The familiar sound of everyday hospital life
When visiting a hospital, especially an intensive care unit, the constant beeping of all kinds of equipment and systems is very irritating for the layperson and it is usually not comprehensible why the staff simply lets some equipment continue to beep, but suddenly rushes to others. But for the hospital staff, who make these decisions in a well-considered manner, and also for the patients, the constant background noise of alarms and signal tones is a serious burden. Not to mention the fact that many devices are also flashing, which does not make things any easier.
The use of signals is specified in particular in IEC 60601-1-8 and includes the following types:
- Audible alarm signals
- Visible alarm signals
- Different alarm signals
At IEC level, this standard was already updated in 2020 with Amendment 2, and the German version DIN EN 60601-1-8 (also known as VDE 0750-1-8) has been in force since December 2021. There is a transitional period for the latter until 06.07.2024. Current developments of medical devices should therefore already be oriented to this new version – the end of the transitional period is not even one and a half months after the end of the MDR transitional period! However, the now second revision resulted in information on specific topics often being spread over the definitions, the main section, affected sections as well as several annexes. It is therefore worthwhile to have a very intensive look. Compared to Amendment 1 of 2013, 20 new definitions of terms have been added, but the sections Alarms and Priorities and Visible Alarms have not been changed, or only slightly. Let’s take a look at the topics:
Alarms and priorities
The standard defines quite clearly what an alarm is or in which situations an alarm should be activated at all. At the same time, the risks of frequent, redundant, false and other unnecessary alarm signals are highlighted. For developers and manufacturers of medical devices, this results in the requirement to consider all alarms from a risk management perspective and to evaluate other signals with regard to possible risks. At the same time, there is an assignment of priorities to the individual alarm conditions, with implications for how the alarms are to be presented. Finally, reminder and information signals are also considered and distinguished from alarms.
The consistent application of this standard is certainly a contribution to the acoustic and visual relief of nursing staff and patients.
Visible alarm signals
Visible alarm signals follow a traffic light system, as in the previous edition of the standard. If this traffic light system is followed, it can make a significant contribution to ensuring that nursing staff correctly identify critical situations and can intervene accordingly.
Audible alarm signals
There have been significant changes in this section compared to the previous edition. These changes are explained in the appendix and are based on the results of extensive studies. For example, the previous melodic beep sequences have been replaced by a combination of audible indications and audible symbols, which should contribute to better spatial location of the source and faster recognition of the reason for the alarm. Individuals are provided with a validation path for deviating signals. A similar path is provided for verbal and other types of signals.
Some users may choose to escape from the flood of signals by quickly “shutting off”, i.e. confirming, muting or deactivating alarms without having taken full notice of them. The new version of the standard adds some rules here. For the manufacturer, the multitude of possibilities of alarm deactivation (the “shutting off”) results in the necessity to develop a clear strategy so that the situation remains clear and comprehensible for the user and the alarm is duly acknowledged.
The new version of the standard takes into account the increasing complexity in hospitals by, among other things, including “distributed alarm systems” and “distributed information systems on alarm conditions” in separate sections. Manufacturers of medical devices should prepare themselves for this in good time, as close integration with clinical processes will be necessary.
Conclusion on the new edition
The new DIN EN 60601-1-8:2021-12 “Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems” integrates new findings and developments relating to alarms in the clinical environment. With consistent application of uniform signals and use according to the risk-based approach, manufacturers can contribute to a significant relief of hospital staff and patients and to a more harmonious sound. Would you also like to set the tone with your product? We would be happy to help you in finding the right one!
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