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March 27, 2012

FDA Sounding Off About 'Alarm Fatigue' Coming From Medical Devices

To us when we’re in the hospital, it’s a welcome sound, that buzz. It signals the nurse that we need her. But imagine you’re surrounded every day, every hour by endless buzzing, beeping, and hissing. Do you think you’d hear any of it, after awhile?

That’s the disturbing conclusion the Food and Drug Administration (FDA) has come to, following a story last year in The Boston Globe that linked this “alarm fatigue” to hundreds of deaths.

The problem is that medical professionals can become desensitized to all the noises that medical devices make, and then miss those sounds that signify that a patient is in trouble.

So the FDA is taking steps to reduce this in hospitals “by intensifying its pre-market review of medical devices that sound alarms and could contribute to the desensitization of nurses,” according to a story by Liz Kowalczyk.

The Boston Globe reports that the agency is stepping up and adding to its training on alarm standards and alarm safety for its reviewers, those who check over 4,000 applications a year from manufacturers looking to be approved to sell their medical devices, including heart and oxygen monitors.

Instead of adding to the noise that alarms on such monitors and on medication pumps, ventilators, and beds make endlessly in hospitals, a top FDA device official has now hinted that “he wants to keep new products that do not serve an important function from needlessly adding to the cacophony,” writes Kowalczyk.

The national organization that accredits hospitals is also jumping in. Over the next few weeks, according to Kowalczyk , it will ask hospitals and nursing homes across the country to come up with “specific recommendations for reducing the number of hospital alarms sounding,” Kowalczyk reports.

Dr. William Maisel, deputy director and chief scientist at the Center for Devices and Radiological Health,  and a cardiologist who previously worked at Beth Israel Deaconess Medical Center in Boston, told Kowalczyk that the FDA “is particularly focused on ‘new alarms trying to measure new things,’’ such as alarms that monitor various physiological functions at once.”

Manufacturers of these devices argue back that monitoring several vital signs at once gives clinicians a better picture of when a patient is in trouble, Kowalczyk writes, though many monitors do just measure one function, such as heart rate and rhythm.

FDA is also considering issuing guidelines to the medical device industry about its expectations on the use of alarms.

Edited by Tammy Wolf
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