Electrosurgical units (ESUs) have been used for decades for surgical cutting and hemostasis. In this study, we evaluate eight full-featured, high-power, solid-state ESUs from four suppliers. We examined these units--all of which can be used for the vast majority of electrosurgical applications--for performance and safety, human factors design, and maintenance and durability. We found that all the evaluated units performed well in our testing and met our safety requirements; thus, we rated them all Acceptable. We did, however, identify a few noteworthy differences that separated some of the evaluated units from each other, as well as from the majority of units that have been in use for a decade or more. The most important of these factors were (i) the availability of new types of output modes (e.g., non-power-controlled modes, low-voltage modes) that produce differences in surgical effect and (2) the presence of certain characteristics and features (e.g., cutting modes with a broad power curve, programmable settings-memory features) that users indicated were helpful. Although we considered these distinguishing factors to be significant, we recognize that the full clinical impact of these developments has not yet been realized. And the ability of an institution to take advantage of any benefits such developments could offer will depend to a large degree on user technique. In this Evaluation, we also present a comprehensive overview of ESU technology; a Technology Management Guide, in which we offer strategies for managing the risks associated with electrosurgery; and an ESU Purchasing Guide, in which we offer guidance for determining the type and model of ESU that will best meet an institution's needs. In a future issue of Health Devices (scheduled for early 1998), we will be publishing an Evaluation of several moderate-power ESUs. These devices can be used for most of the same applications as the high-power units, but they cost much less.
几十年来，电外科设备（ESU）一直用于手术切割和止血。在本研究中，我们评估了来自四个供应商的八台功能齐全、高功率的固态ESU。我们检查了这些设备——所有这些设备都可用于绝大多数电外科应用——的性能和安全性、人为因素设计以及维护和耐用性。我们发现，所有评估的设备在测试中表现良好，符合我们的安全要求；因此，我们将它们全部评为“可接受”。然而，我们确实发现了一些值得注意的差异，这些差异将一些评估的设备相互区分开来，也与使用了十年或更长时间的大多数设备区分开来。其中最重要的因素是：（i）新型输出模式（例如，非功率控制模式、低电压模式）的可用性，这些模式会产生不同的手术效果；（ii）用户表示有帮助的某些特性和功能（例如，具有宽功率曲线的切割模式、可编程设置-记忆功能）。尽管我们认为这些区分因素很重要，但我们认识到这些发展的全部临床影响尚未实现。机构利用这些发展可能带来的任何好处的能力在很大程度上取决于用户技术。在本评估中，我们还全面概述了ESU技术；一份技术管理指南，我们在其中提供管理与电外科相关风险的策略；以及一份ESU采购指南，我们在其中提供指导，以确定最能满足机构需求的ESU类型和型号。在《健康设备》（定于1998年初出版）的未来一期中，我们将发表对几款中功率ESU的评估。这些设备可用于与高功率设备大多数相同的应用，但成本要低得多。
