Use-Related Risk Analysis (URRA)

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).

• Since 2016, FDA expects medical device and pharmaceutical companies to provide a URRA as part of the pre-market approval process and to be iterated upon if any changes are made post-market. Yet, flaws or issues with the URRA continue to be cited, by the FDA, as one of the top reasons for submission deficiencies, additional questions, challenges, and slowing down approvals. A poorly constructed URRA can jeopardize a submission and result, minimally, in the conduct of an additional Human Factors (HF) Validation Test. 

• A well-constructed URRA should identify, characterize, and communicate a product’s use-related risk profile. Does the design prevent or mitigate those risks to an acceptable level? In some cases, the URRA may demonstrate human factors validation testing is not needed (rarely, but it happens).

• If the product presents uncontrolled / mitigated risk of harm (CDER, CBER) or serious harm (CDRH) to the users, patients, or the environment, it is likely to be challenged by the FDA and other regulatory authorities. This could result in the need for redesign of the product and/or its labeling followed by additional testing.  

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:

• Known use problems / Customer Complaints with similar or predicate devices.
• Deep knowledge of your intended users’ capabilities and limitations.
• An understanding of the actual use environment – factors that can impact device use (noise, lighting, cramped spaces, stress, distractions, urgency, etc.).
• A list of potential use-related hazards such as: delays in therapy, no therapy, under dosing, overdosing, etc. 
• A list of potential harms that occur should the hazard arise.
• Severity of the clinical harm.
• Design based mitigations to prevent / mitigate the use-related risk for critical tasks.
• Tracing to your human factors testing.

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. 

Contact Us

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.