The FDA has received reports of reusable medical devices that retained patient material, such as blood and bone, even after being cleaned. The presence of such debris can lead to infection or other adverse patient outcomes. At least some of these devices were intrinsically difficult to clean due to their design.

As part of our regulatory science program, the FDA is exploring the use of computational modeling software as a possible way to help identify device designs that facilitate better reprocessing. Although computer modeling cannot replace laboratory testing of cleaning validation methods, such software may help improve the design process.

Purpose:

The FDA encourages the development of computational modeling as a tool to assist in the device design process. This software may help manufacturers determine how debris accumulates within a specific device type, and help identify design features that predispose a device to harbor foreign materials even after reprocessing procedures.

About Computational Modeling:

Simulation tools—such as finite element analysis and computational fluid dynamics—are used in many disciplines to recreate expected and unexpected outcomes in the development stage of a range of products. When used in conjunction with real-world testing and proper validation methods, these techniques may help developers identify and correct problematic design features before they reach the marketplace and become a hazard.

How to Participate:

The FDA encourages medical device manufactures, simulation software developers, and academic institutions to collaborate and explore how simulation tools can be leveraged to help eliminate this public health concern. 

For more information, contact: Shanil Haugen at [email protected], Ryan McGowan at [email protected], or Matt Myers at [email protected].