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首页> 外文期刊>Surgical Endoscopy >Towards spill-free in-bag morcellation: a health failure mode and effects analysis
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Towards spill-free in-bag morcellation: a health failure mode and effects analysis

机译：朝向无溢袋的毛刺：健康失败模式和效果分析

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Background To assess potential risks of new surgical procedures and devices before their introduction into daily practice, a prospective risk inventory (PRI) is a required step. This study assesses the applicability of the Health Failure Mode and Effects Analysis (HFMEA) as part of a PRI of new technology in minimally invasive gynecologic surgery. Methods A reference case was defined of a patient with presumed benign leiomyoma undergoing a laparoscopic hysterectomy or myomectomy including in-bag power morcellation; however, pathology defined a stage I uterine leiomyosarcoma. Using in-bag morcellation as a template, a HFMEA was performed. All steps of the in-bag morcellation technique were identified. Next, the possible hazards of these steps were explored and possible measures to control these hazards were discussed. Results Five main steps of the morcellation process were identified. For retrieval bags without openings to accommodate instruments inside the bag, 120 risks were identified. Of these risks, 67 should be eliminated. For containment bags with openings 131 risks were identified of which 68 should be eliminated. Of the 10 causes most at risk to cause spillage, two can be eliminated by using appropriate bag materials. Myomectomy appears to be more at risk for residual tissue spillage compared to total hysterectomy. Conclusion The HFMEA has provided important new insights regarding potential weaknesses of the in-bag morcellation technique, particularly with respect to hazardous steps in the morcellation process as well as requirements that bags should meet. As such, this study has shown HFMEA to be a valuable method that identifies and quantifies potential hazards of new technology.
机译：背景，以评估新的外科手术和设备的潜在风险，然后在他们介绍日常实践之前，预期风险库存（PRI）是必需的一步。本研究评估了健康失效模式和效果分析（HFMEA）的适用性作为微创妇科手术中新技术的PRI的一部分。方法对患有腹腔镜子宫切除术或肌肉切除术的假定良性平滑肌瘤的患者定义参考案例;然而，病理学定义了一个阶段的子宫平滑肌肉瘤。使用袋子的MERCellation作为模板，进行了HFMEA。鉴定了袋内毛皮细胞技术的所有步骤。接下来，探讨了这些步骤的可能危害，并讨论了控制这些危害的可能措施。结果鉴定了梅塞尔化过程的五个主要步骤。对于没有开口的检索袋，以容纳袋内的仪器，确定了120个风险。在这些风险中，应消除67个。对于具有开口的容纳袋131，鉴定出风险，其中应消除68个。对于引起溢出的风险最大的10个原因，可以通过使用适当的袋材料来消除两种。与总子宫切除术相比，肌瘤切除术似乎更具危险的残留组织溢出。结论HFMEA对袋内毛板技术的潜在弱点提供了重要的新见解，特别是对于毛刺过程中的危险步骤以及袋子应该满足的要求。因此，本研究表明，HFMEA是一种识别和量化新技术潜在危害的有价值的方法。

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