Friday, July 12, 2013
WASHINGTON — Walk into a hospital intensive-care unit and hear the din: A ventilator honks loudly. An infusion pump emits a high-pitched beep-beep every six seconds. A blood-pressure monitor pushes out one long tone after another.
This particular racket, at MedStar Washington Hospital Center, comes from medical devices and equipment that scans for potentially dangerous changes in patients’ heart rhythm, blood pressure and other vital signs.
But most of the noises are false alarms or don’t require action. The ventilator sounds a warning because a patient coughs. The infusion pump beeps after running out of a medication the patient no longer needs. The blood-pressure monitor goes off after a nurse adjusts a catheter in the patient’s artery.
The sheer number of alarms — several hundred per patient per day — can cause alarm fatigue. Nurses and other workers, overwhelmed or desensitized by the constant barrage, sometimes respond by turning down the volume on the devices, shutting them off or simply ignoring them — actions that can have serious, potentially fatal consequences.
Clinicians and patient-safety advocates have warned of alarm fatigue for years, but the issue is taking on greater urgency as hospitals invest in more complex, often noisy devices meant to save lives.
Last month, the Joint Commission, which accredits hospitals, directed facilities to make alarm safety a top priority or risk losing their accreditation. The commission is requiring hospitals, starting in January, to identify the alarms that pose the biggest safety risks by unnecessarily adding noise or being ignored. By 2016, hospitals must decide who has the authority to turn off alarms.
“We are saying, ‘Here’s an issue that hurts and kills people,’ “ said Ron Wyatt, medical director of the commission’s health-care improvement division.
The parents of Mariah Edwards won a $6 million malpractice settlement after their 17-year-old daughter died last year following a tonsillectomy at a Pennsylvania surgery center. After the surgery, she was given a painkiller that slowed her breathing. By the time nurses checked on her 25 minutes later, she had suffered profound and irreversible brain injury. She died 15 days later.
A nurse said in her deposition that the alarm on the respiratory monitor was muted, said Joel Feller, an attorney for the family. After Edwards’s death, the center announced several changes, including that alarms would no longer be muted.
The Joint Commission received 98 reports of alarm-related incidents — including 80 deaths — in the 31/2-year period that ended in June 2012. In more than 60 percent of the cases, alarms either were inappropriately turned off or were not audible in all areas. Those voluntary reports are a gross undercount, says the commission, which estimates that there were close to 1,000 alarm incidents in which patients died or were injured, or faced those risks.
The ECRI Institute, a Pennsylvania-based patient-safety organization, listed alarm hazards as the No. 1 issue on its annual list of the top 10 health-technology dangers for 2012 and 2013.
“I think the main reason is the large growth in the use of monitors that have alarm-based features and the number of alarms that clinicians are needing to deal with,” said Jim Keller, ECRI’s vice president for health-technology evaluation and safety.
At Children’s National Medical Center, a late response to a heart monitor played a role in the death of a patient 10 years ago. That prompted changes, according to Linda Talley, vice president of nursing for critical care.
A special team at Children’s Hospital determined that clinicians heard an alarm every 66 seconds, on average, in the hospital’s neonatal ICU. The team now scrutinizes monthly data to look at the number of alarms and the response times. To reduce noncritical alerts, staff members customize device settings for individual patients. A heart monitor for a newborn, for example, would probably be set to alarm more often than that for an 18-year-old.
Because each manufacturer’s device alarms are different, the hospital also standardizes equipment as much as possible; one vendor supplies all the heart monitors, for instance.
Technicians in non-critical-care areas keep track of flashing lights and other visual alarms on a central monitor and text the urgent alerts to nurses’ mobile phones.
Patient-safety experts and health officials have known of the potential harm for years.
At Johns Hopkins Hospital, “it took a few adverse patient events to focus attention on the problem,” according to a medical technology group’s report about Hopkins’s safety efforts. The incidents took place in 2006, but officials declined repeatedly to say how many there were and whether patients died.
Experts say there should be better reporting of “near misses” or incidents that could be dangerous.
Two years ago, the Advancement of Medical Instrumentation hosted an alarm summit; the FDA, the Joint Commission, the ECRI Institute and the American College of Clinical Engineering took part. A report identified the need for smarter technology that can check more than one indicator and weed out nuisance alarms.
Manufacturers, however, are reluctant to invest in more expensive technology because of liability.
The FDA, which regulates medical devices, is increasing staff awareness of alarm safety when it reviews applications for new devices.
The agency is also working with industry, hospitals and other groups to standardize alarm sounds, especially for life-critical events, said William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health.