Revealing the scope of surgical device malfunctions: Analysis of the "hidden" Food and Drug Administration device database.
Am J Surg
; 221(6): 1121-1126, 2021 06.
Article
de En
| MEDLINE
| ID: mdl-33745689
ABSTRACT
BACKGROUND:
We compared surgical device malfunction reports in the Food and Drug Administration (FDA) public Manufacturer and User Facility Device Experience (MAUDE) with those in the FDA nonpublic Alternative Summary Reporting (ASR).METHODS:
General surgery device product code categories in MAUDE and ASR from 1999 to 2018 were identified. Changes in the rates of categories and adverse events were evaluated by Poisson regression.RESULTS:
There were 283,308 (72%) general surgical device malfunctions in MAUDE and 109,954 (28%) in ASR. Reports increased annually in ASR versus MAUDE, particularly for surgical staplers and clip devices (p < 0.05). ASR contained approximately 80% of these reports; MAUDE 20%. In MAUDE, 42.9% of surgical device malfunctions and 20.2% of stapler/clip malfunctions resulted in patient injury or death. ASR listed no injury or death information.CONCLUSIONS:
ASR contained a significant portion of surgical device malfunctions hidden from public scrutiny. Access to such data is essential to safe surgical care.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Instruments chirurgicaux
/
Panne d'appareillage
Type d'étude:
Observational_studies
Limites:
Humans
Pays/Région comme sujet:
America do norte
Langue:
En
Journal:
Am J Surg
Année:
2021
Type de document:
Article
Pays de publication:
EEUU
/
ESTADOS UNIDOS
/
ESTADOS UNIDOS DA AMERICA
/
EUA
/
UNITED STATES
/
UNITED STATES OF AMERICA
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US
/
USA