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Safely Introducing New Surgical Devices in Minimally Invasive Gynecologic Surgery: An Argument for Use of the IDEAL Framework.

MedStar author(s):

Davis-Cooper, Shelby

, MWHC

, Minimally Invasive Gynecologic Surgery Fellowship

Citation: Journal of Minimally Invasive Gynecology. 2023 Oct 20PMID: 37866715Institution: MedStar Washington Hospital CenterDepartment: Minimally Invasive Gynecologic Surgery Fellowship | Obstetrics and Gynecology/Female Pelvic Medicine and Reconstructive SurgeryForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2023 ISSN:

1553-4650

Name of journal: Journal of minimally invasive gynecologyAbstract: CONCLUSION: The laparoscopic power morcellator and Essure cases illustrate possible shortcomings in our device approval system that could be improved upon using the IDEAL framework, which limits device use until safety and efficacy data have been established and recommends postmarket surveillance. Copyright © 2023 AAGL. Published by Elsevier Inc. All rights reserved.DATA SOURCES: News media publications, agency websites, legal articles, and scientific papers.METHODS OF STUDY SELECTION: Articles and papers were selected that described events leading to FDA approval of these devices and subsequent complications.OBJECTIVE: To review the Food and Drug Administration (FDA) premarket regulatory and postmarket surveillance processes for 2 minimally invasive gynecologic surgery case studies-the laparoscopic power morcellator and the Essure permanent birth control device-and to introduce the IDEAL (Idea, Development, Exploration, Assessment, Long-term) framework for safely introducing and monitoring minimally invasive gynecologic surgery devices.TABULATION, INTEGRATION, AND RESULTS: Based on current FDA premarket regulatory processes, 67% of devices do not currently require premarket review and only 1% are subject to clinical trial requirements. The IDEAL framework delineates 5 phases for safe introduction of medical devices: idea, development, exploration, assessment, and long-term study.All authors: Ramanathan A, Davis-Cooper S, Iglesia CBFiscal year: FY2024 Digital Object Identifier:

https://dx.doi.org/10.1016/j.jmig.2023.10.015

Date added to catalog: 2024-01-22

Holdings ( 1 )
Title notes ( 6 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	37866715	Available		37866715

CONCLUSION: The laparoscopic power morcellator and Essure cases illustrate possible shortcomings in our device approval system that could be improved upon using the IDEAL framework, which limits device use until safety and efficacy data have been established and recommends postmarket surveillance. Copyright © 2023 AAGL. Published by Elsevier Inc. All rights reserved.

DATA SOURCES: News media publications, agency websites, legal articles, and scientific papers.

METHODS OF STUDY SELECTION: Articles and papers were selected that described events leading to FDA approval of these devices and subsequent complications.

OBJECTIVE: To review the Food and Drug Administration (FDA) premarket regulatory and postmarket surveillance processes for 2 minimally invasive gynecologic surgery case studies-the laparoscopic power morcellator and the Essure permanent birth control device-and to introduce the IDEAL (Idea, Development, Exploration, Assessment, Long-term) framework for safely introducing and monitoring minimally invasive gynecologic surgery devices.

TABULATION, INTEGRATION, AND RESULTS: Based on current FDA premarket regulatory processes, 67% of devices do not currently require premarket review and only 1% are subject to clinical trial requirements. The IDEAL framework delineates 5 phases for safe introduction of medical devices: idea, development, exploration, assessment, and long-term study.

English