Updated on October 30, 2023

·

Created on July 23, 2019

Odon Device

Upcoming Update

Odon Device is a simple assisted vaginal delivery device for complicated labor

Developed By
  1. Jorge Odón
Content Partners
Unknown

Author

Product Description

The Odon Device was designed for assistive birth delivery in cases of prolonged labor, transverse, or breech babies. The device, which is currently under clinical trial, is intended to reduce complications from prolonged labor, such as infection, and newborn complications, such as birth asphyxia.

Target Regions

Africa, Central Asia, East Asia, East Asia and Pacific, North Asia, South America, South Asia, Southeast Asia

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$50.00

Target Users (Target Impact Group)

Community, Small and Medium-sized Enterprises

Distributors / Implementing Organizations

WHO, Becton Dickinson and Company

Manufacturing/Building Method

The Becton Dickinson Company has the rights to manufacture the Odon Device, however, manufacturing has not yet begun.

Intellectural Property Type

Patent Protected

User Provision Model

Product is not yet available on the market

Distributions to Date Status

None

Clinical application

Prolonged labor

Consumables

None

Training level required

Minimal Device Training required

Anesthetic needed?

None

Type of grip

Handles

Design Specifications

The Odon Device is a vaginal delivery device that employs a circumferential air cuff over the fetal head to perform instrumental vaginal delivery. The product consists of a soft plastic cup that fits around the head of the baby, an inserter that grasps the head, and a polyethylene sleeve that is inflated with air that allows for the guidance of the baby out of the birth canal. A force of up to 19 kg can be applied to aid in the extraction process.

Product Schematics

Technical Support

None

Replacement Components

Unknown

Lifecycle

Unknown

Manufacturer Specified Performance Parameters

Performance targets include: low cost, compact dimensions, usable globally, ease of use, safe for both fetus and mother, reduces risk of inoculability between mother and child.

Vetted Performance Status

The WHO Human Reproduction Program supported the evaluation of this product in hospitals in Argentina and South Africa. The device was successfully inserted into 93% of women, and 71% had a successful delivery after one-time application.

Safety

There are risks of mechanical failure while operating, and of maternal or newborn trauma during use.

Complementary Technical Systems

None

Academic Research and References

Requejo, J.H. and Belizán, J.M., 2013, Odon Device: a Promising Tool to Facilitate Vaginal Delivery and Increase Access to Emergency Care, Reproductive Health, 10(1), pp. 42.

World Health Organization Odon Device Research Group, 2013, Feasibility and Safety Study of a New Device (Odón Device) for Assisted Vaginal Deliveries: Study Protocol, Reproductive health, 10(1), pp. 33.

Schvartzman, J., Krupitski, H., Merialdi, M., Betran, A.P. and Requejo, J., 2018, Odon Device for Instrumental Vaginal Deliveries: Results of a Medical Device Pilot Clinical Study, Reproductive health, 15(1), pp. 45.

O’brien, S., Winter, C., Burden, C., Boulvain, M., Draycott, T., and Crofts, J., 2017, Fetal Head Position and Perineal Distension Associated with the Use of the BD Odon Device™ in Operative Vaginal Birth: a Simulation Study, BJOG: An International Journal of Obstetrics & Gynaecology, 124, pp. 10–18.

O’brien, S., Mouser, A., Odon, J., Winter, C., Draycott, T., Sumitro, T., Alisantoso, D., Lim, W., Merialdi, M., Stankovic, A., et al, 2017, Design and Development of the BD Odon DeviceTM: a Human Factors Evaluation Process, BJOG: An International Journal of Obstetrics & Gynaecology, 124, pp. 35–43.

O’brien, S., Winter, C., Burden, C., Boulvain, M., Draycott, T., and Crofts, J., 2017, Pressure and Traction on a Model Fetal Head and Neck Associated with the use of Forceps, Kiwi™ Ventouse and the BD Odon Device™ in Operative Vaginal Birth: a Simulation Study, BJOG: An International Journal of Obstetrics & Gynaecology, 124, pp. 19–25.

Compliance with regulations

The device has not been approved for use in the US but has been evaluated by the WHO, which found that the device was feasible but will require a randomized-controlled trial to evaluate effectiveness and safety compared to other accepted methods.

Other Information

None

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