Ivenix supports and actively participates in ISMP’s newly revised
and expanded Smart Infusion Pump Guidelines

Ivenix supports and actively participates in ISMP’s newly revised and expanded Smart Infusion Pump Guidelines

The Fresenius Kabi Pharmacy Team

The Institute for Safe Medication Practices (ISMP) held its first infusion pump summit back in 2008, examining drug libraries, implementation and clinical practice, and published the Guidelines for Safe Implementation and Use of Smart Infusion Pumps in 2009. For a decade, the guidelines became the industry’s best practices. Since then, smart pump technology has evolved and spread to nearly all U.S. hospitals.

In 2018, the second National Invitational Summit was held and focused on infrastructure, continuous quality improvement data, clinical workflow and interoperability with the electronic medical record (EMR).  ISMP’s newly revised and expanded safety recommendations in the 2019 Optimizing Safe Implementation and Use of Smart Infusion Pumps report supports the optimization of smart infusion pump technology and assist organizations in the transition to pump interoperability.

Ivenix was honored to support ISMP’s summit and actively participate in the development of key safety recommendations. Below, we explore a few of the guidelines highlighting major infusion issues – drug library updates, secondary infusion errors and free-flow conditions – and how Ivenix has addressed them.

Drug Libraries

In the last two years, several studies have highlighted the inadequacy of infusion drug libraries. A survey of almost 800 respondents found that less than 10% of nurses responded correctly when asked about the steps required to update a drug library.ⁱ  Another study showed that 31% of infusions used outdated drug libraries and 22.6% of alerts were from outdated libraries.ⁱⁱ  There was also the case of missed alerting involving the high alert medications propofol and potassium chloride, which could have resulted in patient harm.ⁱⁱⁱ

As a result of these drug library delinquencies, the new guidelines recommend the use of smart infusion pumps that are capable of prompt wireless drug library updates. ISMP is also recommending hospitals use smart pumps in which clinicians are defaulted into the dose error reduction software (DERS) and, are informed when operating outside of the safety net.

Ivenix leverages an advanced IT platform to make sure each patient infusion is safe and free of unnecessary alerts. Our team does this by ensuring all large-volume pumps and infusion systems are updated in near real time, and each clinician is defaulted into DERS, as well as continuously informed when they are infusing outside of DERS.

Secondary Infusions

There is evidence that secondary infusion errors are difficult to solve due to overreliance on the clinician. A multiphase study by the Health Technology Safety Research Team highlighted the complexities associated with secondary infusions. The team identified eight main issues and contributing factors of secondary infusions administration with the potential to lead directly to patient harm.^iv

Some of the issues identified from this study included:

• Insufficient bag head height differential;
• Unclamped secondary IV tubing;
• Continuous medications set up as a secondary medication;
• Secondary bags connected to sets that facilitate back flow into the primary infusion; and
• Secondary medication connected to a high alert primary medication infusion among others.

Two of the major contributing factors associated with these issues include inadequate nurse training and poor technology design.

ISMP recommends that healthcare organizations use automated secondary IV management systems to reduce secondary infusion errors.  ISMP is also recommending institutions employ means to prevent the interruption of certain medications such as high-alert continuous drugs and only infusing bolus infusions with a smart pump capable of doing so.

In addition to a robust drug library that ensures clinicians can only program an infusion on an inlet as intended by the healthcare organization, the Ivenix pump also uses a pneumatic pumping mechanism. Therefore, the pump does not rely on gravity to deliver a secondary infusion. Ivenix’s best in class system automates secondary IV delivery ensuring the complete delivery of a secondary infusion – including overfill. The system independently infuses from each inlet and does not rely on head height differential. The system minimizes reliance on a nurse’s memory, to avoid all the aforementioned infusion errors.

The Ivenix smart infusion pump also has an upstream occlusion alarm that annunciates when there is no secondary bag or syringe attached to the secondary port, or if the secondary infusion is clamped. The alarm cannot be disabled. This system ensures that a secondary infusion is delivered as programmed each and every time.

Free-flow Elimination

Infusion pumps have been unable to protect patients from uncontrolled flow due to poor design of the pump or administration sets. ISMP has written about free-flow issues^v and in 2017, ECRI Institute listed uncontrolled flow in the “Top 10 Technology Hazards for 2017” report.^vi  As recently as four months ago, the FDA issued Class I recalls for a smart pump and accompanying administration sets that were leading to over-infusion and free-flow conditions.

Ivenix recognized a significant root cause of free-flow conditions was the misloading of IV tubing sets due to issues such as faulty doors and confusing tubing sets. The Ivenix System has a loading feature that forces the clinician to only load the administration set cassette in one way. If a clinician attempts to load the cassette upside down or backwards, the pump lever will not close. Moreover, a clinician cannot misload a tubing set and there is no door on the Ivenix smart infusion pump that could misalign or crack, causing free-flow conditions.

Another cause of free-flow errors is removal of tubing during an active infusion. Ivenix countered that by locking the cassette during a running infusion. In order to remove the administration set, a clinician must pause or stop an infusion. The administration set contains a flow dial, which is controlled by the pump. Pausing or stopping an infusion causes the pump to automatically close the flow dial, effectively preventing free-flow conditions.

Ivenix is committed to solving today’s infusion therapy problems and we’re thrilled to champion the new ISMP guidelines on safe implementation and use of smart infusion pumps.

Is your smart infusion pump vendor closely aligned with the new guidelines?  Please reach out to them to ensure we are all keeping every patient safe.  To learn more about the Ivenix Infusion System, please contact us.

ⁱ DeLaurentis P, Walroth, T, Fritschle A, Yu D, Hong J, Yih, Y, Fuller J. Stakeholder perceptions of smart infusion pumps and drug library updates: A multisite, interdisciplinary study. Am J Health-Syst Pharm. 2019; 76:1281-1287

ⁱⁱ DeLaurentis P, Hsu K, Hoz Armenta A, Bitan Y. Investigating Delays in Updates to Infusion Pump Drug Limit Libraries. AMIA Annu Symp Proc. 2017 Feb 10;2016:490-495. eCollection 2016.

ⁱⁱⁱ Hsu,K, DeLaurentis P, Bitan Y, Degnan D, Yih Y. Unintended Patient Safety Risks Due to Wireless Smart Infusion Pump Library Update Delays. J Patient Saf 2019;15: e8–e14

^iv Cassano-Piché A, Fan M, Sabovitch S, Masino C, Easty AC, Health Technology Safety Research Team, Institute for Safe Medication Practices Canada. Ont Health Technol Assess Ser [Internet]. 2012 May; 12(16):1-132. Available at http://www.hqontario.ca/en/eds/tech/pdfs/2012/multipleinfusions1b_May.pdf

^v Institute for Safe Medication Practices (ISMP). Infusion Free-Flow Apparently Still a Risk. ISMP Acute Care Medication Safety Alert! Jun 14 2007. Available at https://www.ismp.org/resources/infusion-free-flow-apparently-still-risk

^vi ECRI Institute. EXECUTIVE BRIEF Top 10 Health Technology Hazards for 2017. Health Devices Nov 2016. Available at https://www.ecri.org/Resources/Whitepapers_and_reports/Haz17.pdf