The December 2022 issue of IEEE Spectrum is here!

Close bar

FDA Proposes New Rules on Public Defibrillators

The FDA responds to reports of defects plaguing these heart-helping machines

1 min read
FDA Proposes New Rules on Public Defibrillators

Today the U.S. Food and Drug Administration proposed to tighten its regulation of publicly displayed machines used to shock a stopped heart back to life. Such automatic external defibrillators, or AEDs, have become common in malls, gyms, schools and other public spaces, but they haven't always worked properly in a pinch.

Between 2005 and 2012 the FDA received reports of 45,000 problems with AEDs, many having to do with defects in design and fabrication or in components obtained from suppliers. The agency's proposed rules would require manufacturers to provide clinical results before going to market, submit to an on-site inspection of manufacturing processes and then pass annual reviews of each product's track record.

"The FDA realizes that this is a lot to ask—clinical trials, studies, possibly animal trials, manufacturing approval and so forth all take time to conduct," says Mark Harris, the Seattle-based journalist whose sweeping exposé of the problem, "A Shocking Truth," appeared in IEEE Spectrum in March 2012. However, he adds, manufacturers "have had plenty of time to acquire data and should have been doing so, especially considering the many problems AEDs have experienced." 

Ten days ago the article won the Grand Neal Award, one of the highest awards in business journalism. 

The Conversation (0)

Are You Ready for Workplace Brain Scanning?

Extracting and using brain data will make workers happier and more productive, backers say

11 min read
A photo collage showing a man wearing a eeg headset while looking at a computer screen.
Nadia Radic

Get ready: Neurotechnology is coming to the workplace. Neural sensors are now reliable and affordable enough to support commercial pilot projects that extract productivity-enhancing data from workers’ brains. These projects aren’t confined to specialized workplaces; they’re also happening in offices, factories, farms, and airports. The companies and people behind these neurotech devices are certain that they will improve our lives. But there are serious questions about whether work should be organized around certain functions of the brain, rather than the person as a whole.

To be clear, the kind of neurotech that’s currently available is nowhere close to reading minds. Sensors detect electrical activity across different areas of the brain, and the patterns in that activity can be broadly correlated with different feelings or physiological responses, such as stress, focus, or a reaction to external stimuli. These data can be exploited to make workers more efficient—and, proponents of the technology say, to make them happier. Two of the most interesting innovators in this field are the Israel-based startup InnerEye, which aims to give workers superhuman abilities, and Emotiv, a Silicon Valley neurotech company that’s bringing a brain-tracking wearable to office workers, including those working remotely.

Keep Reading ↓Show less