Risks and Benefits

The risks and benefits of the Vocera Communications EMDAN product.

Introduction

This section of the Directions For Use (DFU) is intended to provide a thorough understanding of the effects and expectations associated with the appliance. The goal of this risk/benefit information is to aid you in deciding to use the appliance in a given situation, and to ensure that you use the appliance as labeled.

Risks and Benefits

Alarm notification is a function that is critical to patient safety and effective nursing vigilance. As the number of alarming medical devices used at the bedside has grown, concerns about effective alarm notification and response has likewise grown. For a summary of issues surrounding alarm notification, see the AAMI report on clinical alarms from the 2011 summit, convened by Association for the Advancement of Medical Instrumentation (AAMI), FDA, the Joint Commission, American College of Clinical Engineers (ACCE) and ECRI Institute.

Properly used, secondary alarm notification systems can be an effective tool in improving alarm notification responses. The following is a discussion of the risks and benefits associated with Vocera Communications Engage Medical Device Alarm Notification and similar secondary alarm notification systems.

Risks

Warning: Alerts delivered to mobile devices might be considered primary alarms by caregivers. Continue to remind users that Clinical Alert notification is secondary and always continue to monitor patients at primary patient monitors.

System Dependency Risks

The Operating Information Checkout procedure has been designed to provide users with a convenient validation process to ensure that all of the systems are working at the beginning of a shift. The use of this procedure is strongly encouraged.

An alarm may appeared to be canceled, but is not, when a patient monitor goes into a fail state and generates an alarm cancelled message. The caregiver training should include proper action instructions for alerts, and routine equipment inspection and calibration should be scheduled in the hospital.

To work properly, Vocera Engage Medical Device Alarm Notification is dependent on a number of other systems: the medical device system(s) communicating alarms, the system providing nurse to patient staff assignments, the staff-carried mobile device intended to communicate alarm notifications and responses, and the IT infrastructure (wired and wireless networks, servers, and computers) that supports all of these systems. The risks associated with each of these sub-systems will be discussed in the following sections.

Medical Device System

Vocera Engage Medical Device Alarm Notification can only annunciate alarms received from medical devices. Should the medical device system stop communicating alarms, Vocera Engage Medical Device Alarm Notification will no longer receive any alarms to communicate to staff. This risk can be mitigated by ensuring your medical device system is configured for high reliability (check with your medical device manufacturer for recommendations). To ensure that communications between the medical device system(s) and Vocera Engage Medical Device Alarm Notification are working, remote system monitoring is recommended so that staff is notified of any failures so that down-time procedures can be implemented and the failure corrected (check with your medical device manufacturer and IT department for recommendations).

Staff Assignment

The proper functioning of nurse to patient staff assignments is required to direct alarms to the responsible caregiver. Due to escalation features of Vocera Engage Medical Device Alarm Notification, alarms will be received by a caregiver on the unit, even when no nurse to patient staff assignment is made for a given patient. However, for optimal performance, it is important that nurse to patient staff assignments be made for each patient on the unit at each shift change. Staff should also be aware that receiving alarms for patients they are not assigned to cover may indicate incomplete or incorrect nurse to patient staff assignments. Should a caregiver receive alarms for patients they are not assigned to cover, a supervisor should be notified and nurse to patient staff assignments should be checked to ensure they are correct and complete for that shift.

Mobile Devices

Vocera Engage Medical Device Alarm Notification relies on properly configured and operating mobile devices (typically wireless phones) carried by staff receiving alarm notifications. Devices must be properly registered and configured within their own system (e.g., phones provisioned with their phone switch). Proper configuration is confirmed through user acceptance testing upon installation, and should be repeated by the customer, or Vocera, each time subsystems are changed in any way.

To ensure that staff receive the messages and alarms intended for them, it is critical that when staff comes on shift, that they "sign on" to their staff-carried device, and that they are registered within Vocera Engage Medical Device Alarm Notification. Staff-carried devices are wireless and only work when they are associated with the wireless network. These mobile devices provide a visual indicator (typically a stylized antenna icon, or signal strength indicator bars) that shows whether the device is connected to the network. Users should develop a habit of watching the wireless network visual indicator to know when they may be disconnected from the network and unable to receive alarms.

Vocera Engage Medical Device Alarm Notification is configured to escalate alarms that do not receive a response to back-up caregivers. When the mobile device is not configured correctly, then alerts cannot be delivered to the correct caregiver and caregiver action is delayed. This may occur when no user, or an incorrect user, is associated with the mobile device in the mobile device system, or when a hospital has multiple mobile device servers from different manufacturers and a mobile device is configured to work on the wrong mobile device system. Users should follow the mobile device OEM DFU for the mobile device system, and follow the checkout procedures in the Vocera DFU.

The Administrator should see the Vocera Installation instructions for device configuration. Built-in-escalations will alert secondary or tertiary caregivers in the event the primary or secondary caregivers fail to respond. Primary, secondary and tertiary recipients can be configured as groups. Caregivers cannot call one another if their phones are a part of a different phone system. When a hospital has multiple mobile device servers from different manufactures, a mobile device on one server cannot contact a phone on a different server. The Customer Acceptance testing before go-live should address multiple mobile device servers at the site, and should also require acknowledgement of a successful wireless site survey.

The SpectraLink OAI system has a set maximum number of access points that will not allow any additional devices to connect when all points are in use, creating the hazard where OAI network access points overload and caregiver action is delayed. It is important to limit the number of people in escalation paths when using OAI hardware, and to not assign groups to be recipients when using OAI hardware.

IT Infrastructure

Vocera Engage Medical Device Alarm Notification is dependent on properly working IT infrastructure to operate. This infrastructure includes the appliance, client computers, wired and wireless networks. Should any of these infrastructure components fail to meet Vocera Engage Medical Device Alarm Notification specifications, or fail completely, alarm notification may be delayed, interrupted, or become inoperable. It is important that IT monitoring best practices (typically with a variety of Simple Network Management Protocol (SNMP) monitoring tools) be followed to ensure that IT infrastructure continues to operate within specifications and that IT support is notified in the event of a failure so that users may adopt down time procedures and so that failures may be corrected.

Benefits

Conclusion

This completes the risks and benefits discussion.