MEDICAL DEVICE MANAGEMENT
A strong case for new AE (Medical Devices) role
Professor John Sandham CEng, FIHEEM, discusses the potential positive impact of the new role of IHEEM Authorising Engineer (Medical Devices) – which ‘became official’ on 2 June – drawing on the insights gained from a case study conducted within an NHS Trust, which explored what he dubs ‘the transformative potential of a collaborative, expert-led, intervention in medical device management policy’.
Hospitals globally face persistent challenges in medical device management, impacting patient safety, operational efficiency, and financial sustainability. This paper draws insights from a seminal doctoral case study conducted within an NHS Trust, which explored the transformative potential of a collaborative, expert-led intervention in medical device management policy. The study identified systemic issues such as fragmented procurement, inconsistent training, and siloed departmental operations, directly contributing to avoidable patient harm and escalating costs. Findings demonstrate that an independent, expert-driven approach, analogous to the role of an Authorising Engineer (Medical Devices) (AE (MD)), can effectively identify latent risks, drive comprehensive policy redesign, and foster a culture of continuous improvement. This would result in significant benefits – including substantial cost savings, enhanced patient safety, improved staff competency, and strengthened clinical governance, thereby positioning the AE (MD) as a vital strategic asset for NHS Trusts in an increasingly complex regulatory and technological landscape.
The enduring challenge of medical device management Medical devices are foundational to contemporary healthcare delivery, underpinning diagnostics, therapeutic interventions, and patient rehabilitation. However, their escalating volume, diversity, and technological complexity, present formidable management challenges for healthcare organisations globally. Reputable international and national bodies, including the National Audit Office (NAO), National Patient Safety Agency (NPSA), Medicines and Healthcare products Regulatory Agency (MHRA), NHS Resolution (formerly NHS Litigation Authority), and the World Health Organization (WHO), have consistently documented critical issues stemming from suboptimal medical device management. These issues directly impact patient safety, and contribute significantly to escalating healthcare costs. The persistence of these challenges is starkly evident in recent data, demonstrating a continuing issue over the past two decades. As early as 2004, an NPSA report highlighted ‘uncontrolled purchasing and device management, in the absence of competency-based training’, as significant contributing factors to incidents.1
The
Care Quality Commission (CQC), in its 2010 report, even listed device management as one of the worst-performing areas of NHS management.2
This historical context is reinforced by more recent figures: a comprehensive
global investigation by the International Consortium of Investigative Journalists (ICIJ) in 2018, ‘The Implant Files’, linked poorly tested or faulty medical devices to over 1.7 million injuries and nearly 83,000 deaths globally over a decade, highlighting systemic failures in regulatory systems and transparency.3,4
In the UK, NHS Resolution
reported total clinical negligence payments of £2.87 bn in 2023/24, with a significant portion of claims directly or indirectly linked to equipment issues,5
tangible impact of device management failures.
Continuing equipment incidents Furthermore, analysis of NHS ‘Never events’ data for 2024/25 indicates a continuing presence of incidents involving equipment, reinforcing the fact that device- related harm remains a persistent concern.6
underscoring the
The author says: “Medical devices are foundational to contemporary healthcare delivery, underpinning diagnostics, therapeutic interventions, and patient rehabilitation.”
The MHRA
continues to report adverse incidents involving medical devices, including beds and associated equipment, with serious cases leading to injury and death, thereby emphasising the critical importance of appropriate staff training, correct use, and adequate service and maintenance.7
These figures, alongside ongoing
challenges in medical device vigilance and the increasing complexity of devices – including Software as a Medical Device (SaMD), underscore the fact that suboptimal medical device management has been a continuing issue over the past two decades.8 The UK government’s proactive response, exemplified
by the introduction of new Health and Social Care Act Regulations, including CQC Regulation 15 (Premises and Equipment), aims to address patient safety concerns related to medical devices.9
This regulation specifically mandates that equipment used by service-providers must August 2025 Health Estate Journal 35
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