医疗器械知识制品的联邦共享与持续改进：一种概念模型
Federated Sharing and Continuous Improvement of Medical Device Knowledge Artifacts: A Conceptual Model
中文总结 AI 辅助
本文提出一种以制品为中心的联邦交换基础设施模型，解决医疗知识制品共享与改进的本地管控问题，通过整合式文献综述明确相关研究现状，构建可支持离线使用与记录反馈的联邦学习网络。
中文摘要 AI 辅助
医疗机构使用数字系统交换临床病例信息，拥有数字生产设施的医疗中心在诊疗过程中创建设计，这些设计与生产记录通常留存于制作站点，其他站点可能难以找到合适的设计或了解医护人员使用时的情况，移动医疗中心在脱离医院系统工作时也可能无法访问相关数据。本文提出一种以制品为中心的联邦交换基础设施模型，允许医院和移动医疗中心在管控自身记录与决策的同时，共享并改进医疗知识。一项整合式文献综述筛选了910条记录，将240篇文献对应到6个研究问题，详细研读了72篇文献以追踪从本地使用到共享知识决策的路径。该综述发现，目前尚无通用流程将本地使用记录与关于向后续用户共享知识变更的决策关联起来。所提模型将病例数据留存于各站点，记录每次使用所依据的制品版本，联邦机制允许各站点共享经审核的版本并反馈使用记录供审核，移动单元可在部署前接收制品并在离线状态下记录使用情况，重新联网后即可与其他站点交换这些记录。床旁制造展示了医疗器械知识制品如何将设计与生产记录关联，同时由诊疗站点管控产品发布，联邦机制可形成一个受管控的学习网络，使一个站点的经验能改进其他站点使用的医疗知识制品，同时保持各站点的本地自主权。
英文摘要
Healthcare organisations use digital systems to exchange information from clinical cases. Medical centres with digital production facilities create device designs during care. These designs and production records often remain at the site that made them. Other sites may struggle to find a suitable design or learn what happened when staff used it. Mobile medical centres may also lose access when they work away from hospital systems. This paper proposes an artifact-centred model for a federated exchange infrastructure that lets hospitals and mobile medical centres share and improve medical knowledge while controlling their own records and decisions. An integrative literature review screened 910 records and mapped 240 publications across six questions. We read 72 publications in detail to trace the path from local use to a decision about shared knowledge. The review found no common process that links a record of local use to a decision about changing the knowledge shared with later users. The model keeps case data at each site and records which artifact version informed each use. Federation lets sites share reviewed versions and return records from use for review. Mobile units can receive artifacts before deployment and record their use while offline. After reconnecting, they can exchange these records with other sites. Point-of-care manufacturing shows how a medical device knowledge artifact connects a design to production records while the care site controls product release. Federation could form a governed learning network where one site's experience improves medical knowledge artifacts used elsewhere while authority remains local.
