Effective management of use-related risks is crucial to ensuring the safety of your combination products. In the past, labeling and training were justifiable strategies for reducing use-related risks.
Today, users require more assurance that you have exercised due diligence to create a product that has minimal potential for use-related errors that could compromise medical treatment.
One way to eliminate or mitigate use-related risks is through incorporating human factors testing into your design, development and risk-management processes.
Managing Risks With Human Factors Testing
Human factors testing focuses on the complex interactions between users and combination products, specifically those that combine drugs or biologics with devices. It requires you to consider users, use environments and user interfaces when designing and developing your products.
Human factors testing offers a variety of methods for identifying use-related hazards.
Your choice of approaches is dependent on many factors specific to the products you are developing, such as the availability of information on use-related problems associated with similar products.
FDA Recommendations for Human Factors Testing
The FDA’s recommendations for human factors testing were set out in two draft guidances released in February 2016.
The first, entitled “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development,” defines human factors testing and outlines the process considerations for submitting human factors data for your combination products. It stresses the importance of identifying and correcting user interface design shortcomings so that use-related hazards are minimized or eliminated.
The other, entitled, “List of Highest Priority Devices for Human Factors Review,” lists the specific types of combination products for which you should include a report summarizing your human factors testing, results and conclusions in your premarket submissions.
Incorporating human factors testing early on and throughout the design process can help you avoid costly modifications or updates later. Calling in a consultant to help you with this process could be worth the investment and will guarantee use-related hazards are eliminated or reduced to the lowest practicable level.
Quality Solutions Now (QSN) specializes in combination products and can provide you with the support you need to ensure your products are safe and effective.