• Health Devices. 1993 May 1;22(5-6):211-94.

AbstractCombined defibrillator/monitors enable the operator to assess and monitor the ECG and rapidly deliver a defibrillating countershock to patients suffering from ventricular fibrillation during a cardiac arrest. In addition, these units provide synchronized cardioversion for treating other arrhythmias, such as ventricular tachycardia, and most now offer external noninvasive pacemaker capability for treating patients with ventricular bradycardia or asystole. Defibrillator/monitors are critical resuscitation instruments and must perform effectively to avoid the otherwise preventable death of a cardiac arrest patient. However, both ECRI and the Food and Drug Administration (FDA) continue to receive a large number of problem reports on these devices each year. Device failures can occur for such reasons as operator error, depleted or defective batteries, or component failures. We evaluated eight units--three intended for crash-cart use and four intended for portable use, all with noninvasive pacemaker capability either standard or as an option, as well as one portable physiologic patient monitor to which a defibrillator (with or without a pacing option) can be attached--from six manufacturers.* We also evaluated one stand-alone noninvasive pacemaker. Although we did not include automated external defibrillators (AEDs) in our study, two of the evaluated units have options that allow them to function as AEDs. We rated the seven crash-cart and portable defibrillator/monitor/pacemakers according to three primary applications: (1) general crash-cart use, (2) prehospital (emergency medical service [EMS]) use, and (3) in-hospital transport. They are rated either Acceptable or Acceptable--Not Recommended for these applications, based primarily on technical performance (including battery operation, which is especially important in portable units), characteristics (such as line-powered operation and portability), features (such as automatic documentation), and human factors design (especially ease of use); some are inappropriate for specific uses because of their respective limitations in these applications. The portable physiologic patient monitor is not rated, but is discussed.** All of the pacemakers available as components of the evaluated units are acceptable for use; however, in most cases, purchasing decisions should be made according to defibrillator/monitor needs. The stand-alone pacemaker is rated Unacceptable because of its numerous performance, safety, and human factors disadvantages and because, other than its being a stand-alone unit, it offers no advantages over the other evaluated pacemakers; see "The Zoll NTP-1000 Stand-alone Noninvasive Pacemaker." Readers are cautioned not to base purchasing decisions on our ratings and rankings alone, but on a thorough understanding of the issues surrounding defibrillator/monitors and noninvasive pacemakers, which can be gained only by reading this study in its entirety.(ABSTRACT TRUNCATED AT 400 WORDS)

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