Clinical engineering
will need a lot of softer skills – persuasive skills, management and leadership skills. Ultimately, as a community, we are stronger together,” he concluded
Authorising Engineer (Medical Devices) The role of Authorising Engineer (Medical Devices) was also announced at EBME Expo - this strategic imperative aims to enhance patient safety and organisational resilience within NHS Trusts. The concept of an Authorising Engineer (AE) is firmly established in other high- risk domains within healthcare infrastructure, such as medical gas and decontamination, where independent experts provide essential assurance of compliance and safety. The Institute of Healthcare Engineering and Estate Management AE (MD) role extends this critical independent oversight to the highly complex and rapidly evolving domain of medical devices. Prof. Sandham believes this independence
is paramount because internal audit functions, while valuable, can sometimes be constrained by organisational politics, resource limitations, or inherent biases stemming from familiarity with existing practices. He pointed out that the AE (MD)’s external
validation transcends a mere compliance check; it can be “profoundly innovative”, fostering benchmarking against leading practices and introducing advanced solutions for risk mitigation and efficiency that may not be apparent from within the Trust’s immediate operational context. Such an independent role is “key to unlocking new paradigms for policy and practice,” he argued. “Personally, I don’t see it as another layer of
bureaucracy, as some people have claimed. I see it as a way of getting the strategic engagement that Richard Scott was talking about. There are already 17 authorising engineering roles, and medical devices is the 18th. The reason why we have these roles is because it makes the NHS safer – and, in fact, we could be setting an example for the rest of the world,” he continued. He pointed out that only 50% of clinical engineering departments or EBME departments have quality management registration: “For me, that’s a concern – either it’s because the strategic management within the organisation don’t recognise that they require some sort of quality management process and won’t fund it, or it’s because the department themselves don’t see the importance in it. And for me, that is shocking,” Prof. Sandham asserted. Illustrating some of the challenges, he
showed a photo of a cluttered storeroom piled high with medical equipment: “There is a lot of old equipment that hasn’t been disposed of. There are plenty of companies that will take
old equipment. It’s a mess – but why?
...This could be happening in your organisation…I’ve seen organisations that are spending tens of thousands of pounds maintaining equipment that is not used. It’s a waste of money. Get rid of it!” he exclaimed. He went on to highlight the invisible risk of mismanaging medical devices. A consortium of investigative journalists found that 1.7 million injuries in 10 years were caused through avoidable medical device incidents, while there were 83,000 deaths. “This is globally; it isn’t just a UK issue – it’s a global issue…If it was an aviation or an oil and gas company, the safety would be paramount. The risk analysis would be high on their agenda, but it isn’t for medical devices. The NHS, according to a 2023-24 report, paid out £2.87 billion for cases of avoidable harm. A lot of these were linked to misuse of medical devices. Yet they are preventable,” Prof. Sandham commented. “So, what can we do about it? We know that there are authorising engineers who are making other areas safe – for example, there’s an authorising engineer for medical gasses. Why hasn’t there been one for medical devices? Surely these also carry a very high risk?... Senior execs don’t pay attention to medical devices, but they do pay attention to authorising engineers. Having an authorised engineer for medical devices will make them pay attention,” he argued. Prof. Sandham pointed out that 98% of
the incidents reported in the UK are linked to misuse. However, to take staff out of their clinical areas and train them (even on just the high-risk devices) can often prove challenging.
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www.clinicalservicesjournal.com I November 2025
“If you take a member of staff off a ward, somebody has to replace them while they’re being trained. There’s a cost to that and it’s a large cost, but there’s a much higher cost to not doing the training, as NHS litigation shows. “In fact, there is an even greater cost – the human cost. These are people, family members, friends, who are being harmed unnecessarily. The CQC have told us that medical devices are in the bottom tier of NHS performance, and we must ask ourselves ‘why?’” Prof. Sandham explained that he undertook
research, which found that the most important factor affecting patient safety is how we buy medical equipment: “The way we buy medical equipment can lead to standardisation, which in turn leads to easier training. We can also make decisions about consumables and other aspects. Therefore, procurement must be part of the medical devices committee. An authorising engineer with strategic oversight can say, ‘you’re not putting any purchasing through your medical devices community’,” he pointed out. At one exemplary Trust, only the medical
devices committee could approve medical equipment, unless it was an emergency purchase. They effectively created a catalogue of ‘standard devices’. “The procurement department crossed
things off immediately if they weren’t on the standard devices list. These are just some of the innovative things that an authorising engineer could put forward. They are not there to police or check up on you; an authorising engineer is a critical friend who can share with you how you can do better,” he concluded. For details of EBME Expo 2026, visit:
https://ebme-expo.com
CSJ
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