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Biomedical subjects

B Haggar

Publications and source records attributed to B Haggar.

3 recordsLinked to original sources

A new rhythm library for testing automatic external defibrillators: performance of three devices.

A library of arrhythmias obtained from patients with cardiac arrest was developed. Such a data base will permit both in vitro testing of the rhythm analysis system of automatic external defibrillators before clinical field trials are conducted and comparison of devices. Defibrillators equipped with voice/electrocardiographic tape recorders and used in the prehospital defibrillation programs in Iowa and King County, Washington provided the rhythm source. From these recordings, segments of ventricular fibrillation with minimal artifact and a duration of greater than or equal to 6 s were selected. Segments of ventricular fibrillation (n = 102) were categorized by average peak amplitude as fine (1 to less than 3 mm), medium (3 to less than 7 mm), coarse (7 to less than 12 mm) and extra coarse (greater than or equal to 12 mm), and transcribed onto high fidelity videocassette tapes. Nonventricular fibrillation cardiac arrest rhythms (n = 144), which included wide complex idioventricular rhythms, ventricular and supraventricular tachycardias, asystole and artifact, were also transcribed. Automatic external defibrillators developed by three manufacturers reached a treat (shock) decision on 88 to 93% of the ventricular fibrillation rhythms and on 5 to 10% of the nonventricular fibrillation rhythms. The latter decisions were defined as false positive, though for many rapid nonventricular fibrillation rhythms, countershock may be the appropriate treatment response. There were no statistically significant differences among the three devices in the shock/no shock decisions. A variety of ventricular fibrillation arrhythmias and terminology to express the preclinical performance of automatic external defibrillators are defined. Three commercially available automatic external defibrillators appear to successfully identify ventricular fibrillation and nonventricular fibrillation rhythms.(ABSTRACT TRUNCATED AT 250 WORDS)

Arrhythmias, Cardiac↗

How do regulatory agencies ensure the release of a safe medical device?

This article describes the current regulatory activities of the Food and Drug Administration (FDA), in particular the FDA techniques for regulating medical-device approvals, medical-device reporting, and medical-device-company inspections. Also discussed are the FDA Modernization Act and the methods the FDA is using to implement the act.

Device Approval↗

The automatic external defibrillator-pacemaker: clinical rationale and engineering design.

Prompt defibrillation is the cornerstone of therapy for out-of-hospital sudden cardiac arrest. Overwhelming evidence indicates that victims whose cardiac arrest is witnessed and whose ECG rhythm is ventricular fibrillation can be successfully resuscitated, with significant prolongation of life. The automatic external defibrillator-pacemaker (AEDP) is designed to be used by family members of patients with known heart disease, by basic level technicians in emergency rescue systems, and by lay rescuers in corporate-industrial-public environments. The AEDP is designed for safety and ease of use. It incorporates a highly sensitive and specific electronic diagnostic logic. It defibrillates and paces with a unique tongue-chest electrode system or through two adhesive chest electrodes. The AEDP should be a cost-effective device for the treatment of sudden cardiac arrest and can play a major role in public health strategies for optimizing care for this enormous problem.

Biomedical Engineering↗