目的 通过调研医院人工智能医疗器械(artificial intelligence medical devices,AIMD)在医院的使用现状、潜在使用人员对产品接受程度以及对未来产品的期望,从使用者角度为AIMD生产研发企业提供产品研发方向、生产质量管理体系完善的意见和建议.方法 基于AIMD产业发展现状,设计AIMD使用现状及需求调研问卷,通过问卷网平台,以微信消息的方式邀请医院医学影像技术部门、设备管理部门等相关人员进行问卷填写,利用Excel 2019对调研结果进行分析.结果 共回收66份问卷,分布在26个省(市、区)的医院.通过分析可知,目前人工智能医疗器械产品在医院的普及程度较好,60.61％的受访者(40人)对人工智能医疗器械产品有一定了解,普遍对人工智能医疗器械未来发展持乐观态度.91.00％的受访者(60人)表示人工智能医疗器械产品确实减轻了工作量,但86.36％的受访者(57人)仍对人工智能医疗器械产品的可靠性持怀疑态度.结论 通过调研分析,对人工智能医疗器械产品在医院的使用情况有了初步了解,为人工智能医疗器械生产研发提供参考.

Objective To understand the current situation of artificial intelligence production enterprise quality management system, so as to provide reference basis for the research and standardization of Artificial Intelligence Medical Device (AIMD) product quality management. Methods Based on YY/T 0287-2017 Medical Device Quality Management System for Regulatory Requirements, Medical Equipment Production and the Quality Control Standard for Independent Software Appendix and Xavier GMLP report, the relevant factors were screened and the questionnaire was designed by combining expert consultation and literature review. Then, a total of 32 representative AIMD enterprises were invited to fill in the questionnaire. Descriptive statistical analysis was performed on the data results using Excel 2016. Results Through in-depth analysis of the four themes in product planning and design, result output, product quality control and product change, it was found that it was necessary for enterprises participating in the survey to improve the quality management system of AIMD products to different degrees. Conclusions This study is the first time to systematically investigate the status quo of quality management of AIMD enterprises. The result will be useful for the establishment and continuous improvement of product quality management system. It will also provide a reference for the research of AIMD product quality management and the establishment of the standard.