Regulatory Focus™ > News Articles > Device Provides Patients, Caregivers with Verbal Instructions for Use

Device Provides Patients, Caregivers with Verbal Instructions for Use

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.

Assisting Patients-and Strangers

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).


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