I agree that alarm fatigue is an issue. There are often occasions when i go into the ITU or CCU and alarms are sounding for long periods of time. I sometimes wonder whether they are secondary alarms and therefore less urgent for the nursing staff to deal with, but upon inspection, many time i have seen what i would consider to primary alarms being ignored for minutes. I have spoken to nurses about this and been told to keep my nose out of their business. I personally think alarms should only go off for something that may be life threatening, and then increase in volume over a short period of time.
Alarms are covered under the EU medical devices directive MDD93/42:
2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:
- eliminate or reduce risks as far as possible (inherently safe design and construction),
- where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,
- inform users of the residual risks due to any shortcomings of the protection measures adopted.
12.3. Devices where the safety of the patients depends on an external power supply must include an alarm system to signal any power failure.
12.4. Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health
The EU Medical devices directive is not defining alarms to a clinical level, these are purely general manufacturing rules left open to interpretation.
