Impact of FDA advisory on reported vacuum-assisted delivery and morbidity

Skip to Content
If you are seeing this message, you may be experiencing temporary network problems. Please wait a few minutes and refresh the page. If the problem persists, you may wish to report it to your local Network Manager.

It is also possible that your web browser is not configured or not able to display style sheets. In this case, although the visual presentation will be degraded, the site should continue to be functional. We recommend using the latest version of Microsoft or Mozilla web browser to help minimise these problems.

FIRMAN ABDULLAH, access your9 Titles
Saved TitlesPrenatal DiagnosisHealth EconomicsJournal of Continuing Education in the Health ProfessionsJournal of Hospital MedicineHuman Brain MappingNeurourology and UrodynamicsUltrasound in Obstetrics and Gynecologymore...Manage Saved TitlesHelp1 Articles
Saved ArticlesQuantitative characterization of color Doppler images: Reproducibility, accuracy, and limitationsManage Saved ArticlesHelp0 Searches
Saved SearchesYou do not have anything saved in this menu.Manage Saved SearchesHelpMy CartMy Profile
Log Out




Home / Medicine and Healthcare / Obstetrics and Gynecology



The Journal of Maternal-Fetal Medicine
What is RSS?

Volume 9, Issue 6 , Pages 321 - 326
Published Online: 15 Feb 2001

Copyright © 2000 Wiley-Liss, Inc.

Save Title to My Profile
Set E-Mail Alert





--------------------------------------------------------------------------------

< Previous Abstract | Next Abstract >

Save Article to My Profile Download Citation

Abstract | References | Full Text: PDF (126k) | Related Articles | Citation Tracking


Article
Impact of FDA advisory on reported vacuum-assisted delivery and morbidity
Michael G. Ross *, Meredith Fresquez, Mostafa A. El-Haddad
Department of Obstetrics and Gynecology, Harbor-UCLA Medical Center, Torrance, California

email: Michael G. Ross (MikeRoss@ucla.edu)

*Correspondence to Michael G. Ross, Harbor/UCLA Medical Center, 1124 West Carson Street, RB-1, Torrance, CA 90502

Keywords
FDA advisory; vacuum; manufacturers


Abstract

Objective
In May 1998 the US Food and Drug Administration (FDA) issued a health advisory reporting neonatal injuries/deaths following vacuum delivery and encouraged voluntary reports of future adverse events. We compared FDA reports of vacuum delivery adverse events prior to and following the advisory.

Methods
The FDA database (MAUDE) was searched for vacuum deliveries using brand name, manufacturer name, and procedure string searches. Cases were sorted by report date, source, and manufacturer. Neonatal morbidity was quantified as deaths and life-threatening or nonlife-threatening events.

Results
A total of 80 reported adverse cases were identified after duplicate cases were consolidated. Twenty-five were reported to the FDA prior to the 1998 advisory and 55 in the immediate 6-month period following the advisory. There was a 22-fold increase in reported events from five events/year prior to the advisory to an estimated 110 events/year following the advisory. The distribution of reporting sources changed significantly following the advisory with increased manufacturer (8-43%) and decreased voluntary reports (56-20%). All major brand names were represented. During the 6 months following the FDA advisory there were 10 neonatal deaths, 30 life-threatening events, 12 nonlife-threatening events, and three equipment-related reports. Infant deaths were due to intracranial or subgaleal hematomas. Injuries included skull fracture, scalp abrasions, and cephalohematomas.

Conclusions
The FDA advisory was associated with a 22-fold increase in the rate of reported adverse events. This increase in reporting likely represents both enhanced awareness of complications as well as an increase in vacuum-related adverse neonatal sequelae. As vacuum delivery is associated with greater neonatal morbidity/mortality than was previously recognized, the adage that the vacuum is designed to come off before infant damage occurs appears unsubstantiated. It is recommended that manufacturers quantify the suction and traction capabilities of present and new proposed vacuum cup designs. J. Matern.-Fetal Med. 2000;9:321-326. © 2000 Wiley-Liss, Inc.



--------------------------------------------------------------------------------
Received: 16 May 2000; Revised: ; Accepted: 28 July 2000
Digital Object Identifier (DOI)

10.1002/1520-6661(200011/12)9:6<321::AID-MFM1000>3.0.CO;2-W About DOI




Related Articles
Find other articles like this in Wiley InterScience
Find articles in Wiley InterScience written by any of the authors
Wiley InterScience is a member of CrossRef.





All Content
Publication Titles
Enter words or phrases


Advanced Search
CrossRef / Google Search
Acronym Finder


The Journal of Maternal-Fetal Medicine

Enter words or phrases

Select a Field All Fields Article Titles Author Full Text / Abstracts Author Affiliation Keywords Funding Agency References Article DOI



Vol: Issue: Page:




This journal is listed in the U.S. National Library of Medicine's PubMed index.





Need a reprint?

Paper or electronic reprints are available for all content published on Wiley InterScience. Inquiries can be submitted online.

Find out more about reprints





--------------------------------------------------------------------------------

About Wiley InterScience | About Wiley | Privacy | Terms & Conditions
Copyright © 1999-2007 John Wiley & Sons, Inc. All Rights Reserved.