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March 26, 2012

FDA working to trim hospital ‘alarm fatigue’

Steps up review that beeping devices undergo before they hit market

The Food and Drug Administration is taking steps to reduce “alarm fatigue’’ in hospitals by intensifying its pre-market review of medical devices that sound alarms and could contribute to the desensitization of nurses - a problem that The Boston Globe reported last year was linked to hundreds of deaths.

The agency is providing additional training on alarm standards and alarm safety to its reviewers, who are responsible for scrutinizing 4,000 applications a year from manufacturers seeking permission to sell their medical devices, including heart and oxygen monitors.

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Alarms on such monitors and on medication pumps, ventilators, and beds already blare endlessly in hospitals, and one of the FDA’s top device officials indicated that he wants to keep new products that do not serve an important function from needlessly adding to the cacophony.

Dr. William Maisel, deputy director and chief scientist at the Center for Devices and Radiological Health, said reviewers are poring over new applications “with increased awareness’’ about whether alarms provide information important to patient care and measure what a company claims they measure. “We certainly recognize our important role in addressing the alarm issue,’’ he said.

The national organization that accredits hospitals is also tackling the problem. Starting in the next couple of weeks, it plans to survey hospitals and nursing homes nationwide to develop specific recommendations for reducing the number of hospital alarms sounding.

Maisel, a cardiologist who previously worked at Beth Israel Deaconess Medical Center in Boston, said 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 claim that considering several parameters together allow them to better predict when a patient is in trouble. Many monitors measure just one function, such as heart rate and rhythm.

“If a company comes in and says we have developed an alarm that is a combination of these three things and is linked to outcomes, we want to see the data that supports that,’’ Maisel said.

The agency also is considering more comprehensive measures, such as issuing guidance documents that would communicate to industry a “significant changing expectation’’ regarding the use of alarms. Maisel declined to elaborate.

A Globe investigation last year identified at least 216 deaths nationwide between January 2005 and June 2010 linked to alarms on patient monitors that track heart function, breathing, and other vital signs. In many cases, medical personnel did not react with urgency or did not notice the alarm, a type of desensitization that occurs from hearing alarms - many of them false - all day long.

The Globe found that at least 119 other people died since 2005 in incidents involving warning alarms on ventilators, such as caregivers failing to respond to beeps warning of a problem or setting alarms improperly so they sounded too softly or not at all.

Maisel said the “FDA could do everything right, but if the health care community is not doing its job, that won’t be enough.’’ Many of the patient safety lapses with ventilators are “not a malfunction of the alarm but the use of the alarm. Someone turned the volume down or didn’t hear it,’’ he said.

After the Globe published its series, the national organization that accredits hospitals, The Joint Commission, promised to tackle the failure of medical staff to respond to patient alarms, making it a top priority in 2011.

The commission drafted a national patient safety goal last year on alarm management, which signals the issue is a high priority that hospitals must address to remain accredited.

But advisers to the group wanted more specific recommendations for managing alarms and dealing with alarm fatigue, said Maureen Carr, project director for standards and survey methods.

So, the organization plans to survey 4,500 hospitals and 1,000 long-term care facilities to help develop more specific recommendations.

Joint Commission leaders said they are proceeding carefully because the answers are not obvious, considering that alarms can save lives as well as lead to patient harm.

“It’s helping people understand whether the alarm is important or not,’’ said Dr. Robert Wise, the commission’s medical adviser for health quality evaluation. “It’s not just about alarms but about everything a nurse has to pay attention to. People just can’t get their job done.’’

Wise said the organization is “trying to avoid coming to solutions that don’t work,’’ which would lead to “solution fatigue.’’

Liz Kowalczyk can be reached at kowalczyk@globe.com.
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