Cause of Device-Related Incident
Device factors; External factors; Support system failures; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Home Healthcare; Nursing

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
Electromagnetic or radio-frequency interference (EMI and RFI)

Mechanism of Injury or Death
Monitoring failure; Suffocation

Support System Failures
Failure to train and / or credential

Tampering and/or Sabotage
*Not stated

User Errors
Accidental misconnections; Failure to read label; Inappropriate reliance on an automated feature

UMDNS
Apnea Monitors [12-575]

Infant Home Apnea Monitors: Essential Safety Features and Practices



Hazard [Health Devices Apr 1990;19(4):142-5]

This article was initially issued as a hazard bulletin on February 7, 1990.

Essential Safety Features

The first four features listed below, which are lacking on many older monitors (and some newer ones), are necessary for effective monitoring. Parents can continue to use existing monitors, but should arrange to replace or modify them as soon as possible. The fifth feature is also important for safe monitoring, but replacing or modifying a unit without it is not as crucial if parents take the precautions discussed below.

1. Heartbeat Detector

Apnea monitors must include a built-in heartbeat detector. No apnea monitor is capable of detecting every apnea. Because apneas of 20 seconds or longer are often accompanied by decreases in heart rate, most apnea monitors have a built-in heartbeat detector as a backup. Therefore, if an apnea monitor equipped with this feature fails to detect and alarm for the baby's apnea, it can still alarm if a decrease in heart rate also occurs.

2. Remote Alarm

Apnea monitors must have a remote alarm feature to alert parents in other rooms. An apnea monitor alarm can go undetected by a parent working or sleeping in a separate room from the baby. At present, most apnea monitors have remote alarm capability, but few monitors are used with a remote alarm.

3. Power-Loss Alarm (Nonbattery-Operated Units)

Apnea monitors that operate on line power only must have an audible power-loss alarm. If a power failure occurs, the parents will then be alerted and can watch the baby until power is restored. These alarms are usually powered by a small replaceable battery. Until a replacement is available, parents should use a separate power-loss alarm (available from most hardware stores).

4. Safe Electrodes

Apnea monitors must not have lead wires that can be plugged into an extension cord while connected to a baby. Providers must replace older-style lead wires that have this capability. Electrode lead plugs have been accidentally plugged into 120-volt extension cords or electrical outlets, causing electrocution and severe burns. Most lead wires now in use have protected plugs to prevent such accidents.

5. Battery-Charge or AC-Power Indicator

Apnea monitors should have an indicator that shows the user whether the unit is operating on battery power or is being powered (and charged) from line (AC) power. If a monitor does not have a battery-charge or AC-power indicator, parents should obtain a remote alarm to help alert them to a low-battery condition and should also thoroughly check the monitor before each use.

Battery-operated monitors that do not have a battery-charge or AC-power indicator present a safety risk. For example, a user may incorrectly connect the power cable plug such that the unit is not charging. In this case, the monitor will continue to work until the battery voltage is too low and a low-battery alarm sounds. However, with a poorly charged or older battery, the voltage may drop quickly to a point where the alarm stops sounding—perhaps so quickly that a parent will not be alerted. Using a remote alarm and performing a daily check as described below reduce the need to immediately obtain a unit with such an indicator.

Essential Safety Practices

The following guidelines will help ensure that apnea monitors will perform effectively. Remember: Monitors cannot detect all types of apnea and may miss some apneas. On the other hand, some monitors may seem to frequently sound false alarms. Parents should not ignore alarms or stop using a monitor just because it alarms when the baby seems to be breathing regularly.

1. Daily Check Before Use

  • At least once a day, parents should verify that the monitor and remote alarms sound by disconnecting the leads from the baby. Because of the loudness of the alarm, parents may wish to do the daily check at a time when it will not disturb the baby.
  • If the monitor has a self-test feature, parents should follow the manufacturer's instructions for using it.
  • Parents should carefully inspect electrodes, lead wires, and power cords and plugs.
  • Parents should immediately notify the home care service of any signs of electrode or cable damage or of any signs of unusual monitor operation.

2. Monitoring Check During Use

  • Any time the apnea monitor sounds an alarm, parents should immediately check the baby, even if the unit alarms momentarily.
  • Whenever possible, parents should operate the monitor on line power. They should be sure that the battery is charging by checking the battery-charge or AC-power indicator or by checking that the power cord or charger cable is plugged in. They should also keep unused extension cord and wall outlets capped.
  • Each time parents check the baby, they should check the monitor. The respiration light, if present, should blink only once with each breath, and the heartbeat light should blink in a consistent pattern. Parents should look for any unusual performance of the monitor, such as an unusually high number of breath or heartbeat detections.
  • Parents should keep a logbook to record the time and date of any event, including unusual observations about monitor operation. If the monitor is not operating as expected, they should immediately call the home care service and keep using the monitor.

3. Monitor Placement

Parents should place the monitor on a table, dresser, or shelf, not on the floor. They should be sure that toys or other items are not nearby because they may block displays or muffle audible alarms.

4. Electrical Interference

Parents should place the apnea monitor and the baby several feet away from electrical devices such as televisions, nursery monitor intercoms, oscillating fans, and humidifiers. Although uncommon, interference from such devices may affect apnea monitor performance. In rare cases, severe interference from local television and radio stations or from "ham" or CB radio transmitters may affect the monitor.

Apnea monitors, like other electronic devices, contain complex circuitry that, at this time, is not immune to all forms of electrical interference. Frequent false alarms or an unusually high number of heartbeat or breath detections may indicate an interference problem. (Reminder: The respiration light should blink only once with each breath, and the heartbeat light should blink in a consistent pattern.)

If parents suspect an interference problem, they should immediately call the home care service and keep using the monitor.

5. Remote Alarm

Parents should place a remote alarm in their bedroom if they sleep in a separate room from the baby. They should also use the remote alarm in other areas where they may spend time and the monitor alarm may not be heard (e.g., basement, laundry room, garage).

6. Baby's Bed

Parents, children, and pets should not sleep with a baby that is being monitored. Their movement can interfere with the apnea monitor and prevent it from working properly.

7. Monitor Settings

Babies are typically monitored for eight months or more and grow fast during that time. Therefore, the settings may have to be changed periodically to match the infant's growth. Only a doctor or home care professional should change monitor settings.

8. Training

Parents should be trained to use the monitor correctly, to perform cardiopulmonary resuscitation (CPR), and to recognize the signs of apnea. They should review and understand educational material provided on infant apnea and on operation of the monitor.

9. Support

Home care service professionals should provide regular follow-up visits to reinforce training and verify proper operation of the monitor. They should inspect the monitor at least every three months to verify proper performance, preferably using a patient simulator, and document their findings.

Summary

  1. Providers should ensure that apnea monitors have the critical safety features described above, including:
    • Built-in heartbeat detector
    • Remote alarm
    • Power-loss alarm (line-power-only units)
    • Safe electrode leads
  2. If a monitor does not meet these criteria, parents should obtain a new or modified unit as soon as possible. While waiting for a new or modified monitor, they should continue to use the existing unit following the safe practices outlined in this article.
  3. Parents and caregivers should always follow the safe practices for use of apnea monitors listed above, regardless of which brand or model monitor is used.
  4. Providers should make this information available to parents and address these issues in apnea monitor training programs.

Bibliography

Connection of electrode lead wires to line power [hazard report]. Health Devices 16(2):44-6 (Feb 1987).

Infant home apnea monitors [evaluation]. Health Devices 16(3-4):79-109. (Mar-Apr 1987).

Infantile apnea and home monitoring. U.S. Department of Health and Human Services. NIH Publication No. 87-2905.

UMDNS Term

Apnea Monitors [12-575]

Cause of Device-Related Incident

Device factor: Design/labeling error

User errors: Accidental misconnection; Failure to read label; Inappropriate reliance on an automated feature

External factors: Power supply; Electromagnetic or radio-frequency interference (EMI and RFI)

Support system failure: Failure to train and/or credential

Mechanism of Injury or Death

Monitoring failure; Suffocation

 


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