Electrosurgical units.
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.
D004598:Electrosurgery / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D004869:Equipment Safety; D005069:Evaluation Studies as Topic; D006801:Humans; D013673:Technology Assessment, Biomedical