Towards spill-free in-bag morcellation

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

van Den Haak, Lukas (Leiden University Medical Center)
van der Eijk, A.C. (Leiden University Medical Center)
Sandberg, Evelien M. (Leiden University Medical Center)
Frank, Gerard Peter G.M. (Leiden University Medical Center)
Ansink, Karin (Leiden University Medical Center)
Pelger, R.C.M. (Leiden University Medical Center)
de Kroon, Cor D. (Leiden University Medical Center)
Jansen, F.W. (TU Delft Medical Instruments & Bio-Inspired Technology; Leiden University Medical Center)

2018

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.

Hysterectomy
Laparoscopy
Morcellation
Myomectomy
Sarcoma

http://resolver.tudelft.nl/uuid:11525c86-38ae-4c13-a091-1a9e2b367451

https://doi.org/10.1007/s00464-018-6284-z

0930-2794

Surgical Endoscopy: surgical and interventional techniques (online), 32 (10), 4357-4362

Institutional Repository

journal article

© 2018 Lukas van Den Haak, A.C. van der Eijk, Evelien M. Sandberg, Gerard Peter G.M. Frank, Karin Ansink, R.C.M. Pelger, Cor D. de Kroon, F.W. Jansen