FDA issues safety communication regarding HeartStart automated external defibrillators
SILVER SPRING, Md. — The Food and Drug Administration on Tuesday issued a safety communication on HeartStart automated external defibrillators from Philips Healthcare, noting that certain HeartStart AED devices may be unable to deliver needed defibrillator shock in a cardiac emergency situation.
The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation.
“The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected an error during a self-test,” stated Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”
These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home and HeartStart HS1 OnSite. Users, who may include consumers and first responders, should contact Philips Healthcare for a replacement AED unit.
In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock.
In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective.
Innovative BioDefense inks deal with Picketts Health to distribute Zylast antimicrobial product globally
LAKE FOREST, Calif. — Innovative BioDefense, manufacturer of the Zylast line of broad-spectrum, persistent antimicrobial products, on Tuesday announced an exclusive relationship with Australian-based Picketts Health to provide a modification of their proprietary lotion and antiseptic sanitizer for use in Picketts Health’s patented Orbel hand sanitizer applicator.
“We are pleased Picketts Health has taken an important step towards solving the issue of compliance with the introduction of the Orbel,” stated Colette Cozean, Innovative BioDefense CEO. “Their choice in bringing Zylast in as the formulary shows their commitment to providing the premier antimicrobial solution.”
The first markets Picketts Health plans to target are the United Kingdom, South Africa, Australia and China. Zylast is protected by trademarks and patents pending in many countries worldwide.
The Orbel was designed to increase hand-hygiene compliance and help prevent the spread of bacteria, viruses and infections. Portable, with single-handed activation of a regulated dose, the Orbel’s multi-directional balls evenly facilitate distribution to all parts of the hands for increased protection.
Zylast has shown to kill 99.99% of most disease-causing germs in 15 seconds and is persistent for six hours, the company stated.
Infirst Healthcare to promote pediatric cough-cold brand Dr. Cocoa in U.S. market
LONDON — Infirst Healthcare earlier this month secured the rights to market Dr. Cocoa, an award-winning cocoa-flavored pediatric cough remedy.
“Many cough treatments have deficiencies in their efficacy, safety and compliance profiles and Infirst Healthcare is committed to finding solutions that address these issues," Manfred Scheske, Infirst CEO said. "Introducing compliance optimized pediatric products that taste better to children is a step in this direction. We are excited about the start of our U.S. operations in the pediatric OTC market.
Dr. Cocoa was named "Best Product" at the 2013 US Cough & Cold ECRM conference, an award sponsored by DSN. The patent protected line of products has been formulated with real chocolate in order to improve compliance for better symptom relief.
The Dr. Cocoa brand is brought to life through the Dr. Cocoa Owl character which depicts the family doctor speaking to children and parents in a knowledgeable and credible way, and will be used throughout all marketing and communications activity, the company noted.
With this agreement, Infirst Healthcare now holds the exclusive global rights for the use of cocoa and chocolate in cough products. Infirst Healthcare will be building its U.S. presence and preparing for the launch of Dr. Cocoa in 2014. Infirst Healthcare will be represented in the U.S. by Advantage Consumer Healthcare.