title: The Development of a New Medical Device for Standardized Episiotomy: A Pre-Clinical Validation Study.
abstract: BACKGROUND
  The aim of this study was to present the validation and optimization process for a new innovative medical device to create a standardized episiotomy.
  
  
  METHODS
  We performed a preclinical validation study.
  
  
  METHODS
  This study was performed at the University hospital.
  
  
  METHODS
  Animal, cadaver.
  
  
  METHODS
  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.
  
  
  METHODS
  Ability to perform a standardized incision, ease of use.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Femke
authors.initials: F
authors.lastname: Mulder
authors.forename: Dorine
authors.initials: D
authors.lastname: Piersma
authors.forename: Sebastiaan
authors.initials: S
authors.lastname: Veersema
authors.forename: Joris
authors.initials: J
authors.lastname: van der Post
authors.forename: Jan-Paul
authors.initials: JP
authors.lastname: Roovers
mesh_terms: D000818:Animals; D002102:Cadaver; D004841:Episiotomy / Q000295:instrumentation*; D005260:Female; D006785:Hospitals, University; D006801:Humans; D010502:Perineum / Q000601:surgery; D011247:Pregnancy; D013523:Surgical Equipment; D013552:Swine; D014621:Vagina / Q000601:surgery