List date(s) this work was published or aired.
May 10, 2012
Provide a brief synopsis of the story or stories, including any significant findings.
Publicly accessible automated external defibrillators (AEDs) can seem near-miraculous in their ability to pull sudden cardiac arrest victims back from sure death. Not surprisingly, stories of their successes have a strong emotional appeal in a country where more than 900 people die of cardiac arrest every day. But actually measuring and analyzing the national scope and impact of this “bystander” AED emergency response model remains an elusive goal for policy makers and the nation’s health care research community. The goal of this story project was to take a comprehensive look at all aspects of AEDs use and actual health impact across the country. Findings include: We found that even as governments, corporations and individuals purchase and install an estimated $500 million worth of AEDs each year there is a lack of central registries at the city, state and national level capable of routinely gathering data about AEDs’ exact locations or battery power levels or overall operational status. Also unknown are the criteria used to place many of them in their current locations, or how many times they are used by members of the public, or what the outcomes of those emergency response events are, or how the bystander AED model’s overall national benefits compare to its overall costs. AEDs are curious in that they are a Class III medical device sold as consumer electronics products through mass-market outlets like Walmart and Amazon.com. Class III devices are the most strictly regulated by FDA and are typically only available via physicians and hospitals; AEDs are covered by the same rules that apply to defibrillators implanted in the body. But the two kinds of devices are subject to very different record-keeping protocols. Essentially, no meaningful records are kept on AEDs. For instance, surgically-implanted defibrillators must be documented in a central national registry run by the American College of Cardiology. When the FDA issues advisories about potential mechanical problems or dangers in various implantable models, it’s relatively easy to know where the defective units are, as well as to communicate with the hospital and surgeons that put them in. But what happens when the FDA must issue advisories about potentially defective AEDs whose malfunction could directly result in a life not being saved? FDA adverse events report records show at least 1,150 instances when an AED has failed to operated properly and the cardiac arrest victim being treated died. The FDA internal documents say that “Over the past five years we have seen persistent safety problems with all types of external defibrillators, across all manufacturers of these devices. From Jan. 1, 2005 to July 10, 2010, there were 68 recalls, exhibiting an increase from nine in 2005 to 17 in 2009, the last complete year for which data are available. During this period, the FDA received more than 28,000 medical device reports (MDRs), which also exhibited an increase from 4,210 in 2005 to 7,807 in 2009.” But even when the device malfunctions that caused those failure are identified, there is no way to contact the owners of all similar AED models or recall and repair those models. Those faulty AEDs simply remain hanging on the wall until the next cardiac arrest victim collapses nearby and dies as a result of a non-functional AED.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
This story was based on extensive interviews with government and academic scientists who study the world of cardiac arrest and public health. The scattered studies of many of those scientists each contained facts that have largely gone unpublicized. Additional document were obtained from the FDA and local and regional emergency response and academic research organizations.
Explain types of human sources used.
All sources for this story where either academic or government health service scientists or cardiac/emergency response managers or researchers. This include people from the American Heart Association’s Emergency Cardiovascular Care Committee, the emergency medicine departments of Ohio State University Medical Center, the University of Washington, he University of Pennsyvlania’s emergency medicine department, University of Pittsburgh Medical Center’s Prehospital Care Services, the Resuscitation Outcomes Consortium, the Sudden Cardiac Arrest Association and others.
Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
No corrections, clarifications or challenges.
Advice to other journalists planning a similar story or project.
The privacy laws prohibit government offices and emergency responder organizations from identifying individuals who have been either saved by an AED or who have died as a result of a faulty AED being used in a resuscitation attempt. And this human element would make for a very powerful sort of story about how AED issues. I had even thought about running ads asking members of the public who had been treated with an AED or families who knew a family member died because of a faulty or unavailable one — but that effort turned out to be beyond the scope of this particular story.