HTSI Submits Comments on Alarm Safety Goal
Medical device alarms are vital for ensuring proper patient care and alerting healthcare providers of life-threatening conditions. However, if improperly managed, they also can compromise patient safety. Recognizing this threat, The Joint Commission (TJC) sought stakeholder feedback earlier this year on a proposed National Patient Safety Goal (NPSG) on alarm management for critical access hospitals and hospital accreditation programs.
Over the last year, the AAMI Foundation’s Healthcare Technology Safety Institute (HTSI) has looked into numerous issues that could compromise patient safety, with alarm fatigue being a top priority. The institute submitted comments to TJC, providing some of its ideas for improving alarm system management.
In its general comments about the NPSG, HTSI emphasized that the vocabulary the safety goal used should be consistent with international standards for medical devices. “For example, saying we have an ‘alarms problem’ isn’t sufficiently clear. We may be talking about alarm signals, alarm conditions, alarm settings, or alarm systems,” the institute emphasized, adding that its comments will follow the vocabulary in the international standard IEC 60601-1-8:2006.
It referred TJC to the glossary in the AAMI publication summing up a 2011 summit on clinical alarms, convened by AAMI, the FDA, TJC, the American College of Clinical Engineering, and ECRI Institute. A free copy of that summit report is available at www.aami.org/publications/summits/index.html.
HTSI also noted that it assumed TJC was referring to audible alarm sounds in the NPSG. It recommends that the commission clarify whether it was addressing audible alarms or all types of alarm signals.
When turning to specific recommendations, the institute backed TJC’s idea of having healthcare facility leaders establish alarm system safety as a priority. However, it also suggested that institutions maintain an alarm systems committee that would report to a patient safety executive. That executive would provide guidance for alarm system management.
The alarm systems committee also would be in charge of a database of all equipment with patient-related clinical alarm sounds, HTSI suggested. Members would assign priority status—high, medium, or low—for managing these alarm sounds. The committee also would be tasked with creating and maintaining guidance for the management of and response times for alarm signals deemed critical to the patient’s life.
In response to TJC’s proposal that healthcare facilities conduct an annual inventory and identify the most important alarms to manage, HTSI noted it would be more telling to assess the number of audible alarm signals “per patient per bed per day” resulting from “inactionable conditions” as opposed to “the number of audible alarm signals that are attributable to false positive alarm conditions.”
“The number of ‘false positives’ may not deliver all of the information a healthcare organization may need to reduce the overall excess alarm noise in the environment and ultimately improve care,” HTSI said in its comments. “If false positive alarm signals are the metric that is tracked for accreditation, hospitals must widen their alarm limits to meet a number of ‘false positive’ signals. This action will just decrease the sensitivity of patient monitoring and may in fact NOT improve care at all.”
Finally, HTSI emphasized the need for documented annual staff education on alarm management policies and procedures.
HTSI was established to improve patient safety through the use, design, and manufacture of healthcare technology. It has identified four areas of initial focus: infusion systems, clinical alarms, reprocessing of reusable medical devices, and interoperability.. To read more about HTSI’s efforts to improve alarm system safety, please go to www.aami.org/htsi/alarms/index.html.
Posted: March 5, 2013