Medical devices management


Authorising Engineer (MD): a vital new role


Prof. John Sandham CEng FIHEEM provides an insight into the role of Authorising Engineer (Medical Devices) and explains why this strategic imperative will enhance patient safety and organisational resilience within NHS Trusts.


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 leads to 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.


Introduction: the enduring challenge of medical device management in healthcare 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, a National Patient Safety Agency (NPSA) report highlighted “uncontrolled purchasing and device management, in the absence of competency-based training,” as significant contributing factors to incidents.1 The 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 billion in 2023/24, with a significant portion of claims directly or indirectly linked to equipment issues,5


underscoring the


tangible impact of device management failures. Furthermore, analysis of NHS Never Events data for 2024/25 indicates a continuing presence of incidents involving equipment, reinforcing that device-related harm remains a persistent concern.6


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 that suboptimal medical device management is 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 Care Quality Commission (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 be clean, secure, suitable, properly used, and properly maintained. Yet, despite these clear regulatory mandates,


practical implementation at the organisational level often lags, creating a persistent disconnect between policy intent and operational reality. I would suggest that an independent, expert oversight function, such as the Authorising Engineer for Medical Devices, AE (MD), is crucial for bridging this implementation gap and driving sustainable, transformative improvements in medical device management across the NHS.


The case for independent oversight: the Authorising Engineer (Medical Devices) 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.


August 2025 I www.clinicalservicesjournal.com 23


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