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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.

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obstetric safety devices

Obstetric Safety - Devices

North Carolina Obstetric Quality Initiatives

February 22, 2008

Marvin Hage, MD

Perinatal Consulting

mhage@ec.rr.com

objectives
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.
lessons of history
Forceps

Prophylactic forceps

EFM

Vacuum

Intran

Operator

Device Design

Product liability

Product cost

Product redesign

Lessons of History
some recent examples
Some Recent Examples
  • Maternal
    • Bakri balloon
    • Intravenous catheter balloons - Roberts
    • Glidescope
    • Intermittent pneumatic compression
  • Fetal
    • STAN
product availability
Product Availability
  • R & D phase
  • FDA approval – Pre marketing
  • Local purchase
    • Technology Assessment Committee
    • Cost
  • Credentialing
  • Surveillance – Post marketing
proposed north carolina state quality improvement response
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
conclusions
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.
references
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.

web sites
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