Assessing and Adopting New Medical Devices for Obstetric and Gynecologic Care: ACOG Committee Opinion Summary, Number 801.

Abstract

The purpose of this document is: 1) to help obstetrician-gynecologists better understand the U.S. Food and Drug Administration's regulatory process for the marketing of medical devices; 2) to educate obstetrician-gynecologists on the importance of understanding available evidence on the safety, efficacy, and indications for devices in clinical practice; 3) to encourage obstetrician-gynecologists to report safety events associated with medical devices; and 4) to provide guidance on what to consider when adopting new medical devices. The decision to incorporate new technology in a patient's care may be complex. Some medical devices are marketed for gynecologic conditions but may have unclear indications for use or unclear safety and efficacy profiles, or both. Patients often have questions about treatments and procedures involving devices, especially if a device has received media attention; therefore, a basic understanding of how devices are regulated and what type of data are or are not required before a device is brought to market is important for patient care. When adopting a new medical device, obstetrician-gynecologists should achieve proper training and should understand the evidence on safety and effectiveness and the indications for the device's use. Obstetrician-gynecologists and other health care providers should be aware of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database and, ideally, should become familiar with the adverse event report form and report serious adverse events that may be associated with a medical device, use errors, product quality issues, and therapeutic failures.