Alex ZarnehGood morning, everybody. My name is Alex, I'm head of medical physics at Mid Yorkshire Hospitals NHS Trust, which encompasses corridor of M62. That includes Wakefield, Dewsbury and Pontefract.

So we're a large acute Trust with an establishment of around 40 members of staff within my remit. We offer services in terms of management of medical devices, medical devices library, radiation protection, laser protection and recently the trust made a decision that the HSU department should also come under our remit, which is an interesting concept.

I act as the head of radiation protection services. That means I'm a certified laser protection advisor and certified radiation protection advisor. When I discussed this with John, his concept was to bring something different to this seminar and something parallel to management of medical devices. So if you're sitting there thinking, "Well, that's got nothing to do with us", we'll see how far we get with this.

If I can just ask you to - not to embarrass you - but just to raise your arms the colleagues here who are involved in dealing with a radiology department, whether it's looking after the ultrasound, mobile x-rays or just going and doing something for them. Can we just have a show of hands please?

Well that's quite encouraging because having been in this profession for about 34 years in the same Trust, because nobody else would offer me a job, it's interesting because I strongly believe that it is part of our remit as we've just heard to manage medical devices. A piece of radiology kit is a medical device, ultrasound scan is a medical device, and we need to get off our benches in that little silo that John was showing and engage with radiology, pathology etc.

From my experience, they would actually welcome your presence in their departments. Don't worry about politics. Don't worry about it because it doesn't exist in my books. I don't do politics. If you went and spoke to the radiology department and you said, "We'd like to look at your ultrasound machines" whether it's doing first line or just safety tests, they would absolutely welcome you because that's how we started about nine years ago by a simple conversation in the corridor.

We realised that they were paying about £60,000 a year to an organisation to come and do just quality assurance for them. I engaged with them with my staff, the ones who were interested, we spent about - John was talking investment, it will be cheaper in the long-term - we spend about £6000-7000 on phantoms  and we gave them a first class service and then they came to me and they said, "Can you take over our contracts?" so we became a centralised budget-holder for the Trust. So if an X-ray tube goes down, they will ask the company to fit it and it comes out of a centralised budget they don't have to worry about.

So just some concepts in there to overlay what we've just heard that actually what does management of medical devices mean? It's not just infusion pumps, it's not just delivering mattresses to the users. John talked about regulations, talked about guidance documents. Unfortunately for management of medical devices we do have guidance documents, and this is why 10% has gone up and that's why 2% has gone up and that's why the Chief Executive actually is not interested because although we've got Care Quality Commission standards, outcome 11 etc., (I'll make sure that these slides go on your website, John, so you're not distracted from writing them). The guidance documents for managing medical devices that we do as well is a little bit woolly because you end up in arguments with the users and discussions etc.

So who is at risk when we talk about radiation safety? So the patients are, visitors are, members of the public are, in this case staff, radiographers, helpers, anyone else who comes in contact with the radiation area. So we can see the parallel to what you've just heard, because if the equipment is not maintained properly, the user is at risk, the patient is at risk, the relative could be at risk because they could come in to visit the patient, they would touch the device and they would get electrocuted. I don't want to get into an argument of well is it class C and class 2B and all this ___.

 Alex Zarneh EBME-2014In terms of the regulations, just for your information, we have extremely well defined regulations. These are Acts of Parliament. It is - the first one is known as Ionising Radiation Protection Regulations, I should say, and then it says medical exposure. The first one is all about radiology equipment that has to be maintained, has to be QA'd, has to have proper service visits, anything that you do with an infusion pump relates to IRR, that's what we call it. So if you go into radiology and you mentioned IRR to them, they should understand what it is. The equipment gets handed over to the supplier formally when they've finished the room, they hand it back to the user and there is legal documentation that gets signed.

So we're in a very fortunate position that the Act of Parliament means you can get prosecuted. I'm not saying if you didn't maintain medical devices the Trust won't get prosecuted, but this is an Act of Parliament, that is what it is. I'm aware that very recently an EBME manager has been dismissed because they missed a lot of routine servicing. I think if you look at the investigation, which I haven't seen but they've spoken to me just asking some of my views on this, I did what John was talking about and I said to them, "What is your policy? What was this person following that they did not follow?" Okay? So, that's an interesting concept.

The Medical Exposure Regulations is about the patients. It's about members of the public; it's about people who come to an x-ray room to have an x-ray done. There are a whole series of guidelines and regulations about the amount of x-rays we can give to individuals, and it is cumulative so we talk about how many x-rays did you receive in a year. The reason, if you've heard about PACS. We don't carry films anymore in the hospitals because you used to come to see the consultant, you had a chest x-ray done and they lost the film.

They used to send you for another x-ray, quick and easy fix. That is no longer legal because that means you've given double exposure without justification. These are the wordings that we used. These all get investigated on the radiation incident, so it's quite robust the way the regulations work. So we're quite fortunate that we can use this. Now, who is responsible? Okay - sorry, who is the regulator? Well in this case it's the Health and Safety Executive because they regulation the IRR regulations. HSE regulates medical device regulations. So if there's an incident, if that train today hits a bridge, the first thing you hear HSE have been informed because they come and prosecute.

The HSE came to prosecute us two years ago because we had a patient death that was attributed to a bed, and the gap between the railings was not compliant because it was an old bed, okay? So we received an improvement notice. What was interesting was, when they asked who was responsible for the beds, nobody was responsible... because everybody thought it was estates, then they thought it was facilities, then they thought it was the company, and everybody thought it was Medical Physics. Since then, the decision was taken that they would come under the remit of Medical Physics, which is an interesting concept.

Care Quality Commission have taken over the regulation of ERMA , which is exposure to members of the public and the patients. They're interested in it because when we get somebody in who's had a fracture and is 18 years old or of child-bearing age, you need to be aware of how much radiation you're giving to these people. So all the incidents get reported to ERMA and it gets investigated, and they make a decision whether to prosecute or not.

So you can see how well defined it is, and there's no woolliness about this. There's woolliness about our profession, there's woolliness about what we call ourselves. John gave us a very good presentation of the Chief Executive who did not read the policy, or was not aware there was a policy because there's somebody else who does it. What may trigger an inspection? For us it could be an excessive number of radiation incidents, a tip-off from somebody or very little incidents reported.

Right, this is the interesting part. Who is responsible? The Chief Executive of the Trust is responsible for ensuring the regulations are being adhered to. There's absolutely no woolliness about this. In our Trust, the Chief Executive is the responsible person. Yes, he has delegated it to me but he has a responsibility for it, and I've been asked to go to the Trust board and do a presentation about the responsibilities of Trust board members, and I've just created some simple slides to go and talk to them about it.

Staff.., your radiology group manager or whatever they call themselves, head of clinical services, and of course your radiation protection advisor. So what I'm trying to say is that it's worth when we go back from here to think about this and to go and introduce ourselves to them. I was in a Trust recently doing a different visit and I tried to find who their medical physics was and who their EBME  or medical engineering, whatever they call themselves, were because I could go and introduce myself and have a coffee with them because I had a couple of hours to kill.

Nobody knew who they were. When I found the chappie he said, "I don't work for them, I work for the library". "Yes", he said, "We used to be part of them but we got divorced, we fell out". It was quite interesting. "We've nothing to do with them any more."

If the inspector comes around, very similar to what will happen in the medical devices, there'll be a formal meeting, they will ask the Chief Executive questions, they will see the radiology manager, they will interview everybody, they will walk around departments, inspect, there'll be a final briefing either an enforcement notice or a compliance notice. It's worth putting this on top of John's policies and the slides he was showing and saying, "Why can't we put this practice in place? Why can't we make sure the board knows about it? Who do I need to talk to to do a mini presentation?"

Believe me or not, they would welcome it because the Trust board members get really fed up and bored at the meetings and they love it when somebody turns up with slides. Yes, there is a lot of paperwork, there is a lot of documentation because that's what the regulation says: evidence is what we need to show and we tend to show that.

Compliance expectation; we have what we call ERMA schedule one. ERMA schedule one is our policies; it's the medical devices management policies. It's policies of what / how do you deal with a pregnant patient? How do you deal with somebody who's got a pacemaker in? How do you deal with somebody - so it's all very well defined policies so we can say, "It's similar to my Library policy, PPM policy".

Governance. We need to put governance - it's our responsibility, our duty to do it. The governance aspect of this gets reported to the chief nurse. If you walk around your hospital, you will see people wearing their Dosimeters, their  badges  because that is major - the amount of - I don't have mine with me, but amount of x-rays that the people get and they get measured and if there's excessive radiation they get taken off those duties.

Risk assessment, safety rules, procedures, monitoring, clinical user training, we've talked about it, and of course protective equipment, that's your environment. In the radiology department it's about lead aprons. So you can see the parallel between what happens outside our little kingdom that we've created and we go in every morning and shut the door, and it says authorised staff only so nobody else comes in.

We moved to a new department and the first thing our receptionist did is put a sign on the door and it said, "Authorised staff only, please do not enter." I just ripped it off and I threw it away. I said, "Well this is a department, I want people to come and see us. We're just keeping them out." "Well, it's to keep reps out." "Yes, but," I said, "We don't need to keep reps out, we need to socialise with people and talk to them."

So you can see the parallel, and we make sure they're risk-assessed, protocols are in place, documents are stored in a readable format and we also have management systems for monitoring purposes. So you can see the link, so when you go to talk to them, you go to introduce yourself to your radiology department, you'll be very informed, very professional, they will listen to you and they would welcome you, and I would encourage you to do that.

I'll move on from the radiation part to laser safety. Is anybody in the audience involved with your lasers in your Trust? Okay, a similar area, they'll be used in your theatres, mainly your ophthalmic department. They will have a number of lasers and what you will find is somebody is paying a lot of contract money for them and there isn't much to do on them actually except to measure the output. So there's another area of growth for our profession to enter into that field.

So you can speak to your - go and find out who your laser protection advisor is, have a conversation because they'll be the first people probably who get called if there's a problem with a laser and say, "I can also help you" because if there's a troubleshooting there - and they'll absolutely love that. Foot switch breaks down; the light doesn't come on because the bulb is gone.

What are the regulations? Absolutely none. I'll stand here without being embarrassed; I'll say that, because the use of lasers in England, Scotland and Southern Ireland have been de-regulated. Up until about five years ago there was a lot of regulations that you needed to register, you needed to be properly authorised, trained, have a laser protection advisor, have a safety advisor, like you will not send a panel beater out to service an infusion pump, but the government decided this was too much hassle, they deregulated it. There are national standards, which are about guidance, laser protection eye-wear, safety of laser products, very similar to what we do with an infusion pump, that we use these guidelines to ensure compliance.

So they have been de-regulated, However, North Wales, South Wales, Northern Ireland - it's like a train call this, isn't it - Isle of Man - passengers to platform three - have full regulations in place. That means if you want to open a laser clinic in any of these areas you come under very similar to Care Quality Commission regulations. So the therapist, the people who want to run it, have to be fully qualified, certified, have a lot of knowledge, documentation in place to register for its use.

In England, to be fair, some councils are taking interest in this. So if you go to Liverpool for example, you can open a cosmetic laser clinic, you've seen a lot of adverts about hair removal, you see a lot of adverts about tattoo removal, laser IPL machines. You can go on two days of training, you can learn how to use the machine, and you become a therapist, you can buy a cheap IPL machine for about £10,000 and open a laser hair removal clinic, or go to people's houses and do it on a mobile basis, which is quite interesting.

So, cosmetic clinics, salons, have opened across the country using cheap imported machines. John was talking about before you buy an infusion pump or machine or whatever you're buying, make sure it's fit for purpose, it meets the needs of clinical users etc.. I'm not going to ask anybody to put their hands up here if they've had any laser or IPL treatment, but it's an interesting concept because you - I do some inspections actually for the - for some of these clinics and you see some disaster areas because they've actually got somebody in there who are doing hair removal etc.

You ask them a lot of questions, like John was saying you ask the Chief Executive and I ask them questions and they start looking at me thinking, "He's just landed from Mars or the moon". So that's where they are mainly used, in the cosmetic industry. I would encourage anybody that - who - I'm not against the practice, I don't make a judgement; we are not here to make any judgements about anybody or anything. I think whoever wants to have this treatment, I would certainly ask them some serious questions: who is your therapist - I would definitely ask them who their medical doctor is because at the end of the day you've got these people who are dealing with your skin. They are putting lasers, heat, on your skin to remove your hair, etc.

So that's the reality of it. I had a call last week from a therapist in London who was looking for a laser protection advisor, she picked my name off from the Society of Radiation Protection Board's website and I asked her some questions, and she said, "Yes I've got my IPL machine, I'll email you my certificate, I'll be fully trained". I asked her some questions, I said, "Before I become your laser protection advisor, can you send me the syllabus of the training, and she asked me what a syllabus was, how do you spell it? Then I asked her, I said, "Have you done any physiology training? Have you done any NVQ about skin?" and she says "Oh no, we don't need that because they've shown me how to use the machine so I don't burn the patients. So I referred her to somebody else.

So very little knowledge of skin, physiology of tissue, and they just go ahead and take on… - so I'm just trying to give you some parallel about regulations.

What are the hazards? They're quite serious. You can go and talk to your laser protection advisor because it's a very strong beam of light, it could cause blindness and eye injury, and there are examples of this happening in this country because you're putting a lot of heat onto the skin to remove the hair, to bend the hair follicle. Therefore an excessive amount of heat causes skin burns and scarring.

The number of insurance claims in this country has really gone up by about 30% in the past two years, probably currently I'm involved - maybe I'm exaggerating - in about 10 or 12 serious incidents, investigations for various clinics who are being sued. I'm acting as an expert for them. In actual fact, one of them it's not far from here, who's going to go to court and they've asked me to give witness statements in there. Everything comes back to training and knowledge, so everything on the medical devices comes back to training and knowledge. Whether it's training of people who work at the bench level, or whether it's the training of the user out there who switches it on and presses the button and it goes bang.

So it's quite an interesting situation. I think it's sad. I think it's very sad because it is a safe practice if it's done properly, but you can again see the parallel because every time I get an incident, or I'm emailed, I send them a series of questions, I ask about the therapist's knowledge, training certificates, servicing of the laser, service records, calibration records, clients' medical history because if everything is correct they shouldn't be burnt. But they've made a mistake somewhere along the line. It's like the nurse who made a mistake and instead of thinking this was a Graseby MS16 pump, used 26. I'm not trying to knock Graseby, but - or instead of - was a Carefusion  infusion pump, they used Braun settings or whatever.

So it's quite an interesting concept. So that's the summary of introducing yourself - I'm sure some of you knew about this anyway - to the other side of the profession, which John and I and some other colleagues here we had discussions last night and we have a passion for this, that it gets us out of our little silo, we get out of our departments, we go and talk to other stakeholders out there and offer our services to them.

I think that's the only way the profession will grow, become united, strengthen ourselves, our reputation grows in the Trust, the Trust becomes heavily dependent on us because we give them a first class service. But unfortunately some of this needs investment, but as we've already heard investment long term it will be cheaper.

So if you can go to radiology tomorrow morning, don't be scared, talk to them about what do they do with ultrasound machines, ask them to show it to you, talk to sonographers, try and bring it under the management policy and just say, "Ah, we can come and have a look at that connector for you" and their expertise grows as well. I've got three and a half minutes and that's it. Thank you for your attention.


Dr. Alex Zarneh's presentation may be downloaded here:


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