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What is UOUP (the User Interface of Unknown Provenance) in medical software?
When preparing your UOUP usability engineering process documentation according to IEC 62366, you might encounter the term User Interface of Unknown Provenance. What is the UOUP (or User Interface of Unknown Provenance) in medical software? Today, we will answer this question.
TL;DR
UOUP (User Interface of Unknown Provenance) relates to the usability of a medical device. It originates from IEC 62366-1:2015. This standard addresses the user interface (or part of it) of a medical device developed before the standard was published. As a result, there are no records of a usability engineering process in accordance with IEC 62366-1:2015 for that component.
If you decide to use UOUP in medical software, you must follow a specific evaluation route set in IEC 62366. This route consists of five steps:
preparing use specifications,
reviewing post-production information,
identifying hazards and hazardous situations,
conducting risk control, and
evaluating residual risk.
What is UOUP?
UOUP stands for User Interface of Unknown Provenance. It comes from IEC 62366-1:2015, an international standard that “specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety”. We delve into IEC 62366 in a separate article.
IEC 62366 defines it as a “user interface or a part of a user interface of a medical device previously developed for which adequate records of the usability engineering process of this standard are not available”.What does it mean? Well, UOUP considers all parts of a user interface that were designed, developed, and commercialised before the publication of IEC 62366-1:2015 (February 2015).
As a medical software manufacturer, you might use some components which fall into the category of UOUP. Thus, you might be obliged to prepare proper documentation. So, let’s get into the examples to understand UOUP in medical software better.
Examples of UOUP in medical software
There are several cases for which medical device interfaces may fall under the definition of a UOUP, including:
Already-marketed medical devices that were not originally developed under the provision of IEC 62366:2007, nor IEC 62366-1:2015.
Already-marketed medical devices which were developed under the IEC 62366:2007 standard.
To name some specific examples of UOUP in medical software, think about the LCD screen-equipped Holter monitor with built-in software with a user interface developed under provisions of IEC 62366:2007. Another example could be software for digital imaging in radiology developed and marketed before the IEC 62366-1:2015 publication.
Warning!
To better understand the following part, you might want to learn about the general process of usability engineering. You can find out more about it in our article on IEC 62366.
How to Evaluate UOUP?
IEC 62366 states that you have to undergo a specific process of the UOUP’s evaluation. Although it’s slightly simplified compared to the regular usability engineering process, you still have to meet several requirements. What is the usability engineering process for the User Interface of Unknown Provenance?
Step 1 – Prepare use specification
As a manufacturer, you are required to establish a use specification as needed in section 5.1 of the IEC 62366. What is a part of the use specification? You should include information such as intended medical indication, intended patient population, use environment, and other things we describe in detail here.
Step 2 – Review post-production information
Once you describe your use specifications, you should review all the post-production information concerning the medical device with UOUP. This may include all the complaints or field reports for incidents or near incidents.
Once you identify cases of use error (action or lack of it leading to a result not intended by the manufacturer) that could result in hazardous situations, that information should be gathered and stored in the usability engineering file.
Step 3 – Identify hazards and hazardous situations related to usability
Next, you must review the risk analysis of your medical software, which contains UOUP, to ensure that you have identified all the hazards and hazardous situations associated with usability.
Remember
Hazards are potential sources of harm, and hazardous situations are about the conditions in which people are exposed to hazards.
Step 4 – Conduct a risk control
As you have identified all the hazards and hazardous situations connected to the UOUP, you should implement and document the risk control measures you have undertaken to reduce risks to an acceptable level.
Bear in mind that if you decide that your UOUP needs some changes, it stops being considered as UOUP and has to undergo the complete engineering usability process, which is described in the IEC 62366-1:2015, section 5.
Step 5 – Evaluate residual risk
Based on the things you have established in steps 3 and 4, you should re-evaluate the overall residual risk according to ISO 14971:2019, 7.3.
What does it mean? Residual risk remains after all the risk control measures have been applied to your medical software. It can’t be fully eliminated, thus, leading to the potential harm of the user.
To sum up
User Interface of Unknown Provenance (UOUP) can be one of the components of your medical software. You don’t have to develop your device’s interface from scratch – you can use it in its current form, as it’s already commercialised.
But it comes with its own set of risks you should keep in mind – you don’t know the entire history of this product in terms of its usability engineering. Thus, you must undergo a specific route proposed in the IEC 62366-1:2015 to adapt documentation to new standards. If you follow the information set in Annex C, you can prepare a complete usability engineering file and maintain safety.
Do you have questions about IEC 62366, MDR, or ISO 14971?
Our experts on regulatory affairs will help you through the meanders of the regulations related to medical software.
