A Common Ground Begins with Common Language

Clinicians, equipment designers, and regulators have long recognized that medical device alarms are a major patient safety problem and that an effective alarm management policy needs to be implemented for alarm safety improvement. It is comforting to see the vast strides that have been made in alarm management and reductions in alarm fatigue. However, communication between these disparate groups has been hampered by lack of consistency in terminology. A clear understanding of alarm terminology is needed to ensure we are discussing the same things and are taking the right action to resolve issues.


A task force was established through the AAMI Foundation Coalition for Alarm Management in September, 2014. The charter for the group was to “Develop a Compendium of Accepted Taxonomy Required for Alarm Management”.


1. Investigate and review current standards, literature, organizations where terms have been defined and vetted

2. Create definitions for clinical terms that to not appear in standards

3. Create a recommendation to the AAMI Alarms Standards Committee to incorporate these terms into the standard.


The methodology used would be to:


a. Investigate where terms have already been defined and vetted; and create definitions for clinical terms where no standard term exists

b. Work with the AAMI Alarms Standard Committee to incorporate terms into the standard


The team was enthusiastic and optimistically felt we could get the terms gathered and defined in about 6 months. From that point, we would publish the taxonomy and begin to insert the standardized terms into published literature and into the AAMI standard(s).

Sounds simple enough right? After all, there were published documents and standards that have these terms defined. There were multiple organizations that publish alarm management related documents, studies, and guidelines. We would simply leverage these, get a consensus, compile the terms and definitions into categories, and send to the various organizations and standard committees for them to begin using.


As it turns out, we could not have been more wrong! While our premise was true, the terms used and definition in one publication by one author was not the same as in another document, by a different author. Some parts of the industry used one derivative of a term while another used a different one. For example, the patient monitoring manufacturers use the term alarms while the electronic record companies use the term alerts. And, the standards world has yet other definitions. In fact, in the AAMI/ANSI/ISO 60601-1-8 alarm standard, the term “alarm” is never used as a noun. Rather it is an adjective as in “alarm condition”, “alarm signal”, or “alarm system”. It must be done that way for clarification. If in the standard the term alarm was used as a noun, it would not be clear if it meant an alarm condition or an alarm signal and that clarity must be certain or manufacturers would be confused as to the true meaning the standard is trying to convey.


An alarm system is defined as “parts of medical electrical equipment or a medical electrical system that generate alarm conditions and, as appropriate, present alarm signals.” Designers of medical equipment have great flexibility in designing an alarm system for their equipment, but still must follow international standards to ensure patient safety.


Medical equipment is designed to include an alarm system when there is a need to notify the operator (user) that the equipment has determined that an alarm condition (hazardous situation) exists in the patient or the medical equipment. This notification is used as a means of risk control. The presumption is that the users can change their actions to prevent or reduce the severity of the harm associated with the hazardous situation.


The means of notifying the user is called an alarm signal. Medical equipment generates alarm signals when the equipment determines that such hazardous situations exist unless a user has inactivated one or more of the available alarm signals. The main objective of alarm signals is to avoid potential or actual adverse events related to an alarm condition (sometimes called an alarm hazard).


The terms and definitions utilized in this taxonomy come from international standards, a review of available literature, and multiple discussions with industry leaders in an attempt to reach agreement.


Taxonomy

By definition, a taxonomy is a classification system that is used to group classes of like objects. In biology for example it is a branch of science that encompasses the description, identification, and classification of organisms. Figure 1 shows a taxonomy diagram.



Figure 1 Life Taxonomy


For alarm terminology, the taxonomy looks like Figure 2.


Figure 2 Alarm Taxonomy


These are the classes and we look further into them to get to the terms that are the heart of our task. Our methodology to help us define the terms used surrounding ‘alarms’ required us to understand the classifications. By doing so, we were able to determine some context or concepts for the terms which in turn helped us to clarify a definition.


As stated earlier, we soon discovered there were multiple definitions coming from multiple sources. We realized there was more to these terms than just a simple definition. In some cases, there were concepts that were needed along with examples to help clarify what the term either did mean or could mean so we could add some context. And along with the definition that came from the standards, there were common clinical names or synonyms as well as terms the manufacturers used. In many cases these are different, and in a few cases they were the same.


So, as the classifications came forward, the alarm terms were placed into these classifications. The expanded taxonomy looks like Figure 3.



Figure 3 Alarm Taxonomy Terms


So, how are these terms defined? And what is the definition that will be used across the industry? After all, that is the task that we set out to accomplish. And, it is one that may not have an answer that meets everyone’s needs.


Understanding this, the Coalition team looked at each of the terms in the categories and identified the concept, reviewed the definitions from the ISO 60601-1-8 Alarm Standard (or other standards), added notes, examples, explanations, identified common clinical names/synonyms, and common manufacturer terms. As previously noted, there has been significant discussions regarding the difference between “Alarm” and “Alert” and these terms are often used interchangeably. A subcommittee was formed in 2014 with the charter to clarify these two terms. However, their work was not finalized into a technical information report and debate continues today.


The following is a list of terms and definitions resulting from this work. Those indicated with “*” are incorporated into the ISO 60601-1-8 second amendment scheduled for release in 2019. Text in italics are concepts, definitions, synonyms, or common terms used by manufacturers that were compiled by the Coalition team.


Class: Conditions and Signals


*Alarm Condition: state of the ALARM SYSTEM when it has determined that a potential or actual HAZARDOUS SITUATION exists for which OPERATOR awareness or response is required

Concept: state when an alarm system has determined a hazardous situation exists

Common Clinical Names/Synonyms: ‘in alarm’ ‘alarm’

Common Manufacturer Terms: ‘medical alarm’


*Physiological Alarm Condition: ALARM CONDITION arising from a monitored PATIENT-related variable

EXAMPLE 1 High exhaled anesthetic agent concentration.

EXAMPLE 2 Low exhaled tidal volume.

EXAMPLE 3 Low oxygen saturation measured by pulse oximetry.

EXAMPLE 4 High arterial pressure.

EXAMPLE 5 High heart rate.

Concept: patient-related alarm condition

Common Clinical Names/Synonyms: ‘clinical alarm’ ‘physiological alarm’

Common Manufacturer Terms: ‘Alarm’


*Technical Alarm Condition: ALARM CONDITION arising from a monitored equipment-related or ALARM SYSTEM-related variable

EXAMPLE 1 An electrical, mechanical or other failure.

EXAMPLE 2 A failure of a sensor or component (unsafe voltage, high impedance, signal impedance, artifact, noisy signal, disconnection, calibration error, tubing obstruction, etc.).

EXAMPLE 3 An algorithm that cannot classify or resolve the available data.

Concept: equipment-related alarm condition [The design of the alarm system determines the states causing technical alarm conditions, resulting in an alarm signal.]

Common Clinical Names/Synonyms: ‘equipment alarm’ ‘device alarm’

Common Manufacturer Terms: ‘INOP’ ‘ERROR’


*Alarm Condition Delay: time from the occurrence of a triggering event either in the PATIENT, for PHYSIOLOGICAL ALARM CONDITIONS, or in the equipment, for TECHNICAL ALARM CONDITIONS, to when the ALARM SYSTEM determines that an ALARM CONDITION exists

Concept: When the equipment recognizes that a potential problem exists, wait before declaring an alarm condition to ensure that it has persisted

Common Clinical Names/Synonyms: ‘delay’

Common Manufacturer Terms: ‘hold off’ ‘delay’


*Alarm Signal: type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an ALARM CONDITION

Concept: signal generated to indicate the presence of an alarm condition

Common Clinical Names/Synonyms: ‘alarm notification’ ‘alarm light’ ‘alarm sound’ alarm noise’

Common Manufacturer Terms: ‘alarm’


Other Signals:


*Reminder Signal: periodic signal that reminds the OPERATOR that the ALARM SYSTEM is in an ALARM SIGNAL-inactivation state

Concept: Awareness of existing alarm signal inactivation state

Common Clinical Names/Synonyms: ‘tone’ ‘beep’

Common Manufacturer Terms: ‘reminder tone’


*Information Signal: any signal that is not an ALARM SIGNAL or a REMINDER SIGNAL

EXAMPLE SpO2 tone

Concept: Non alarm-related

Common Clinical Names/Synonyms: ‘wave’ ‘numeric’

Common Manufacturer Terms: ‘waveform’ ‘parameter’


Alert: Not defined in ISO 60601-1-8 or by the Coalition team.

[The following definition was proposed in 2014 by a committee that was focused on defining the difference between Alarms and Alerts: Provides notification of the patient condition or ME EQUIPMENT that provides contextual awareness that may improve the clinical workflow and/or patient condition through clinical intervention without providing a method of risk control.]

Concept: Advisory system that does not inherently require immediate response or awareness

Common Clinical Names/Synonyms: None described

Common Manufacturer Terms: ‘technical alarm’ ‘advisory alarm’ ‘soft yellow alarm’ ‘soft INOP (inoperable)’ alarm’ ‘NOOP (no or non-operational)’


Class: Attributes/Alarm Parameters


*Alarm Limit: threshold used by an ALARM SYSTEM to determine an ALARM CONDITION

Concept: The parameter value distinguishing a normal condition from an alarm condition

Common Clinical Names/Synonyms: ‘alarm setting’ ‘default’ ‘boundaries’

Common Manufacturer Terms: ‘alarm set point’ ‘alarm threshold’


*High Priority: indicating that immediate OPERATOR response is required

NOTE 1 The priority is assigned through RISK ANALYSIS.

NOTE 2 Interruption of current workflow is expected.

Concept: Urgent – the alarm signal(s) requires prompt attention. Requires an interruption of workflow. high priority, medium priority and low priority are all subset modifiers of alarm signal.

Common Clinical Names/Synonyms: ‘red alarm’ ‘red alert’ ‘crisis alarm’

Common Manufacturer Terms: ‘red alarm’ ‘crisis alarm’ ‘3-star alarm’


*Medium Priority: indicating that prompt OPERATOR response is required

NOTE 1 The priority is assigned through RISK ANALYSIS.

NOTE 2 Re-planning of current workflow is expected.

Concept: Important – need re‑planning of workflow

Common Clinical Names/Synonyms: ‘yellow alarm’ ‘warning alarm’ ‘yellow alert’

Common Manufacturer Terms: ‘warning alarm’ ‘hard yellow alarm’ ‘hard INOP alarm’ ‘2-star alarm’


*Low Priority: indicating that OPERATOR awareness is required or future action might be needed

NOTE 1 The priority is assigned through RISK ANALYSIS.

NOTE 2 Planning of future workflow may be expected.

Concept: Awareness – Re‑planning of future workflow will be needed

Common Clinical Names/Synonyms: ‘alert’ ‘low level alarm’ ‘technical alarm’

Common Manufacturer Terms: ‘advisory alarm’ ‘soft yellow alarm’ ‘soft INOP alarm’ ‘NOOP’


Auditory Alarm Signal (or Audible Alarm Signal): Not specifically defined in the ISO 60601-1-8 standard, but the term “auditory” is used as an adjective to indicate audible alarm signal. The intention is to draw attention to equipment/patient and communicate priority.

Concept: Alert operator (user) with a sound

Common Clinical Names/Synonyms: ‘alarm sound’ ‘alarm noise’

Common Manufacturer Terms: ‘alarm sound’


Class: Accuracy and Perception


Alarm Condition Accuracy: Not specifically defined in the ISO 60601-1-8 standard.

Concept: Degree to which an alarm condition is true

Common Clinical Names/Synonyms: None described

Common Manufacturer Terms: ‘sensitivity and specificity’


*True Negative Alarm Condition: absence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM

Concept: Alarm System performed correctly and the User takes no action

Common Clinical Names/Synonyms: None described

Common Manufacturer Terms: None described


*False Negative Alarm Condition: absence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM

Concept: alarm condition that is missed

Common Clinical Names/Synonyms: ‘no alarm’ ‘alarm fail’ ‘adverse alarm event’

Common Manufacturer Terms: None described


*True Positive Alarm Condition: presence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM

Concept: alarm System performed correctly and User takes action

Common Clinical Names/Synonyms: None described

Common Manufacturer Terms: None described


*False Positive Alarm Condition: presence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM

Concept: alarm condition that is invalid

Common Clinical Names/Synonyms: ‘false alarm’ ‘nuisance alarm’ ‘alarm failure’

Common Manufacturer Terms: None described


*Clinically Actionable Alarm Condition: type of ALARM CONDITION for which a panel of experts would agree that OPERATOR action is necessary to prevent HARM within the time frame implied by the priority communicated by the ALARM SYSTEM

NOTE 1 An OPERATOR action can include assessment of a PATIENT or the changing of ALARM LIMITS.

NOTE 2 A LOW PRIORITY ALARM CONDITION, which requires action within the time frame of a LOW PRIORITY, MEDIUM PRIORITY or HIGH PRIORITY timeframe, is considered CLINICALLY ACTIONABLE. A HIGH PRIORITY ALARM CONDITION, which requires action within the timeframe of a LOW PRIORITY or MEDIUM PRIORITY timeframe, is considered CLINICALLY NONACTIONABLE.

NOTE 3 A FALSE POSITIVE ALARM CONDITION is never considered CLINICALLY ACTIONABLE even though an unrelated OPERATOR action might be required to prevent a future FALSE POSITIVE ALARM CONDITION.

Concept: alarm condition that the operator (user) considers valid and useful. In the clinical setting, this usually means when the clinician requires timely notification. Notification requires an alarm signal. The priority of the resulting alarm signal should be determined by the urgency of any necessary intervention.

Common Clinical Names/Synonyms: ‘alarms requiring timely intervention’

Common Manufacturer Terms: None described


*Clinically Non-Actionable Alarm Condition: type of ALARM CONDITION for which a panel of experts would agree that OPERATOR action is not expected within a timeframe equal to or shorter than the timeframe implied by its priority

NOTE 1 A LOW PRIORITY ALARM CONDITION, which requires action within the time frame of a MEDIUM PRIORITY or HIGH PRIORITY timeframe, is considered ACTIONABLE. A HIGH PRIORITY ALARM CONDITION, which requires action within the timeframe of a LOW PRIORITY or MEDIUM PRIORITY timeframe, is considered CLINICALLY NONACTIONABLE.

NOTE 2 CLINICALLY NONACTIONABLE ALARM CONDITIONS are considered detrimental to OPERATOR performance and PATIENT safety.

NOTE 3 ALARM SIGNALS for an ALARM CONDITION of which the OPERATOR is already aware are considered CLINICALLY NONACTIONABLE.

Concept: alarm condition that the user considers not useful

Common Clinical Names/Synonyms: ‘nuisance alarm’ ‘disruptive alarm’ unwanted alarm’ wrong alarm’ ‘alarm failure’ ‘clinically insignificant’ ‘technically correct, but with no clinical significance’

Common Manufacturer Terms: ‘alarm condition that should be disabled, not needed for this patient’


*Alarm Fatigue: situation wherein the presence of frequent ALARM SIGNALS desensitizes an OPERATOR to an ALARM SIGNAL

NOTE 1 A desensitized OPERATOR can fail to perceive, recognize or act on an ALARM SIGNAL.

NOTE 2 The response of a desensitized OPERATOR can be inadequate, delayed or nonexistent.

NOTE 3 ALARM FLOOD can cause ALARM FATIGUE.

Concept: Condition that occurs when a user is desensitized by the presence of excessive alarm signals, many of which are non-actionable or in some cases false and no response to the alarm signal occurs and harm to the patient could result

Common Clinical Names/Synonyms: ‘alarm flood’ ‘alarm overload’ ‘excessive alarms’ ‘alarm apathy’ ‘alarm desensitization’

Common Manufacturer Terms: ‘alarm fatigue’ ‘alarm flood’


*Alarm Flood: situation wherein OPERATORS receive more ALARM SIGNALS in a time period than they can manage appropriately.

NOTE The Coalition team did not provide a definition of this term

Concept: Same as Alarm Fatigue

Common Clinical Names/Synonyms: None described

Common Manufacturer Terms: None described


*Nuisance Alarm: ALARM SIGNAL for which a panel of experts would agree that the HARM associated with the ALARM SIGNAL is greater than the benefit associated with action resulting from the ALARM SIGNAL

NOTE 1 A NUISANCE ALARM SIGNAL contributes to ALARM FATIGUE.

NOTE 2 A NUISANCE ALARM SIGNAL can arise from a CLINICALLY NONACTIONABLE ALARM CONDITION.

NOTE 3 A NUISANCE ALARM SIGNAL can cause an inappropriate OPERATOR action.

EXAMPLE Causing the OPERATOR to set ALARM LIMITS to an inappropriate setting.

NOTE 4 An ALARM SIGNAL that unnecessarily irritates or startles the PATIENT or OPERATOR can be a NUISANCE ALARM SIGNAL.

Concept: Not defined by Coalition team.

Common Clinical Names/Synonyms: None described

Common Manufacturer Terms: None described


Class: Alarm Signal Inactivation States


*Alarm Off: state of indefinite duration in which an ALARM SYSTEM or part of an ALARM SYSTEM does not generate ALARM SIGNALS

Concept: operator (user) action limited inhibition of alarm signals

Common Clinical Names/Synonyms: ‘disabled alarm’ ‘alarm suspend’

Common Manufacturer Terms: ‘alarm inhibit’ ‘alarm disable’ ‘alarm suspend’


*Audio Off: state of indefinite duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate an auditory ALARM SIGNAL

Concept: operator (user) action limited inhibition of auditory alarm signals

Common Clinical Names/Synonyms: ‘disabled alarm’ ‘alarm suspend’

Common Manufacturer Terms: ‘alarm silence’ ‘alarm mute’


*Alarm Paused: state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate ALARM SIGNALS

Concept: time interval limited inhibition of alarm signals

Common Clinical Names/Synonyms: ‘alarm silenced’ ‘alarm suspend’

Common Manufacturer Terms: ‘alarm silence’ ‘alarm suspend’


*Audio Paused: state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate an auditory ALARM SIGNAL

Concept: time interval limited inhibition of auditory alarm signals

Common Clinical Names/Synonyms: ‘alarm silenced’ ‘alarm suspend’

Common Manufacturer Terms: ‘alarm silence’ ‘alarm suspend’


*Alarm Acknowledged: state of an ALARM SYSTEM initiated by OPERATOR action, where the auditory ALARM SIGNAL associated with a currently active ALARM CONDITION is inactivated until the ALARM CONDITION no longer exists or until a predetermined time interval has elapsed

NOTE ACKNOWLEDGED only affects ALARM SIGNALS that are active at the time of the OPERATOR action.

Concept: alarm condition no longer exists, limited inhibition of alarm signals

Common Clinical Names/Synonyms: ‘alarm acknowledge’ ‘alarm silenced’ ‘alarm suspend’

Common Manufacturer Terms: ‘alarm silence’ ‘alarm suspend’ ‘silence/reset’ ‘alarm acknowledge’


Class: General


*Alarm Settings: ALARM SYSTEM configuration, including but not limited to:

– ALARM LIMITS;

– the characteristics of any ALARM SIGNAL inactivation states; and

– the values of variables or parameters that determine the function of the ALARM SYSTEM

Concept: current configuration of the parameters that determine the function of the alarm system

Common Clinical Names/Synonyms: ‘thresholds’ ‘settings’ ‘limits’

Common Manufacturer Terms: None described


*Alarm Preset: set of stored configuration parameters, including selection of algorithms and initial values for use by algorithms, which affect or modify the performance of the ALARM SYSTEM

Concept: initial alarm settings values for use by the alarm system

Common Clinical Names/Synonyms: ‘defaults’

Common Manufacturer Terms: ‘unit defaults’


*Default Alarm Preset: ALARM PRESET that can be activated by the ALARM SYSTEM without OPERATOR action

NOTE MANUFACTURER- or RESPONSIBLE ORGANIZATION-configured ALARM PRESETS are possible types of DEFAULT ALARM PRESETS.

Concept: initial alarm settings values for use by the alarm system that can only be changed under the ‘password’

Common Clinical Names/Synonyms: ‘manufacturer settings’ ‘limit defaults’

Common Manufacturer Terms: None described


Sub-Class:

Default Alarm Preset Attributes


Manufacturer Default Alarm Preset: default alarm preset provided by the manufacturer

Concept: the out of the box default alarm preset provided by the manufacturer

Common Clinical Names/Synonyms: ‘manufacturer settings’

Common Manufacturer Terms: ‘manufacturer defaults’


Responsible Organization Default Alarm Preset: default alarm presets controlled by the unit manager

Concept: one or more default alarm presets created by the institution

Common Clinical Names/Synonyms: ‘unit settings’

Common Manufacturer Terms: ‘user defined alarm threshold’ ‘unit defaults’


Operator Default Alarm Preset: default alarm presets controlled by an individual user

Concept: one or more default alarm presets created by an individual operator

Common Clinical Names/Synonyms: ‘user settings’ ‘specialist settings’

Common Manufacturer Terms: None described


Alarm Customization: Not defined

Concept: Adjusting the alarm preset based on the patient’s condition

Common Clinical Names/Synonyms: None described

Common Manufacturer Terms: None described


Summary

While this may not be all of the terms used, the Coalition team made good headway in compiling an “Alarm Terms” taxonomy. Increasingly, the terms outlined here are being used in published literature and are being incorporated into the upcoming amendment to the ISO 60601-1-8 alarm standard. Further collaboration between standards groups and industry is required and it is doubtful there will ever be 100% consensus, but we have a strong start.


Special thank you to the members of the Coalition team:

Marge Funk; Maria Cvach; Alan Lipschultz; Steven Treacy; Dave Osborn; Arieh Halpern; Nancy Blake; Daniel Burgoon; Greg Spratt; Shawn O’Connell; Tim Vanderveen.


And a special thank you to any others who contributed to this effort.

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