Alarm risk management
Overview of the risks involved in the operation of alarm system, and measures to mitigate these risks
- The sound disrupts the user's current attention
- Users get used to the sound alarm, gradually disregard the alarms
- Users are liable to shut the sound temporarily off, and then forget to
Avoiding nuisance alarms
- Apply sound alarms only in emergency
- Avoid sound for information signals and for non-urgent alarm
conditions, such as technical failures of sensors
- Make the adjustment of the alarm limits easier than silencing it.
Unnoticed alarm conditions
The users might fail to notice the existence of alarm conditions. Alarm
conditions may be unnoticed because:
- The alarm system is turn off
- The alarm limits are set to extreme values
- The sound is muted, either temporarily or by mistake
- Speaker malfunctioning
- Visual backup does not exist, or is unnoticeable
- The user is not familiar with the system
Assuring that the alarm condition is noticeable
- The system should provide visual indication that it is on
- Users should not be required to anticipate the rate of false alarms or
missed alarms based on knowledge of the alarm limits. The alarm limits
should expressed in terms of safety levels
- The system should provide a single two-way means for sound control
- The system should provide visual indication that the alarm is muted
- Test sound should be heard on enabling the sound
- The system should continuously test the sound level and provide visual
indication when it might not be heard.
- Visual alarm should be used as backup of the sound alarms
- The visual backup and indications should be salient and visible from
all around the patient
- The users may practice the alarms in a training mode.
The user might not get the proper sense of emergency:
- Sound melodies by 60601-1-8 are misleading
- Visual alarms of emergency are not well distinguished from visual
indications used for normal monitoring.
- The user is not familiar with the system alarms in different alarm
Assuring proper recognition of the alarm conditions
- Sound alarms should be used only for emergency situations
- Visual alarms in emergency should be attentive, using flashing and
- The alarm characteristics (pitch, speed, sharpness, colors) should
correspond to the emergency level.
- The users may practice the alarms various alarm conditions in a
The user might fail to identify the source for the alarm.
Example: the injection that run out of fluid
Facilitate mapping from monitor to responsible sensor
The sensors should include status indicators