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UK national survey on nuclear medicine in-house clinical software: the calm before the storm

Year: 2024

Type: article

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.

Source: Nuclear Medicine Communications

DOI: 10.1097/mnm.0000000000001917

Authors: Anthony W. Murray, James W. Scuffham, John C. Dickson, Matthew Memmott, On Behalf of the UK Heads of Nuclear Medicine Physics Group

Institutions: Leeds Teaching Hospitals NHS Trust, Royal Surrey NHS Foundation Trust, University College London Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

OpenAlex ID: W4403470902

FWCI:

Cites: 2

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Related to: 10