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

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 tec...

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Autores principales: van den Haak, Lukas, van der Eijk, Anne C., Sandberg, Evelien M., Frank, Gerard Peter G. M., Ansink, Karin, Pelger, Rob C. M., de Kroon, Cor D., Jansen, Frank Willem
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132883/
https://www.ncbi.nlm.nih.gov/pubmed/29987561
http://dx.doi.org/10.1007/s00464-018-6284-z
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author van den Haak, Lukas
van der Eijk, Anne C.
Sandberg, Evelien M.
Frank, Gerard Peter G. M.
Ansink, Karin
Pelger, Rob C. M.
de Kroon, Cor D.
Jansen, Frank Willem
author_facet van den Haak, Lukas
van der Eijk, Anne C.
Sandberg, Evelien M.
Frank, Gerard Peter G. M.
Ansink, Karin
Pelger, Rob C. M.
de Kroon, Cor D.
Jansen, Frank Willem
author_sort van den Haak, Lukas
collection PubMed
description 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.
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spelling pubmed-61328832018-09-13 Towards spill-free in-bag morcellation: a health failure mode and effects analysis van den Haak, Lukas van der Eijk, Anne C. Sandberg, Evelien M. Frank, Gerard Peter G. M. Ansink, Karin Pelger, Rob C. M. de Kroon, Cor D. Jansen, Frank Willem Surg Endosc New Technology 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. Springer US 2018-07-09 2018 /pmc/articles/PMC6132883/ /pubmed/29987561 http://dx.doi.org/10.1007/s00464-018-6284-z Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle New Technology
van den Haak, Lukas
van der Eijk, Anne C.
Sandberg, Evelien M.
Frank, Gerard Peter G. M.
Ansink, Karin
Pelger, Rob C. M.
de Kroon, Cor D.
Jansen, Frank Willem
Towards spill-free in-bag morcellation: a health failure mode and effects analysis
title Towards spill-free in-bag morcellation: a health failure mode and effects analysis
title_full Towards spill-free in-bag morcellation: a health failure mode and effects analysis
title_fullStr Towards spill-free in-bag morcellation: a health failure mode and effects analysis
title_full_unstemmed Towards spill-free in-bag morcellation: a health failure mode and effects analysis
title_short Towards spill-free in-bag morcellation: a health failure mode and effects analysis
title_sort towards spill-free in-bag morcellation: a health failure mode and effects analysis
topic New Technology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132883/
https://www.ncbi.nlm.nih.gov/pubmed/29987561
http://dx.doi.org/10.1007/s00464-018-6284-z
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