Teen’s death, $6 million settlement put the spotlight on alarm fatigue

The Joint Commission issues ‘Sentinel Event Alert,’ considers NPSG

(Editor’s note: This is part one of a two-part series on alarm fatigue. In this issue we discuss how to reduce alarm fatigue. In next month’s issue, we tell you how The Johns Hopkins Hospital reduced alarms up to 74% in some areas.)

The death of a 17-year-old female at a surgery center and the resulting $6 million malpractice settlement due to allegations that staff were not alerted by alarms, along with a just-released “Sentinel Event Alert” on alarm fatigue, has outpatient surgery managers reviewing their policies and their practices.

High school junior Mariah Edwards had a routine tonsillectomy in March 2012. Afterward, Mariah was placed in the postanesthesia care unit (PACU) and given fentanyl. Over the next 25 minutes, her respiratory condition rapidly worsened and went unnoticed by nurses, according to a statement from the firm Ross Feller Casey in Philadelphia.1

The nurses failed to perform required assessments and were not warned by the equipment monitoring Mariah’s vital signs because it was not set properly and was muted, the law firm said. “Sadly, as a result of these oversights and others, Mariah sustained significant brain damage due to oxygen deprivation and died 15 days later,” the firm said.

Patients should ask questions not only about the procedure, but also about recovery room care, said Joel J. Feller, the family’s attorney and a founding partner at Ross Feller Casey, in a statement. The firm has provided a list of such questions on its website at http://www.rossfellercasey.com/post-op-checklist.

The firm said that as a result of Mariah’s death, the surgery center imposed policy changes, including the following:

• Each patient who has received IV narcotics in the PACU must be assigned one-on-one nurse care.

• Patient monitoring equipment may no longer be muted.

• Curtains restricting the view of the patient can no longer be drawn.

• There must be a dedicated charge nurse to oversee nurse staffing and patient flow in the unit.

ECRI Institute, an independent, nonprofit institute that researches and assesses best practices in patient safety and quality, has called clinical alarms the no. 1 health technology hazard of the year. Over a recent four-year period, a Food and Drug Administration (FDA) database shows that there were more than 560 alarm-related deaths. The Joint Commission’s (TJC’s) sentinel event database includes reports of 80 alarm-related deaths and 13 serious alarm-related injuries during a similar period. TJC has just released on Sentinel Event Alert on medical alarm safety and has proposed a National Patient Safety Goal (NPSG) to address the issue.

In an interview with Same-Day Surgery, Paul Schyve, MD, senior advisor for healthcare improvement at TJC, said, “The danger specifically of alarm fatigue is that alarms that are important to the patient’s safety are ignored. The ignoring may occur because they’ve literally been shut off, or may not be loud enough to be heard, turned down because of volume, or the number of alarms going off, they literally — even though they are going off loud enough to be heard — are ignored because so many alarms going off at the same time.”

In releasing the recent “Sentinel Event Alert,” TJC said, “Pre-set or default settings also may cause problems because the device sounds a warning even when no action or decision by a caregiver is required. Rather than calling attention to a patient’s needs, these settings may distract caregivers.” TJC, along with the Association for the Advancement of Medical Instrumentation (AAMI), ECRI Institute, and American College of Clinical Engineering, held a summit in 2011 to address concerns about medical device alarms. (For more information on the summit, see Resources at end of this article.)

The solution requires actions related to “people, processes, and technology,” TJC says. “By making alarm safety a priority, lives can be saved,” it says.

Steps to reduce alarm fatigue from TJC

TJC’s “Sentinel Event Alert” recommends that healthcare organizations take the following actions, which it says correspond with recommendations made by AAMI and ECRI Institute:

• Ensure that there is a process for safe alarm management and response in areas identified by the organization as high risk. Seek input from patient care providers, healthcare engineers, risk managers, and information technology professionals, to establish policies and processes for alarm safety that include the regular review of trends and patterns that reveal improvement opportunities.

A multi-disciplinary task force or an alarms system safety committee can take a “deep dive” approach to alarm systems in your hospital, suggests Mary K. Logan, JD, CAE, president of the AAMI. “On the task force or committee, include nursing, clinical engineers/biomedical equipment technicians, individuals that can analyze alarm data, risk managers, device vendors, and patient safety officers,” Logan says.

Support from administrators, department heads, and other upper management personnel is critical, she says.

• Prepare an inventory of alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions, and identify the default alarm settings and the limits appropriate for each care area.

Schyve says, “What we recommended is that they, number one, look at where all the alarms are they use in high risk areas, essentially preparing an inventory that are used in high risk areas for high risk conditions, also for high risk populations and, finally, for high risk individual patients.”

These are clinical judgments that should be made by clinical providers, he emphasizes.

• Establish guidelines for alarm settings on alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions. Include identification of situations when alarm signals are not clinically necessary. Organizations should consider how to reduce nuisance alarm signals and to determine whether critical alarm signals can be heard in patient care areas.

According to TJC, between 85% and 99% of alarm signals don’t require clinical intervention. In an ambulatory surgery center, there may be a risk that alarms are going off that alert staff to something that isn’t a problem, so as a result, staff may begin to ignore the alarms, Schyve says. You must set priorities in terms of which alarms staff need to pay attention to, he says.

For example, if a heart rate alarm goes off, staff may know that the heart rate might drop for a couple of minutes, then return to normal, so they don’t need to rush into the room to resolve the issue. Does that mean you’ve set the alarm to be too sensitive so that it’s going off more than it should? Yes, Schyve says, however, it points to the need for clinical judgment “which alarms are important, and what should be the parameters for a particular alarm.” When you use default parameters for every patient, regardless of the health of the patient or the procedure, some alarms might be too sensitive, while others might not be sensitive enough for particularly patients, he says. “It’s not that one would expect physicians would order specific alarm limits for each patient individually,” Schyve says. “Surgeons and nurses sit down together and decide what guidelines, under what circumstances should we use alarms and change from default levels.”

When the members of the task force or committee have a clear understanding of the problem, they should state the facility’s goal, such as “eliminate X percent of alarm signals throughout the facility,” Logan says. “Share your goals with hospital staff, administration, department heads, everyone,” she says. “Make sure they are all on board.”

Collect baseline data from your network or direct observations, Logan advises. She suggests reviewing the data collection recommendations in AAMI’s white paper titled “Using Data to Drive Alarm System Improvement Efforts, The Johns Hopkins Hospital Experience.” (See “The Safety Innovations Series” in Resources at end of article.)

“Share the baseline data with unit managers, and work with unit managers in developing a plan of action — e.g., re-setting alarm parameters,” she says.

• Establish guidelines for tailoring alarm settings and limits for individual patients.The guidelines should address situations when limits can be modified to minimize alarm signals and the extent to which alarms can be modified to minimize alarm signals. Inspect, check, and maintain alarm-equipped medical devices to provide for accurate and appropriate alarm settings, proper operation, and detectability. Base the frequency of these activities on criteria such as manufacturers’ recommendations, risk levels, and current experience.

Develop alarm system policies, such as who sets alarm parameters and who can change them, Logan says.

“Compare the data after implementation of the action plan to the baseline data to find improvements or benchmarks toward your goal,” Logan says.

• Provide training and education for all clinical care team members on safe alarm management and response in high-risk areas.

“Create new education and training programs on alarms systems for staff, and assess these programs on a regular basis for effectiveness,” Logan advises.

The Johns Hopkins Hospital reduced the number of non-critical bedside alarms in some areas of the hospital up to 74%. A vendor was responsible for the training, says Maria Cvach, MSN, RN, CCRN, assistant director of nursing clinical standards at Johns Hopkins and leader of the hospital’s alarm improvement efforts since 2006.

In addition, “We have alarm champions on each unit who are knowledgeable,” Cvach says. The hospital relies on unit-based experts to determine what kinds of training they need in their area, she says.

• Share information about alarm-related incidents, prevention strategies and lessons learned with organizations such as AAMI, ECRI Institute, the FDA and TJC.

“Recognize the solutions and resolution of alarms system management improvement as long-term and ongoing, not a one-time thing,” Logan says.

Reference

1. PRNewswire. 17-year-old girl’s tragic death after routine tonsillectomy leads to post-operative care changes. Feb. 5, 2013. Accessed at http://prn.to/11L3OYO.

Resources

• The Joint Commission’s “Sentinel Event Alert” on alarm fatigue can be accessed at http://www.jointcommission.org. Under “Topics,” select “Sentinel Event – Sentinel Event Alert.”

• Read a summary of the 2011 summit on alarm fatigue, at www.ismp.org/sc?id=170. Inside this publication there is a list of “top 10 things . . . .” that healthcare facilities can do now to improve alarm systems.

• The AAMI “Horizons” 2011 Issue focusing on alarm systems can be accessed at http://www.aami.org/publications/AlarmHorizons/index.html.

• AAMI has a collected of white papers, collective called “The Safety Innovations Series,” that highlight recommended actions, steps, pathways, and analytical tools for alarm system solutions. Web: http://www.aami.org/htsi/safety_innovation.html.