Opinion
VIEWPOINT
Vineet Chopra, MD, MSc The Patient Safety Enhancement Program, Center for Clinical Management Research, Ann Arbor VA Medical Center, Ann Arbor, Michigan, and Department of Internal Medicine, University of Michigan Health System, Ann Arbor. Laurence F. McMahon Jr, MD, MPH Department of Internal Medicine, University of Michigan Health System, Ann Arbor, and Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor.
Corresponding Author: Vineet Chopra, MD, MSc, Department of Internal Medicine, University of Michigan Health System, 2800 Plymouth Rd, Bldg 16, Room 430W, Ann Arbor, MI 48109 ([email protected] .edu).
Redesigning Hospital Alarms for Patient Safety Alarmed and Potentially Dangerous Because hospital alarms alert clinicians to deviations from a defined normal state, these auditory and visual signals are designed to improve patient safety. Contemporary alarms are diverse, ranging from devices that monitor heart rate to those that sound when patients try to leave their beds. Indeed, it is difficult to imagine modern health care without these electronic sentinels of safety. Despite their benefits, alarms may also increase the possibility of harm. In a sentinel event alert, the Joint Commission called medical alarms a “frequent and persistent” patient safety problem and designated them 2014 National Patient Safety Goal No. 6 following reports of several alarm-associated deaths.1 Since 2010, the nonprofit ECRI Institute has also rated alarm problems among the top 10 health technology hazards, recently calling them “the number one medical hazard of 2014.”2 Notably, because alarm-associated adverse events are voluntarily reported, the true magnitude of this problem might exceed published estimates. Why may this technology have resulted in adverse outcomes? Like many innovations, alarms were first developed to provide benefit to an exceedingly small group of high-risk patients. Because clinical events and hemodynamic alterations often presaged harm in this population, alarms were successful at averting complications. Encouraged by these benefits, the medical community expanded this model to other low-risk populations. The consequence of this well-intentioned generalization is epitomized in the din of chirps, beeps, bells, and gongs that typify hospitals today. It is thus not surprising that concerns regarding safety have emerged, even in populations for whom these protective devices were once considered most valuable.3 Conceptually, an alarm is effective when 3 processes occur: (1) the alarm activates only when a serious problem develops, (2) a clinician recognizes the alarm as being indicative of said problem, and (3) the necessary know-how to address the problem at hand exists. This deceptively simple model is limited by myriad human and technical complexities. For example, alarms may not activate as intended or designed, creating false-negatives. Conversely, alarms may activate too frequently or in the absence of a serious problem, leading to false-positives. For example, cardiac monitors frequently alarm for bradycardia in patients with low normal (often, sleeping) heart rates, just as intravenous pumps sound a repetitive signal when an infusion is complete. Ironically, a movement to promote silence in hospitals has emerged in part as a result of alarm noise. These initiatives are motivated to reduce dissatisfaction—because patients are per-
haps the only people not acclimated to the sounds emanating from the many devices attached to them. These 2 examples—termed alarm failure and alarm fatigue—may account for a substantial proportion of alarm-associated adverse events in hospitalized patients.2-4 On a typical hospital ward, it has become difficult to escape the disharmony generated by alarms, the consequences of which can be harmful.4 For example, a man was recently found dead in his hospital bed despite being placed on a cardiac monitor; investigations reportedly revealed that the alarm was set to the off position for unclear reasons.5 In a similar tragedy, a 17-year-old Pennsylvania girl reportedly died from respiratory suppression related to medications when alarms to monitor breathing reportedly were set to mute.6 Although disheartening, these events are predictable because hospital-based clinicians often search for silence in order to function effectively. Simply put, alarms now seem to exist for everything as opposed to alerting clinicians to clinically important problems. How then to solve this conundrum? Based largely on root-cause analyses, approaches such as simplifying alarm schema, disabling off switches, and retraining the workforce to improve alarm etiquette were suggested.1 Although valuable, these interventions treat the apparent aspects rather than the underlying problem. Instead, what is needed is a complete reimagining of alarm systems from a patient-centric perspective. How might this be designed? First, many alarms illogically and paradoxically distract from those that require attention. As a first step, creating an alarm priority (eg, those that are critical compared with those that are clinically unnecessary) is needed. The use of any audible or visual alert that does not signify a clear or potential risk (eg, infusion complete alerts on intravenous pumps) in the context of its implementation should be carefully reconsidered. Relatedly, any alarm that has an off or mute function should also be critically appraised, as no clinically relevant alert should ever need to be turned off; rather, the existence of such an option is a tacit admission of the limited effectiveness of the device in question. Second, alarms must be reconfigured to clinical workflow to ensure critical information is provided at the time of care. For instance, infusion pump alerts should trigger only when a nurse enters the room, just as alerts that signify the presence of an indwelling device may activate when physicians approach patients. It is also important to consider how and when alarms manifest, as systems that alert must be separated from those that inform. Thus, many alerts need not be auditory, immediate, or activated in a patient
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JAMA March 26, 2014 Volume 311, Number 12
Copyright 2014 American Medical Association. All rights reserved.
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1199
Opinion Viewpoint
room. Vibratory or visual alerts on special wristbands or directed nonurgent alerts via e-mail represent more nuanced notifications. Additionally, escalation or targeting logic based on alarm priorities should be developed (eg, medication renewal = notify intern or resident at end of shift vs significant hemoglobin decrease = notify all team members immediately). The technology for these approaches exists today; proximity sensors, radiofrequency identification tags, and web-based systems for message routing are but a few examples of available solutions. Third, the multifaceted, Bayesian nature of clinical decisionmaking should be incorporated to create an intelligent and integrated system. Alarms are ineffective in part because they are insular and disconnected from each other. A low blood pressure alarm means little in isolation to a clinician. If, however, the blood pressure reading is also accompanied by a rapid heart rate and knowledge that these trends represent deviations from baseline, a meaningful message is created. This type of artificial intelligence that recognizes clinical patterns, learns “baselines,” and synthesizes real-time trends to process alerts could move hospital alarms from their currently fragmented state to a more unified, patient-centered clinical monitoring model. In this new approach,
the focus shifts from the individual alarm to integration of data from all patient-linked devices. The type of alarm and to whom and how it is communicated will depend on the clinical importance of the information and the urgency required for an intervention. Therefore, a new combination of low blood pressure, rapid heart rate, and oxygen desaturation will trigger not only bedside alarms, but also remote monitors and automated stat pages to all clinicians. Conversely, an erratic pulse-oximetry waveform or isolated, low–blood pressure reading could initiate a nurse call for a device or patient check. Importantly, each of these models may be customized to adapt to the workflow of individual facilities or tiers of academic medical centers, ensuring a flexible approach. Existing hospital alarms no longer provide an umbrella of safety. The scope and design of these systems must shift from the status quo to a biologically valid, clinically relevant, patient-centered model. Existing technology allows integration and intelligent assessment of patient data to create advanced alarm systems. Changes to design and implementation of alarms are necessary to improve patient safety. No longer should hospitals be alarmed and potentially dangerous.
http://www.jointcommission.org/assets/1/18 /JCP0713_Announce_New_NSPG.pdf. Accessed January 15, 2013.
ARTICLE INFORMATION Published Online: March 3, 2014. doi:10.1001/jama.2014.710. Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Chopra and McMahon report being co-inventors of technology that tracks the presence and duration of indwelling vascular and urinary catheters in hospitalized patients. The system uses a special sensor and wireless receiver to pair with and record the presence of catheter-based devices, but the technology is not an alarm.
2. Keller JP Jr. Clinical alarm hazards: a “top ten” health technology safety concern. J Electrocardiol. 2012;45(6):588-591. 3. Siebig S, Kuhls S, Imhoff M, Gather U, Schölmerich J, Wrede CE. Intensive care unit alarms—how many do we need? Crit Care Med. 2010;38(2):451-456. 4. Kowlaczyk L. “Alarm fatigue” a factor in 2nd death. http://www.boston.com/lifestyle/health /articles/2011/09/21/umass_hospital_has_second
_death_involving_alarm_fatigue/. Accessed December 5, 2013. 5. Kowalczyk L. MGH death spurs review of patient monitors. http://www.boston.com/news/health /articles/2010/02/21/mgh_death_spurs_review_of _patient_monitors/?page=1. Accessed November 5, 2013. 6. Sun LH. Too much noise from hospital alarms poses risks for patients. http://www .washingtonpost.com/sf/feature/wp/2013/2007 /2007/too-much-noise-from-hospital-alarmsposes-risk-for-patients/. Accessed February 4, 2014.
REFERENCES 1. The Joint Commission. The Joint Commission announces 2014 National Patient Safety Goal.
1200
JAMA March 26, 2014 Volume 311, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of Birmingham User on 05/31/2015
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VIEWPOINT
Vineet Chopra, MD, MSc The Patient Safety Enhancement Program, Center for Clinical Management Research, Ann Arbor VA Medical Center, Ann Arbor, Michigan, and Department of Internal Medicine, University of Michigan Health System, Ann Arbor. Laurence F. McMahon Jr, MD, MPH Department of Internal Medicine, University of Michigan Health System, Ann Arbor, and Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor.
Corresponding Author: Vineet Chopra, MD, MSc, Department of Internal Medicine, University of Michigan Health System, 2800 Plymouth Rd, Bldg 16, Room 430W, Ann Arbor, MI 48109 ([email protected] .edu).
Redesigning Hospital Alarms for Patient Safety Alarmed and Potentially Dangerous Because hospital alarms alert clinicians to deviations from a defined normal state, these auditory and visual signals are designed to improve patient safety. Contemporary alarms are diverse, ranging from devices that monitor heart rate to those that sound when patients try to leave their beds. Indeed, it is difficult to imagine modern health care without these electronic sentinels of safety. Despite their benefits, alarms may also increase the possibility of harm. In a sentinel event alert, the Joint Commission called medical alarms a “frequent and persistent” patient safety problem and designated them 2014 National Patient Safety Goal No. 6 following reports of several alarm-associated deaths.1 Since 2010, the nonprofit ECRI Institute has also rated alarm problems among the top 10 health technology hazards, recently calling them “the number one medical hazard of 2014.”2 Notably, because alarm-associated adverse events are voluntarily reported, the true magnitude of this problem might exceed published estimates. Why may this technology have resulted in adverse outcomes? Like many innovations, alarms were first developed to provide benefit to an exceedingly small group of high-risk patients. Because clinical events and hemodynamic alterations often presaged harm in this population, alarms were successful at averting complications. Encouraged by these benefits, the medical community expanded this model to other low-risk populations. The consequence of this well-intentioned generalization is epitomized in the din of chirps, beeps, bells, and gongs that typify hospitals today. It is thus not surprising that concerns regarding safety have emerged, even in populations for whom these protective devices were once considered most valuable.3 Conceptually, an alarm is effective when 3 processes occur: (1) the alarm activates only when a serious problem develops, (2) a clinician recognizes the alarm as being indicative of said problem, and (3) the necessary know-how to address the problem at hand exists. This deceptively simple model is limited by myriad human and technical complexities. For example, alarms may not activate as intended or designed, creating false-negatives. Conversely, alarms may activate too frequently or in the absence of a serious problem, leading to false-positives. For example, cardiac monitors frequently alarm for bradycardia in patients with low normal (often, sleeping) heart rates, just as intravenous pumps sound a repetitive signal when an infusion is complete. Ironically, a movement to promote silence in hospitals has emerged in part as a result of alarm noise. These initiatives are motivated to reduce dissatisfaction—because patients are per-
haps the only people not acclimated to the sounds emanating from the many devices attached to them. These 2 examples—termed alarm failure and alarm fatigue—may account for a substantial proportion of alarm-associated adverse events in hospitalized patients.2-4 On a typical hospital ward, it has become difficult to escape the disharmony generated by alarms, the consequences of which can be harmful.4 For example, a man was recently found dead in his hospital bed despite being placed on a cardiac monitor; investigations reportedly revealed that the alarm was set to the off position for unclear reasons.5 In a similar tragedy, a 17-year-old Pennsylvania girl reportedly died from respiratory suppression related to medications when alarms to monitor breathing reportedly were set to mute.6 Although disheartening, these events are predictable because hospital-based clinicians often search for silence in order to function effectively. Simply put, alarms now seem to exist for everything as opposed to alerting clinicians to clinically important problems. How then to solve this conundrum? Based largely on root-cause analyses, approaches such as simplifying alarm schema, disabling off switches, and retraining the workforce to improve alarm etiquette were suggested.1 Although valuable, these interventions treat the apparent aspects rather than the underlying problem. Instead, what is needed is a complete reimagining of alarm systems from a patient-centric perspective. How might this be designed? First, many alarms illogically and paradoxically distract from those that require attention. As a first step, creating an alarm priority (eg, those that are critical compared with those that are clinically unnecessary) is needed. The use of any audible or visual alert that does not signify a clear or potential risk (eg, infusion complete alerts on intravenous pumps) in the context of its implementation should be carefully reconsidered. Relatedly, any alarm that has an off or mute function should also be critically appraised, as no clinically relevant alert should ever need to be turned off; rather, the existence of such an option is a tacit admission of the limited effectiveness of the device in question. Second, alarms must be reconfigured to clinical workflow to ensure critical information is provided at the time of care. For instance, infusion pump alerts should trigger only when a nurse enters the room, just as alerts that signify the presence of an indwelling device may activate when physicians approach patients. It is also important to consider how and when alarms manifest, as systems that alert must be separated from those that inform. Thus, many alerts need not be auditory, immediate, or activated in a patient
jama.com
JAMA March 26, 2014 Volume 311, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of Birmingham User on 05/31/2015
1199
Opinion Viewpoint
room. Vibratory or visual alerts on special wristbands or directed nonurgent alerts via e-mail represent more nuanced notifications. Additionally, escalation or targeting logic based on alarm priorities should be developed (eg, medication renewal = notify intern or resident at end of shift vs significant hemoglobin decrease = notify all team members immediately). The technology for these approaches exists today; proximity sensors, radiofrequency identification tags, and web-based systems for message routing are but a few examples of available solutions. Third, the multifaceted, Bayesian nature of clinical decisionmaking should be incorporated to create an intelligent and integrated system. Alarms are ineffective in part because they are insular and disconnected from each other. A low blood pressure alarm means little in isolation to a clinician. If, however, the blood pressure reading is also accompanied by a rapid heart rate and knowledge that these trends represent deviations from baseline, a meaningful message is created. This type of artificial intelligence that recognizes clinical patterns, learns “baselines,” and synthesizes real-time trends to process alerts could move hospital alarms from their currently fragmented state to a more unified, patient-centered clinical monitoring model. In this new approach,
the focus shifts from the individual alarm to integration of data from all patient-linked devices. The type of alarm and to whom and how it is communicated will depend on the clinical importance of the information and the urgency required for an intervention. Therefore, a new combination of low blood pressure, rapid heart rate, and oxygen desaturation will trigger not only bedside alarms, but also remote monitors and automated stat pages to all clinicians. Conversely, an erratic pulse-oximetry waveform or isolated, low–blood pressure reading could initiate a nurse call for a device or patient check. Importantly, each of these models may be customized to adapt to the workflow of individual facilities or tiers of academic medical centers, ensuring a flexible approach. Existing hospital alarms no longer provide an umbrella of safety. The scope and design of these systems must shift from the status quo to a biologically valid, clinically relevant, patient-centered model. Existing technology allows integration and intelligent assessment of patient data to create advanced alarm systems. Changes to design and implementation of alarms are necessary to improve patient safety. No longer should hospitals be alarmed and potentially dangerous.
http://www.jointcommission.org/assets/1/18 /JCP0713_Announce_New_NSPG.pdf. Accessed January 15, 2013.
ARTICLE INFORMATION Published Online: March 3, 2014. doi:10.1001/jama.2014.710. Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Chopra and McMahon report being co-inventors of technology that tracks the presence and duration of indwelling vascular and urinary catheters in hospitalized patients. The system uses a special sensor and wireless receiver to pair with and record the presence of catheter-based devices, but the technology is not an alarm.
2. Keller JP Jr. Clinical alarm hazards: a “top ten” health technology safety concern. J Electrocardiol. 2012;45(6):588-591. 3. Siebig S, Kuhls S, Imhoff M, Gather U, Schölmerich J, Wrede CE. Intensive care unit alarms—how many do we need? Crit Care Med. 2010;38(2):451-456. 4. Kowlaczyk L. “Alarm fatigue” a factor in 2nd death. http://www.boston.com/lifestyle/health /articles/2011/09/21/umass_hospital_has_second
_death_involving_alarm_fatigue/. Accessed December 5, 2013. 5. Kowalczyk L. MGH death spurs review of patient monitors. http://www.boston.com/news/health /articles/2010/02/21/mgh_death_spurs_review_of _patient_monitors/?page=1. Accessed November 5, 2013. 6. Sun LH. Too much noise from hospital alarms poses risks for patients. http://www .washingtonpost.com/sf/feature/wp/2013/2007 /2007/too-much-noise-from-hospital-alarmsposes-risk-for-patients/. Accessed February 4, 2014.
REFERENCES 1. The Joint Commission. The Joint Commission announces 2014 National Patient Safety Goal.
1200
JAMA March 26, 2014 Volume 311, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of Birmingham User on 05/31/2015
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