COVID Testing Kit: uFMEA Case Study
Overview
Regulatory submissions for medical devices must demonstrate that use-related risks are identified, analyzed, and mitigated. Failure to sufficiently identify these risks can lead to use errors with real patient safety consequences, as well as gaps in documentation that can delay or jeopardize market authorization. To illustrate how early human factors risk analysis helps teams identify and document these risks, we conducted an independent review using publicly available materials for a COVID-19 antigen test card.
The Challenge
At the time of its Emergency Use Authorization from the U.S. Food and Drug Administration, the COVID-19 antigen kit was intended for use by healthcare professionals. The speed of deployment and the critical role of rapid testing during a global pandemic made intuitive, unambiguous instructions essential for safe use.
Given these stakes, we conducted a use Failure Modes and Effects Analysis (uFMEA) to identify gaps in the packaging and instructional materials where a lack of clarity or explicit guidance could increase the likelihood of use errors and potential harm.
Our Approach
1. Expert review of instructional materials
Our Human Factors experts independently evaluated publicly accessible instructional materials, including the Procedure Card and Product Insert, to assess the step-by-step workflow and identify areas that could be confusing, misleading, or reliant on assumed knowledge. Our evaluation was informed by Nielsen’s 10 Usability Heuristics, with particular attention to error prevention and listing concrete steps with adequate context. Findings were consolidated to develop a detailed breakdown of the materials’ current state. This approach leveraged diverse expert perspectives, from engineering to UX, to generate insights that informed the identification of potential failure modes resulting from user action or inaction.
2. Task analysis
We identified user goals and broke those down into tasks and steps, mapping the process from preparation through result interpretation. This task analysis provided the foundation for identifying where use errors could realistically occur.
3. uFMEA
Using the task analysis, we developed a uFMEA to:
- Identify potential use errors and failure modes
- Evaluate potential harms and their severity
- Identify existing risk controls
- Assess severity and likelihood of risks using a risk level matrix
Key Insights
Our analysis demonstrated how multi-step workflows can break down, even for trained users.
Information placement can influence safe use
When critical information resides in lengthy reference materials rather than quick-reference guides, steps may be skipped or performed inconsistently.
All critical steps, no matter how simple, should be documented
The quick-reference Procedure Card documented the sample test procedure steps and result interpretation but omitted specimen collection. Gaps like these can become more significant when products are used by lay users.
Instructions should present steps in the order they must be performed
By mapping the workflow from start to finish, task analysis highlighted potential use risks that can occur before the product is even opened. When early preparation steps are separated from the main procedure, users may not recognize them as part of the workflow.
The Impact
For a product like this COVID-19 antigen test that was deployed rapidly and at massive scale, a uFMEA conducted early could have flagged critical instructional gaps before they reached end users. Our team applies this same approach to help clients surface use-related risks before usability testing begins, strengthening risk management documentation and supporting a more efficient path to regulatory submission.