Presentation
MDD17 - Human Factors Actual Use Studies: A Literature Review
DescriptionThe FDA requires that human factors (HF) evaluations are conducted for combination products or medical devices to ensure safe and effective use. Human factors studies generally fall into two categories: Simulated Use or Actual Use HF. Simulated Use studies aim to assess product usability in a simulated environment, and often employ manikins, injection pads, and placebo/surrogate drug product to replicate use conditions. Actual Use HF studies on the other hand may include the use of a real medical device, administration of drug product, and/or testing in the real use environment. Simulated Use studies have been more commonly used in practice, but Actual Use HF studies may be recommended by regulatory agencies in certain scenarios. This includes cases where the device or use environment are poorly understood or difficult to simulate, and situations where actual administration of the drug product may affect users’ performance of critical tasks.
Despite the FDA’s endorsement of Actual Use HF studies, there has been confusion on what qualifies as an Actual Use HF study and what does not. The 2023 FDA Guidance on Combination Products introduced new information on Actual Use HF studies with the aim of clarifying some of this ambiguity. The main criterion that was added in the 2023 Guidance was that studies must include a human factors observer to be considered Actual Use HF. Despite this inclusion, industry could still benefit from additional examples and clarification on when Actual Use HF studies may be necessary.
In response to this new information, a literature review was performed to examine what Actual Use HF studies look like in practice and circumstances in which they have been implemented in the past. This review had three main goals:
1. Clear up ambiguity on what constitutes an Actual Use HF study in practice.
2. Understand scenarios where Actual Use HF studies have been conducted.
3. Identify trends in study design, data collection tools and methods, and clinical/HF endpoints for Actual Use HF studies.
Despite the FDA’s endorsement of Actual Use HF studies, there has been confusion on what qualifies as an Actual Use HF study and what does not. The 2023 FDA Guidance on Combination Products introduced new information on Actual Use HF studies with the aim of clarifying some of this ambiguity. The main criterion that was added in the 2023 Guidance was that studies must include a human factors observer to be considered Actual Use HF. Despite this inclusion, industry could still benefit from additional examples and clarification on when Actual Use HF studies may be necessary.
In response to this new information, a literature review was performed to examine what Actual Use HF studies look like in practice and circumstances in which they have been implemented in the past. This review had three main goals:
1. Clear up ambiguity on what constitutes an Actual Use HF study in practice.
2. Understand scenarios where Actual Use HF studies have been conducted.
3. Identify trends in study design, data collection tools and methods, and clinical/HF endpoints for Actual Use HF studies.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives