Does eCRI respond to FDA Safety Alert on Laerdal automated external defibrillators?
ECRI has several concerns with the FDA's Safety Alert: It does not adequately characterize the frequency or severity of the problems listed and provides a specific recommendation for only one. The specific recommendation provided for the Heartstart 1000s instructs EMS systems using this model to abandon established, successful practices and to adopt a new procedure that contradicts the American Heart Association's (AHA) protocol for AED use and could cause confusion and an increased risk of operator shock. It has caused enough concern that some EMS systems have taken Laerdal AEDs out of service or have hesitated to place new units into service. Unless alternative defibrillators are used, this will prevent patients from receiving the potentially lifesaving therapy of early defibrillation and can lead to unnecessary loss of life. The FDA Safety Alert is intended to raise the awareness of safe and effective use of medical devices; it does not have the force of law.
Although retrospective, this study points to striking differences in the clinical presentation of CD in individuals in South Florida, United States, and Ankara, Turkey, diagnosed during the same time period at both institutions. Turkish patients were younger, and more likely to present with chronic diarrhea, hypoalbuminemia, and microcytosis-as was more commonly seen in the United States in the 1960s and 70s. These findings raise the question of an interplay of demographics with diet and genetics in the presenting symptoms of CD in these 2 distant geographic areas.