CLINICAL ENGINEERING CONFERENCE
including government, the Medicines and Healthcare products Regulatory Agency (MHRA) and NHS England, to help our members plan effectively.” The ABHI is part of the life sciences
sector, a market that covers a broad spectrum of industries, including biopharma, medical tech (also known as HealthTech) and service sector companies. According to Andrew, the sector is so broad as the lines as to what constitutes a “medical device” are blurring. “HealthTech industry dynamics are changing,” continued Andrew. “For a high proportion of SMEs, sales are being consolidated into bigger industries. Larger corporations aren’t simply buying smaller companies, but consolidating with each other. Digital technologies are dominated by the health information systems.” With regards to Brexit, the ABHI are planning for a worst case scenario, and many companies have already moved out of the UK. “There are a great deal of issues,” Andrew noted, “such as changes to packaging and labelling – and regulation is a big question mark. “The MHRA are taking a pragmatic approach, but for UK exporters, we’re not sure what’s happening. In terms of research and development, there is a great deal of funding from the EU – so what will happen when that goes? “Workforces will be reduced – indeed, since Brexit was announced, less people have arrived from the European Union, A lot may leave, and we are heavily reliant on these people across the board. Workforces have always been an issue for the NHS, and immigration was one way to help. “Further issues are raised when considering trade borders and tariffs – ie: will everything that comes into the UK have a tariff on it?”
Medical device training
Paul Lee, medical devices training manager at ABM University Health Board, shared his thoughts on training – both now and going
Paul Lee, ABM University Health Board. forward. Andrew Davies, ABMI.
He provided a brief history of medical devices and the, often, inadequate measures used to clean them. This, he observed, changed very quickly once CE Marking was introduced. “There are 1.5 million different medical devices,” he said. “This includes everything from a cannula, the needle put into your hand to deliver drugs, right through to the ventilator that keeps you alive in intensive care. “My current job is to design, develop and deliver medical device training courses for all our staff – doctors, nurses and other practitioners – based on what we consider to be the risks. “My department is also involved in product evaluation – looking at new medical devices as they are rolled out, then identifying who needs to be trained and delivering ongoing training across the health board. “I also look into incidents and errors, reviewing how the devices are used, the design of the machine and sometimes the environment in which it is used, so we can reduce the risks.” Paul, a scientist registered with the UK Science Council, is also involved with research and publications, as well as innovative practical applications. He continued: “With so many infusion devices it’s important to define them; some are active, some are passive; some are invasive, some non-invasive. I was recently called in to help define a training programme for nurses, and the training required for all the devices was different.” Highlighting the importance of scheduling a training session, Paul explained that it needed to take place in a working environment, rather than in a spare room. “When we assess nurses, we need to assess them in the clinical environment, rather than in a stock room,” he said. “For cleaning, we are also faced with a broad range of products, and there are mixed messages from staff and suppliers. I recently went to a hospital where a patient had contracted sepsis because a
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cannula had been put in incorrectly. This had been done by a fully trained member of staff and, when I asked why the cannulas had different colours, nobody could tell me why. “I visited another hospital where, during intravenous therapy, devices were left uncleaned, and syringes were unlabelled. The sister said to me: ‘What’s your problem? I never killed anyone!’” Paul noted that with adverse events in hospitals it is important to learn from them, and recommended a range of training options: l National Training Hub for Operative Technologies in Healthcare (THOTH)
l National Association of Medical Device Trainers Education & Trainers (NAMDET)
l Medical Device Driving Licence (MDDL) l e-LfH Hub - e-Learning for Healthcare.
Looking forward, Paul suggested that the future of medical device training would lean heavily on new technologies – in particular: l Virtual reality (VR): Immersive multimedia or computer-simulated reality, which replicates an environment that simulates a physical presence in the real world or an imagined world, allowing the user to interact
l Augmented reality (AR): A live, direct or indirect view of a physical, real-world environment whose elements are augmented (or supplemented) by computer-generated sensory input – such as sound, video, graphics or GPS data Mixed reality (MR). Sometimes referred to as hybrid reality, this is the merging of real and virtual worlds to produce new environments and visualisations where physical and digital objects co-exist and interact in real time.
Use and usability in the development of medical devices
Dr Tom Clutton-Brock, director at ERDF Medical Devices Testing and Evaluation Centre, has maintained a career-long research interest in medical technology, with particular interests in patient safety, monitoring systems and point-of-care testing.
NOVEMBER 2019
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