Achieving compliance with The Joint Commission’s Sentinel Event Alert on optimizing smart infusion pump safety with DERS.
Part Four of Four: Recommendations 7 and 8
Ivyruth Andreica PharmD, BSN, FISMP, Clinical and Medication Safety Pharmacist, Ivenix, Inc.
Robert Canfield, Director of Marketing, Ivenix, Inc.
The Joint Commission recently issued a Sentinel Event Alert regarding optimizing smart infusion pump safety with dose error reduction software (DERS).1 Currently, DERS is the standard of care for ensuring healthcare organizations safely administer IV infusions1. Best practices state that healthcare organizations should have Dose Error Reduction Software (DERS) compliance goals of at least 95% or better.2 However, many healthcare organizations implementing infusion technology do not realize all of the benefits of smart infusion pumps.
In this four-part series, we will examine each of the recommendations identified in “Sentinel Event Alert 63: Optimizing Smart Infusion Pump Safety with DERS” made by The Joint Commission. We will also share how the Ivenix Infusion System supports hospitals in improving patient safety by addressing the challenges presented by these recommendations.
Read Part One: Recommendations 1 and 2
Read Part Two: Recommendations 3 and 4
Read Part Three: Recommendations 5 and 6
Joint Commission Recommendation #7:
Identify and address human and environmental factors — such as understaffing, variation in pumps that can create confusion in controls, workflow distractions, and low lighting or glare — that contribute to smart infusion pump programming errors in your hospital1.
Industry watch groups and the FDA have identified design shortcomings of traditional infusion technologies. Some examples of infusion pump problems reported to the FDA are:
- Confusion of controls like key bounce causing extra digits to be entered
- Ambiguous trouble codes making problem isolation a challenge
- Infusion pump fails to generate an audible alarm for a critical problem, such as an occlusion3
At Ivenix, we think differently…
The Ivenix Infusion System design focuses on infusion therapy challenges with modern human factors and simplicity as core requirements. This approach resulted in a fundamentally different way of pumping fluid, interacting with clinicians, and simplifying workflows. Reducing cognitive load is achieved by utilizing one-step intuitive processes. Ivenix removes technology distractions from the workflow by minimizing reliance on product tip sheets and redundant steps. This simplification is achieved by keeping the clinical user on a single data entry path wherever possible. Workarounds are deterred by providing clinicians a simple user interface with minimal steps and consistent workflows. The usability of the Ivenix Infusion System has received industry recognition as demonstrated by the Human Factors and Ergonomics Society (HFES) 18th Annual Stanley Caplan User-Centered Product Design Award.
Figure 1: Programming screen of the Ivenix Infusion System
Key bounce is not possible with the Ivenix Infusion System large volume pump (LVP) because a cellphone-like touch screen has replaced touchpad keys. Trouble codes displayed include a complete yet concise text-based explanation of the issue in plain language to make resolving the cause quick and straightforward. Because the pump has an automated secondary IV management system, it actively pumps the secondary medication while sensing occlusions often caused by a forgotten closed roller clamp and alarms to notify the clinician. Also, with the automatic occlusion recovery, patients can straighten their arm, and the clinician does not have to go into the room to clear an occlusion alarm.
Low lighting and glare should be considered in the design of any modern infusion system. Screen visibility is optimized by backlight and brightness configurations, a high-resolution display, clear text-based screens, and configurable intelligence supporting the timed dimming of the screen to reduce glare and support a restful patient sleep period. This unique configuration can be customized in different units or departments as preferred by the hospital.
Read more about Infusion pump problems reported to the FDA.
Joint Commission Recommendation #8:
Keep the smart pump fleet safe from security threats and during downtime1.
Cybersecurity continues to be a real threat to the integrity and safety of medical devices. Multiple infusion device manufacturers have published product alerts and recalls associated with product vulnerabilities. Many infusion pumps presently in use in hospitals today lack a modern capability to address cybersecurity issues responsively. Too often, best practices in network security are relied on by medical devices as the only barrier between a poorly secured system and a nefarious actor.
At Ivenix, we think differently…
The Ivenix Infusion System is designed from the bottom up to be cyber-secure. Ivenix provides protections against attacks, active software tools to detect intrusions and respond, and the ability to apply security patches in minutes when new vulnerabilities are discovered. The Ivenix Infusion System Large Volume Pump (LVP) has no external wired connections making it impossible to connect with a cable and attack the software integrity of the pump. The pump communicates wirelessly over an encrypted connection to the proprietary Ivenix Infusion Management System (IMS) (server software) using the same protocols the banking industry uses. These protocols ensure that both the pump and server software verify their identity, and multiple types of cyberattacks are stopped. This identity verification is critically important to assure hospitals that corruption of the pump software is not possible. The system also ensures the drug library cannot be nefariously altered, and data communication from the pump to other systems like the EMR, alarm notification platforms are secure.
While other systems may use lightweight protocols to increase speed, this requirement is outdated. All modern wireless networks support more than enough speed and capacity to support encrypted wireless network connectivity.
Data stored on the Ivenix LVP (pump) and IMS (server software) are encrypted at rest and when in transit. This securing of data protects the smart pump fleet from security threats during clinical use and downtime.
The Ivenix Infusion System is the first and only infusion system fully developed and cleared under the new FDA guidance with increased scrutiny around cybersecurity.3
Read more about Top Vulnerabilities and Threats in Health IT
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1. The Joint Commission. Optimizing Smart Infusion Pump Safety with DERS. Sentinel Event Alert. 4-14; 2021; Issue 63
2. Institute for Safe Medication Practices. Guidelines for optimizing safe implementation and use of smart infusion pumps. 2020
3. Food and Drug Administration. Infusion Pumps Total Product Life Cycle (fda.gov). 2014