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

Abstract

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. 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. 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. 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.