Odon Device

Jorge Odón

The Odon Device is an assistive delivery device for mothers experiencing prolonged labor.

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
Feedback

Product description Brand name and 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 development, is intended to reduce complications from prolonged labor, such as infection, and newborn complications, such as birth asphyxia.

Target region(s) Target region for distribution/implementation (listed by country if specified)

Africa, South America

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

WHO, Becton Dickinson and Company

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

50 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Forceps, vacuum extraction, C-section

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Health care workers: obstetricians, nurses, midwives

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

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

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Patented

User Provision Model Where can the product be purchased/acquired by end users?

Product is not yet available on the market

Distribution to date Number of units that have been deployed, downloads or users to date

The exact number of devices distributed is unknown as the product is still in clinical trials.

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Clinical application

Prolonged labor

Consumables

None

Training level required

Midwife plus minimal device training

Anesthetic needed?

None

Type of grip

forceps, vacuum, etc?

Handles

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

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 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 Design and assembly illustrations

Technical support Technical support provided by

None

Replacement components Availability of replacement components (in-country, by order,...)

Unknown

Lifecycle Disposal and warranty

Unknown

Manufacturer specified performance targets Designer / Manufacturer specified targets

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 Findings of manufacturer evaluations or independent testing centers

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.

Testing organizations Independent lab, academic research centers, etc.

WHO Human Reproduction Program, Becton Dixon Company

Safety Potential hazards / risks related to operation of this product

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

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

None

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

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), p. 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), p. 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), p. 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 Device^TM: 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 Product certifications and standards referenced by designer/manufacturer

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.

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

The initial study included 49 women (some during their first delivery and some who had previously delivered). Each subject had an uncomplicated delivery and only one fetus. The device was tested in the late stage of labor. The study was done in a hospital in Argentina and one in South Africa.

The manufacturer now plans to pursue a randomized pivotal clinical trial (as of March 2018).

Other information

None

In context photographs (0)

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In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

Snapshot

Product description Brand name and product description

Target region(s) Target region for distribution/implementation (listed by country if specified)

Africa, South America

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

WHO, Becton Dickinson and Company

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

50 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Forceps, vacuum extraction, C-section

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Health care workers: obstetricians, nurses, midwives

Manufacturing & delivery

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

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

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Patented

User Provision Model Where can the product be purchased/acquired by end users?

Product is not yet available on the market

Distribution to date Number of units that have been deployed, downloads or users to date

The exact number of devices distributed is unknown as the product is still in clinical trials.

Performance & use

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Clinical application

Prolonged labor

Consumables

None

Training level required

Midwife plus minimal device training

Anesthetic needed?

None

Type of grip

forceps, vacuum, etc?

Handles

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

Product schematics Design and assembly illustrations

Technical support Technical support provided by

None

Replacement components Availability of replacement components (in-country, by order,...)

Unknown

Lifecycle Disposal and warranty

Unknown

Manufacturer specified performance targets Designer / Manufacturer specified targets

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 Findings of manufacturer evaluations or independent testing centers

Testing organizations Independent lab, academic research centers, etc.

WHO Human Reproduction Program, Becton Dixon Company

Safety Potential hazards / risks related to operation of this product

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

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

None

Research & standards

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

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), p. 42.

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

The manufacturer now plans to pursue a randomized pivotal clinical trial (as of March 2018).

Other information

None

Feedback

In context photographs (0)

You can use the form below to contribute a photo of this product.

In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

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Odon Device

Jorge Odón

In context photographs (0)

In context files & documents (0)

Feedback from users, customers & distributors