Using Third-Party Software for Alarm Notification: Risks and Recommendations
February 1, 2017 | Evaluations & Guidance
There are a number of different ways for clinicians and hospital personnel to be notified of relevant medical device alarms. The device itself is the primary means of notification, but there are several methods for supplementing the alarms to make notification more effective. These include central stations, ancillary wall-mounted displays, and software solutions that send alarms to handheld communication devices such as pagers and phones.
This article is focused on the software solutions provided by third-party vendors1involved in sending alarms to clinicians' communication devices—also commonly known as secondary or ancillary notification. This method may involve a number of different software and hardware applications from different vendors. Each of these systems may have a different regulatory status, if they are regulated at all, and their applied use in alarm notification may not align with their intended use as defined in their FDA clearance statement. This type of off-label use, in the absence of appropriate controls, could affect the timeliness of notification or delivery of alarms and open up the hospital to liability in the event of a patient safety incident.
While ECRI Institute does not recommend off-label use of these systems, we recognize that in some real-life applications, such use does occur. This may happen for a variety of reasons, including financial constraints, a facility's lack of awareness of the intended use, or unclear policies for implementation and use. The goal of this article is to raise awareness about the possible discrepancies in the intended and applied use of these systems and the risks involved with such use. For hospitals that intend to continue the off-label use of...