You have a medical device you wish to market. Function is critical, but no more so than usability. How will people use it? What kind of user failures need to be considered in documentation and testing? Are you confident your interface is intuitive and clear? After all, the effectiveness of your device relies on consistently error-free use.
FDA Guidance on “Applying Human Factors and Usability Engineering to Medical Devices” and the “List of the Highest Priority Devices for Human Factors Review” have recently been released to help improve device design and instructions for use to minimize user errors and potential harm. Device manufacturers are responding by actively initiating human factors and usability engineering to many high priority devices.
The “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff” FDA Guidance, also recently released, focuses on the criticality of applying human factors to medical devices requiring reprocessing instructions.[i] Inadequate processing of medical devices is a major concern in health care facilities. There have been several cases reported of inadequate reprocessing of reusable devices in recent years, prompting more interactive FDA oversight to ensure proper validation of user instructions.
Human factors research provides validity and value to the dynamic medical device design, manufacturing and approval processes. Proper implementation improves safety outcomes by assessing how users interact with a medical device and interface design of the device. The application of usability engineering and human factors testing and validation prior to pre-market submission is strongly recommended by FDA in order to demonstrate safe and effective device use. There are several factors to consider when assessing the necessity of a human factors study for premarket submission and while designing the study.
In this webinar, attendees will learn more about successfully applying and executing human factors and usability testing.
This register is being presented with Medical Alley. Please register here at their website.
[i] U.S. Food and Drug Administration. (2011, June 21). Applying Human Factors and Usability Engineering to Medical Devices. Guidance for Industry and Food and Drug Administration Staff. Retrieved February 03, 2016, from http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm259760.pdf
[i] U.S. Food and Drug Administration. (2016, February 03). List of Highest Priority Devices for Human Factors Review. Draft Guidance for Industry and Food and Drug Administration Staff. Retrieved February 09, 2016, from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM484097.pdf
[i] U.S. Food and Drug Administration. (2015, March 17). Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff. Retrieved February 09, 2016, from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf
Megan N. Fox, MBA, CCRP, Senior Medical Research Manager, NAMSA
Megan N. Fox, MBA, CCRP, is a Senior Medical Research Manager with NAMSA. Megan holds an MBA from Walden University, her B.S. from the University of Minnesota, and is a Certified Clinical Research Professional through SoCRA. She has over 12 years of experience in the clinical medical device industry with both small and large medical device companies across multiple therapies. Megan specializes in developing and managing IDE and post-market clinical trials globally.