An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh
| Autor: | Jason M. Sandberg, Ryan Terlecki, Amy M. Pearlman, Ian Gray |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Medical device
Female Urology Databases Factual Urology media_common.quotation_subject Urinary Incontinence Stress 030232 urology & nephrology computer.software_genre lcsh:RC870-923 Pelvic Organ Prolapse Food and drug administration 03 medical and health sciences 0302 clinical medicine Gynecologic Surgical Procedures Medicine Humans User Facility Quality (business) Registries Surgical mesh Adverse effect Categorical variable media_common 030219 obstetrics & reproductive medicine Database business.industry Equipment safety United States Food and Drug Administration Data Collection lcsh:Diseases of the genitourinary system. Urology United States Data Accuracy Safety Equipment Original Article Female business computer Report Source |
| Zdroj: | Investigative and Clinical Urology, Vol 59, Iss 2, Pp 126-132 (2018) Investigative and Clinical Urology |
| ISSN: | 2466-0493 |
| Popis: | Purpose: To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States. Materials and Methods: We reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event. Results: There were numerous examples of missing, duplicated, and non-standardized entries. Analysis revealed 64 reports with duplicated information, and six reports representing multiple patients. Forty-seven percent of medical device reports did not identify a reporter source. At least 28% of reported devices are no longer on the US market. There was wide variability in the quality and completeness of submitted reports and true adverse event rates could not be accurately calculated because the number of total cases was unknown. Conclusions: The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh. While it functions to collect information related to isolated adverse events, systematic limitations of the MAUDE database, that no doubt extend to other medical devices, necessitate the development of new reporting systems. Alternatives are under development, which may allow regulators to more accurately scrutinize the safety profiles of specific medical devices. |
| Databáze: | OpenAIRE |
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