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. 

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This CAD Program Can Design New Organisms

Genetic engineers have a powerful new tool to write and edit DNA code

11 min read
A photo showing machinery in a lab

Foundries such as the Edinburgh Genome Foundry assemble fragments of synthetic DNA and send them to labs for testing in cells.

Edinburgh Genome Foundry, University of Edinburgh

In the next decade, medical science may finally advance cures for some of the most complex diseases that plague humanity. Many diseases are caused by mutations in the human genome, which can either be inherited from our parents (such as in cystic fibrosis), or acquired during life, such as most types of cancer. For some of these conditions, medical researchers have identified the exact mutations that lead to disease; but in many more, they're still seeking answers. And without understanding the cause of a problem, it's pretty tough to find a cure.

We believe that a key enabling technology in this quest is a computer-aided design (CAD) program for genome editing, which our organization is launching this week at the Genome Project-write (GP-write) conference.

With this CAD program, medical researchers will be able to quickly design hundreds of different genomes with any combination of mutations and send the genetic code to a company that manufactures strings of DNA. Those fragments of synthesized DNA can then be sent to a foundry for assembly, and finally to a lab where the designed genomes can be tested in cells. Based on how the cells grow, researchers can use the CAD program to iterate with a new batch of redesigned genomes, sharing data for collaborative efforts. Enabling fast redesign of thousands of variants can only be achieved through automation; at that scale, researchers just might identify the combinations of mutations that are causing genetic diseases. This is the first critical R&D step toward finding cures.

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