Answers
03/02/1990

<TITLE>Safety Alert on Infant Apnea Monmitors</TITLE>
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                SAFETY ALERT ISSUED ON INFANT APNEA MONITORS
    FDA's Center for Devices and Radiological Health has sent a Safety
Alert, "Important Tips for Apnea Monitor Users," to health professionals, 
manufacturers and distributors of infant apnea monitors.  The agency is 
asking them to use this information in educating home users about the proper
use of these devices.  The following may be used to answer questions. 
    Apnea monitors are electronic devices designed to signal when breathing 
has stopped.  They are used for infants who periodically cease breathing
during sleep.  Home monitors are used when possible to avoid costly and 
lengthy hospital stays. 
    FDA is concerned that problems with home apnea monitors can occur when
parents do not fully understand how to use the monitors properly.  FDA
cautions that although the devices are useful, they can occasionally give a 
false alarm or fail to sound an alarm at the proper time.  For example, the 
monitor could mistake movement caused by choking for breathing. 
    In the alert, FDA tells parents that they should use the monitor even 
though it is not perfect and they should not stop using it until their
doctor tells them to stop.  FDA also warns against trying to adjust the 
monitor to reduce false alarms, because this may increase the chance that 
the monitor would miss a real apnea.
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    FDA further advises parents : 
    -- not to sleep in the same bed as their monitored baby because their 
movement could fool the monitor and cause it to miss apneas,
    -- to keep pets and other children away because they might disconnect 
the monitor,
    -- to be sure they can hear the alarm.
    FDA recommends that users regularly check the monitor's breath detection
indicator to make sure it is working properly, and the battery or charger 
connection. 
    Finally, users are advised to read, understand and follow the 
manufacturer's instructions provided in the manual that comes with the apnea
monitor.  If the monitor is not working properly, users should contact the
equipment provider immediately for service and let the manufacturer know
about any problems. 
    FDA is encouraging health professionals who prescribe apnea monitors to 
use the safety alert to answer questions about the use of these devices.
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