Risk-Based Maintenance of Medical Devices for use with Humans (2018)

Type of publication:

*Nigel Watkinson

University of Derby

Medical devices continue to increase in quantity and complexity, and as they have a direct correlation with human health and safety their correct use and operation is paramount. This includes effective maintenance to retain serviceability and extend service life. Hospital Clinical Engineering departments are responsible for developing and operating Equipment Management Programs to ensure the safety and reliability of devices whilst optimising lifecycle costs for the organisation. Maintenance of engineering assets traditionally involves following manufacturers predetermined servicing activity at fixed intervals; however, alternative approaches have been employed in many engineering industries to optimise maintenance management resources with reduced risk. Risk-based maintenance (RBM) strategies being the most recent development are evaluated in this paper to consider their appropriateness with medical devices in UK hospitals. A mixed methods approach is used for the research study with a literature review of RBM in engineering industries, analysis of a survey of 74 UK medical engineering professionals and equipment service data
from local organisation. The current and future position of RBM is discussed including development of RBM methodology to be employed with medical devices in UK hospitals.

The study identifies strong endorsement of RBM principles by medical engineering professionals, including widespread employment of RBM, yet with no standardisation. Opposition to RBM is also encountered in favour of traditional approaches with variations in attitude to risk. Recommendations include collaboration of UK professionals for further research and development of medical device specific RBM with standardisation of methodology and approach with engagement of healthcare regulatory authorities.