对于孩子来说安全吗? 放射学中的AI医疗设备忽视了儿科适用性
Brendan S Kelly1, Jennifer Lee2, Edward Antram3
1Department of Clinical Radiology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK. brendan.kelly@gosh.nhs.uk.
European radiology
|October 8, 2025
概括
大多数欧洲放射性人工智能医疗器械缺乏明确的儿科用品标签,从而危及患者的安全. 建议制定标准化的儿科安全指标,以确保在儿童医学中适当使用人工智能.
科学领域:
- 医学成像和人工智能 医学成像和人工智能
- 监管科学 监管科学
- 儿科健康 儿科健康
背景情况:
- 在美国FDA批准的设备中,人们注意到AI医疗器械的预期用途和目标人群的标签不一致,特别是针对儿童的医疗器械.
- 在欧洲批准的AI医疗器械的标签问题,特别是放射学领域的标签问题,在很大程度上仍未得到解决.
研究的目的:
- 评估欧洲批准的AI医疗器械在放射学中的标签明确性和适用于儿科人口的适用性.
- 识别与标签不清晰相关的潜在风险,例如儿童患者无意中非标签使用.
主要方法:
- 从公开可用的数据库中对监管机构批准的放射学AI医疗器械进行全面审查.
- 独立审查关于使用情况,模式和预期人群的产品信息.
- 对具有不清楚预期群体的设备的科学文献和营销材料进行标准化审查.
主要成果:
- 只有2%的AI医疗器械被明确标记为儿童使用,11%的AI医疗器械适用于所有年龄段.
- 显著的大多数 (41%) 设备在数据库中缺乏明确的预期人口信息.
- 进一步的调查显示,这些不清楚的设备中有7%包括儿科患者,但即使经过额外的审查,47%仍然不清楚.
结论:
- 欧洲大多数受监管的放射性人工智能医疗器械都显示出关于儿科使用的信息缺失或模糊.
- 这种缺乏明确性带来了重大风险,包括潜在的非标签性使用和危及患者安全.
- 建议倡导标准化儿科安全指标,以提高透明度和问责制,与欧盟AI法案的原则保持一致.
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