Medical device alarms pose safety issues for hospitals

The constant beeping of alarms and an overabundance of information transmitted by medical devices, such as ventilators, blood pressure monitors, and electrocardiogram machines, is creating “alarm fatigue,” which puts hospital patients at serious risk, according to a Sentinel Event Alert that The Joint Commission issued in April. Although medical device safety is part of life safety code activities in hospitals and ambulatory surgery centers, clinicians play a critical role in addressing alarm safety. Specifically, the issue of medical device alarms is of interest for surgeons because their patients’ outcomes are often dependent on postoperative care and safety, including proper monitoring of intravenous (IV) pumps and other devices that track vital signs.

Alarming number of problems

Information from a U.S. Food and Drug Administration (FDA) database shows that more than 560 patients died over the course of a four-year period due to alarm-related problems, and The Joint Commission’s Sentinel Event database includes reports of 80 alarm-related deaths and 13 serious alarm-related injuries during a similar period. (Because reporting requirements and programs vary, and may overlap, it can be challenging to determine a clear picture of the scope of the problem.)

Patient deaths related to monitoring device alarms have also been the focus of national media attention and special reports by the Association for the Advancement of Medical Instrumentation (AAMI) and ECRI Institute. The Joint Commission, the AAMI, ECRI Institute, and the American College of Clinical Engineering also brought together patient safety and health care experts at a 2011 summit to seek solutions to problems associated with medical device alarms.
Alarms are intended to alert caregivers of potential problems but may compromise patient safety if they are not properly managed. Many patient care areas have numerous alarms, and the barrage of warning noises can have a desensitizing effect on nurses, technicians, and other caregivers. As a result, these individuals may ignore alarms or even disable them.

Other related issues include too many medical devices with alarms or individual alarms that are difficult to hear. Preset or default settings also may cause problems because the device sounds a warning even when no caregiver action or decision is required. Rather than calling attention to a patient’s needs, these settings may distract caregivers.

Confronting the issue

Alarm fatigue issues vary greatly among hospitals and even within different units in a single hospital. Although there are many variables, the Alert makes it clear that in order to reduce risks related to alarms on medical devices, a series of actions still needs to occur related to people, processes, and technology.

“Alarm fatigue and management of alarms are important safety issues that we must confront,” says Ana McKee, MD, executive vice-president and chief medical officer, The Joint Commission. “The recommendations in this Alert offer hospitals a framework on which to assess their individual circumstances and develop a systematic, coordinated approach to alarms. By making alarm safety a priority, lives can be saved.”

The Joint Commission Alert recommends that health care organizations take the following actions, which correspond with recommendations made by both the AAMI and the ECRI Institute:

  • Ensure that there is a process for safe alarm management and response in areas that the organization has identified as high-risk.
  • 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 in which limits may be modified to minimize alarm signals and the extent to which alarms may be modified.
  • Inspect, check, and maintain alarm-equipped medical devices to provide for accurate and appropriate alarm settings, proper operation, and detectability. Base the frequency of these activities on such criteria as the manufacturers’ recommendations, risk levels, and current experience.

The Joint Commission Alert also recommends that all clinical care team members receive training and education in safe alarm management and response in high-risk areas. In addition, health care institutions should consider methods for reducing nuisance alarm signals and for determining whether critical alarm signals can actually be heard in patient care areas. Based on input from patient care providers, health care engineers, risk managers, and information technology professionals, organizations should also establish policies and processes for alarm safety that include the regular review of trends and patterns that reveal improvement opportunities. Finally, the Alert urges organizations to share information about alarm-related incidents, prevention strategies, and lessons learned with organizations such as the AAMI, the ECRI, the FDA, and The Joint Commission.

Beyond issuing the Alert, The Joint Commission is considering the development of a National Patient Safety Goal to help health care facilities address this issue. A field review of the proposed goal composed of voluntary feedback from health care providers and other stakeholders occurred in February, and public comments are now under review. The Joint Commission already has numerous accreditation standards in place related to alarm safety. The standards address such issues as leadership, the environment of care, provision of care, and staff training and education.

The warning about medical device alarms is part of a series of Alerts that The Joint Commission has issued. Much of the information and guidance provided in these Alerts is drawn from The Joint Commission’s Sentinel Event database, one of the nation’s most comprehensive voluntary reporting systems for serious adverse events in health care. The database includes detailed information about both adverse events and their underlying causes. Previous Alerts have addressed risks associated with the use of opioids, health care worker fatigue, diagnostic imaging risks, violence in health care facilities, maternal deaths, health care technology, anticoagulants, wrong-site surgery, medication mix-ups, health care-associated infections, and patient suicides, among other topics.

The complete list and text of past issues of the Sentinel Event Alert can be found on The Joint Commission website. A podcast featuring a Joint Commission standards expert discussing medical alarm devices is also available on The Joint Commission website.

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