By Tracy Miller, MPA, CBET

Sick people go to the hospital expecting to get better. Those who are very sick are usually put on a physiological monitor, an alarm, to alert clinical staff of patient vital sign abnormalities. Part of the national norm and accepted as a quality care practice, this auditory communication between clinical staff and patient helps limit the cost of care by reducing the number of staff. However, the system is far from perfect: according to the U.S. Food and Drug Administration (FDA), more than 500 alarm-related deaths occurred between 2009 and 2012. A key factor behind these statistics is alarm fatigue.

Although there is no official definition, “alarm fatigue” is generally described as a situation where an excess number of clinical alarms lead to an adverse patient. The exact number of alarm fatigue occurrences is unknown, since many of them have no ill effect on the patient and go unnoticed. For instance, the alarm sounds when a patient’s heart rate falls outside the designated limit; after a short period of time, perhaps 30 seconds, the alarm stops and the patient’s heart rate returns to the set limit and stays there.

If no one responded to the alarm, no one heard the alarm, and the patient suffered no ill effect, was there an alarm issue? Obviously. But will it get recorded as one? Unfortunately, probably not. For this reason, alarm fatigue is very hard to study and understand. When you factor in the complexity and various causes of alarm fatigue, finding a way to eliminate the problem becomes a huge challenge.

In the past, studies on alarm fatigue focused on individual causes and individual solutions; more recent studies suggest a different approach, including the creation of alarm committees, alarm management programs, smart monitors, noise reduction strategies, standardized alarm tones, interactive communication methods and—most important—buy-in from upper management.

Understanding the Issue

Although the term is new, alarm fatigue has existed for years; reports of this problem date back to 1974, according to the Emergency Care Research Institute (ECRI).

So if there has been a known problem for almost forty years, why hasn’t it been addressed? Actually, it has. In the last four decades, equipment has changed, and entire systems have been built to monitor patients more effectively. Alarm fatigue has simply achieved more notoriety since The Joint Commission made improving the effectiveness of clinical alarm systems one of their National Patient Safety Goals (NPSG) of 2003.1,2 And more recently, in 2012, ECRI cited alarm fatigue as its number-one technology hazard.

Many studies have been conducted to determine a cause, but the problem remains difficult to define. Researchers have identified as many as 11 possible causes of alarm fatigue. So if no one can define the problem, how can it be fixed?

Causes and Potential Solutions

Discussions about the causes of alarm fatigue abound, but few debate one of the main reasons: the “crying wolf” syndrome.3 This theory asserts that false alarms—those that are not medically significant and do not require a medical caregiver response—can cause desensitization to alarms among care givers and prevent them from responding appropriately.

Researchers surmise there may be as many as 700 alarms per day per patient, an estimated 80% to 99% of which are false or clinically insignificant.4,5 Another study illustrates a connection between perception and desensitization, i.e., if an alarm is perceived reliable 99% of the time, it will be responded to 99% of the time. However, if it is perceived reliable only 10% of the time, it will only be responded to 10% of the time.2

Many researchers have focused on effective ways to reduce nuisance alarms and some state they have achieved much success. In a 2010 article in The American Journal of Critical Care (AJCC), Cvach and Graham claim to have reduced the number of alarms by 43% by implementing an alarm management program. The idea of such a program is not only to make adjustments to avoid false alarms, but also to prevent missing true alarms. The belief is that the patient is safer when alarms are properly managed.6,7

A good alarm management program requires clinician buy-in, along with the painstakingly slow, small steps of understanding and adjusting each alarm setting. One particular program took ten months and several experts to implement.7

The techniques and processes clinicians use to adjust alarms also have limitations; caution is advised when adjusting for appropriate alarm parameters. When attempting to achieve a realistic setting, it is possible to miss a true alarm condition. If the alarm does not alert the staff, this results in a lack of care when care might truly be needed. For example, if the alarm limits are too wide, there is greater risk of missing a true alarm.

Smart Monitors and Standardized Alarm Tones

Another approach to reducing alarm fatigue is to create “smart monitors” programmed with “reactive intelligent agent technology.”8,2 Monitors that can look at more than one parameter, utilize trending devices, add delays, and filter signals before triggering an alarm will reduce the number of false alarms, while decreasing the risk of missing true alarms.4

Research proves that the development and implementation of these devices has a very positive impact upon alarm fatigue and alarm issues. Additionally, regulatory bodies have issued suggestions to help healthcare institutions develop available data and integrate it into their systems.

Some consideration has been given to standardizing alarm tones to help reduce alarm fatigue. Research shows that the human is only capable of discriminating five to seven different categorical sounds4 and that the inconsistency of alarm tones further complicates the issue.9 Currently, there are hundreds of manufacturers, each with their own alarm tones, volumes, and sounds, making it impossible for staff to differentiate between them all. This smorgasbord of alarm tones causes confusion and misinterpretation of the alarms.10

While some people believe monitors should be standardized so staff will have fewer alarm tones to remember and distinguish, others argue that use of fewer, better alarms will significantly improve the alarm fatigue issues.11

Some researchers suggest reducing noise levels in the hospital. A study at a hospital in Providence, Rhode Island, found that the intensive care areas had peak sound levels greater than 80 decibels, which makes it difficult for staff to distinguish the alarm tone, level or location. Quieting the hospital may not seem like a huge issue, but it has proven to be an effective tool in combating alarm fatigue.12

High-Tech Solutions

Several technology companies have developed products designed to address alarm fatigue by linking personal communications devices, such as cell phones and pagers, to the medical device via software and computers. These “black boxes,” however, are not considered medical devices, so are not rated, designed, tested, or held to the federal standards of medical equipment. The results cannot be guaranteed or insured and these types of devices should only be considered secondary or back up alarms. The primary alarm still requires approval from the Food and Drug Administration (FDA). Also, these black boxes create an extra link to the chain, which could add another possible failure point.13

One final obstacle that needs to be evaluated is stand-alone equipment, i.e., any medical device with no external communication device other than the display and the audible alarm. This type of equipment includes, but is not limited to, infusion pumps, infant incubators, ventilators, and apnea monitors. Considered “old style,” stand-alone equipment will eventually be connected to an electronic medical record (EMR) network for monitoring and documentation purposes, according to researchers.13 However, there is no research currently available on how to implement these devices into an alarm fatigue program.

Regulatory Body Recommendations

As individual researchers continue to search for answers, health care regulatory bodies have also been evaluating solutions for alarm fatigue and alarm issues. In 2012, the Healthcare Technology Safety Institute (HTSI), a division of the Association for the Advancement of Medical Instrumentation (AAMI), addressed the matter and offered the following suggestions for healthcare providers:14

  • Understand the problem and state your goals;
  • Share your goals with hospital staff;
  • Recognize the problem as institution-wide;
  • Recognize the resolution of the problem as long-term and on-going;
  • Get support from administration to achieve the goals;
  • Engage a multi-disciplinary team to study and address the problems;
  • Conduct a fault tree analysis to understand the failures;
  • Identify a key metric, such as the average number of alarm conditions per bed per day.

HTSI’s suggestions do not constitute legal, regulatory, operational, or procedural advice, but are intended as a helpful resource.

In 2013, The Joint Commission began work on a new National Patient Safety Goal on alarm management for hospitals and critical access hospitals.15 The goal will take effect in stages beginning in January 2014. It is expected to include four elements of performance (EPs) recommendations that encompass the following activities:

  • Establish alarm safety as a critical access hospital priority, ensuring a process for safe alarm management and response in high-risk areas;
  • Prepare an annual inventory of alarm-equipped medical devices used in high-risk areas and for high-risk conditions, and identify appropriate default settings;
  • Establish guidelines for alarm settings on devices used in high-risk areas and identify when alarm signals are not clinically necessary;
  • Create guidelines for tailoring alarm settings for individual patients and address situations when limits can be altered to minimize alarm signals;
  • Inspect, check, and maintain medical devices to provide for accurate and appropriate alarm settings, proper operations, and detectability;
  • Train all clinical care team members on alarm management and response in high-risk areas.

The first two EPs will take effect in January 2014 with the remainder to be implemented by the end of the following year. The aim of the new goals is for facilities to better understand the nature of the problem with clinical alarms and develop solutions.

As for the implementation process of an actual alarm fatigue program, it may be a little early for many institutions.

The good news is that health care facilities have the support of regulatory agencies and viable suggestions as a helpful resource. Manufacturers are also doing their part to develop and implement alarm fatigue solutions.

Risk Reduction

No one has a perfect solution in the matter of alarm fatigue, but eliminating false alarms is the first step. Fewer false alarms are directly related to a better response rate, and eliminating false alarms reduces the amount of data to study. For example, if a facility’s alarm fatigue committee wants to study response time to alarms, it will be much easier to examine data from 350 alarms a day per room than to study 700 to 800.

The next step is to evaluate individual facilities to identify its most vulnerable areas. To accomplish this, AAMI suggests forming an alarm committee comprising clinicians, who will obtain insight from bedside responders. Through this feedback and research, the most vulnerable areas can be singled out and problems addressed. Involving clinicians in this part of an alarm fatigue program will make it more effective.

Finally, and perhaps most important, without upper management buy-in, any alarm fatigue program will not prevail. Alarm fatigue management is not simple, quick, or inexpensive. Hospitals have spent millions on programs to reduce alarm fatigue risk, and still cannot eliminate it.

To date there is no solution, but only risk reduction tactics. What is best for one institution may or may not be the top choice for another. Further intensive study and research into existing alarm programs will be necessary before any one tactic can be determined.

References

1. Harris, R.M., Manavizadeh, J., McPherson, D.J., Smith, L., (2011). Do you hear bells? The increasing problem of alarm fatigue. Pennsylvania Nurse,

2. Phillips, J., (2006). Clinical alarms: Complexity and common sense. Critical Care Nursing Clinics of North America, 18.

3. Lawless, S.T., (1994). Crying Wolf: false alarms in a pediatric intensive care unit. Critical Care Medicine, 22, 981-985.

4. Cvach, M., (2012). Monitor alarm fatigue: An integrative review. Biomedical Instrumentation and Technology, July/August.

5. Bitan, Y., Meyer, J., Shinar, D., Zmora, E., (2004). Nurses’ reaction to alarms in a neonatal intensive care unit. Cogn Tech Work, 6, 239-246.

6. Ballst, B., Block, F. E., Nuutinen, L., (1999). Optimization of alarms: A study on alarm limits, sounds, and false alarms, intended to reduce annoyance. Journal of Clinical Monitoring and Computing, 15.

7. Cain, S., Hooper, J., Jacobs, B., (2011). Cardiopulmonary monitor and clinically significant event in critically ill children. Horizons, Spring.

8. Blum, J.M., Kruger, G.H., Sanders, K.L., Gutierrez, J.,(2009). Specificity improvements for network distributed physiological alarms based on simple deterministic reactive intelligent agent in the critical care environment. Journal of Clinical Monitoring and Computing, 23, 21-30.

9. Hetu, R., Momtahan, .K., Tansley, B., (1993). Audibility and identification of auditory alarms in the operating room and intensive care unit. Ergonomics, 36.

10. Creighton, K., Graham, C., Cvach, M., (2010). Monitor alarm fatigue: Standardizing use of physiological monitors and decreasing nuisance alarms. American Journal of Critical Care, 19, 28-34.

11. Edworthy, J., Hellier, E., (2005). Fewer but better auditory alarms will improve patient safety. Quality Safety Healthcare, 14.

12. Carlisle, C.C., Cook, T.E., Kahn, D.M., (1998). Identification and modification of noise in an ICU setting. CHEST Clinical Investigations in Critical Care, 114.

13. Bernat, P., (2012). CE-IT Community town hall meeting on interoperability with clinical alarms. Association for the Advancement Of Medical Instrumentation, Webinar.

14. “Using Data to Drive Alarm System Improvement Efforts: The Johns Hopkins Hospital Experience.” Arlington, Va: AAMI Foundation Healthcare Technology Safety Institute. 2012. Available at http://www.aami.org/htsi/SI_Series/Johns_Hopkins_White_Paper.pdf

15. “Prepublication Requirements: National Patient Safety Goal on Alarm Management,” Oakbrook Terrace, Ill: The Joint Commission. June 25, 2013. Available at http://www.jointcommission.org/assets/1/18/PREPUB-06-25-2013-NPSG060101.pdf

Tracy Miller, MPA, CBET, is a biomed at Bronson Methodist Hospital in Kalamazoo, Mich. For more information, contact [email protected]