A Use-Related Risk Analysis (URRA) for a medical product - as its name implies - documents the manufacturer’s analysis of the risk of harm that may arise when the intended users use the medical product (e.g., system, software, device) in the intended use environment. This living document is the backbone of any human factors program as it is a crucial for identifying needed mitigations, is key for test protocols, and ultimately provides the data needed to conduct robust residual risk analyses (an FDA expectation).
Oftentimes companies ask why there is a need to have a separate risk analysis focused on users especially as others have typically been drafted such as dFMEAs (design) and pFMEAs (process) for example. The reason is quite simple as URRAs focus on humans and we are error prone. We make mistakes or experience ‘near misses’ in our daily lives all the time with products that likely have much lower risk profiles. When we have these similar experiences with medical products, when we are often reliant on them for a therapeutic effect, the stakes are much higher.
Ideally, by design (FDA’s preferred method) and with built-in safety features, a medical product should prevent the risk of harm while providing its intended use. When risk can’t be prevented, other aspects of the product own the job - such as labeling or including user training, if applicable. The URRA should provide the reader of your analysis with the ways risk has been either prevented or mitigated, step by step, based on use errors people could make with your device.
If it sounds overwhelming, we can help.
We design well-crafted URRAs that include the following:
At Eurofins Human Factors MD, we have developed and contributed to countless URRAs. Understanding the common pitfalls, we endeavor to create files that are complete, realistic, and can be interpreted readily by all members of your team: Design Engineers, Regulatory, Quality, and Clinical/Medical staff, your vendors, and of course the FDA.
If you have a medical device or combination product that needs a URRA, or you need help wrangling your current URRA into a usable form, send us an email so we can discuss how our team can assist.