Infusion pumps are essential to safe patient care, yet even the most rigorously tested devices can encounter unexpected challenges once they reach real-world clinical environments. A scenario involving a mid-sized infusion pump manufacturer highlights just how quickly post-market usability issues can escalate—and how human factors expertise can help identify and resolve them. In this case, dosing errors and alarm overrides began surfacing in hospital settings despite the device meeting all pre-market requirements, underscoring the persistent gap between laboratory-based testing and real-world clinical use.

Scenario Overview

The manufacturer received multiple reports indicating dosing errors and alarm overrides in hospital settings. While the devices met all pre-market testing requirements, clinicians were encountering challenges that were not detected during laboratory-based tests. Pressure from regulatory agencies and frontline healthcare providers, together with strong internal direction from senior leadership, prompted the manufacturer to swiftly identify and address the causes of the dosing errors.

Infusion pumps, widely used in hospitals to deliver precise volumes of medication over specific timeframes, are inherently complex devices. They interact directly with clinical workflows, require precise programming, and often involve multiple safety features such as drug libraries, dose limits, and alarms about situations such as occlusions, air in the line, or low batteries. When even a single step in the workflow is bypassed or performed incorrectly, the risk of an adverse event increases. In this scenario, repeated post-market reports raised concerns about device usability in real-world clinical settings, highlighting the gap between laboratory-based pre-market testing and everyday hospital use.

Challenges Identified

Post-market issues often arise from how devices interact with real-world clinical workflows and environments. In this scenario, several contributing factors were identified:

Alarm fatigue: Repeated alarms, some false or non-critical, caused delayed responses, increasing the risk of dosing errors.
Drug library misuse: Because it did not adequately support their workflows, clinicians occasionally bypassed or misused the built-in drug libraries, increasing the chance of overdose or underdose.
Regulatory pressure: The manufacturer needed a clear understanding of usability concerns to support post-market follow-up, risk management, and internal quality system requirements.

These challenges reflect a common post-market problem: even devices that undergo pre-market testing can exhibit usability problems once deployed in complex clinical environments. Understanding how device interactions with real-world environments and clinical workflows contribute to adverse events is critical to resolving existing problems.

A Human Factors Approach to Reducing Risk

To respond effectively, the manufacturer partnered with human factors experts to evaluate the infusion pump through a post-market lens—grounded in clinical reality rather than laboratory testing alone.

Step 1: Analyze real-world interactions
The team began by mapping typical clinical workflows to identify where errors were most likely to occur. They examined infusion pump use from initial programming to medication delivery and monitoring, identifying points where missteps, workarounds, or bypasses could contribute to adverse events. This step provided a clear picture of how the device functions in a real-world context, highlighting potential risks that were not evident during pre-market testing.

Step 2: Validate use cases with clinicians
To ensure they understood actual practice, and real-world constraints the team engaged frontline clinicians through advisory boards and focus groups. Clinicians shared insights on pain points, workarounds, and areas where the current device design could lead to errors. These clinician inputs guided modifications to better support existing workflows and work environment constraints, enabling safer use.

Step 3: Provide actionable insights
The human factors engineering (HFE) analysis informed clear, actionable findings for the manufacturer, including:

Clinician perspectives to guide safer designs that better support workflows.
Comprehensive HFE reports, summative study protocols, and use-error risk analyses.
Objective evidence to support regulatory submissions, post-market surveillance, and related quality system processes.

By framing the analysis in terms of real-world constraints and clinician workflow challenges, the manufacturer was able to make evidence-based decisions about where to focus corrective actions on usability improvements.

Step 4: Support regulatory readiness
The insights developed through HFE activities helped the manufacturer document the rationale behind design change decisions and safety mitigations, supporting regulatory expectations, and internal quality assurance (QA) review. The independent HFE evaluation provided objective evidence and analysis that informed corrective and preventative actions (CAPAs), post-market submissions, and internal follow-up processes.

The Outcome

With a structured human factors approach, the manufacturer achieved measurable improvements:

Reduced risk of recurring errors: By identifying and addressing usability problems, the manufacturer minimized risks of continued dosing errors and alarm mismanagement.
Stronger post-market responses: Independent HFE insights helped the manufacturer respond to reported safety events with a clear plan to address usability issues.
Improved clinician confidence and adoption: Clinician input guided device training and intended workflow redesigns, improving trust in the device.
More efficient internal processes: By leveraging independent resources, the manufacturer supplemented internal HFE staff and accelerated post-market review and mitigation.

This scenario demonstrates how systematic post-market human factors evaluation can translate into practical improvements for infusion pump safety.

Key Takeaways

This scenario highlights several important lessons for manufacturers navigating post-market safety challenges:

Post-market issues often stem from device design problems not discovered during laboratory-based validation tests.
HFE analyses provide actionable insights that reduce risk, inform mitigation strategies, and improve overall device usability.
Independent analysis informs credible post-market strategies and strengthens internal QA processes.
Manufacturers can proactively translate insights from HFE analyses into safer, more effective products, enhancing adoption and regulatory confidence.

Conclusion

Post-market safety challenges often stem from real-world complexities that traditional testing cannot fully capture. By applying rigorous human factors methods, manufacturers can proactively reduce risks, strengthen regulatory readiness, and enhance clinician trust. If your organization is looking to improve device usability, address post-market safety events, or build a more resilient product strategy, our team is ready to help.

Learn more about Med Safety Board’s services and how our HFE experts can support your post-market safety efforts.