Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):194-7. doi: 10.1097/SPV.0b013e31825f36ed.
The adoption of new technology or procedures into a clinician's surgical armamentarium is driven by multiple factors. Patient safety and anticipated long-term improvement in outcomes should be the primary objective that guides a surgeon's decision to deliver care involving new procedures. Surgically complex procedures require a balance of knowledge, surgical skill, and experience, with appropriate ongoing surgical volume and monitoring of outcomes and adverse events. Transvaginal placement of surgical mesh for pelvic organ prolapse has the potential to improve quality of life and anatomic outcomes (especially in the anterior compartment), but also has potential serious adverse events as outlined by the FDA's July 2011 Safety Communication. This document provides Guidelines for privileging and credentialing of physicians planning to implement or continue using this new technology in clinical practice.
新技术或新手术方法被临床医生纳入其手术技能范畴是由多种因素驱动的。患者安全以及预期的长期疗效改善应是指导外科医生决定采用新手术方法进行治疗的首要目标。复杂的外科手术需要知识、手术技巧和经验的平衡,同时要有适当的持续手术量以及对疗效和不良事件的监测。经阴道植入手术网片治疗盆腔器官脱垂有可能改善生活质量和解剖学疗效(尤其是在前盆腔),但正如美国食品药品监督管理局(FDA)2011年7月的安全通报所指出的,也可能引发严重不良事件。本文档为计划在临床实践中实施或继续使用这项新技术的医生提供了特权授予和资质认定指南。