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

Gynecologic and obstetric investigation

PubMedID: 26584431

Mulder F, Piersma D, Veersema S, van der Post J, Roovers JP. The Development of a New Medical Device for Standardized Episiotomy: A Pre-Clinical Validation Study. Gynecol Obstet Invest. 2016;.
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.

DESIGN
We performed a preclinical validation study.

SETTING
This study was performed at the University hospital.

SAMPLE
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.

MAIN OUTCOME MEASURES
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.

CONCLUSION
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.