Heart alarm was off; device issues spotlight a growing national problem
By Liz Kowalczyk, Globe Staff | February 21, 2010
A Massachusetts General Hospital patient died last month after the alarm on a heart monitor was inadvertently left off, delaying the response of nurses and doctors to the patient’s medical crisis.
Hospital administrators said they immediately began an investigation, which led them to inspect and disable the off switch on alarms on all 1,100 of Mass. General’s heart monitors within a day of the death. The hospital also has temporarily assigned a nurse in each unit to specifically listen for alarms, out of concern that sometimes even functioning alarms can’t be heard over the din of a busy ward.
Patient safety officials said the tragedy at Mass. General shines a spotlight on a national problem with heart sensors and other ubiquitous patient monitoring devices. Numerous deaths have been reported because alarms malfunctioned or were turned off, ignored, or unheard.
“This is one of the most frequent and serious problems we see,’’ said Jim Keller, a vice president for ECRI Institute, a nonprofit research and consulting organization based in Pennsylvania that specializes in medical devices. On its top 10 list of health technology hazards last year, it listed alarms on patient monitoring devices as number two.
The Joint Commission, an Illinois-based organization that inspects and accredits hospitals, said it also has seen a surge in alarm-related incidents.
Dr. Gregg Meyer, senior vice president for quality and patient safety at Mass. General, said the hospital could not discuss details of the death because of patient confidentiality laws, other than to say the person was on a heart monitor that was manufactured by General Electric.
Meyer and Jeanette Ives Erickson, the hospital’s chief nurse, said the “crisis’’ alarm on the machine, which would have alerted staff that the patient was experiencing a “serious problem,’’ was off, but they are not sure why.
Normally an alarm would blare in the patient’s room and at a central nursing station, they said. Screens in the room and at the nursing station display the patient’s heart rhythm, but it’s likely that in this case nurses were not in the patient’s room because they were busy with other patients, Meyer said.
The screens at the nursing station depict information for many patients, so one patient’s abnormal heart rhythm might not jump out in the absence of an alarm, he said.
A nurse discovered the patient was in crisis when she went to make a routine check, Meyer said. He would not say how long the patient was in trouble before the problem was discovered.
“The death of this patient was tragic, and our hearts go out to this family and all the caregivers who were affected by this,’’ Meyer said. “Our priority is to find out what happened, why did it happen, and what can we do to make sure it never happens again.’’
One possibility, Erickson said, is that someone turned off the switch during a previous patient crisis because they believed it would pause the alarm, not turn it off for good.
Many monitors allow critical alarms only to be paused for brief periods, not turned off entirely, and Keller at ECRI said sometimes employees are confused because of differences between brands.
Mass. General administrators do not believe that someone turned off the alarm because it was too noisy or annoying, Erickson said, as has happened in other cases across the country.
Erickson said that during the hospital’s investigation, administrators discovered that “alarms cannot always be heard . . . when a unit is very busy.’’ So on Feb. 12, she put in place a plan to assign a nurse to every central nursing station to “ensure a timely response to alarms.’’ She said this is a temporary solution until the hospital turns up the volume on all the alarms, installs new speakers, and assesses whether these changes solve the problem. The hospital also rolled out an educational program for nurses on working with the GE monitoring systems.
Jennifer Francis, spokeswoman for GE Healthcare, said the company would not comment on whether other hospitals have experienced problems with its cardiac monitors.
“We are aware of this tragic incident at Massachusetts General Hospital. At this time, GE Healthcare is partnering with MGH to investigate the incident. GE Healthcare is committed to the highest level of patient care and safety in the use of its products,’’ she said in a written statement.
Dr. Lucian Leape, a specialist on medical safety at the Harvard School of Public Health, said one key question for manufacturers is why they would ever make a machine that allows hospital staff to turn off a critical alarm.
“Every piece of equipment we have has a failure rate, things go wrong,’’ he said. But “how come there are devices where this is possible? Why do you have a monitor you can turn off?’’
Meyer said hospital administrators are not interested in assigning blame to individual staff members because that would be unfair and counterproductive in trying to encourage open reporting and discussion of problems. Rather, he said, hospital officials want to fix the underlying systemic issues with monitoring patients, which is why they disabled the alarms’ off switches. In an e-mail to Mass. General employees Friday, president Peter Slavin praised staff for reporting the incident to hospital safety officials.
The hospital reported the death to the Massachusetts Department of Public Health. Officials there said they are reviewing the matter, but will not comment until the investigation is complete. The federal Centers for Medicare & Medicaid Services also has reviewed the incident, because federal inspectors happened to be at the hospital shortly after the death occurred for a routine inspection. As part of their work, they reviewed hospital safety records. CMS officials said they could not comment on the findings until they are submitted to Mass. General and the hospital has an opportunity to respond.
Keller, of ECRI, said the number of patients who have died or been injured because of problems with alarms is uncertain. Kathryn Pelczarski, director of ECRI’s applied solutions group, said a search of the US Food and Drug Administration database of adverse events found 237 reports of alarm-related deaths between 2002 and 2004. Of the 2,200 medical device problems hospitals reported to ECRI between 2000 and 2006, 12 percent involved alarms, said Pelczarski, whom hospitals often hire to help them fix technology problems.
“Alarm fatigue’’ is one of the most common problems she sees, where nurses and doctors are besieged with so many alarms that they lose their urgency.
Alarms have multiplied in hospitals as technology has become more sophisticated. A very sick patient could be hooked up to a heart monitor, a ventilator that assists breathing, infusion pumps that dispense medications, and a pulse oximeter that measures the oxygen level in blood. Each is equipped with alarms sensitive to small changes in a patient’s physiology.
“There may be so many alarms going off it sort of becomes the background noise,’’ Pelczarski said. “We have seen situations where all the nurses are responsible for all alarms within that unit and there is the assumption that someone else will get that alarm. I frequently see alarms turned down to the point of being inaudible.’’
George Mills, a senior engineer at the Joint Commission, said early in the past decade, inspectors sometimes found that hospital staffers were so overwhelmed by alarms, they were muzzling them with gauze and tape and otherwise blunting the noise. After an educational effort by the organization in 2005, employees stopped overriding alarms and manufacturers improved new machines, in part by making them harder to turn off, he said.
But Mills said the Joint Commission has seen a resurgence of the problem in the last year or so and the group is “again trying to heighten awareness.’’
Liz Kowalczyk can be reached at kowalczyk@globe.com.
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