1 / 9

Obstetric Safety - Devices

Obstetric Safety - Devices. North Carolina Obstetric Quality Initiatives February 22, 2008 Marvin Hage, MD Perinatal Consulting mhage@ec.rr.com. Objectives. Review/Identify “new” safety devices designed to decrease morbidity or mortality related to obstetrical care.

aurelia-vaughn
Download Presentation

Obstetric Safety - Devices

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Obstetric Safety - Devices North Carolina Obstetric Quality Initiatives February 22, 2008 Marvin Hage, MD Perinatal Consulting mhage@ec.rr.com

  2. Objectives • Review/Identify “new” safety devices designed to decrease morbidity or mortality related to obstetrical care. • Identify statewide responses of implementation/evaluation of current and future devices.

  3. Forceps Prophylactic forceps EFM Vacuum Intran Operator Device Design Product liability Product cost Product redesign Lessons of History

  4. Some Recent Examples • Maternal • Bakri balloon • Intravenous catheter balloons - Roberts • Glidescope • Intermittent pneumatic compression • Fetal • STAN

  5. Product Availability • R & D phase • FDA approval – Pre marketing • Local purchase • Technology Assessment Committee • Cost • Credentialing • Surveillance – Post marketing

  6. Proposed North Carolina State Quality Improvement Response • A registry of new obstetric related safety devices. • A network to assess devices • Gather public information • Report experience and technique of use. • Share effectiveness reports • Share adverse effect reports • An Obstetric Patient Safety Foundation

  7. Conclusions • There will be increasing numbers of devices designed to improve obstetric outcomes. • We have a professional responsibility to assess and monitor these devices for effectiveness and safety. • We have a “translational” responsibility to implement those devices that will improve obstetric outcomes.

  8. References General: Committees on Ethics and Genetics of American College of Obstetricians and Gynecologists. ACOG Committee Opinion. Number 364 May 2007. Patents, medicine, and the interests of patients. Obstetrics & Gynecology. 109(5):1249-54, 2007 May. Wagner NJ. Quatrano LA. Nicholson CE. Translating civilian and defense technologies for pediatric critical care and rehabilitation research. Technology & Health Care. 14(1):49-58, 2006. Morgenweck CJ. Innovation to research: some transitional obstacles in critical care units. [Review] [26 refs] Critical Care Medicine. 31(3 Suppl):S172-7, 2003 Mar. Williams D. Year-end perspectives: the introduction of new technologies. Medical Device Technology. 14(10):10-2, 2003 Dec.

  9. Regulatory: FDA - CDRH FDA - Section 884 MAUDE Purchasing/Promotion: CIMIT Hospital Buyer MDRWeb Medical Device Medical Device Link Manufacturers: Barnev – Continuous labor assessment Clinical Innovations – Vacuum, IUPC Cook – Bakri, Uterine Artery Catheter Kendall – SCD’s Neoventa - STAN Utah – IUP Catheter Verathon – Glidescope Web Sites

More Related