Reducing medical device alarms by an order of magnitude: A human factors approach.

Erik Koomen,Craig S Webster,David Konrad,Willem B De Vries,Johannes G Van Der Hoeven,Thomas Best,Diederik Ampj Gommers,Jozef Kesecioglu,Teus H Kappen

doi:10.1177/0310057x20968840

Abstract

The intensive care unit (ICU) is one of the most technically advanced environments in healthcare, using a multitude of medical devices for drug administration, mechanical ventilation and patient monitoring. However, these technologies currently come with disadvantages, namely noise pollution, information overload and alarm fatigue—all caused by too many alarms. Individual medical devices currently generate alarms independently, without any coordination or prioritisation with other devices, leading to a cacophony where important alarms can be lost amongst trivial ones, occasionally with serious or even fatal consequences for patients. We have called this approach to the design of medical devices the single-device paradigm, and believe it is obsolete in modern hospitals where patients are typically connected to several devices simultaneously. Alarm rates of one alarm every four minutes for only the physiological monitors (as recorded in the ICUs of two hospitals contributing to this paper) degrades the quality of the patient’s healing environment and threatens patient safety by constantly distracting healthcare professionals. We outline a new approach to medical device design involving the application of human factors principles which have been successful in eliminating alarm fatigue in commercial aviation. Our approach comprises the networked-device paradigm, comprehensive alarms and humaniform information displays. Instead of each medical device alarming separately at the patient’s bedside, our proposed approach will integrate, prioritise and optimise alarms across all devices attached to each patient, display information more intuitively and hence increase alarm quality while reducing the number of alarms by an order of magnitude below current levels.

Highlights

Patient monitoring systems and other medical devices are currently based on a single-device paradigm, in the sense that each device is designed to operate in isolation and to generate alarms independently at the patient’s bedside
Noise levels in hospital intensive care unit (ICU) have been recorded at a mean of 71.9 dBA, being equivalent to a busy office environment or the use of a vacuum cleaner in the room,[7] with peak noise levels of 96 dBA,[8] which is the equivalent of a propeller plane flyover at 150 metres
A paradigm shift in the way medical device alarms are designed is overdue, and healthcare professionals, device manufacturers, vendors and policymakers need to appreciate that our current patient data infrastructure is still based on a single-device safety paradigm which is obsolete in modern hospitals

Summary

Introduction

Patient monitoring systems and other medical devices are currently based on a single-device paradigm, in the sense that each device is designed to operate in isolation and to generate alarms independently at the patient’s bedside. Alarm design has changed little in this time, and safety and useability testing are conducted only at the level of the individual device, rather than considering safety and useability at the system level, comprising the many devices which are typically connected to each patient.[9] Manufacturers of these technologies currently meet their legal and regulatory requirements by displaying as much of the information considered useful to healthcare providers as possible on each device, and creating the option to alarm every single parameter.[10,11,12] such sophisticated devices typically operate independently from each other. A departure from the single-device paradigm implies that all involved parties—patients, healthcare professionals, device manufacturers, vendors and the regulatory bodies—need to work together to design safe patient alarms at a systems level This requires cooperation similar to that which occurred between pilots and engineers during the design process that led to the creation of the modern commercial aircraft cockpit. This is only a small extension of what clinicians already do in terms of accounting for the medical context and considering possible artifacts when several medical devices are in use

Conclusion

Findings

Declaration of conflicting interests