1. UK national survey on nuclear medicine in-house clinical software: the calm before the storm.
- Author
-
Murray AW, Scuffham JW, Dickson JC, and Memmott M
- Subjects
- United Kingdom, Surveys and Questionnaires, Humans, Quality Control, Software, Nuclear Medicine
- Abstract
Introduction: The use of in-house developed software as a medical device (IHD-SaMD) is core to many nuclear medicine (NM) services in the UK, including applications in nonimaging studies and image processing. Expected regulatory changes in 2025 could have significant implications due to a lack of resources and expertise in the implementation and maintenance of software Quality Management Systems (QMS) and associated standards. This survey investigated the national use of IHD-SaMD and the readiness of services to adapt to the upcoming regulatory changes., Method: An online survey was used to investigate the current national usage of IHD-SaMD. Representatives of 64 UK NM physics services were invited to participate, with 43 responding., Results: It was found that 98% of respondents use IHD-SaMD clinically. About 65% use IHD-SaMD that respondents felt was under-supported (e.g. legacy software). Approximately 60% of respondents use or support two or more pieces of IHD-SaMD. Around 66% of respondents use a QMS in their department, with about 48% using a software-specific QMS. Most respondents indicate understaffing, particularly with regard to IT/software skillsets. Almost all respondents indicate without an increase in the preparedness and understanding of the requirements, all dependent clinical services would be severely impacted or indeed stopped., Conclusion: This national survey shows that pending regulatory changes could significantly impact NM services, up to and including stopping clinical services. Additional resources would be required to support in-house software management under an appropriate QMS or move to European conformity marking (CE)-marked software where available. This must be urgently considered and addressed by all NM stakeholders., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
- Published
- 2025
- Full Text
- View/download PDF