Towards spill-free in-bag morcellation: a health failure mode and effects analysis

Abstract

BackgroundTo 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.MethodsA 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.ResultsFive 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.ConclusionThe 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.

Uterine Leiomyosarcoma

“…But even using these tools, accidental morcellation of early uLMS tumors (stage Ia with a diameter of less than 5 cm confined to the uterus) may not be avoided, and stage Ia is the best prognostic group in uLMS. Therefore attention should be payed to risk analysis of endoscopic in-bag procedures [47] in order to improve safety by means of appropriate tools and operation procedure pathways for patients outside a score-defined risk population.…”

A New Method to Improve the Environmental Sustainability of the Operating Room: Healthcare Sustainability Mode and Effect Analysis (HSMEA)

“…Evaluation of the HFMEA has shown that although it is a time-and resource-intensive method, it is useful for assessing and improving the safety of healthcare processes [30][31][32]. The HFMEA has proven successful for improving patient safety in processes such as blood transfusions, drug administration, and in the introduction of new surgical techniques [33][34][35].…”

To Laparoscopically Preserve Fertility in Intraabdominal Giant Myoma with Application of Contained In-Bag Morcellation: Mission Impossible?

“…Therefore, a cautious manipulation of the tumor, bags and instruments minimizes the risk of intraoperative spillage, especially in cases of larger myomata. Moreover, there is a lack of evidence regarding how much of a bag puncture would provoke tissue spillage, as well as the meaning of micro-spillage occurring in inadvertent breach of bag integrity [ 25 ]. In the presented case no tissue spillage or bag puncture occurred.…”