The Development of a New Medical Device for Standardized Episiotomy: A Pre-Clinical Validation Study

The aim of this study was to present the validation and optimization process for a new innovative medical device to create a standardized episiotomy. We performed a preclinical validation study. This study was performed at the University hospital. Animal, cadaver. Together with technical engineers,...

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Bibliographic Details
Published inGynecologic and obstetric investigation Vol. 81; no. 3; p. 207
Main Authors Mulder, Femke, Piersma, Dorine, Veersema, Sebastiaan, van der Post, Joris, Roovers, Jan-Paul
Format Journal Article
LanguageEnglish
Published Switzerland 01.01.2016
Subjects
Animals
Cadaver
Episiotomy - instrumentation
Female
Hospitals, University
Humans
Perineum - surgery
Pregnancy
Surgical Equipment
Swine
Vagina - surgery
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Summary:The aim of this study was to present the validation and optimization process for a new innovative medical device to create a standardized episiotomy. We performed a preclinical validation study. This study was performed at the University hospital. Animal, cadaver. Together with technical engineers, we designed a new medical device that involves a knife and cuts back from buttock toward introitus, in contrast to the conventional episiotomy. We optimized the design and its performance in consecutive animal and cadaver studies. Ability to perform a standardized incision, ease of use. After multiple adjustments, based on the results of multiple animal and cadaver studies, a medical device was developed to perform a standardized clean-cut episiotomy of 4-6 cm length. We have shown that optimizing the technical performance and safety of an innovative device in animals, prior to opposing patients to its potential hazards, is feasible. Our design optimizing study can be used as a model for the pre-clinical validation of future innovative medical devices.
ISSN:1423-002X
DOI:10.1159/000440976