• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Take Precautions with Audible Alarms on Ventilators

By LCDR Kimberly Love, BS; Courtney Jennings Millin, PhD; and CDR Charles Kerns, MS, BSN, RN

(Article reprinted from Nursing2011, September issue.)

MECHANICAL ventilators provide essential respiratory support to critically ill patients in healthcare facilities, in homes, and during patient transport. Providing care to patients requiring mechanical ventilation can be challenging due to factors such as the severity of the patient’s illness and complexity of the equipment. Many nurses rely too heavily on ventilators’ built-in safety features—specifically their alarms, which are intended to alert staff to a potential problem with the patient or ventilator that may require immediate attention.

In 2010, the FDA received over 2,500 adverse event reports associated with ventilator use. About a third of these events indicated an alarm-related issue. Although some of these alarm-related adverse event reports reflected deteriorating patient condition, indicating that the ventilator alarms had functioned appropriately, many indicated preventable audible ventilator alarm malfunctions or human error.

What went wrong?

These case reports represent preventable audible alarm-related issues.

Case 1. During a complex medical procedure involving a critically ill patient, staff didn’t hear the ventilator alarm when the endotracheal tube inadvertently became disconnected

from the mechanical ventilator. An investigation of the event indicated that the audible ventilator alarm volume had been turned down by another staff member during a previous procedure and hadn’t been reset. This resulted in a delay in identifying the disconnected endotracheal tube and a preventable patient injury.

Case 2. A patient in the ICU became disconnected from the ventilator. Although the device alarmed, the adjustable audible alarm volume had been turned down and the alarm wasn’t loud enough to be heard by the ICU nursing staff. The patient subsequently died.

Case 3. A ventilator-dependent pediatric patient lived at home; the mother fell asleep and didn’t hear the ventilator alarm when the ventilator tubing became disconnected from

the patient’s tracheostomy. After an unspecified period, the patient’s father arrived home and found that the ventilator tubing wasn’t connected to the patient. The patient subsequently died.

What precautions can you take?

In each of these cases, poor patient outcomes, resulting from inappropriate ventilator audible alarm volume settings, could have been easily prevented. In light of these cases, we recommend taking the following steps to prevent serious ventilator alarm issues:

  • Be familiar with the ventilators in your facility; not all ventilators have the same features or safety mechanisms, including alarms.
  • Follow your facility’s established protocols to ensure ventilator setting information is communicated to other staff members, especially during shift changes and patient admissions or transfers.
  • At the beginning of your shift and as clinically indicated, confirm that ventilator settings are correct (as prescribed) and clinically appropriate and that alarms are appropriately set.
  • Confirm that audible alarms can be heard in the intended environment of use (such as in the home or ICU, or during transport).
  • Adjust audible alarm settings only when clinically necessary according to facility policy.
  • When you hear a ventilator alarm, respond immediately by going to the patient’s bedside.
  • If possible, quickly identify the reason for the alarm and intervene appropriately.
  • Immediately assess the patient to identify any deterioration in clinical status caused by the alarm situation, such as change in mentation, respiratory distress, decreased SpO2, bradycardia, or hypotension.
  • If patient compromise is identified, activate the rapid response team and manually ventilate the patient with a manual resuscitation bag. If the patient is unresponsive, apneic, and pulseless, call a code and initiate basic life support.
  • Follow your facility’s protocol for reporting ventilator adverse events and near-misses.

REFERENCE

  1. Food and Drug Administration. MAUDE–Manufacturer and user facility device experience database. 2011.

Although you need to support your healthcare facility’s adverse event-reporting policy, you may voluntarily report a medical device that doesn’t perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax 1-800-FDA-0178) or online. Diane Dwyer, BSN, RN, who coordinates Device Safety, is a nurse consultant at the Center for Devices and Radiological Health at the FDA in Silver Spring, Md.

LCDR Kimberly Love is a biomedical engineer at the Center for Devices and Radiological Health at the FDA in Silver Spring, Md., where Courtney Jennings Millin is a biologist and pediatric liaison/analyst and CDR Charles Kerns is a nurse consultant and acting chief of the Product Evaluation Branch II. Both LCDR Love and CDR Kerns are active duty officers serving in the U.S. Public Health Service.

The authors have disclosed that they have no financial relationships pertaining to this article.