A number of Philips ($PHG) automated external defibrillators may still be duds, potentially failing to deliver the shock needed in an emergency despite a recall initiated more than a year ago intended to address the issue, the FDA cautioned. Regulators issued a safety alert to warn consumers about the ongoing problem, an embarrassment for the Dutch consumer and healthcare electronics giant.
The FDA specifically named several models of Philips Healthcare's HeartStart defibrillators in the alert: the HeartStart FRx, HS1 Home and HS1 OnSite automated external defibrillators (AEDs). Philips Healthcare's Philips Medical Systems division produced the affected models between 2005 and 2012, the FDA said.
Philips initiated a recall of each model in 2012 because an internal electrical component failed, hitting more than 700,000 devices. Regulators noted that Philips issued a medical device safety notice in November 2013 warning consumers that the issue was ongoing. An attempt to reach Philips about the matter at presstime was unsuccessful.
Philips is the target of this FDA safety alert, but the company isn't necessarily being singled out. The regulatory agency announced in March that it would consider imposing stricter regulations on external defibrillators, forcing manufacturers to undergo random inspections and submit clinical proof of safety, similar to requirements that implantable defibrillators face for the far-more-rigorous PMA process. External defibrillators, used in airports and shopping malls, have previously faced the much easier 510(k) clearance path to market, but regulators decided on a crackdown because of thousands of failure reports for the devices.
Regarding the FDA safety communication, regulators said that all of the recalled HeartStart AEDs should still be kept in service until Philips Healthcare or another manufacturer replaces them, even with the risk of problems.
"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," Steve Silverman, director of the Office of Compliance for the FDA's Center for Devices and Radiological Health, said in a statement.
- read the FDA announcement
- here's the full FDA safety communication