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基于统计过程控制和纵向质量保证的手术追踪系统的性能评估
I Butz1, M Fernandez1, A Uneri1
1Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD, USA.
Computer assisted surgery (Abingdon, England)
|November 9, 2023
概括
一个新的质量保证系统使用几何精度和统计过程控制进行手术追踪器测试. 这种快速,例行测试可以识别跟踪器性能问题,确保可靠的外科导航.
科学领域:
- 医疗器械性能评估 医疗器械性能评估 医疗器械性能评估
- 手术导航技术的技术手术导航技术
- 医疗保健中的质量保证
背景情况:
- 手术追踪器对于在手术过程中准确定位仪器至关重要.
- 现有的性能评估方法可能不支持常规的纵向测试.
- 确保手术追踪器的持续准确性和可靠性对于患者安全至关重要.
研究的目的:
- 报告一项用于外科追踪器的性能评估和质量保证 (QA) 的新系统.
- 实施使用几何精度和统计过程控制 (SPC) 的常规纵向测试.
- 为手术追踪系统建立快速的质量保证过程 (<1分钟).
主要方法:
- 设计了一个简单的质量保证测试幻象,基于针对目标注册错误 (TRE) 的分析模型的注册信托.
- 配置了一个带有开源软件的追踪器测试台,以测量基于TRE的准确性和Jitter.
- 进行第一阶段SPC分析以确定系统控制限制和第二阶段每周质量保证,长达32周.
主要成果:
- 对六个经过测试的NDI追踪器 (2个EM,4个IR) 建立了控制极限.
- 与红外 (IR) 追踪器相比,电磁 (EM) 追踪器显示了更高的精度和Jitter控制极限.
- 像Vicra这样的旧追踪器显示出性能下降的证据 (例如,增加了Jitter,p < .05).
结论:
- 开发的系统可以为手术追踪器提供高效 (<1分钟) 和常规的纵向QA.
- 该过程成功地确定了跟踪器性能变化和随着时间的推移潜在的退化.
- 干预解决了大多数故障,突出了该系统在维持外科导航准确度方面的实用性.
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