| Impact of FDA advisory on reported vacuum-assisted delivery and morbidity. | |
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MedLine Citation:
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PMID: 11243287 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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M G Ross; M Fresquez; M A El-Haddad |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: The Journal of maternal-fetal medicine Volume: 9 ISSN: 1057-0802 ISO Abbreviation: J Matern Fetal Med Publication Date: 2000 Nov-Dec |
Date Detail:
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Created Date: 2001-03-12 Completed Date: 2001-04-12 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 9211288 Medline TA: J Matern Fetal Med Country: United States |
Other Details:
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Languages: eng Pagination: 321-6 Citation Subset: IM |
Affiliation:
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Department of Obstetrics and Gynecology, Harbor-UCLA Medical Center, Torrance, California, USA. MikeRoss@ucla.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Cerebral Hemorrhage
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etiology Female Hematoma / etiology Humans Infant Mortality Infant, Newborn Pregnancy Scalp / injuries Skull Fractures / etiology United States United States Food and Drug Administration* Vacuum Extraction, Obstetrical / adverse effects* |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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