MEDICAL DEVICE MANAGEMENT Procurement policy •Buying devices Training policy •Using devices Maintenance policy


• Maintaining devices


Governance policy


• Managing policy compliance


Procurement planning is essential to transformation.


with robust external verification of their oversight, and the tangible effectiveness of their policies, thereby strengthening the overall clinical governance framework.


Discussion: The value proposition of the Authorising Engineer (Medical Devices) The compelling findings in this paper strongly support the critical need for, and immense value of, an Authorising Engineer (Medical Devices) (AE (MD)) role within NHS Trusts. The AE (MD) functions as a vital external check, providing expert, unbiased insights that yield multifaceted benefits: n Bolstering patient safety: By independently identifying and mitigating latent risks across the entire medical device lifecycle – from strategic procurement to safe disposal, the AE (MD) directly contributes to reducing avoidable patient harm. This is crucial given the continued incidence of device-related injuries and deaths globally and within the UK.


John Sandham


John Sandham DProf, CEng, FIHEEM, MIET, is a British Chartered Engineer, Fellow of IHEEM, and an entrepreneur with over 35 years’ experience in healthcare technology management. He has successfully built multiple businesses in clinical engineering and property development. John holds a Doctorate in Medical Devices Management, and has authored over 300 educational articles. An Honorary Professor at the University of Warwick, mentoring postgraduate students, and a Visiting Senior Research Fellow at Middlesex University, he chairs the Annual EBME Expo, and serves as an executive advisor to MTS Health (a Sodexo company). He is also dedicated to improving global healthcare access as Chairman of My Bridge International and a Trustee of the Amalthea Trust.


n Ensuring regulatory compliance: The AE (MD) provides credible external validation that a Trust’s medical device management system adheres to national legislation and guidance (e.g. MHRA 2021,7


evolving


UK MDR), thereby safeguarding the organisation’s reputation, and mitigating the risk of regulatory penalties.


n Optimising financial investments: Through driving standardisation and efficient procurement practices, the AE (MD) facilitates significant cost savings, and ensures better utilisation of costly medical assets, contributing to long-term financial sustainability.


n Enhancing operational efficiency: By streamlining processes, reducing device downtime, and improving staff competency, the AE (MD) contributes to smoother clinical operations and improved patient throughput.


n Driving strategic organisational impact: By providing strategic recommendations based on expert analysis and benchmarking, the AE (MD) empowers Trusts to adopt a proactive, learning-orientated approach to medical device management, fostering continuous improvement and organisational resilience in the face of evolving healthcare demands.


The success of the case study in transforming policy and practice through collaborative action research, led by an expert AE (MD) ‘equivalent’, serves as a compelling model for how the IHEEM-accredited AE (MD) can contribute to a safer, more efficient, and more compliant, healthcare environment.


Conclusions The complexities of medical device management in NHS Trusts pose significant challenges, directly impacting patient safety, costs, and operational effectiveness. This paper unequivocally demonstrates that a structured, independent, and expert-led intervention, analogous to the Authorising Engineer (Medical Devices) role, is not merely beneficial, but represents a strategic imperative. By rigorously focusing on systemic issues, particularly the pivotal role of procurement, and by fostering multidisciplinary collaboration, an AE (MD) can drive the


38 Health Estate Journal August 2025


development and implementation of best practice policies that yield tangible improvements in patient safety, enhance financial stewardship, and build organisational resilience. The profound insights from this research provide a robust foundation for advocating the wider adoption of the AE (MD) role across the NHS, ultimately contributing to a safer, more effective, and more sustainable, healthcare system for all.


References 1 National Patient Safety Agency. (2004). Standardising and Centralising Infusion Devices. NPSA.


2 Care Quality Commission. (2010). Regulation 16. Outcome 11: Safety, availability, and suitability of equipment. Croner-1, 2025. https://tinyurl.com/ye2xwcnz


3 International Consortium of Investigative Journalists (ICIJ). (2018a, 25 November). Medical Devices Harm Patients Worldwide As Governments Fail On Safety. [Online] https://tinyurl.com/3afv8j69


4 International Consortium of Investigative Journalists (ICIJ). (2018b, 25 November ). New Database Tracks Faulty Medical Devices Across The Globe. [Online] https://tinyurl.com/ hz5a4rtz


5 NHS Resolution. NHS Resolution continues trend of resolving more cases without need for litigation. [Online] 23 July 2024. https://resolution.nhs.uk/2024/07/23/nhs-resolution- continues-trend-of-resolving-more-cases-without-need-for- litigation/


6 Medical devices: examples of reportable incidents. [Online] MHRA. 15 January 2025. https://tinyurl.com/2na5xpws


7 Managing Medical Devices – Guidance for Healthcare and Social Services Organisations. [Online] MHRA, January 2021. https://tinyurl.com/44a4ud2j


8 Managing Medical Devices: Guidance for healthcare and social services organisations. MHRA, 2006.


9 Care Quality Commission, 2014. Regulation 15: Premises and equipment. https://tinyurl.com/4sd4avd2


10 Sandham J. Achieving a Best Practice Model for Medical Devices Management Policy. Doctoral Thesis. Middlesex University, 2013.


11 Sandham, J. (2012). Equipment policy: Meeting regulations. Clinical Services Journal; May 2012; 29–32.


12 Zuber-Skerritt O. New Directions in Action Research. Falmer Press, 1996.


13 Hart E, Bond, M. (1995). Action Research for Health and Social Care. Open University Press, 1995.


14 Stringer ET. Action Research. Sage, 23 August 1999. 15 Mcfarlane M. Biggest Quality Challenges in the Medical Device Industry. Greenlight Guru, 31 March 2025. https://www.greenlight.guru/blog/quality-challenges


16 World Health Organization. Increasing Complexity of Medical Technology and Consequences for Training and Outcome of Care. [Online] August 2010. https://iris.who.int/ handle/10665/70455


17 Cognidox. Training management in your medical device QMS: what’s required? [Online] https://www.cognidox.com/blog/ training-management-medical-device-qms


18 World Health Organization (Trainings - World Health Organization (WHO). 23 February 2025. [Online] https://tinyurl.com/3srnvax8


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