Philips HeartStart FRx, Home, and OnSite AEDs are safe and effective, and owners should not hesitate to retrieve and use these life-saving devices in cardiac arrest emergencies. That’s the lead. Yet, you wouldn’t know that from all the frightening media headlines generated in response to the recent FDA safety communication regarding these AEDs. Nor from the plaintiff’s lawyers who are already soliciting cases involving these devices (imagine what they would say if one of these AEDs wasn’t used to try to save an SCA victim).
Let’s cut through the hype and get to the true state of affairs. n September 2012, Philips initiated a voluntary medical device recall for HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs. Through its own factory monitoring and analysis processes, the company discovered that an internal component could affect the ability of a small number the AEDs to make a therapy decision. This recall affects between 600,000 and 700,000 devices shipped between December 2005 and July 2012, about half in the U.S. In January 2013, the FDA designated this action as a Class II recall “after determining that the chance of serious adverse consequences or death due the device failure is remote.”
The September 2012 Philips recall notice and the January 2013 FDA Class II recall notice indicate the affected AEDs are safe and effective and remind AED owners of their responsibility to properly maintain these devices. Specifically, the notices advise owners to contact Philips if an affected AED emits a pattern of triple chirps during self-testing which indicate the possibility of component failure. In the absence of the triple chirp, the notices indicate that the AEDs are ready to save lives.
On November 19, 2013, at the FDA’s request, Philips issued an updated Maintenance Advisory further clarifying when owners should contact Philips for service on these devices. Simply put, and reiterating information from the earlier notices, the advisory says that if an affected AED emits a triple chirp during self-testing, the owner needs to contact Philips to have the device serviced or replaced. In the absence of a triple chirp, these AEDs are safe, effective, and ready to deliver a shock if needed.
On December 3, 2013, the FDA published a safety communication about these AEDs which is what triggered the recent media frenzy and heightened lawyer interest. In its recommendations, the FDA says:
“Please be aware that the Philips HeartStart AEDs are designed to automatically test themselves at regular intervals to ensure they are ready for use. The HeartStart AED should emit a triple chirp sound and have a flashing “i-button” if it detects a serious problem that could prevent the HeartStart AED from delivering an electrical shock.”
Notably, the FDA’s safety communication advises owners of devices emitting a triple chirp to:
“Keep the recalled HeartStart AED in service until Philips Healthcare replaces the device or you can obtain another working AED. 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.”
In response to the FDA’s safety communication, Philips issued a Statement Regarding HeartStart FRx, Home and OnSite Automated External Defibrillators (AEDs) Self-Test Safety Alerts. The statement notes that internal component failure is an extremely rare occurrence which, if it occurs, will be detected during self-testing. The company reports that only 61 of 605,000 affected AEDs have been returned for service or replacement due to this issue (0.01%) and there have been no reports of patient harm resulting from a failure of this component.
Every AED manufacturer (along with many other medical device companies) have initiated recalls for a variety of reasons. But the good news is that nearly all issues potentially impacting AED performance are detected through device self-testing. By design, AEDs check themselves regularly and report results in real time to AED owners via text, visual, and audible prompts. This gives owners the opportunity to have AEDs serviced before they are needed in sudden cardiac arrest emergencies.
These built-in safeguards help make AEDs safe, effective, and essential in the fight to save more sudden cardiac arrest victims. Indeed, as we noted in our FDA reclassification submission and related blog post, despite many AED recalls over the years, the devices work as expected during rescue attempts over 99.5 percent of the time. We calculate that AEDs have a very low point-of-use failure rate of between 0.19% and 0.49%. In contrast, implantable defibrillators have a failure rate as high as 1-2%.
Which brings us to the issue of FDA media messaging and overall media coverage. The FDA’s reclassification and recall media messaging focuses on the fact of recalls and the risk of AEDs failing when they are needed. Broadly speaking, the media hypes reclassification and recalls with headlines designed to grab eyeballs rather than provide actionable information. In both cases, the information fails to inform readers of the most important fact needed to put reclassification and recalls in proper context – that AEDs work when needed nearly 100% of the time and have saved hundreds of thousands of lives. The very real risk of hyping reclassification and recalls is that AED users will either not use, or hesitate to use, AEDs when SCA strikes because of concerns about device reliability. This could cost lives unnecessarily.
There is a very important lesson to be learned from all of this. The lesson relates to the responsibilities of AED ownership. The standard of care requires AED owners to properly inspect and maintain their AEDs. Modern AEDs help with this task by periodically self-testing and generating audible and visual alerts telling owners of any problems. This self-testing process is one key reason AEDs work when needed nearly 100 percent of the time. AED owner failure to regularly inspect and maintain AEDs is one major reason for the 0.5 percent failure rate during rescue attempts. This is a people problem, not a device problem. The current media coverage is just another reminder of AED owner responsibilities. That is the key takeaway.
The publicity surrounding AED recalls is an important prompt to take good care of your AEDs so they will take good care of those who might be saved from sudden cardiac death. And AED owners, retrievers, and users should feel confident that deployed devices are ready to use and will save lives when needed.
SOURCE: Richard Lazar, Readiness Systems, Reprinted with permission
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