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Sunday, April 26, 2009

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

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Home / Medicine and Healthcare / Obstetrics and Gynecology



The Journal of Maternal-Fetal Medicine
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Volume 9, Issue 6 , Pages 321 - 326
Published Online: 15 Feb 2001

Copyright © 2000 Wiley-Liss, Inc.

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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.



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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




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