Obstetric Safety - DevicesObstetric Safety - Devices

North Carolina Obstetric Quality InitiativesFebruary 22, 2008Marvin Hage, MD

Perinatal Consultingmhage@ec.rr.com

ObjectivesObjectives

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 HistoryLessons of History

Forceps Prophylactic

forceps EFM Vacuum Intran

Operator Device Design Product liability Product cost Product redesign

Some Recent ExamplesSome Recent Examples

Maternal– Bakri balloon– Intravenous catheter balloons - Roberts– Glidescope– Intermittent pneumatic compression

Fetal– STAN

Product AvailabilityProduct Availability

R & D phase FDA approval – Pre marketingLocal purchase– Technology Assessment Committee– Cost

CredentialingSurveillance – Post marketing

Proposed North Carolina State Quality Proposed North Carolina State Quality Improvement ResponseImprovement ResponseA 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

ConclusionsConclusions

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.

ReferencesReferences

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 SitesWeb Sites

Regulatory:FDA - CDRHFDA - Section 884MAUDE

Purchasing/Promotion:CIMITHospital BuyerMDRWeb Medical DeviceMedical Device Link

Manufacturers:Barnev – Continuous

labor assessmentClinical Innovations –

Vacuum, IUPCCook – Bakri, Uterine

Artery Catheter Kendall – SCD’sNeoventa - STAN Utah – IUP CatheterVerathon – Glidescope