Alarm Anthology: Research Highlights
The National Coalition recognized the growing alarm burden in clinical care settings, from the types of alarm signals to the challenge of making sense of alarm sounds. Coalition members conducted several research studies to overcome the challenges in clinical practice and in industry. For example:
Maria Cvach, director of policy management and integration at The Johns Hopkins Health System, clinical safety specialist at the Armstrong Institute for Patient Safety and Quality, and chair of the AAMI Foundation’s National Coalition for Alarm Management Safety, has taken an evidence-based approach to alarm management.
At The Johns Hopkins Hospital, Cvach led efforts to use data to drive alarm system improvement efforts, from gathering and analyzing quantitative data to identifying the contributing conditions to alarm burden and alarm fatigue. At the kickoff meeting of the coalition, she identified the top five knowledge gaps related to alarm management to set an agenda for researchers and practitioners:
- Lack of documentation and data to analyze reported events and near misses to understand root problems
- Lack of evidence-based rationale for the configurations of alarm settings
- Lack of understanding of the best types of alarm signals to elicit a response
- Lack of knowledge regarding who should be monitored and for how long
- Lack of understanding about the best secondary alarm notification systems
Among many other contributions to the National Coalition, Cvach also worked closely with the AAMI Foundation to create the critically important Clinical Alarm Management Compendium,
which provides the alarm management settings used by many forward-thinking hospitals.
Judy Edworthy, director of the Cognition Institute and professor of applied psychology at the University of Plymouth, UK, created and validated new auditory alarm signals using modern psychoacoustic principles for medical equipment. The new alarm sounds were designed and tested for:
- Learnability (how easy they are to learn and remember).
- Localizability (listeners’ ability to detect where the sound is coming from in 3D space).
- Performance in a more realistic, simulated environment and in other more realistic settings that use typical noise and/or involve a clinician or other participant doing other tasks at the same time.
Key medical device standards committees fast-tracked an amendment to international standards for medical electrical equipment to reflect this research. The International Technical Commission (IEC) and International Standards Organization worked jointly on Amendment 2 to IEC 60601-1-8, General Requirements for Basic Safety and Essential Performance—Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems. The amendment was approved internationally in 2020. AAMI plans to adopt this standard in 2021.
Daniel McFarlane, principal scientist at Philips Healthcare, was an alarm safety subject matter expert for military combat systems before being recruited by AAMI President and CEO Emeritus Mary Logan to refocus his career on alarm safety for healthcare. He secured U.S Department of Defense funding to conduct a foundational study on alarm safety for healthcare, and published the results in the PLoS One journal. “My organization is a world-leading manufacturer of medical devices, and it is discussing how to improve alarm safety design,” he said.
Putting Knowledge into Practice
The work of the National Coalition for Alarm Management Safety has helped Cheryl Hoerr, director of respiratory services at Phelps Health in Rolla, MO, develop “a greater appreciation of the processes outside of the critical care environment that affect clinical alarm systems.
“As a clinician,” Hoerr added, “I am essentially the ‘end user.’ I now understand that clinical alarms must be evaluated in the planning, evaluation, and purchase phases before ever being introduced to the patient care environment.” As chair of her hospital’s clinical alarms committee, she has shared this knowledge with team members, who are implementing new processes to ensure clinical alarms are considered when evaluating new equipment.
The team also has implemented a new process for intake of new equipment. Clinical Engineering assesses alarm system functioning and sets alarm signal volumes before any staff training begins. The team used resources from the National Coalition, including case studies and webinars, to develop a training program for all staff on the importance of critical alarms to patient safety, which is now a mandatory annual training.
The National Coalition’s work led the healthcare system to make alarm management safety a priority—and the coalition’s resources convinced a key stakeholder that action was necessary. This resulted in surveys, pilot projects, and improvements to alarm systems management.
“This was a significant safety initiative that benefited many healthcare institutions.”
—Mike Capuano, manager of biomedical technology at Hamilton Health Sciences in Hamilton, Ontario
Gaining an understanding of the implications of alarm fatigue from the National Coalition led to a large, multidisciplinary team to address the issues at Monument Health (formerly Regional Health) in Rapid City, SD.
“We used the toolkits as we developed a very detailed, step-by-step policy,”
—Corrina Johnson, nurse manager at Regional Health in Rapid City, SD