Ten million women per year experience serious pregnancy-related medical complications such as bleeding, infection and trauma,[ii] and 260,000 maternal deaths occurred in 2012.[iii] Ninety-nine percent of these mortalities occur in developing countries.[iv] Approximately 3 million newborn babies die each year, and an additional 2.6 million are stillborn, in part due to complications from obstructed labor during childbirth.[v]
"Obstructed labor is a major killer of young women and adolescent girls," said Dr. Margaret Chan, Director-General of the World Health Organization. "The Odon Device offers a low-cost simplified way to deliver babies, and protect mothers, when labor is prolonged. It promises to transfer life-saving capacity to rural health posts, which almost never have the facilities and staff to perform a C-section."
The Odon Device is designed to gently deliver newborns through the birth canal during complicated second-stage labor. Devices presently utilized for this purpose, such as forceps and vacuum assist, may cause damage to mothers and newborns, especially if applied by inexperienced birthing attendants.[vi] C-sections are performed extensively to address prolonged labor in high income regions such as the U.S. and Western Europe, but are far less accessible in developing countries where the majority of maternal and newborn mortalities occur.
"Our shared goal is to ensure innovations reach women and children who need them most, to save and improve their lives," said Dr. Peter Singer, CEO of Grand Challenges Canada, a member of the Saving Lives at Birth partnership. "I commend BD for committing to take this potentially life-saving and health-improving innovation to scale in a sustainable and affordable way."
"When a mother or newborn dies during childbirth, it has a devastating impact on families and communities," said Vincent Forlenza, Chairman, CEO and President, BD. "We are honored to work with the WHO and the Saving Lives at Birth partners to bring this truly innovative new device to scale and make it broadly accessible in the countries where it is most needed."
BD will utilize its core competencies in medical device design, quality systems, process design and manufacturing to develop the Odon Device and establish high-scale, low-cost production. These development activities will be accomplished at the Company's technology center in Singapore. BD will deploy the Odon Device through its global organization and offer affordable access pricing in developing countries. The device will initially be introduced in priority countries with a large burden of maternal mortality as determined by the WHO.
"To bring an end to preventable child and maternal deaths we need to work together to make affordable, innovative solutions available throughout the developing world," said USAID Administrator Rajiv Shah. "BD has extensive experience in bringing health products to market and this partnership promises to accelerate the development of the Odon Device, assuring it scales quickly to reach the communities that need it most."
The Odon Device was invented in Argentina by Jorge Odon, an automotive technician. WHO championed the Odon Device in the Grand Challenge for Saving Lives at Birth competition, and will lead implementation of clinical studies for the device in collaboration with BD and a steering committee of world experts in obstetrics and gynecology. The first phase of a clinical study was completed successfully in Argentina in 2012.
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs nearly 30,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.
[i] Mortality Breakdown from UNICEF. The State of the World's Children 2009: Maternal and Newborn Health. December 2008.
[ii] WHO. PMNCH Fact Sheet: Maternal mortality. September 2011.
[iii] UNFPA. Reported 2012.
[iv] WHO. Maternal mortality Fact Sheet. May 2012. http://www.who.int/mediacentre/factsheets/fs348/en/
[v] WHO. Maternal mortality Fact Sheet. May 2012. http://www.who.int/mediacentre/factsheets/fs348/en/
[vi] Gibbons L, Belizan JM, Lauer JA, Betran AP, Merialdi M, Althabe F. "Inequities in the use of cesarean section deliveries in the world." Am J Obstet Gynecol. 2012. 206(4):331.
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SOURCE BD (Becton, Dickinson and Company)