An Alarming Trend

If you’ve ever spent any appreciable amount of time in a hospital or other medical care facility, you may have been driven temporarily insane by the never-ending chorus of medical device alarms. I was recently reminded of a few nights I spent in the hospital with my dad a year or so ago. Just when I thought I was drifting off to sleep, one of the infusion pumps delivering his pain medication would go off and wake both of us up. This got me thinking about alarm fatigue, and the drain that so many medical device alarms must have on medical staff, not to mention patients and family.

In his presentation at the Human Factors & Ergonomics Society Health Care Symposium last month entitled Human Factors in Patient Monitoring: From Noise to Signals, David Barash of GE Healthcare noted that alarm fatigue has been considered the #1 medical device hazard over the past 2 years. He explained that many alarms are false positives or clinically insignificant and don’t need to be addressed. (Alarm thresholds are often overly conservative in an attempt to lower risk to the patient.) Mr. Barash went on to say that the increased number of these false positives reduces the trust medical providers place in alarms and thereby increases the likelihood of the providers not responding to them, which would obviously be detrimental to the patient if a truly serious alarm condition were to occur. Unfortunately, we’re not just dealing with hypothetical scenarios. In a White Coat Notes article, Liz Kowalczyk of the Boston Globe reported that “the FDA was able to identify 560 alarm-related deaths in a recent four-year period.”¹ It’s the story of the boy who cried “wolf” all over again, only on a much larger scale and the players have changed.

So what can be done to reduce the impact of alarm fatigue on healthcare providers? The IEC 60601-1-8 collateral alarm standard for medical devices was updated late last year. One of the purposes of the update was to help standardize device alarms so that it would be easier for medical staff to recognize the highest priority issues. The Joint Commission issued a Sentinel Event Alert on Monday about this problem, including the following recommendations, the first 5 of which are also recommended by AAMI and the ECRI Institute:²

• Leadership ensures that there is a process for safe alarm management and response in high-risk areas (as identified by the organization).
• Prepare an inventory of alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions, and identify the default alarm settings and the limits appropriate for each care area.
• Establish guidelines for alarm settings on alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions; include identification of situations when alarm signals are not clinically necessary.
• Establish guidelines for tailoring alarm settings and limits for individual patients. The guidelines should address situations when limits can be modified to minimize alarm signals and the extent to which alarms can be modified to minimize alarm signals.
• Inspect, check, and maintain alarm-equipped devices to provide for accurate and appropriate alarm settings, proper operation, and detectability. Base the frequency of these activities on criteria such as manufacturers’ recommendations, risk levels, and current experience.

Additional strategies include:

Training and education

• Provide all members of the clinical care team (as defined by the organization) with training on the organization’s process for safe alarm management and response in high-risk areas (as identified by the organization), and on the safe use of the alarmed medical devices on which they rely. Also provide ongoing training on new alarmed medical devices and updates to alarmed medical devices, and ensure that new members of the clinical care team receive training on the alarmed medical devices on which they rely.

Equipment and physical environment

• To help reduce nuisance alarm signals, change single-use sensors (for example, ECG leads), according to manufacturer’s recommendations, unless contraindicated.
• Assess whether the acoustics in patient care areas allow critical alarm signals to be audible.

Leadership and organizational planning

• Re-establish priorities for the adoption of alarm technology; the priority-setting process should drive technology adoption rather than allowing technology to drive the process.
• Establish a cross-disciplinary team that includes representation from clinicians, clinical engineering, information technology, and risk management, to address alarm safety and the potential impact of alarm fatigue in all patient care areas.
  • Establish a process for continual improvement and constant optimizing of alarm system policies and configurations.
  • Review trends and patterns in alarm-related events to identify opportunities for improving alarm use.
  • Implement an alarm system management policy, including the periodic review of alarm coverage processes and systems, and the development of realistic, implementable strategies to address vulnerabilities.
• Share information about alarm-related incidents, prevention strategies, and lessons learned with appropriate organizations, such as AAMI, ECRI Institute, the FDA, and The Joint Commission.

What do you think about The Joint Commission’s recommendations? Do you have any advice to offer from personal experience? If so, we’d love to hear it!

-KB

1. Kowalczyk, Liz (April 2013), “Joint Commission warns hospitals that alarm fatigue is putting patients at risk”, Boston Globe (Boston, Massachusetts).
2. Patient Safety Advisory Group, “Sentinel Event Alert: Medical device alarm safety in hospitals”, The Joint Commission, www.jointcommission.org.