Human Factors Testing is an essential part of developing instructions for use (IFU) that are understood and followed in Sterile Processing Department (SPD) at the healthcare facility or for users expected to clean homecare devices at home. The human factors test allows the device manufacturer the opportunity to have certified, sterile processing technicians perform the reprocessing (cleaning, disinfection, and/or sterilization) steps outlined in the device’s IFU. Subjective feedback around the performance, challenges, and understanding of the instructions is collected so the manufacturer can assess whether the instructions adequately support the users’ safe and effective processing of the device. Observation of the user’s performance of the instructions is also documented. Where needed, the manufacturer then has an opportunity to modify instructions to mitigate risks related to instruction challenges.
Documenting human factors testing in your design history file provides evidence that the needs of the intended users were considered in the development of the IFU. Providing this information as part of a premarket submission for a new device will reduce the need for requests for additional information and facilitate FDA’s review of human factors testing information contained in your submission.
Applicable Standards
- FDA Guidance – Applying Human Factors and Usability Engineering to Medical Devices
- AAMI TIR55:2014 Human Factors Engineering for Processing Medical Devices
Device Type Expertise*
- Surgical Instruments
- Orthopedics
- ENT
- Dental
- Respiratory
- Flexible/Rigid Endoscopes and Accessories
- Robotics
- Dialysis
- Homecare Devices
* Our scope of expertise is continuously expanding. A Nelson Labs expert can help develop methods and test plans for a variety of devices outside of the specifics listed above.
Study Outline
Human factors studies are custom designed based on standard hospital practices and on the manufacturer’s cleaning, disinfection, and sterilization procedures for clinical processing. Consult with one of our test experts for specific project details.
Additionally, we offer our customers the ability to utilize our representative SPD space and contracted SPD technicians to perform human factors testing using their own protocols and staff if preferred.
Testing Locations
- Salt Lake City, UT, USA
Learn more about our locations and their certifications.
Contact Us
If you have additional questions about human factors testing for reprocessing instructions, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.
