Guidance on Alarm Systems

The recent release of amendment 2 of the IEC 60601-1-8:2006,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 will provide additional guidance for manufacturers that develop medical devices that include an alarm system. This amendment is the result of many years work from a team of dedicated individuals representing manufacturers, users, regulatory agencies, and researchers from the medical device industry.

Some changes that are notable are the inclusion of alarm sounds that have been validated and are readily available on the IEC website. These are .wav files and are being made available at no cost so they can easily integrate into medical devices with little minimal design and development effort. These were developed through a grant from the Association for the Advancement of Medical Instrumentation® (AAMI) to Dr. Judy Edworthy, a renowned audiologist and Professor of Applied Psychology at Plymouth University, Plymouth, United Kingdom. These sounds are designed to guide the healthcare professional to the device that is the communicator of the alarm signal and to readily identify which type of physiologic alarm condition is responsible for that alarm signal. These are intended to be real world sounds that are different from the ding-ding-ding that we hear from medical devices today.

Additional changes/modifications to the standard are the expansion of the definitions of an alarm system. Specifically a distributed alarm system. When the original standard was developed, and even when it was amended in 2012 the types of alarm systems were not as sophisticated as they are today. For example a "secondary alarm notification" to a pager was a one way signal to a caregiver letting them know an alarm condition existed on a patient. Today, as part of a distributed alarm system, that caregiver can receive that information on a smart phone, review the alarm condition, including waveform, and respond with accept or reject responsibility (as they may be busy). When an alarm signal is rejected, the system can escalate the alarm signal to a different designated back-up caregiver. All of that is configured to fit the needs of the specific facility and specific unit.

Another update to the standard is in the requirements for the logging in an alarm system. This includes what should be included in an alarm system log and how it is stored, accessed, and managed.

If you would like additional information regarding this topic, I would be happy to share a guidance document that I have developed over the past few years that includes some examples, scenarios, and (hopefully) provides clarification about alarm systems. And you should obtain a copy of this revised standard. Compliance to its requirements will go a long way to improving patient safety.

When is an Alert an Alarm?

For years in the medical device industry we have discussed alerts and alarms and their implications for medical devices. In many cases, the two terms are used interchangeably. While there has been confusion, there has been no clear definition or at least a standard, defined term for the distinction between the two. Many companies, especially the Electronic Medical Record companies use the term alert and feel this will enable them to be shielded from regulatory oversight. In looking at the context of the EMR, that is understandable since this is historical data, often minutes delayed from actual occurrence.

We also have paging companies (now mostly using smart phone technology) who continue to send messaging and provide messaging solutions to enable better communication between caregivers, and between caregivers and patients. But, many of these still say they provide alerts, not alarms. This may be true and this is not necessarily a bad thing, just maybe limiting and/or misleading.

FDA has published a guidance on changes to existing software policies as a result of the 21st Century Cures Act (Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, Sept. 27, 2019). In this guidance, FDA clarifies possible ambiguities from the draft guidance documents regarding software functions that they consider a medical device [emphasis mine].

"Section 520(o)(1)(D) of the FD&C Act does not capture software functions intended to generate alarms or alerts or prioritize patient-related information on multi-patient displays, because these functions involve analysis or interpretation of laboratory test or other device data and results. For example, if a software function is intended to prioritize patients in an Intensive Care Unit based on their clinical status, then this function is intended to interpret or analyze device data, results, and findings and is, therefore, not excluded from the definition of device under section 520(o)(1)(D) of the FD&C Act. Similarly, software functions that analyze medical device data in order to provide a notification or flag (e.g., that a parameter is out of range) are not excluded from the definition of device under subsection (D)). The examples included in the draft of this guidance that described alarms, alerts, or flags have been removed from this guidance, because they are not excluded from the definition of device under subsection (D). These functions are addressed in section 520(o)(1)(E) of the FD&C Act, the regulation of which will be described in a separate guidance document."

Adding complication to the issue is the use of the term “alarm”. The standard does not use the term as a noun. There is an ALARM CONDITION and an ALARM SIGNAL. And, clinicians refer to the term alarm as a noun. In context, a clinician will explain the patient is “in alarm” meaning the patient has entered an ALARM CONDITION and the ALARM SYSTEM is generating an ALARM SIGNAL. (See my previous post “A Common Ground Begins with Common Language")

In the statement from FDA, they intend to focus on alarms or alerts that are intended to notify a caregiver to take immediate clinical action. So by that definition, an alert and an alarm have the same implications if they are intended for the caregiver to take clinical action to avoid harm to the patient.

So, what are the differences between the two? The ANSI/AAMI/IEC alarms committee (ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012 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) was asked in their upcoming update to define the term alert to help industry clarify the difference. Keep in mind alarm condition has been a defined term. Alert has been used in other standards but has not been a defined term, and the definition the committee developed, while not finalized did not generate additional comments.

Here are the definitions (including ALARM SIGNAL):

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

NOTE 1 An ALARM CONDITION can be invalid, i.e. a FALSE POSITIVE ALARM CONDITION.

NOTE 2 An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION.

ALARM SIGNAL

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

ALERT

ALERT SIGNAL

INFORMATION SIGNAL notifying the OPERATOR of a condition of the PATIENT or ME EQUIPMENT providing contextual awareness that is intended to improve the clinical workflow or understanding of the PATIENT condition, but the awareness is not related to providing RISK CONTROL

EXAMPLE 1 A notification that it is time to draw the next blood sample.

EXAMPLE 2 A battery status notification that replacement will be needed in a day.

EXAMPLE 3 A notification that it is time to bathe the PATIENT.

The committee, which had representation from industry, regulatory bodies, and clinical caregivers intended to define these such that an ALARM CONDITION differs from an ALERT by indicating the potential for patient harm and need for operator intervention. An ALERT SIGNAL is a signal that provides notification of a condition to caregivers but is not requiring action that changes the clinical workflow or indicates harm.

So, as for the question “When is an Alert and Alarm?”, the answer is simply, it’s not! No matter what companies call it, if it requires immediate clinical intervention or action, it is an indication of a hazardous situation with potential harm to the patient and the indication is an ALARM SIGNAL resulting from an ALARM CONDITION.

For a company that is providing ‘Clinical Communications’ to message a caregiver with an ‘alert’ that comes from a patient monitor or other medical device indicating the need for the caregiver to take clinical action and to not have that device regulated by FDA is misleading. Some companies, when asked about FDA compliance have stated “we aren’t ready to talk about that.” Companies that do comply with FDA oversight, that provide alarm notification, typically target acute care settings. At issue is that we are seeing more companies entering this market without any oversight. They call it “alert messaging” and are not concerned about regulatory compliance.

This lack of regulatory compliance can save a lot of expense for these companies. However, what happens when there is an issue? Regulatory oversight by FDA and other global notified bodies helps to ensure the company has a Quality Management System and their products are developed and manufactured based on risk hazard analysis. In doing so, products that are placed on the market have undergone a more rigid set of checks and balances during the design and manufacturing process and if an issue does arise, they must address it both from a corrective and preventive point of view.

If you are looking at a clinical communications tool for your hospital, ask if the products will be providing alarm information and if so, do they have FDA clearance to market. Make sure the company can back up their claims, and if necessary, ask them for the evidence of their FDA clearance.

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.