Role of Large Clinical Datasets From Physiologic Monitors in Improving the Safety of Clinical Alarm Systems and Methodological Considerations: A Case From Philips Monitors.

Azizeh Khaled Sowan,Charles Calhoun Reed,Nancy Staggers

doi:10.2196/humanfactors.6427

Abstract

BackgroundLarge datasets of the audit log of modern physiologic monitoring devices have rarely been used for predictive modeling, capturing unsafe practices, or guiding initiatives on alarm systems safety.ObjectiveThis paper (1) describes a large clinical dataset using the audit log of the physiologic monitors, (2) discusses benefits and challenges of using the audit log in identifying the most important alarm signals and improving the safety of clinical alarm systems, and (3) provides suggestions for presenting alarm data and improving the audit log of the physiologic monitors.MethodsAt a 20-bed transplant cardiac intensive care unit, alarm data recorded via the audit log of bedside monitors were retrieved from the server of the central station monitor.ResultsBenefits of the audit log are many. They include easily retrievable data at no cost, complete alarm records, easy capture of inconsistent and unsafe practices, and easy identification of bedside monitors missed from a unit change of alarm settings adjustments. Challenges in analyzing the audit log are related to the time-consuming processes of data cleaning and analysis, and limited storage and retrieval capabilities of the monitors.ConclusionsThe audit log is a function of current capabilities of the physiologic monitoring systems, monitor’s configuration, and alarm management practices by clinicians. Despite current challenges in data retrieval and analysis, large digitalized clinical datasets hold great promise in performance, safety, and quality improvement. Vendors, clinicians, researchers, and professional organizations should work closely to identify the most useful format and type of clinical data to expand medical devices’ log capacity.

Highlights

Alarms on clinical devices are intended to call the attention of caregivers to patient or device conditions that deviate from a predetermined “normal” status
Despite the technological and healthcare improvements related to efforts to meet the National Patient Safety (NPS) goal, adverse patient events continue to occur related to alarm system design and performance, care management and the complexity of the patient care environment
Future directions are aimed at awareness, a focused effort towards the reduction of false alarms, and soliciting all constituents involved in clinical alarms to meet and develop action plans to address key issues

Summary

INTRODUCTION

Alarms on clinical devices are intended to call the attention of caregivers to patient or device conditions that deviate from a predetermined “normal” status. For a clinical alarm to be effective it must be triggered by a problem which adversely affects the patient, personnel must identify the source and meaning of the alarm, and correct the problem prior to an adverse patient event This deceptively simple set of concepts has not yet resulted in clinical alarm systems that universally meet usability and other performance objectives directed toward improving patient safety. The document includes a review of relevant literature, analyzes available adverse event databases, and presents results from a national survey containing constructive feedback from clinical users and other support staff This information offers valuable insights into current clinical alarm issues, and how clinical alarms can be improved to enhance patient safety

BACKGROUND

D3 E2 O1 O3 P1 G TOTAL

Design Standards

13. The staff is sensitive to alarms and responds quickly

Findings

13 Ensuring the Safety of Marketed Medical Devices