Alarm hazards have been one of ECRI Institute’s Top 10 Health Technology Hazards since the list’s inception in 2007. Alarms can become mere noise disassociated with the meaning behind the alert. Alarms can “overwhelm clinicians with data, but underwhelm them with information that is sufficiently sensitive or specific about critical changes in patient conditions” (AAMI “Clinical Alarms”).
Back in the Spotlight
A 2010 adverse event in Massachusetts is largely responsible for bringing alarm safety back into the spotlight (Cvach). The patient, an 89-year-old man, was on a cardiac alarm, and over 20 minutes, his heart rate slowed and stopped. Investigation of the event determined that the volume on the alarm was turned off and, further, that the volume settings could be easily and inadvertently modified by staff, most of whom were not aware of this feature. (McKinney) The case was settled privately for $850,000 (Associated Press).
Another recent case serves as a reminder that alarm safety is not only a concern in the hospital environment. A 17-year-old patient underwent an uncomplicated tonsillectomy and received an intravenous dose of fentanyl for pain management at the ambulatory surgery center’s postanesthesia care unit. She experienced respiratory depression followed by respiratory arrest, suffered profound brain damage, and died. Investigation revealed that not only was the patient left unobserved for 25 minutes after administration of the fentanyl but also that the alarms monitoring her respiration and cardiac function were muted. (ISMP)
Alarm hazards have even made headlines in the popular press. In the July 7, 2013,
Washington Post, journalist
Lena H. Sun noted that healthcare workers respond to the several hundred alarms per patient per day by simply ignoring them, muting them, or shutting them off (Sun). Nuisance alarms are a key contributing factor to the phenomenon known as alarm fatigue because they make up the bulk of alarms that are heard each day; 80% to 99% of alarms are clinically insignificant (Cvach).
The Joint Commission has released a 2014 National Patient Safety Goal (NPSG) underscoring the importance of reducing nuisance alarms and improving the effective use of monitoring technology. Likewise, a 2013 Sentinel Event Alert highlights the fact that of 98 reported events (including 80 reported deaths) in which alarm safety was a factor, 36 involved alarms that were turned off, 30 involved “absent or inadequate” alarms, 25 involved inaudible alarms, and 21 involved incorrect alarm settings (Joint Commission “Medical”).
Alarm safety is necessarily a major patient safety concern. Organizations, with the support of leadership, should therefore convene a multidisciplinary task force to review their alarms. Once this groundwork is laid, ECRI Institute recommends a thorough assessment of all clinical alarm implementations, including the technology used, the environment in which it is used, the process by which it is used, and the staff who use it. Findings from this assessment can then be applied in a solution that will ideally reduce the amount of nuisance alarms that reach clinical caregivers while allowing significant clinical alarms to be managed promptly.
Such solutions are a careful balance—while alarms policies and protocols should be standardized throughout the organization or facility so that alarm signals, tones, visual cues, and response protocols are the same and allow staff to be able to identify and respond appropriately to various alarms wherever they are, the organization may be best served by tailoring alarm limits or parameters to individual areas of care. All such customization should be agreed upon by all stakeholders and spelled out clearly in organization policy.
Therefore, staff education and training are an especially important consideration when creating alarms safety strategies. Although education is not the strongest remediation strategy (NCPS), it is key to ensure that frontline staff who will be responding to alarms know how to properly do so.
Recent years have seen the introduction of several new guidelines and standards to help healthcare organizations increase the safety of their alarms usage while decreasing the amount of clinically insignificant alarms.
In 2011, the Association for the Advancement of Medical Instrumentation (AAMI), with ECRI Institute, the U.S. Food and Drug Administration, the Joint Commission, and the American College of Clinical Engineering, convened a medical device alarms summit. This summit brought together alarms safety perspectives from clinicians, manufacturers, biomedical experts, researchers, patient safety experts, acoustic experts, and regulators to create a comprehensive understanding of the risks inherent in alarm use. The summit identified the following seven “clarion themes,” priorities in the alarm safety movement (AAMI “Clinical”):
- Expand stakeholders’ understanding of the environments where alarms are used
- Improve alarm system management
- Explore methods of alarm integration
- Examine and reconcile challenges in care areas where alarms are used
- Strengthen medical equipment standards
- Clarify regulatory requirements
- Share best practices and lessons learned
In 2012, AAMI published
Recommendations for Alarm Signal Standardization and More Innovation. Through an exploration of Christiana Care Health System’s (Delaware) five-year alarm system implementation, AAMI presents recommendations that benefit any organization looking to review and revise its alarm systems. The Christiana initiative found that monitoring was taking place in “silos”; each unit was practically isolated
from others and following its own system of monitoring, responding to alarms, and setting alarm parameters. Therefore, AAMI recommends that initial assessment of current alarms systems include an exploration of how frontline caregivers receive and respond to alarm conditions and of possible inconsistencies in alarms protocols of separate care areas. Christiana nurses also explained that they ignored lower-level alarms (typically nonclinical or clinically insignificant events). Therefore, part of their action plan focused on the identification of “true alarm conditions,” which became reflected in new alarm settings that were then standardized across the organization. (AAMI “Recommendations”) For more on setting such deliberate alarm limits, see the discussion
Ensure That Alarm Settings Are Actionable.
Identifying these inconsistent alarm management strategies helped Christiana recognize that it needed a broader approach, so it convened a task force that advocated for leadership buy-in and collaboration across the entire organization. The task force identified the best strategy for Christiana’s needs was to be using wireless patient monitors and dedicated monitor technicians who alert caregivers to true alarm conditions. The wireless monitor system was implemented originally in the hospital’s department of medicine, then expanded slowly until it was organization-wide. AAMI notes that successful steps taken in this case were the recognition that alarms are a medical and patient safety concern, the creation of a multidisciplinary task force that can advocate at all levels and in all areas of the organization for a strategic solution, the commitment of support from leadership, the input from would-be system users, and the consultation with other organizations that have undertaken similar implementations. (AAMI “Recommendations”)
Once the system was being deployed, Christiana found its nonstandardized approach to alarm settings, responses, and parameters to be a hindrance. Negotiation among the task force and all physicians who set alarm limits took place revolving around the question “Does this merit a phone call in the middle of the night?” Such focus, notes the task force, allowed clinicians to determine a core list of true alarm conditions, which then replaced the manufacturers’ default settings. Nurses, as the care providers most likely to identify and respond to an alarm, also had a key role in negotiating the standardized alarm settings. AAMI stresses how important it is to “develop a system-wide alarm system policy and protocols that define an alarm management strategy.” (AAMI “Recommendations”)
For another alarms initiative, see
The Johns Hopkins Hospital’s Award-Winning Alarms Initiative. For more information on these and other resources, see
The American Association of Critical-Care Nurses (AACN) offered updated alarm safety guidance in May 2013. Suggested strategies to reduce alarm fatigue include the following (AACN):
- Prepare skin properly for electrocardiogram (ECG) electrode placement.
- Change ECG electrodes daily.
- Consider customizing ECG alarm parameters based on the needs of the individual patient.
- Consider customizing parameters on pulse oximetry. Determine optimal threshold and delay settings with the input of an interdisciplinary team, including biomedical engineering.
- Offer regular education and training about alarms.
- Establish an interdisciplinary alarm safety team.
- Monitor only patients who clinically merit monitoring.
The Joint Commission
In 2013 the Joint Commission released both a Sentinel Event Alert and an NPSG (which takes effect January 2014) dealing with alarm safety issues.
In the Sentinel Event Alert, the Joint Commission points to the following alarm hazard contributory factors, which may occur alone or in conjunction with one another (Joint Commission “Medical”):
- Alarm fatigue
- Noncustomized alarm settings
- Insufficient staff education or training
- Inadequate staffing levels for alarm monitoring
- Unintegrated alarms (i.e., alarms not connected with other medical devices, systems, or networks)
- Alarm equipment failures
The Sentinel Event Alert offers recommendations echoing those published by AAMI and ECRI Institute, namely to secure the support of leadership, assess current alarms and their settings, establish guidelines for alarm parameters (including when alarms are not necessary), create guidelines for the tailoring of alarm settings and limits on a patient-by-patient basis, and regularly review alarms to ensure proper function. It also suggests education of all members of the care team regarding safe alarm management practices, as well as appropriate responses for alarms. Further suggestions
include changing single-use sensors (such as ECG leads)
per manufacturer’s instructions, assessment of the acoustics in each care area, prioritization of alarms as an organizational safety initiative, establishment of a multidisciplinary task force, and sharing of best practices with appropriate organizations. (Joint Commission “Medical”)
The NPSG advances the cause of alarm safety and elevates it to a higher priority. NPSG.06.01.01 reads, simply: “Improve the safety of clinical alarm systems.” This is a deceptively simple directive, however; the NPSG rationale goes on to state the following:
Universal solutions have yet to be identified, but it is important for a hospital to understand its own situation and to develop a systematic, coordinated approach to clinical alarm system management. Standardization contributes to safe alarm system management, but it is recognized that solutions may have to be customized for specific clinical units, groups of patients, or individual patients. (Joint Commission “National”)
As of July 1, 2014, organization leaders are to prioritize alarm safety. Throughout the year, the most critical alarms are to be identified, with consideration of patient safety risk, staff input, potentially unnecessary alarms, and published guidance. By January 1, 2016, management strategies are to be established that stipulate appropriate alarm settings, considerations for silencing alarms, considerations for changing alarm parameters, necessary authority to set or modify alarm parameters, appropriate response protocol, and verification of individual alarm settings. (Joint Commission “National”)
For strategies to assess current alarm safety, see this Risk Analysis online for the interactive education tool
The Alarm Safety Game Show.
Generate Organizational Support
Action Recommendation: Convene a task force and seek leadership buy-in regarding the importance of alarm safety as a quality initiative. Consider the culture of the organization in determining the best method to improve alarm safety.
Organizational culture plays a significant role in the success of an alarms safety initiative. Alarms are not “just a technology problem”; culture and established processes are factors as well. Also, since a coordinated multidisciplinary effort is required to solve the problem, the support of everyone from the top down and bottom up is necessary. (ECRI Institute “Alarm Management”)
Gaining leadership buy-in for such a far-reaching initiative requires a demonstration of the patient safety benefits to key administrators and leadership (AAMI “Clinical Alarms”). Alarm safety should be considered a patient safety initiative and thus a part of the organization’s culture of safety (Konkani et al.) The initiative at Christiana Care Health System mentioned earlier in this Risk Analysis was understood as a necessary step in becoming a center of cardiac excellence (AAMI “Recommendations”).
The risks associated with clinical alarms will vary among care areas, so solutions will need to fit each area.
No “one size fits all” solution will be as effective. Factors that play a role in the alarms cycle and that will need to be assessed or considered include the following (ECRI Institute “Alarm Management”):
- Status or acuity of the patient
- Technology being used to manage or monitor the patient’s care
- Nurse-to-patient ratio
- Care model
- Architectural layout of the unit
Therefore, a multidisciplinary task force should be convened that represents all of these diverse interests, as well as additional stakeholders in the alarms management process. Members’ experience with alarms should be brought to bear in developing a strategy to resolve alarm hazards (ECRI Institute “Best Practices”). Potential committee members include representatives from frontline staff, nursing, medical leadership, telemetry, clinical engineering, information technology, patient safety/risk, and others as appropriate. (ECRI Institute “Strategies”) All of these staff members will have valuable input in assessing current alarm safety and potential future strategies.
Analyze Current Alarms Systems*
Action Recommendation: Analyze current alarms systems to identify potential points of hazard or failure. Use these findings to begin the discussion regarding how to best address the problem of alarm fatigue.
* Unless otherwise cited, text in this section is derived from the following: ECRI Institute. The life cycle of an alarm.
Health Devices 2013 Sep;42(9):294-300.
It is key to understand the areas of risk in the alarm-use process. Consideration of the hypothetical “life cycle” of the alarm—from when the alarm condition develops until it is resolved—can help a task force to identify specific concerns or potential hazards.
When set up correctly and functioning properly, a medical device will activate an alarm when it identifies a relevant change in the patient’s status. Questions to consider include the following: Did the alarm sound? Was it triggered by an event outside set parameters? Did it not sound and should have? Did it sound for something clinically insignificant?
If no alarm sounds, it may have been improperly set up or connected.
Next, consider how the alarm is communicated. In many if not most cases, this means the actual sounding of the device alarm. In other situations, though, it can refer to how monitor staff at central stations are alerted to the potential condition and how they in turn notify care providers or to notification of care providers directly via personal device (e.g., pager, phone). Whatever the method, its reliability should be assessed. Consider the efficacy of the notification process, potential notification system failures, and limits of the technology used.
Then consider the message that is communicated—is there one? If it’s just the actual alarm noise, not necessarily. An appropriate response from caregivers requires such information as what happened to trigger the alarm, how urgent it is, and where to go to provide aid. Audible alarms can be accompanied by visual indicators (such as flashing lights or an additional code delivered to the care provider’s communication device) to guide care providers in urgent situations. Another potential method of steering care providers is to standardize alarm tones and visual indicators throughout the organization so that all staff members understand that a certain level of alarm merits a certain level of response. Secondary alarm notification, when alarms from one device are communicated through another system (e.g., communicating ventilator alarms through a physiologic monitoring system, using an ancillary system for bedside alarms) may not always transfer all information, so they should be tested extensively before installation and use, as well as regularly thereafter to ensure their efficacy.
After an alarm is sounded, who responds? Each care area requires protocols that clearly stipulate
responsibilities and actions to be taken. Likewise, escalation and backup coverage protocols need to be clear too.
Lastly, how do care providers know how to respond to alarms? Staff education, training, and regular review or refresher courses are a significant component of any alarms safety program. Each care area should have its alarm policies in a designated place that is easily accessible for staff members, as alarm limits and settings may differ from area to area. Area policies should offer guidance for setting alarms, define response protocols, clarify when it may be appropriate to silence or disable an alarm, address the possible suspension of monitoring during a procedure or transport, and remain current with clinical realities and best practices.
For more, see
The Life Cycle of an Alarm. Also, please see this Risk Analysis online for an interactive version of this tool.
Aggregate and Mine the Data
Once an analysis is conducted, baseline data should be collected. The quantity and type of alarms that occur in each monitored care unit should be aggregated, analyzed, and used to inform the task force’s decisions. (ECRI Institute “Best Practices”) For example, the Johns Hopkins Hospital’s discovery of up to 700 alarms per bed per day led the alarms committee to recommend minor modifications to alarm parameters, reducing alarms by more than 40%. (ECRI Institute “Best Practices”; Graham and Cvach) This data can also be used to make a patient safety case for an alarms initiative (AAMI “Recommendations”), as well as to understand why the phenomenon of alarm fatigue is so pervasive. Organizations should consider seeking assistance from vendors of physiologic and other monitors in order to best aggregate and begin to examine the data.
Seek Out and Combat Instances of Alarm Fatigue
Action Recommendation: Seek out and combat instances of alarm fatigue. Identify conditions that lead to clinically insignificant alarms and methods of reducing them.
Alarm fatigue, a byproduct of default alarm parameters that are too wide or all-encompassing, decreases the probability that an alarm will be answered—an obvious safety risk. Nuisance alarms or clinically insignificant alarms are responsible for alarms becoming “white noise”; they do not indicate a condition deserving of medical response, and they alarm frequently enough to desensitize staff to alarms. (Graham and Cvach) Alarms may be muted if they sound too frequently, leaving the patient at risk of experiencing an undetected emergency (Ulrich).
Indeed, one study found that out of more than 400 alarms, 70% received no response from nurses. Of the 34 significant (potentially life-threatening) alarms, 41% received no immediate response. Nurses in this study described feeling overwhelmed by alarm frequency, developing workarounds based on patient information, and ignoring alarms they judged to be clinically insignificant. (Varpio et al.) Similarly, caregivers experience the “cry wolf” effect and may respond to alarms less promptly, not knowing if an alarm is being caused by a real condition or an artifact. (Cvach) For more on motion artifacts, see the Risk Analysis
Physiologic monitors are designed to be very sensitive so as not to miss an event; however, if alarm parameters are too wide, alarm fatigue sets in because of the sheer number of times the alarm will sound. (Patients aren’t satisfied with the significant disturbance either; see the discussion Assess Patient Satisfaction for more.) However, if alarm limits are set too narrowly, the possibility increases that an event will not be identified by the monitor. The traditional practice is to err on the side of caution and cope with nuisance alarms as the tradeoff for supposedly not missing any clinically significant alarms. However, writes Maria Cvach, M.S., RN, CCRN, a member of the alarms initiative at the Johns Hopkins Hospital, “Rather than creating a safer environment, a large number of nuisance alarms have an opposite effect, resulting in desensitization.” (Cvach)
Therefore, alarm fatigue must be a prominent consideration in any alarms safety initiative. How exactly it is handled will vary based on the organization’s culture and alarm needs. For example, after the incident discussed earlier in this Risk Analysis, in which an elderly cardiac patient died, the staff created a plan to reduce the severity of alarm fatigue through several approaches. They created a committee to determine and implement best practices for alarm safety, instituted a training program to review monitoring technology and use, set a standard alarm volume, installed distributed speakers to reduce the need for high-volume alarms, and disabled the “volume off” setting on monitors. (McKinney)
Examine Alarm Standardization Strategies
Action Recommendation: Examine alarm standardization strategies. Determine the optimal strategy for the organization, such as standardizing alarm equipment, tones, levels, and response protocols, so that even in an unfamiliar unit, staff members are familiar with the technology, the level of alarm, and the response necessary.
This is not to suggest that alarm
settings across the organization should be standardized. What should be considered for standardization is the equipment used, the auditory tones and signals used, and the response protocols for staff members (Cvach). Alarm limits and parameters, on the other hand, should be considered for customization by care area or patient population, or even by individual patient, if circumstances require. The input of frontline staff, as well as all monitor and alarm users, will be invaluable in such determination.
The organization’s alarm policy should echo the goal of reducing nuisance alarms and simplifying alarm management protocols—ideally, making protocols uniform across the organization. Standardization all the way down to alarm features—tones and other signals—allows floating staff members to correctly identify alarms even in unfamiliar departments. (Cvach; ECRI Institute “Best Practices”) Using the same monitors as frequently as possible across the organization removes the risk that staff will be unfamiliar with a particular model.
Policies should clearly explain the modifications to alarm limits that take place so that staff members may refer to them as needed.
Ensure that Alarm Settings Are Actionable
Action Recommendation: Ensure that alarm settings are actionable. If alarm limits are customized, they must reasonably exclude clinically insignificant conditions while capturing those that are urgent or emergent.
When implementing a quality improvement initiative, it is important to remember that alarm limits must be
“actionable” (Cvach; McKinney). For example, monitors
on patients with chronic lung disease will alarm frequently if set to levels appropriate for normal lung function (McKinney). Likewise, another study found that
adjusting heart rate alarm limits from 120 bpm to 130 bpm in a population for which this was clinically appropriate reduced alarms by 50% (Cvach; Gross et al.).
Tailoring the settings of alarms can help to reduce the amount of nuisance or clinically insignificant alarms, as well. Writes Cvach: “If the alarm that is being generated is considered insignificant, then it should never be activated because the most that it can do is provide noise.” She further notes that setting actionable limits that are individual to the patient can help to control the amount of noise generated—one study did so while eliminating duplicate alarms and found a 43% reduction in high-priority alarms. (Cvach; Graham and Cvach)
Consider Environmental Conditions
Action Recommendation: Consider environmental conditions when examining potential alarm solutions. The physical layout and surroundings within the care area will affect alarm system options, and vice versa.
It is important to ensure that the alarms and care environment work synchronously to support patient safety. The layout of the unit, for example, will influence the alarm system developed and implemented, including the volume of alarms, the chosen method of monitoring patients, and the method in which alarms are communicated.
In the case mentioned earlier involving the tonsillectomy patient, the environment played a significant role. A curtain was drawn around the patient for privacy; however, it also had the effect of blocking line of sight and preventing visual assessment by care providers. Therefore, the Institute for Safe Medication Practices (ISMP) emphasizes the importance of maintaining direct line of sight in the postanesthesia care unit environment. If a curtain is necessary, ISMP suggests that a staff member remain with the patient behind the curtain for monitoring. (ISMP)
Solutions tailored to the environment can include a central monitoring station, for example, to reduce the “long hallway” effect. Or alarms that do not sound near the patient at all but alert the care provider via a wireless receiver might be worth considering (Chen; AAMI “Recommendations”). However, the risks of such systems must be weighed against potential merits to ensure their safety—if using a wireless network, for example, it should be verified that there are no dead areas (where the signal is inadequate) and that a backup network can handle the alarm load if necessary (AAMI “Recommendations).
Environmental considerations also include ambient noise, which should be kept to a minimum so that alarms may be heard (AORN). Also, reduced ambient noise will increase patient satisfaction and reduce staff stress levels.
Potential steps to be taken include the following (Welch et al.):
- Padding trash can lids
- Replacing loud paper towel dispensers
- Limiting overhead paging
- Encouraging staff to speak quietly
- Installing sound-dampening ceiling tiles and wall coverings
The bottom line for environmental considerations is that the environment and intended alarm system must work together to ensure that all patients can be safely monitored and that all alarms can be identified promptly and responded to appropriately. Therefore, alarm systems need to be a consideration early in renovation or new building plans, and care area layout needs to be a primary consideration when assessing alarm system efficacy.
Provide Regular Education for Staff
Action Recommendation: Provide regular education for staff. Especially if alarm limits are customized on an area-by-area basis, staff will need to know what the different limits or parameters are and how to access this information when needed. Likewise, staff members will need to know who has the authority to set or modify alarm parameters or silence alarms altogether.
Education and training for all staff who will interact with monitors and alarms should take place as part of the alarms initiative, and regular refresher courses should occur thereafter. Education regarding bedside monitoring should fall under the jurisdiction of the alarms task force (ECRI Institute “Best Practices”). Likewise, ensure that staff are trained on new devices added to the organization’s inventory, and verify that any updates to existing technology are covered in training (Joint Commission “Medical”). When planning the alarms initiative, remember to budget for staff education (AACN).
Alarm parameter modifications should be communicated to staff verbally and visually during shift changes (AORN; Love et al.). Also, consider a visual indicator, such as a sign, highlighting the customized parameters (AORN).
Assess Patient Satisfaction
Action Recommendation: Assess patient satisfaction. Alarm safety initiatives should include a focus on patient satisfaction, as many complaints are in regard to constantly disturbing noise levels.
It’s not only organization staff members who are affected by the constant sounding of alarms. Patients are affected too. Noise plays a significant role in patient satisfaction; one perspective piece in the New York Times quotes a patient with kidney failure who requires frequent hospitalization: “I can’t get better here, with all those alarms and people waking me up to give me pills and take my blood pressure and get my blood. . . . I feel like I get sicker in the hospital because I can’t get any sleep!” The author goes on to explain that the noise endured by patients (as well as staff members) exceeds recommended levels and approaches the volume of a chainsaw. (Chen)
However, since 2007, the Centers for Medicare and Medicaid Services (CMS) has required most hospitals to survey patients using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey and report data to CMS’s Hospital Compare website, where the survey data is freely available for public scrutiny. HCAHPS specifically questions patients regarding noise levels during their hospital stay.
Therefore, many organizations are taking steps to manage noise levels, including alarms, especially overnight so as to reduce interruptions to patients’ sleep. Potential solutions can include the use of wireless devices for communication as opposed to overhead paging and the installation of sound-dampening ceiling tiles, flooring, or wall coverings. (Landro) For more on HCAHPS, see the Risk Analysis
When Christiana Care created remote alarm monitoring stations, the reduced volume was an unexpected benefit. “It was a much quieter place when we got rid of all those alarm signals and conditions that were clinically insignificant,” AAMI quotes a member of the task force. “Patients were sleeping better. Patient satisfaction was higher and nursing satisfaction was higher because they didn’t have to deal with all of those alarm signals. They knew when they were getting something real.” (AAMI “Recommendations”)