Iowa healthcare professionals may want to take note that the U.S. Food and Drug Administration has issued a safety communication regarding certain brands of automated external defibrillator devices. The HeartStart devices from the medical device manufacturer Philips Medical Systems are considered to present the risk of not delivering the needed electric shock in the cardiac emergencies for which they are indicated, according to the FDA. The agency recommended that the devices, which had already been the focus of an earlier recall, be closely inspected and monitored to ensure readiness in an emergency situation.
The FDA made recommendations to users whose devices detect an error during its self-test mode, advising consumers to keep their equipment until a replacement could be obtained. This was because the agency considered it safer to have the defibrillator on hand during a heart attack even if there was a chance of it not working properly than for at-risk individuals to be without any device while waiting for a replacement.