies touch.

That just gives you the big picture. Achieving a live operational best practice policy, you constantly need to say, "How do we buy?" I imagine there may be 400 technology groups within an acute organisation. If you say, "They all have a life of 10 years," you need to be saying, "How do we buy?" because you need to be replacing 40 technology groups a year and each one of those needs to be standardised.

A technology group may be defined as a device that does a specific function, whether that is therapeutic or diagnostic. Then once that comes into the hospital, how do we make sure the people that are using that are trained? What length of period do we need to buy over? One of the biggest issues with standardisation is that technology groups can have an age variance of up to 15 years, so then if you want to standardise and you’ve got a lot of different devices, how are you going to do that?

We’ve done a number of audits across a number of NHS Trusts and I’d say that the average across all of those organisations is that 70% of their equipment is already past its sell by date. There’s huge pressure on the NHS to replace devices. One of the reasons is that the way that the finance team allocate budgets is to wards departments.

For example, if you’ve got 100 wards and departments in a hospital and each one of those has a line for buying medical consumables, medical products, it gives that hospital or those managers the option to go and standardise in their own area. A ward manager might tell me, "Yes, look, I’ve got all the same blood pressure machines." Great, but the ward next door hasn’t, or, "I’ve got all the same infusion pumps." Great, but the ward next door hasn’t.

I know that a lot of people here probably have moved towards that methodology, so can I have a show of hands of all the people in the room who have a defined replacement programme for their hospital? I’d say probably 10%, which is I suppose heading in the right direction, but it’s not good enough, because most of the people who are in this room are really interested in medical devices management, otherwise you wouldn’t be here.

How many people out there, who haven’t come to this conference because they couldn’t be bothered, are in organisations which have no interest, who have ward managers and department managers who are not interested in reading the policy? How do we deal with them?

There are also multiple sources of acquisition, which can lead to variation, such as charitable funds. You can read that for yourself, but there are lots of routes into a hospital. All of those need to be controlled by your policy.

Medical technology procurement positively impacts on economies of scale, easier training for users, which then improves safety for patients. It also makes it easier for technicians. If technicians have a standard technology group, they could become more expert in repairing and maintaining that technology group.

Also, you can get spare parts cheaper. If you can have a deal with a particular supplier, you can buy the parts, you can buy the equipment over a period of time. It could be two years, it could be three years, but if you then make a supplier realise that "We will be in partnership with you," you can drive good deals with those suppliers. Also, it helps with regulatory compliance.

I’ve talked about technology groups and the impact on policy, but when training users, you must think about standardisation and how to drive that procurement of technology in your organisations in a planned way. It’s all well and good that we have technicians and engineers that can extend the life of equipment, but if that varies, actually us thinking we’re doing a good job, we can actually be part of the problem.

We need to be thinking, "What is a realistic life for a device?" Then if you’re going to vary it, it needs to be done in a planned way. You need to think about that, because that impacts on the training of users. If you, like I mentioned earlier, have devices, 30 different devices across a 15-year age variance, you’re asking for a patient to be injured, you’re asking for additional costs.

The other impact is on storage space. As technology has grown over the last 100 years, a lot of our hospitals are over 100 years old; they haven’t got the storage capacity. You walk into a hospital, there are boxes everywhere. If you don’t standardise, you actually create more of an issue, because you need more space to store the consumables that go with those devices. Then there’s a risk that they’ll use the wrong consumable with the wrong device, which has also happened.

I would say that procurement, when you’re weighting it in policy, it needs to be high. We need to be aware of the importance of procurement, because it impacts directly on maintenance, governance, and training. I’d go so far as to say that procurement is at the centre of healthcare technology management. Therefore, it needs to be at the centre of healthcare technology policy and it needs to be applied.

I said earlier that "Keeping a policy alive can guide conduct," but how do you keep a policy alive? How do you make sure users are aware of policies? Does anybody in this room have a training system for training on a medical devices policy? I’ve got about seven hands up out of 200, so 3.5% of the audience. If you don’t train users on the policy, how do you expect them to understand what they’re meant to do with it? That’s a message you need to take back to your organisations.

Many stakeholders don’t even bother reading policy because there are so many of them. If it directly impacts on that user - and you know it impacts on that user - do something about it; put a system together that will make sure they understand what their responsibilities are, and why it impacts on the patient, and why it impacts on cost.

Improved conduct guided by policy - it can only be guided by policy if those users of the policy are trained and understand the policy, or at least have read the policy. I did interviews across a London NHS Trust with a number of different users who were touched by policy in maintenance, procurement, and clinical staff, going right the way up to the Chief Executive. I won’t mention the name of the organisation, but of maybe 100 people I spoke to, 3 said that they had read the policy.

When I questioned them about the policy, they were like, "I didn’t look at it in that much detail." It tells you that they don’t understand what the importance is of healthcare technology management and the impact on patients and cost. What I would suggest - and this is not me saying this, this comes from the research I mentioned over that 15-year period -- is that medical devices committees implement policy; you have a committee which includes participants from around the organisation who are touched by that policy.

They need to decide the life of each technology group. It doesn’t necessarily have to be the recommended life; it could be 10 years instead of seven years, but they need to decide what the life is and then stick to it, because that’s how they can negotiate with suppliers. They need to create a strategic replacement plan. Three per cent of you have got a strategic replacement plan, according to you; I’d be interested to see them.

They need to buy by technology group, so you look at what is the diagnostic test, what are the users trying to do with this equipment? Then make sure that you buy something that is fit for purpose, not necessarily what they want, but you need to consult with the clinical staff. Then if it’s a big enough purchasing exercise, you can carry out a tender exercise in line with best practice in procurement management. That will drive the best price out of it.

Invite suppliers to demonstrate their technology, because it may be that you think this is the right device for your organisation but it’s not, and also that that supplier will train the users, because there are too many suppliers that will sell you cheap stuff from China who then don’t back that up with training. You might be able to get something at a third of the cost, but what are you sacrificing? Then making sure that it’s only put into use when those users are trained, this is all guided by your policy. Then you can manage your device maintenance effectively as well.

The benefits that are mentioned in all the research say, "What this does, it reduces the asset size," by as much as 30% - if you can improve utilisation. Having a good management policy can reduce the size of your asset. Reducing the size of your asset reduces maintenance spend. Not only will that reduce part spend because you have less equipment and in a standardised fashion mean that you’ll be able to repair it better, quicker, using maybe your own technicians and not OEM technicians, you can improve user training.

This is all coming from the research: improved governance and safer practice. In some instances, potential VAT reclaim - some consumables, some equipment. On maintenance services you can reclaim VAT. I’ve been into organisations where I said, "Do you reclaim your VAT on your maintenance?" and they said, "Yes," and then I’ve checked and they’re not, because the finance department just weren’t aware that they could. The people who were aware, who were working in their silo, didn’t talk to the finance team and were assuming that the finance team were claiming 20% VAT on their maintenance spend and they weren’t.

If we apply policy in the right way, in accordance with the research and the guidelines, it will deliver improved patient care at lower costs, but there is some pain to go through to getting there, getting that direction. The four core areas of healthcare technology policy are procurement training, maintenance, and governance. It needs to be managed in that way. The guidance is out there; I’ve mentioned it in my slides. I’ll put my slides up on the EBME website so you can go and look at them, but the guidance is out there.

John Sandham's presentation may be downloaded here:
https://www.ebme.co.uk/downloads/download/14-2014-seminar/89-device-management-policy