Medical Devices: Evidence and Research (Sep 2023)

An Innovative Design for the Vaginal Speculum

  • Bouquet JM,
  • Naji R,
  • Armas CA,
  • Roldan V,
  • Selkhi S,
  • Bentley CZ,
  • Zapata I,
  • Fisher J

Journal volume & issue
Vol. Volume 16
pp. 211 – 218

Abstract

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Jean M Bouquet,1 Rayyan Naji,2 Carlos A Armas,2 Valentina Roldan,2 Shadi Selkhi,2 Camille Z Bentley,1 Isain Zapata,3 Jensen Fisher4 1Department of Family Medicine, Rocky Vista University College of Osteopathic Medicine, Englewood, CO, 80112, USA; 2Department of Biomedical Engineering, College of Engineering and Computing, Florida International University, Miami, FL, 33174, USA; 3Department of Biomedical Sciences, Rocky Vista University College of Osteopathic Medicine, Englewood, CO, 80112, USA; 4Medical Humanities Department, Rocky Vista University College of Osteopathic Medicine, Englewood, CO, 80112, USACorrespondence: Jean M Bouquet, Department of Family Medicine, Rocky Vista University College of Osteopathic Medicine, 8401, S. Chambers, Englewood, CO, 80112, USA, Email [email protected]: The main objective of this study is to evaluate the effectiveness of a newly designed vaginal speculum, the Bouquet Speculum, in-vitro. The setting of this study was at Florida International University and involved four senior students in the Department of Biomedical Engineering.Methods: A phantom vaginal model was used to test three variables of the Bouquet Speculum (Visibility, Pressure and Gynecologic Tools tests). As this was bench-lab testing with simulated models, no human participants were involved in this study.Results: The results of this in-vitro study are as follows: The visibility test demonstrated statistically better visualization of the cervix and the cervical os (sampling area for pap tests) with the Bouquet Speculum over the existing 2-bladed speculum at all intrapelvic pressures; The pressure test demonstrated an equal radial distribution of force, without breakage, across the Bouquet Speculum; The gynecologic tools test demonstrated that the Bouquet Speculum is compatible with the existing speculum and standard gynecologic tools in terms of retrieving samples and accessing the cervical os and entire cervix during gynecologic procedures and screening.Conclusion: The gynecologic screening and procedural value of this innovative change in the design of the vaginal speculum could save hundreds of thousands of lives every year, provide a more comfortable exam for the patient, and result in a more efficient and user-friendly provider experience.Keywords: medical device, vaginal speculum, public health, gynecology

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