June 20, 2016

The ASA adopted its Statement on Principles for Alarm Management for Anesthesia Professionals at its annual meeting in October 2013.  The introduction to the Statement provides as follows:

As Anesthesia Professionals, we interact with many different types of monitors, machines, infusion pumps and other equipment; many of these devices have audible and/or visual alarms.  We rely on alarms to signal us when set parameters/ thresholds are violated and/or when a potentially abnormal situation has occurred.  A given alarm’s clinical usefulness depends on numerous factors including attributes of the patient (e.g., baseline clinical status and vital signs), the clinical situation at the time (e.g., anesthetic and procedural factors), the intended recipient(s) (e.g., experience, hearing acuity), unintended recipients (who may be distracted or worried), and the physical environment (e.g., noise and light levels).  Management of these alarms becomes challenging, especially in that we must rapidly discern when a trigger is trivial, meaningful or life threatening.

After five years of heading ECRI’s list of Top 10 Health Technology Hazards, missed alarms are now in the number two position.  “Missed alarms” include those occurring “when the condition is communicated to clinical staff, but not appropriately addressed—whether because staff fail to notice the alarm, choose to ignore an alarm that warrants a response, or otherwise respond incorrectly.”  Failing to notice or ignoring an alarm is often the result of the clinicians’ “alarm” or “alert fatigue.”  

Case Report 14-4 from the Anesthesia Quality Institute’s Anesthesia Incident Reporting System AQI-AIRS) defines alarm fatigue as “the process in which providers, exposed to excessive or irrelevant alarms and alerts, modify their responsiveness to alarms—from ignoring alarms to silencing them altogether.”

Anesthesiologists and nurse anesthetists rely on a panoply of monitors to care for their patients on the operating table and in the critical care unit.  One among many examples of the importance of these monitors in triggering life-saving actions comes from a 2014 Ohio malpractice case.  In Burk v. Fairfield Ambulatory Surgery Center, the premature release of a tourniquet placed for a Bier block caused a bolus of lidocaine to be introduced into the plaintiff’s system, which in turn caused her to suffer an arrhythmia and to stop breathing.  Although the blood pressure monitor, pulse oximeter and EKG all had alarms, none sounded, and the patient quickly coded.  She was resuscitated, intubated and transferred to the hospital, where she stayed for 23 days.  The patient sued the surgery center and the anesthesiologist and his group, citing numerous injuries, including cardiac arrest, anoxic brain injury, and memory and speech deficits.  The Ohio appellate court reversed the trial court’s denial of the defendants’ motion for summary judgment and sent the case back to the trial court.

The AQI-AIRS report cited above notes that “The problem of alarm fatigue results from clinical alarms systems functioning as screening rather than diagnostic studies, favoring sensitivity and negative predictive value over specificity and positive predictive value.  The zeal to detect and alarm for every potentially dangerous situation has ironically decreased patient safety by creating an epidemic of false-positive alarms leading to alarm fatigue.” and lists five scenarios showing alarm fatigue that will probably be familiar to many anesthesia professionals.  Some of these scenarios are:

1. Transferred patient from O.R. (kidney/pancreas transplant) to the ICU ... Nurses were busy attaching ECG leads while I packed up portable monitor.  SpO2 is 88 percent, no alarms sounding. O2 Sat number blinking red, but nobody is paying attention to it. Placed mask back on patient and encouraged him to breathe.  SpO2 back to 100 percent.
    
2.  Default alarm volumes on multiple anesthesia machines are found to have been set to the lowest (inaudible volume) value.
    
3. Attending is insisting that all alarms be disabled prior to giving an anesthetic on all cardiac patients.  Anesthesia technicians have been instructed to accomplish this.  I don’t feel this is safe.

In all of these cases, useful alarms were turned off or muted, presumably in response to the distraction or annoyance of false alarms.  Anesthesia clinicians may sometimes set alarm conditions too high, turn alarm volumes down or off, or neglect to adjust alarm default settings for specific patients or populations.  In some instances, the anesthesiologist or CRNA may not hear an alarm, or they may be distracted and might hear the alarms only after a significant amount of precious minutes have lapsed.  In other instances, a series of cascading minor alarm failures is the culprit.

While most clinicians recognize the critical role alarms play, they often become desensitized to alarms and overwhelmed by all the noise.  According to the Joint Commission, one single hospital patient can set off several hundred alarms each day, depending on the severity of their condition, while as few as one percent of all alarm signals even require clinical intervention. 

Keith Ruskin, MD and Dirk Hueske-Kraus, MD noted in their article Alarm Fatigue: Impacts on Patient Safety in the December 2015 issue of Current Opinions in Anesthesiology that “Electronic medical devices are an integral part of patient care.  As new devices are introduced, the number of alarms to which a healthcare professional may be exposed may be as high as 1000 alarms per shift.  The US Food and Drug Administration has reported over 500 alarm-related patient deaths in five years.”  Shefali Luthra, in Screen Flashes and Pop-Up Reminders: ‘Alert Fatigue’ Spreads Through Medicine (Kaiser Health News, June 15, 2016), quoted an assistant professor of medicine at Harvard Medical School as saying that “Clinicians ignore safety notifications [from electronic health records] between 49 percent and 96 percent of the time.” 

Anesthesiology is far from the only clinical specialty in which alarm fatigue is a problem.  “There is general agreement that clinical alarm fatigue is an important safety issue,” stated The Joint Commission in 2013, announcing its National Patient Safety Goal (NSPG) 06.01.01 on clinical alarm safety that was to be implemented in two phases:

Phase I, which was effective on January 1, 2014, required hospitals to establish alarm safety as an organizational priority by July 1, 2014, and to identify during 2014 the most important alarms to manage based on their own internal situations.

Phase II, which began on January 1, 2016, set the expectation that hospitals would establish and implement specific components of policies and procedures for managing the alarms identified in Phase I and begin educating staff about the purpose and proper operation of alarm systems for which they are responsible.

This is one more area in which anesthesiology groups can create value for their hospital relationships.  If there is general agreement that alarm fatigue is a real problem, there is no consensus on the specific ways in which to reduce its effects, only a general agreement that individual hospitals must determine the most important alarms to manage consistent with their own needs and prioritization.

Despite the top five alarm-related knowledge gaps identified in the Association for the Advancement of Medical Instrumentation (AAMI) Foundation’s 2015 Clinical Alarm Management Compendium, i.e., 

1. Lack of documentation and data to analyze reported events and near misses to understand root problem(s)
2. Lack of evidence-based rationale for the configurations of alarm settings
3. Lack of understanding of the best types of alarm signals to elicit a response
4. Lack of knowledge regarding who should be monitored and for how long
5. Lack of understanding about the best secondary alarm notification systems,

hospitals must, this year, implement specific components of policies and procedures for managing alarms and begin educating staff.  Anesthesiologists can lead or at least participate in this process. 

You can update your institution’s identification of its own alarm-related challenges using the Compendium’s List of Alarm Management Challenges on pages 10-11.  The 10 Ideas for Safe Alarm Management on page 12, which “represent approaches common to robust, multidisciplinary teams,” are as follows:

1. Issue a call to action, championed by executive leadership, which recognizes the challenges and risks—and opportunities—of alarm management and commit to solving them.
2. Bring together a multidisciplinary team to spearhead action and build consensus.
3. Gather data and intelligence to identify challenges and opportunities—and be open to surprises.
4. Prioritize the patient safety vulnerabilities and risks to target with alarm management improvements.
5. Set and share goals, objectives, and activities to address patient safety vulnerabilities and risks.
6. Develop and pilot potential solutions.
7. Evaluate the effectiveness of improvements and make adjustments as needed.
8. Develop policies and procedures.
9. Educate to build and maintain staff competencies.
10. Scale up and sustain by creating ownership at the unit level and with continuous improvement.

The best place to start is in your own domain, the OR suite.  The ASA Statement on Principles referenced at the beginning of this Alert starts with the proposition that “Each facility should have an Alarm Management Policy (… AMP) pertaining to Anesthesia equipment and/or devices used by anesthesia professionals.”  and that “the AMP should describe the equipment and alarms found in each care environment (OR, PACU, ICU, Pain clinic, special procedures, etc.).”  It goes on to state that anesthesia professionals who use or monitor the equipment and medical devices with alarm systems “should be involved in the creation and maintenance of the AMP.”  Furthermore,

• Alarm system settings must balance patient and provider safety risks against unintended consequences (distraction, alarm fatigue, intrusiveness).  Thus, ALARM SYSTEM SETTINGS should be locally customized to reflect the patients, the practice, and the perceived risks of the alarm conditions in each care environment.
   
• The AMP should delineate the process for familiarizing all Anesthesia Professionals with the recommended use of Alarm Systems in use in the facility.  The nature and occurrence of such familiarization for each Alarm System should be documented.
   
• Anesthesia Professionals should adjust Alarm settings as appropriate for a particular patient prior to starting an anesthetic.  Clinicians should not indefinitely silence or disable alarms on any device, unless necessary because:  (a) the device or module is not in use, (b) the device or module has malfunctioned, or (c) the patient’s medical condition supports using the AUDIO OFF or ALARM OFF modes. 
   
• In general, individual Anesthesia Professionals should not be able to change default alarm settings of any Anesthesia Equipment.  The AMP should specify an institutional process for changing default alarm settings.

AQI-AIRS Case Report 14-4 (above) gives some pointers on the content and implementation of an anesthesia AMP, stating that it should include specification of various alarm default settings and mandate participation in training and familiarization sessions with the alarm systems for all anesthesia professionals and providing the following examples of desirable content:

1. Establishing an appropriate default anesthesia alarm volume so that the alert would always be loud enough to hear, and
2. Training should include anesthesia technicians and others who could turn off phantom alarms during case turnover to reduce alarm desensitization.
3. Setting specific alarm settings appropriate for the individual patient and case could become a part of the preoperative readiness checklist.
4. Prohibiting the disabling of alarms. 
5. Choosing “process over technology:  The utility of each alarm must be assessed with the overall goals of patient safety and a reasonable work environment. ... It would be reasonable for the alarm policy to include guidelines for alarms alerts arising from related systems, such as the electronic medical record.”
6. Lowering the noise level in the OR and improving acoustics “to make alarm tones easier to detect without worsening the problem of workplace noise with louder alarms.  Use of visual alerts and the development of tactile alarms may also reduce the noise of the O.R.”
7. Increasing alarm delay where appropriate, e.g. where the pulse oximeter or arterial line will be degraded during noninvasive blood pressure measurement when it is necessary to have both these monitors on the same extremity and hence there will be a high frequency of alarms.

The value proposition for the anesthesiology group is clear enough.  Alarm fatigue leads to missed alarms; missed alarms may cause a surgical patient to deteriorate rapidly before the triggering event is noticed.  Injured patients or their families may bring and win malpractice lawsuits against the hospital contractors or employees who rendered alarms inaudible.  The providers’ reputations may suffer.  No one is better able to figure out which alarms require their intervention, and which do not, than the anesthesiologists themselves.  Why not solve a problem for the hospital and do well by doing good?

With best wishes,

Tony Mira
President and CEO