EBME Expo 2025
are often expected to operate a wide array of devices, sometimes with minimal or no formal training. Incorrect setup or misuse of equipment remains one of the leading causes of device-related injury.
3. Lack of reporting and feedback loops - The NIH study’s finding about misclassified deaths points to an even deeper problem: weak feedback systems. If incidents are not accurately recorded, they can’t be analysed, and improvements cannot be made.
4. Underfunded regulation and oversight - Healthcare systems across the world, particularly in lower-resource settings, often lack the infrastructure and regulatory muscle to proactively monitor equipment safety. In wealthier nations, budget constraints and bureaucratic delays still plague incident response.
The role of governance and policy Addressing these issues isn’t just about responding after something goes wrong. It requires proactive, systematic governance that prioritises patient safety throughout a device’s entire lifecycle – from design and production to implementation and retirement. This includes:
l Mandatory reporting systems that are user- friendly, fast, and enforced.
l Regular audits of devices in use, especially in high-risk environments like ICUs and surgical theatres.
l Standardised training for all device operators, including refresher sessions and access to manuals or on-device guidance.
l Transparent public data on adverse incidents, similar to how aviation incidents are reported and studied.
l Strong governance also requires independent oversight. Regulators must have the power to investigate and intervene – not only when deaths occur but when patterns of risk emerge.
What good looks like There are pockets of excellence that can serve as global models. The MHRA’s Yellow Card Scheme is one such example – a tool for both healthcare professionals and patients to report
adverse incidents with medications and devices. Similarly, the FDA’s MedWatch programme plays a vital role in post-market surveillance in the United States. International cooperation is also improving.
The Global Harmonization Task Force and similar initiatives are helping align safety standards and sharing lessons learned across borders. But reporting systems are only as effective as the culture they operate within. Organisations must move from a blame-
oriented mindset to one focused on learning and improvement. Near misses and minor incidents should be viewed as early warnings, not administrative burdens.
What’s at stake? The human cost of medical device failure is not theoretical. Every unreported incident, every ignored design flaw, represents someone’s lost life, limb, or loved one. With the increasing complexity and digitalisation of medical devices – including AI-driven diagnostics and remote monitoring – new risks are emerging every day. If we fail to keep pace with these challenges,
we invite not just individual harm but systemic mistrust in the very technologies designed to save lives. The key to improving patient safety lies in collaboration across all healthcare professions buyers, users, and engineers. This year, the EBME Expo explores multiple themes:
EBME Conference – Chair: Professor John Sandham A driving force in healthcare technology management, Professor John Sandham CEng, holds an Honorary
Professorship at Warwick University, and has served as Chairman of EBME (www.ebme.
co.uk) since 1999. As a Senior Research Fellow at Middlesex University, John is a leading expert who has significantly impacted device management policies and processes within both NHS and private healthcare settings. His proven ability to enhance regulatory compliance and improve patient care is built upon years of practical experience spanning biomedical, diagnostic imaging, endoscopy, and pathology equipment. John’s commitment to disseminating
Frontline medical staff are often expected to operate a wide array of devices, sometimes with minimal or no formal training. Incorrect setup or misuse of equipment remains one of the leading causes of device-related injury.
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www.clinicalservicesjournal.com I June 2025
knowledge is evident through his impressive portfolio of over 300 published educational articles, featured in publications including the Open University Science Review and the Clinical Services Journal. He is a passionate advocate for innovation in healthcare technology. The EBME Conference brings together
clinical engineers, medical device specialists, and technology leaders to explore the latest advancements in biomedical engineering. With a focus on innovation, safety, and performance, the conference provides a platform for knowledge-sharing and best practices that improve patient outcomes through smarter use of medical technology.
Operating Theatres Conference – Chair: Rob Brothwood Rob was an ODP/Team Leader at the Liverpool Foundation Trust, with over 15 years, of predominantly
anaesthetic, experience, as well as holding an honorary contract with Alder Hey Children’s Hospital. Recently, Rob has began a new anaesthetic journey with the University of Birmingham, and is currently in training as an Anaesthesia Associate. This conference focuses on the evolving
needs of operating theatre environments, addressing topics such as surgical equipment innovation, patient safety, and efficiency in perioperative care. Delegates include theatre managers, surgical teams, and clinical engineers, all aiming to optimise performance through technology and process improvement.
Procurement Conference - Chair: David Lawson: Director of Medical Technology, Department of
Health and Social Care David has responsibility for setting the future of UK Med Tech policy, implementation of the new Med Tech Strategy, and is a member of the new Life Science Council advisory board on medical devices regulatory reform. He has a strong interest in supply chain, sustainability and enabling adoption of new innovation. In addition, he has led the implementation of the largest deployment of automated inventory systems in Europe (2010), as well as an off-site consolidation centre (2019) and in-house wholesaler (2021). He has been the procurement lead for the South East London Pathology Programme (£2b) and NHS England
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