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U.S. Department of Health and Human Services

Medical Devices

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Alarming monitor problems

 

By Kathleen M. Weil, RN, BSN, MS

(Article reprinted from Nursing 2009, September issue, p.58.)

A PATIENT ON continuous cardiac monitoring experienced ventricular fibrillation and died without her monitor sounding or displaying an alarm. The incident investigation demonstrated that although the monitor had detected the problem, dysrhythmia processing had been suspended. This meant that dysrhythmias such as ventricular fibrillation, ventricular tachycardia, and asystole wouldn't cause an alarm.

In a similar case, a patient experienced ventricular fibrillation, but the monitor didn't detect it or sound an alarm. Testing showed that the dysrhythmia recognition software package hadn't been installed. When it's installed properly, an indicator is displayed on the patient's monitor screen.

A third case involved a perinatal monitor. The staff didn't notice a visual alarm that occurred when a fetal heart rate was outside the defined parameters. In the investigation performed later, biomedical engineers found that the equipment was set up to provide only visual alarms and not audible alarms. The report stated that audible alarms could have prevented a serious outcome.

What went wrong?

In events like these, users aren't familiar with the monitoring equipment or fail to recognize or confirm the status of the alarms or dysrhythmia detection. Alarms can very easily be disabled or silenced, either temporarily or permanently. It's also easy to overlook onscreen symbols that indicate that an important feature (such as dysrhythmia detection or alarm volume) isn't engaged or available.

A search of the FDA's Manufacturer and User Facility Device Experience

(MAUDE) database yielded 566 alarm related death reports from 2005 to 2008. Follow-up investigations often showed that users weren't familiar with how the monitoring equipment worked or hadn't checked the monitor's alarm status.

What precautions can you take?

To avoid alarm-related adverse events, use these suggestions:

  • Don't silence alarms without first checking on the patient.
  • Be sure to correctly discharge patients from their monitors on their transfer or discharge from the bed, unit, or hospital.
  • Make sure that all patient alarms are appropriately activated and not suspended, that dysrhythmia detection functions are available and appropriately activated, and that the alarm volume is high enough to be heard outside the patient's room. Perform these checks when assuming care of patients from colleagues, after shift changes, and after patients are transferred,
  • Become familiar with all monitor functions, especially dysrhythmia detection, alarms, and icons on the screen, and the meanings of various alarm sounds.
  • Make sure that new staff members, including travel and float nurses, are adequately trained on the unit's monitors before they care for monitored patients.
  • Never rely solelyon pagers, mobile phones, and other secondary alarm enhancements for alarm communication.
  • Learn the hospital's backup plan if monitors become dysfunctional and make sure that the plan is readily accessible to staff. It should also be in your hospital or unit's policies and procedures.
  • Immediately report any device malfunctions or concerns to the biomedical or clinical engineering team. Remove the device from operation according to the hospital's policies and procedures until it's been evaluated.

ECRI weighs in

The ECRI Institute has identified these alarm hazards for clinicians:

  • Carefully evaluate the device being considered for purchase and include key personnel, such as clinical users, in the decision process.
  • Evaluate how the device handles alarms. Is it configured in a way that's logical, safe, and consistent with your facility's practice?
  • Make sure that the staff understands the purpose and significance of each alarm.  
  • Make sure that alarms are quickly and consistently conveyed to all required staff, from monitor technicians to clinical staff caring for monitored patients. Important considerations include speaker volume, floor layout, and physical distance of the device to the nearest staff member.
  • Use monitors and alarms as they're intended to help keep your patients safe.

REFERENCE

1. ECRI. Top 10 health technology hazards Health Devices. 2006;37(11):343-350.

RESOURCES

American College of Clinical Engineering. Clinical alarms management and integration. http://www.acce-htf.org/clinical.asp

Impact of Clinical Alarms on Patient Safety. "Plymouth Meeting, PA: American College of Clinical Engineering Healthcare Technology Foundation, 2006.

http://www.acce-htf.org/White%20Paper.pdf

Although you need to support your healthcare facility's adverse event-reporting policy, you may voluntarily report a medical device that doesn't perlorm as intended by contacting MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178) or online at http://www.fda.gov/ medwatch/how.htm.

Diane Dwyer, RN, BSN, who coordinates Device Safety,is a nurse consultant at the Center for Devices and Radiological Health at the FDA in Rockville, Md.

Kathleen M. Weil is a nurse consultant and analyst for a variety of cardiovascular devices in the Office of Surveillance and Biometrics at the Center for Devices and Radiological Health.