The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.
Most mHealth does not have to meet the FDA requirements for application of human factors and usability engineering. Thus – to date -- the processes used to design and assess mHealth have been widely variable and developer dependent.
When considering human factors for medical devices and combination products, running a validation test with the device’s target end users (often clinicians) is universally understood as the primary requirement to meet FDA expectations. However, these activities too often are the extent of clinician involvement in the device lifecycle.
When incorporating human factors into medical device development, conducting user testing and gathering feedback from the device’s target end users is critical. To do this properly, the end user groups must be appropriately defined.
Competing priorities can potentially lead to ethical conflict between consultants and device manufacturers, especially when development is near-complete. The keys to avoiding such conflict are a mutual understanding of shared safety and usability goals, and honest communication.
Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.
Because the validation test is required human factors testing, it can be tempting to skip over preliminary human factors activities during the development process. However, this approach is problematic from both a device usability and a safety standpoint.
How do we ensure that the instructional materials are going to facilitate safe and correct product use, and not introduce the potential for error? Ideally, we want to take the same approach that should be taken for device design: Incorporate human factors evaluations early and often. However, understanding the best way to do this is not always simple.
FDA’s final human factors guidance expands upon the importance of incorporating a robust human factors approach throughout the design and development process, resulting in devices that are safe and usable for the intended user population in the intended use environment. Anyone planning to seek device approval through the 510(k) or PMA submission processes should note these 10 critical updates concerning device validation.
Healthcare is a more dangerous industry than most people realize. People are often surprised when they hear that medical error is the third leading cause of death in the United States, especially considering our expectation that healthcare is here for our benefit. Despite numerous regulations and initiatives focusing on this problem, the magnitude of medical errors persists.