Medical Devices, Alarm Hazards and Patient Safety

Technologic advances in hospitals have increased substantially over the past 25 years and the number of devices with alarms at the bedside has grown exponentially. These alarms are intended to alert the clinician regarding a deviation from a predetermined “normal” status and are considered to be a key tool to improving the safety of patients by communicating information that requires a response or awareness by the operator.

Alarms from monitors, ventilators, infusion pumps, feeding pumps, pulse oximeters, intra-aortic balloon pumps, sequential compression devices, beds, and many other devices beep endlessly, demanding our attention. A study in a medical intensive care unit found that ventilators (46%) were the source of the highest proportion of alarms, followed by monitors (37%). In most other settings, physiological monitors produce the most alarm signals.

It is ironic that the very alarms that are meant to protect patients have instead led to increased unit noise, alarm fatigue and a false sense of security.

Excessive and misleading alerts have been the topic of numerous studies and analysis. In 2002, the Joint Commission on Accreditation of Health Care Organisations reviewed 23 reports of death or injury that were related to mechanical ventilation. Nineteen of those events resulted in death, and 4 resulted in a coma; 65% were related to alarms. More recently, the ECRI Institute identified alarm hazards as the number one device-related risk on its 2008 list of top 10 health technology hazards. The severity and frequency of alarm-related incidents pushed them to the top of the ECRI Institute’s list.

Research has demonstrated that 72% to 99% of clinical alarms are false.

The high number of false alarms has led to alarm fatigue. Alarm fatigue is sensory overload when clinicians are exposed to an excessive number of alarms, which can result in desensitisation to alarms and missed alarms.”

Caregivers with alarm fatigue are more likely to ignore or have trouble distinguishing between alarms, which can lead to delayed treatment and patient harm. Addressing alarm fatigue is “like opening Pandora’s box,” says Maria Cvach, the nurse lead of the alarm committee at Johns Hopkins Hospital in Baltimore, Maryland. There are numerous causes of alarm fatigue, to name but a few:

• The vast number of alarms ringing: A 12-day alarm system analysis at Johns Hopkins indicated there were an average 350 alerts per bed per day. In one intensive care unit, the average was 771 alerts per bed per day.
• False and nuisance alarms: 85%–90% of the alerts that signal throughout a hospital each day are false or nuisance alarms, indicating conditions that don’t require clinical intervention.
• Alarm sound discrepancies: There are alarms in therapeutic devices that may not have hierarchical order so the alarm sounds the same regardless of the situation. There’s also no standardisation of alarm sounds between device manufacturers, making it difficult for health workers to triage their response to alerts.
• Alarm malfunctions: The more often a device issues false alarms, the less likely health workers are to respond. “It’s very much the fable of crying wolf,” says Judy Edworthy, a professor of applied psychology at Plymouth University in the United Kingdom.
  …and more.

Although there’s growing awareness of this problem, there are few efforts to design alarms to be more effective, says Edworthy. Most initiatives to date have focused on tweaking settings to ensure that a narrower range of conditions prompt alarms. One such initiative at Johns Hopkins saw a 24%–74% reduction in the number of alarms per bed per day across six units. Edworthy is collaborating with a hospital to develop alarms that are easier to hear, understand and locate. She says the technology exists to create audible, meaningful alarms, but more investment is needed to make these “smart” alerts a reality.

Other common themes in addressing the issue of alarm fatigue include:

• Education
• Adequate staffing
• Human factor engineering in developing alarms
• Inter-professional teams with a focus on quality issues

The issue of alarm management will likely take on increasing urgency in coming years, as new technologies are brought to market.

Medical device companies are beginning to heed this call for change, says Sean Clarke, director of the nursing collaborative program at McGill University in Montréal, Quebec. Alarm fatigue experts, industry representatives and other diverse stakeholders with mutual interests, urgently need to come together in order to utilise their collective knowledge on the design, use, integration, and servicing of healthcare technology, systems, and devices.

Article credits:
Canadian Medical Association Journal, Canadian Medical Association
Initiatives in Safe Patient Care, published by Saxe Healthcare Communications
U.S. Department of Health & Human Services