Ventilator Alarms Linked to Patient Deaths

Dec 12, 2011 3:59pm

More than 100 people have died in the past six years as a result of problematic alarms on ventilators, which are designed to beep warnings to caregivers when something goes wrong with the machine or the patient’s breathing.

The Boston Globe reports that the problems seem to be related less to the devices themselves and more to human error.  An analysis conducted by the Globe and the ECRI Institute, a nonprofit patient safety organization, found that 119 people died between 2005 and May 2011 in incidents involving ventilator alarms. According to the analysis, an actual malfunction of the ventilator was the cause in only two of those deaths; all others were the result of caregivers’ ignoring the alerts, failing to hear them or setting the alarms incorrectly.

The report is the latest development in alarm fatigue, a problem that occurs when hospital and home-based caregivers become overwhelmed by the number of alarms that blare constantly  from medical devices, such as ventilators or cardiac monitors.

“Alarms occur frequently, and many times they’re false, and because of that many times people fail to act as quickly as they should when an alarm goes off,” Maria Cvach, assistant director of nursing and clinical standards at Johns Hopkins Hospital, told ABCNews.com

Alarm fatigue has been implicated in the deaths of several patients in recent years, including a 60-year-old man at UMass Memorial Medical Center in August 2010.

In 2010,  the U.S. Food and Drug Administration, the agency responsible for regulating the manufacture of ventilators and other medical devices, reported 800 alarm-related adverse outcomes  in patients on ventilators. The agency classified many of them as “preventable” or caused by “human error,” the Globe reports.

 The problems associated with ventilator alarms have been moving steadily to the forefront of hospital and patient care. In September 2011, the FDA issued an alert to caregivers that alarms were going unnoticed, cautioning that nurses and other medical aides were becoming too dependent on the alarms. The ECRI Institute lists alarm hazards as the top item on its annual list of the top 10 health technology hazards.

Mary Logan, the president of the Association for the Advancement of Medical Instrumentation, said the problem of alarm fatigue does not rest solely with caregivers. The environment of care, the design of medical devices and government regulation all play an equal role in quieting the cacophony of beeps that fill hospitals, care facilities and even patients’ homes.

“It’s impossible to pinpoint any one layer in the system that’s causing the problem. It really is a systems issue,” Logan told ABCNews.com.  ”And the only way we’re going to be able to solve it is getting the health care community to work together.”

Patient safety advocates have proposed improvements to ventilator alarms and to other medical devices to help caregivers better distinguish the alarm that signals a patient needs help from the noise of medical devices. For example, the AAMI is proposing a smarter integration of the alarms from all medical devices – ventilators, cardiac monitors, fusion pumps for medication, etc. – to give clinicians more information about when an alarm is vital.

Cvach said  that different makes and models of ventilators give off different sounds and suggested that the FDA establish  standards for alarm sounds for the devices to cut down on confusion for caregivers. She also said that a delay in a device’s alarm could be useful to avoid drawing attention to meaningless fluctuations in measurements, such as those created when a patient coughs or sneezes.

“It sounds counterintuitive to apply a delay, but it actually makes it safer because you’re giving truer, more meaningful information,” she said.

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