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Posted 14 August 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has approved a new medical device, largely unremarkable but for one unusual aspect: It gives instructions to its administrator verbally.
French life sciences manufacturer Sanofi said its Auvi-Q (epinephrine injection, USP) auto-injector had received FDA approval on 13 August 2012. The device is used in patients who are at risk for or have a history of going into anaphylactic shock as the result of an allergic reaction.
The device is used by many patients on themselves, but is also relatively unusual in that the medical circumstances surrounding the event may require a non-physician caregiver-including a stranger-to administer the epinephrine injection on behalf of the patient in an emergency situation.
Sanofi said its Auvi-Q device improves this less-than-ideal situation by talking the user through each step of the administration process, easing the concerns of patients concerned the auto-injectors will be used incorrectly. Sanofi noted the device also features an auto-retractable needle to prevent accidental needle sticks, which are a potential problem for those not used to handling similar devices.
"In the event of a life-threatening allergic reaction, it's important to know how to respond quickly," explained Dr. Vivian Hernandez-Trujillo, a pediatric allergist, in a statement provided by Sanofi. "Auvi-Q offers patients and caregivers guidance through the injection process."
Sanofi noted the device is the first portable epinephrine auto-injector to contain the instruction feature, though similar features are available on automated external defibrillators (AEDs).
Tags: Instruction for Use, Verbal, Auto-Injector, IFU, Latest News, medical device
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