Clinical alarm hazards: a “top ten” health technology safety concern

Clinical alarm hazards: a “top ten” health technology safety concern

Available online at www.sciencedirect.com Journal of Electrocardiology 45 (2012) 588 – 591 www.jecgonline.com Clinical alarm hazards: a “top ten” he...

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Available online at www.sciencedirect.com

Journal of Electrocardiology 45 (2012) 588 – 591 www.jecgonline.com

Clinical alarm hazards: a “top ten” health technology safety concern James P. Keller Jr., MS⁎

Health Technology Evaluation and Safety, ECRI Institute, Plymouth Meeting, PA, USA

Abstract

For the past several years ECRI Institute has published a list of Top Ten Health Technology Hazards. This list is based on ECRI's extensive research in health technology safety and on data provided to its problemreporting systems. For every year that the Top Ten list has been published, Alarm Hazards have been at or near the top of the list. Improving alarm safety requires a systematic review of a hospital's alarm-based technologies and analysis of alarm management policies like alarm escalation strategies and staffing patterns. It also requires careful selection of alarm setting criteria for each clinical care area. This article will overview the clinical alarm problems that have been identified through ECRI Institute's research and analysis of various problem reporting databases, including those operated by ECRI Institute. It will also highlight suggestions for improvement, particularly from a technology design and technology management perspective. © 2012 Elsevier Inc. All rights reserved.

Keywords:

Alarm safety; Alarm fatigue

Introduction For the past five years ECRI Institute has published a list of Top Ten Health Technology Hazards. This list is based on ECRI's extensive research in health technology safety and on data provided to its problem-reporting systems. The list is designed to raise awareness about serious technology problems that ECRI Institute believes hospitals should be incorporating into their patient safety programs. For every year that the Top Ten list has been published, Alarm Hazards have been at or near the top of the list. What's causing the problem and why is it such a safety concern? More and more alarm-based medical devices are being used in patient care. More and more patients are connected to one – or many – alarm-based devices. With the large number of alarm-based devices being used, the number of alarms that clinicians need to respond to has grown to an alarming number. Some reports suggest that in a critical care unit a caregiver can be subjected to 150–400 or more alarms per patient per day. 1 This can be overwhelming for clinical staff and dangerous for patients as many serious patient alarm events are being missed. Further complicating matters is that alarm-based devices are not standardized in many institutions. And many patient monitors have flexible alarm setting features that allow for inconsistent use of alarms.

* ECRI Institute, 5200 Butler Pike, Plymouth Meeting, PA 19426, USA. E-mail address: [email protected] 0022-0736/$ – see front matter © 2012 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jelectrocard.2012.08.050

Improving alarm safety requires a systematic review of a hospital's alarm-based technologies and analysis of alarm management policies like alarm escalation strategies and staffing patterns. It also requires careful selection of alarm setting criteria for each clinical care area. This article will provide an overview of the clinical alarm problems that have been identified through ECRI Institute's research and analysis of various problem reporting databases, including those operated by ECRI Institute. It will also highlight suggestions for improvement, particularly from a technology design and technology management perspective. Also, for many years ECRI Institute has been the repository for a database of arrhythmias and normal electrocardiograms developed by the American Heart Association (AHA). The database has frequently been used to assist with the development of ECG arrhythmia detection equipment and for training of health professionals. This article will include a brief overview of the arrhythmia and electrocardiogram database.

ECRI institute background ECRI Institute is a nonprofit health services research organization with an over forty year history of conducting comparative evaluations of medical devices and investigating risks associated with the use of medical devices. Its evaluations are published in ECRI Institute's monthly Health Devices journal. Health Devices also publishes results of its medical device incident investigations, typically in articles called Hazard Reports. The medical device investigations are based

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on reports submitted by healthcare professionals to ECRI Institute's problem reporting systems and on findings from its Accident and Forensic Investigation Services.

Alarm safety in the news There's been quite a bit of very high-profile coverage of alarm-related deaths in the news over the last few years. In 2010, 2011, and 2012 the Boston Globe 2–7 published major articles on problems with clinical alarms. The first article in the series highlighted a problem at Massachusetts General Hospital where a patient died when the audible alarm for a patient monitor had been turned off. The Globe series was picked up by many other news outlets including the CBS News Morning Show. And it's been getting attention at high levels of the US Government. US Congressman Ed Markey recently wrote a letter to Health and Human Services Secretary Kathleen Sebelius recommending that she commission the Institute of Medicine to conduct a study on how medical device manufacturers and healthcare organizations can better handle problems with clinical alarms. 8 The US Food and Drug Administration co-convened a 2011 Summit with the Association for the Advancement of Medical Instrumentation (AAMI), ECRI Institute, The Joint Commission, and the American College of Clinical Engineering to review ways that alarm safety can be improved. 9 The Joint Commission recently announced that it is collecting information through a survey of hospitals on current practices relative to clinical alarm management to determine how best to address the issue. Among the options it is considering include field education, Sentinel Event Alerts, and accreditation requirements. 10

Typical problems In 2008 the Pennsylvania Patient Safety Authority published a failure mode and effects analysis of alarm interventions during medical telemetry monitoring. It highlighted a typical patient monitor-related alarm incident. The report described a patient being admitted to a “monitored unit” with chest pain and shortness of breath. It noted that “at 3:25 a.m., the patient's nurse observed that the patient's leads were off and on checking on the patient found him in the bathroom unresponsive. Resuscitation efforts were unsuccessful.” The patient's monitor showed that the leads had come off at 2:32 a.m. 11 The first of the Boston Globe articles mentioned above referred to a database search that ECRI Institute conducted in support of the Globe's research. Our search included review of the FDA Manufacturer and User Device Experience (MAUDE) database, ECRI Institute's Health Devices Problem Reporting Network database, and ECRI Institute's Accident and Forensic Investigation files from 2005 to 2010. The key words “alarm” and “death” were used and the results were filtered to include only physiologic monitor-related events. We identified 216 deaths. In 73 of the cases, alarms sounded, but staff silenced them, did not hear them because the volume

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was too low, or did not respond for another reason. Some specific examples from the ECRI Institute search include: • Failure of a patient monitor to detect a patient's ventricular tachycardia because its alarms were paused by the user. (ECRI Institute MAUDE reference ID 1629921) • A new ward layout possibly contributing to the failure of nursing staff to hear a cardiac arrhythmia alarm. (ECRI Institute MAUDE reference ID 1635872) • No alarm for an asystole event because the patient monitor was configured for its alarms to be in a permanent suspend mode. (ECRI Institute MAUDE reference ID 1636788) • A telemetry monitor failed to provide an audible indication of low battery. Its low battery alarm feature was turned off. The reporting hospital stated that the lack of alarm contributed to a patient death. (ECRI Institute MAUDE reference ID 1644347) The 216 events are considered to be a very small sampling of the actual number of alarm events. Although the Safe Medical Devices Act of 1990 requires that hospitals report medical device-related deaths and injuries, the actual amount of device reporting is very low. ECRI Institute has estimated that the number of alarm deaths is at least ten times higher than found in the database search conducted for the Globe. Top ten considerations The findings from our database analyses is one of the contributing factors to ECRI Institute's decision to place alarm hazards as number one on its list of Top Ten Health Technology Hazards for 2012. Other factors include the steady number of accident investigations ECRI institute is asked to perform each year and hospital surveys it has conducted asking about serious alarm-related events. A majority of survey respondents have reported that they have had problems. As mentioned in the introduction, the Top Ten List is part of an awareness raising initiative. Human factors, technology challenges and limitations, difficult patient conditions, a wide variety of environmental conditions, and even staffing cultures make alarm safety a complex problem to solve. This level of complexity needs high-level and focused attention which ECRI Institute determined its high Top Ten ranking could help initiate. 12 Alarm fatigue Alarm fatigue occurs when a caregiver can become overwhelmed by a large number of clinical alarms such that important alarms can be missed or ignored. Many of the alarm-related events reviewed by ECRI Institute's databases analyses can be attributed to alarm fatigue. Looking through the databases one can see report after report indicating that an alarm sounded for a serious condition but it was not heard or responded to by clinical staff in time to avert a bad outcome. Or, alarms are happening so often that

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staff become annoyed and actually turn them off. The following example is a typical case from ECRI Institute's Accident Investigation files and illustrates how the latter can happen. A ventilator-dependent patient's frequent coughing triggers the high-pressure alarm on the ventilator. Frequent response to the alarm by the patient's nurse finds no real problem. The nurse eventually becomes frustrated and increases the limit for the high-pressure alarm to minimize the number of false-positive alarms. Then patient movement crimps breathing circuit or secretions clog the endotracheal tube causing pressure levels that would normally be picked up by the high-pressure alarm. But with the higher pressure setting, these serious conditions are missed, leading to inadequate patient ventilation and possibly death. Alarm management The ventilator scenario described above can trigger a series of questions that will likely point to the need for significant improvement in how hospitals manage their alarms. • Does the nurse understand the purpose of the highpressure alarm? • Was the nurse educated on appropriate use of the ventilator's alarms? • Was the nurse's competence in ventilator use validated? • Does the hospital have a policy for who can and cannot set ventilator alarms? • Is there a policy on how ventilator alarms should be set? • If so, is the policy generic or does it consider specific circumstances (e.g., different alarm setting criteria for different care settings)? ECRI Institute has often found that when hospitals are asked these types of questions, the answer is no and that the hospitals have not given serious consideration for how its staff should be using, setting, and responding to clinical alarms. They're usually lacking any type of coordinated alarm management. A safe and effective alarm management program involves understanding where and what patient safety vulnerabilities exist, establishing goals for reducing risk, and putting a plan in place to achieve those goals. For example, ECRI Institute was asked to help a hospital improve an alarm problem in its 32-bed step-down area. The hospital had an alarm integration system with no escalation plan (i.e., all patients' alarms were sent to all nurses' pagers). This caused diffuse responsibility for alarm response so that the typical assumption was that “someone else will respond to that alarm”. It was an unmanageable situation. Part of ECRI Institute's recommended solution was to develop an alarm escalation plan that delineated responsibility for alarm response. It included defining who receives initial alarm notifications for each type of alarm and who receives back-up alarm notifications for each type of alarm. It also required that time intervals be established for when each escalation would be triggered. It was a much more effective approach to alarm management that

was projected to significantly cut back on alarm frequency and reduce alarm fatigue.

Personal perspectives with alarm fatigue My mother was recently hospitalized for five and a half weeks in a critical care setting. She experienced a massive heart attack that required her to be on a ventilator for most of that time. She also suffered kidney failure and received continuous renal replacement therapy for about two weeks. During that time I heard my share of alarms. Many were triggered by a change in my mother's condition that required an important clinical intervention. But lots of other times they were caused by a difficulty or limitation with one of her devices. Typical problems included artifact on her ECG monitor from shifting in bed, incorrect pulse oximeter readings from low peripheral blood flow, and occlusions in her intravenous lines. And there were many other alarms where it wasn't clear if they were due to a true clinical event or an invalid reading. 13 I remember one incident in which a “non-sustained vtach” alarm had been frequently occurring. My assumption was that the alarms were being caused by mother's motion. She had been extremely fidgety because of discomfort from her ventilator, side effects from her medications, and probably a case of ICU delirium. When the alarms occurred her ECG looked more like noise than tachycardia. So I hadn't been concerned. Her clinical staff didn't seem to be concerned either. And then she suddenly became unresponsive and her monitor sounded a “vtach” alarm. I have no idea if the earlier alarms were warning signs or if they were due to artifact. That's part of the problem. In the interest of patient safety and avoiding missing important events, monitor alarms are set to be highly sensitive. This high sensitivity often comes at the expense of specificity. So, they're often designed to alarm safely. If “noise” looks like a valid signal it's accepted and if it causes a threshold to be crossed, an alarm sounds. Or if a signal is lost there's concern that an important event could be missed, so an alarm sounds. This contributes to the large volume of alarms that caregivers, patients, and their families are subjected to. And for me, it caused alarm fatigue. By the way, my mother recovered from the “vtach” incident and ended up doing well enough to go home about two months after her heart attack.

New directions for technology Medical device manufacturers are working hard to improve the alarm performance of their devices. Some solutions are directed towards improving the sensitivity and specificity of detection systems. Others are focused on better device integration. This should avoid the type of problem I saw in my mother's ICU room in which alarms for her patient monitor were fed to external displays but alarms for her infusion pumps, ventilator, and dialysis machine only sounded in her room. Effective integration requires all alarms for one patient to be presented to caregivers in a coordinated manner. They should not conflict or be repetitive. Good integration will lead to solutions like a heads up display that clearly indicates a

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patient's deteriorating condition in one place. This will be a welcome change to the many discrete and related but different alarms from multiple devices that we have to deal with today. AHA research database ECRI Institute was granted a license from the American Heart Association to distribute a database it developed of Arrhythmias and normal electrocardiograms recordings. They are presented in two series of beat-by-beat, annotated recordings and are broken down into eight arrhythmia categories. The database was developed by the AHA Council on Clinical Cardiology Committee on Electrocardiography and Clinical Electrophysiology with funding from the National Heart, Lung, and Blood Institute. The database is used by healthcare and research organizations for clinician training; product development, for example to correct the kinds of signal detection problems discussed above; and for research. 14 Conclusion Serious incidents related to clinical alarms have been reported for many years. Minimizing risk requires hospitals to implement concerted alarm management improvement programs. These programs need to address need to address communication, workflow, cultural, environmental, and technology solutions. They should plan for solutions that can be implemented today while considering and forecasting for future innovations. References 1. HCPro. From the AHAP blog: Joint Commission and FDA target alarm fatigue. Available at: http://www.hcpro.com/ACC-265320-4634/Fromthe-AHAP-Blog-Joint-Commission-and-FDA-target-alarm-fatigue. html. 2011.

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2. Kowalczyk L. MGH death spurs review of patient monitors. Boston Globe. Also available: www.boston.com/news/health/articles/2010/02/ 21/mgh_death_spurs_review_of_patient_monitors. 2010. 3. Kowalczyk L. Patient alarms often unheard, unheeded. Boston Globe Also available: http://www.boston.com/lifestyle/health/articles/2011/ 02/13/patient_alarms_often_unheard_unheeded/. 2011. 4. Kowalczyk L. No easy solutions for alarm fatigue. Boston Globe Also Available: http://www.boston.com/news/local/massachusetts/articles/ 2011/02/14/no_easy_solutions_for_alarm_fatigue/. 2011. 5. Kowalczyk L. Groups target alarm fatigue at hospitals. Also Available: http://www.boston.com/news/local/massachusetts/articles/2011/04/18/ groups_target_alarm_fatigue_at_hospitals/. 2011. 6. Kowalczyk L. Wide heart monitor use tied to missed alarms. Also Available: http://www.boston.com/lifestyle/health/articles/2011/12/29/ burgeoning_heart_monitor_use_tied_to_missed_alarms/. 2011. 7. Kowalczyk L. FDA working to trim hospital alarm fatigue. Boston Globe Also available: http://articles.boston.com/2012-03-26/healthwellness/31237407_1_alarms-medical-devices-maisel. 2012. 8. Nafziger B. Congressman wants IOM to study alarm fatigue. Dot Med News 2011 Avaliable at: http://www.dotmed.com/news/story/17762/. 2011. 9. Association for the Advancement of Medical Instrumentation. Alarm safety takes center stage at two-day summit. AAMI News. Available at: http://www.aami.org/news/2011/100511.alarm_summit.html. 2011. 10. Bowman D. ‘Alarm fatigue’ reduction efforts underway by FDA, Joint Commission. Fierce Health IT Available at: http://www.fiercehealthit. com/story/alarm-fatigue-reduction-efforts-underway-fda-jointcommission/2012-03-26#ixzz1qJvqb2k2. 2012. 11. Pennsylvania Patient Safety Authority. Alarm interventions during medical telemetry monitoring A failure mode and effect analysis A Pennsylvania Patient Safety Advisory supplementary review. Available at: http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/ 2008/mar5(suppl_rev)/Pages/mar5(supplrev).aspx. 2008. 12. Institute ECRI. Top 10 technology hazards for 2012: the risks that should be at the top of your prevention list. Health Devices 2011; 40(11):358. 13. Keller J. First-hand experience with alarm fatigue. ECRI Inst Patient Safety Blog Available at: http://www.ecri.org/blog/Lists/Posts/Post. aspx?ID=143. 2012. 14. ECRI Institute. American Heart Association ECG database DVD. Available at: https://www.ecri.org/Products/Pages/AHA_ECG_DVD. aspx.