Infusion Pump Safety Initiative
What is the Infusion Pump Safety Initiative?
The Infusion Pump Safety Initiative (IPSI) is a collaboration between the Food and Drug Administration (FDA), manufacturers and distributors of hospital-based infusion pumps, as well as healthcare providers. This interdisciplinary group is working to identify common issues across the infusion pump ecosystem and to pilot studies to discover potential solutions to improve patient safety.
The initial collaboration started in March 2024 with 4 infusion pump manufacturers, 4 healthcare providers, and the regulator (FDA), and expanded to include an additional 2 healthcare providers as of May 2024.
Why Infusion Pumps?
Infusion pumps are essential, complex medical devices used in hospitals across the nation. For over 15 years, infusion pump-related patient safety reports have trended upward, leading FDA to chart considerable improvement efforts to address safety issues associated with infusion pumps.
In 2010, FDA launched an initiative for infusion pump safety after the Institute for Safe Medication Practices (ISMP) publication of guidelines on safe infusion pumps. In 2014, FDA finalized guidance on infusion pump safety, following the positive outcomes from the Safety Assurance Case Pilot Program – which gathered information about industry concerns with safety assurance cases and how the FDA can provide more clarity on its development. Despite these efforts, infusion pump issues continue to be reported, warranting a new approach to safety improvements.
That’s where IPSI comes in. There are improvements to be made by bringing together providers, FDA, and hospital-based infusion pump manufacturers to collaborate about how to solve these problems.
How does IPSI Operate?
IPSI is operating a 3-phase approach. Phase 1 – the Discovery Phase – was completed in Spring 2024 and included interviews and the analysis of de-identified data. Phase 2 – the Solution Development Phase – began March 2024 and includes convenings with interdisciplinary groups to prioritize infusion pump challenges. These convenings will establish a common understanding of issues between the three stakeholder groups, prioritize existing issues, and begin to identify and evaluate pilot solutions. Phase 3 – the Pilot Phase – is where we take action to make infusion pumps safer. The first iteration targets a completion by Fall 2024, then IPSI will continue to reconvene and identify new challenges to address to begin the cycle again.
Participation in IPSI:
- Participation is voluntary
- Participants share expertise, time, and insights
- Participants are expected to spend no more than 4 hours per month in participation
- Through active participation, participants should be willing to make improvements to their workflows within IPSI
We are always looking for new participants, so feel free to fill in the interest form below and someone will reach out to you!
Interested in Learning More?
Fill out the information below:
