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Towards spill-free in-bag morcellation
- Source :
- Surgical Endoscopy, Surgical Endoscopy: surgical and interventional techniques (online), 32(10), Surgical Endoscopy, 32(10), 4357-4362
- Publication Year :
- 2018
-
Abstract
- 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.
- Subjects :
- Leiomyosarcoma
medicine.medical_treatment
Morcellation
Hysterectomy
03 medical and health sciences
Spillage
0302 clinical medicine
Uterine Myomectomy
Medicine
Humans
Operations management
Healthcare Failure Mode and Effect Analysis
Prospective Studies
030219 obstetrics & reproductive medicine
Uterine leiomyosarcoma
business.industry
Laparoscopic hysterectomy
Prospective risk
Sarcoma
Surgical procedures
New Technology
Myomectomy
030220 oncology & carcinogenesis
Uterine Neoplasms
Surgery
Female
Laparoscopy
Reference case
business
Failure mode and effects analysis
Subjects
Details
- Language :
- English
- ISSN :
- 09302794
- Volume :
- 32
- Issue :
- 10
- Database :
- OpenAIRE
- Journal :
- Surgical Endoscopy: surgical and interventional techniques (online)
- Accession number :
- edsair.doi.dedup.....500321f59ef540aae472dd4397da366e