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and Healthcare products Regulatory Agency, which also issues safety information and device alerts. In the US, the FDA records adverse events, with data on them available in its searchable MAUDE database.


Governance of medical devices The safe and effective application of medical devices is achieved by processes in their development and in their application. These can conveniently be described by cocoon layers that surround the device at the point of care.11


The governance processes can be viewed as three layers surrounding the device and its application (figure 3). These have been described in detail by Hegarty et al11


as an A to Z of support, with the first layer comprising processes at the point of care. These processes will ensure the availability of the appropriate devices to satisfy the clinical need; lack of availability is a frequent cause of incidents. It is not sufficient that devices are available, but that they are fully functional and operated by carers who know the devices and how best to use them. These processes can be thought of as safety barriers in Reason’s Swiss Cheese model. Surrounding these point-of-care processes is a layer of governance within the healthcare organisation. It should have strategic plans governing its medical device assets, their financing and selection and acquisition processes. A Medical Devices Committee can be a useful tool to practically ensure oversight. It should link to the organisation’s managing Board, with a Board member responsible for medical devices and their application. The responsible officer will want to ensure that the devices are protected from cyber-attacks and that any patient data collected by medical devices is safeguarded. Procedures should be in place for investigating adverse events involving medical devices and of implementing any safety warnings issued by regulatory authorities and manufacturers. The application of medical devices is protected by national and international standards and regulations and by the governance processes of manufacturers and suppliers. We have seen that a human usability standard exists4


; it complements general and


device-specific standards. Regulatory bodies, in the UK, such as the MHRA, provide medical device governance, liaising with suppliers to ensure devices are safe and effective. Post surveillance of products on the market capture unfolding problems. Professional bodies support and set standards for those who use and those who manage the devices.


Discussion


Medical devices and their application should be governed by structured processes that support the day-to-day delivery of care,


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Figure 3: Governance processes at the point of care, within healthcare organisations and at National and International level that promote safe and effective care.


both within hospitals and the community. Planning and analysis should support the objective of care and the central position of people. This goes beyond “people centred care” with a fundamental deep understanding of why care processes exist. This was the thinking behind the Keystone model, focusing on patient and carer.2 The safe and effective application of medical devices can be enhanced by analysis of care processes using holistic models such as figure 1. They allow the devices to be viewed in the context of care, both at the planning stage when selecting what to procure to meet expected clinical needs, and at their applications, analysing the operation of devices in supporting care. Adverse events are typically caused


by imperfections in barriers that ensure safe operation.1


Reason’s Swiss Cheese


model (figure 2) helps direct attention to these processes and to possible failure mechanisms that need attention. The general concepts of human usability and mistake proofing can guide those planning and using medical devices. Finally, comprehensive governance at national and international level, at the level of the healthcare organisation and right at the point of care, can put in place operating principles to ensure safe and effective application of medical devices for the benefits of patients and carers (figure 3). CSJ


References 1 Reason J. Human error: models and management. BMJ 2000;320:768-70.


2 Patricia Brooks Young and John Amoore. A guide to improving the value of technology-enabled care, the Keystone Model. Scope 2020 29(1):10-11. The Institute of Physics and Engineering in Medicine


3 ECRI Institute: The Top 10 Health Technology Hazards for 2019: 2019 Top Ten Health Technology Hazards (10/2019) (ecri.org).


4 IEC 60601-1-6 3.2 Edition July 2020. Medical Electrical Equipment – Part 1-6: General


About the author


John Amoore graduated with a BSc in Electrical Engineering before furthering his training to a Biomedical Engineering career with an MSc in Physiology and a PhD in Biomedical Engineering. His working career spanned research, academia, industry before applying engineering to healthcare within the NHS. Particular interests include safe use of infusion devices (volumetric and syringe pumps, staff training, application of syringe drivers for palliative care), improved understanding of non-invasive monitors (blood pressure, pulse oximetry, temperature), safe application of medical devices and incident analysis, procurement of healthcare technology and its overall management. Since retiring in 2015 John has continued his interest in the field, contributing to books and articles.


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requirements for basic safety and essential performance – Collateral Standard: Usability.


5 Grout JR. Mistake proofing: changing designs to reduce errors. Quality & Safety in Health Care, 2006; 15: 44-49. DOI 10.1136/qshc.2005.016030


6 Amoore JN. A structured approach for investigating the causes of medical device adverse events. Journal of Medical Engineering. Vol. 2014, Article ID 314138, 13 pages, 2014, http://www.hindawi.com/ journals/jme/2014/314138/


7 Kohn LT, Corrigan JM, Donaldson MM. To err is human. Building a safer health system. National Academy Press, Washington, DC 1999


8 An organisation with a memory: report of an expert group on learning from adverse events in the NHS chaired by the Chief Medical Officer. Department of Health. London: Stationery Office, 2000


9 NRLS national patient safety incident reports: commentary. March 2020. https://improvement. nhs.uk/documents/6571/NAPSIR_commentary_ March_2020.pdf Report template - NHSI website (improvement.nhs.uk)


10 Freedom of Information: NRLS adverse events. November 2019. NHS England » Freedom of Information: NRLS adverse events


11 Medical Device Governance. Chapter 9 pages 495 to 506 in Hegarty F, Amoore J, Blackett P, McCarthy J, Scott R Healthcare Technology Management – A systematic approach. CRC Press: Abingdon, UK, 2017


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