+1-610-668-CORE (2673) info@corehf.com

By Arathi Sethumadhavan and Patricia Anderson 

Instructions for Use (IFU) is a frequently discussed and debated topic in the Health Care Human Factors world. How to test them? What do they mitigate? What should be in them?

Often, companies despair when it comes to their device’s IFU because it seems like users never bother to read the IFU. So, what is the point in pouring time and resources into developing, testing and validating them? While it is true that many users opt not to read IFUs, they are nevertheless hugely important. “Good” IFUs versus “bad” IFUs make a huge difference not only in user experience, but also in how users perform with products. Think about your own experience with “good” and “awful” instructions. Although few people enjoy building Ikea furniture, their instructions have been appreciated because they are easy to follow, easy to use, and are multilingual because they actually include very few words at all (if any). On the other hand, most of us have experience with instructions that leave us exasperated or cause more problems than they solve – perhaps causing us to ignore the instructions all together and “wing it” (such as instructions for setting up a TV).

While “winging it” may work for setting up a TV, not following instructions, or following them incorrectly, can have disastrous effects for medical devices and combination products. With these devices, sometimes, written text is the only way to mitigate certain potential harms (for example, it may be unreasonable to print all the important storage information on a device, but the IFU can contain all that information). There are also plenty of users who do carefully read the IFUs, or refer to them when they get confused or stuck on a particular step. It is therefore the manufacturer’s responsibility to make sure that when users do read and follow the IFU, new use errors or new risks are not introduced.

At Core, we do a lot of testing as well as design of product IFUs. Some of the common issues that we have seen with IFUs include:

–Long text versus action based text  

–Instructions presented in a nonlinear fashion

–Small font

–Lack of distinction between discrete steps

–Vague content (i.e., lacking specificity or, units)

–Use of highly technical or undefined terminology

–Lack of description of the end result

–Images that do not have labeled components

–Missing images

The goals typically associated with IFU testing include:

–Can users find the information?

–Can users comprehend the information?

–Can users take the right action based on the information?

When the goal is to determine whether participants can find the information in the IFU, the following testing technique can be employed:

–Participants are asked questions (commonly referred to as knowledge task questions) which require them to refer to a section in the IFU to answer the questions (e.g., “Storage” section, “Disposal” section). This would help determine the ease with which information can be found in the IFU, including user expectations of where the information would be located (e.g., within a particular step, within a certain section) or the form in which they expect the information to be presented (e.g., picture, table, number, highlighted text) .

When the goal is to determine whether participants can understand information in the IFU, the following testing technique can be employed:

–Participants are asked to read sections of the IFU and restate in their own words what the sections convey, to determine if their comprehension of the text matches the original intent of the text.

When the goal is to determine whether participants can understand information in the IFU and are able to follow the IFU to correctly use the device, the following testing technique can be employed:

–Participants are asked to perform tasks as they read the IFU step-by-step to see if the IFU causes them to perform any task incorrectly or even omit a task.

During validation testing of medical devices, participants are not forced to read the IFU. An IFU is part of the product user interface and the IFU is available for the participant to use if they would do so in real life but they are not asked by the study moderator to refer to the IFU.

Occasionally during validation testing, a particularly important (or “critical”) task can only be assessed via a question rather than through task performance. For example, it may be critical that your device be kept out of the reach of children. However, without bringing children into the study room, it is hard to assess what an adult participant is going to do. Instead, a question may get at that key information. This question will help to evaluate whether the IFU succinctly presents information about critical tasks that users can locate and comprehend.

As parting thoughts, while it is easy to dismiss an IFU as something that is presumably thrown away by users, in the world of medical devices and pharmaceutical products, an IFU is very much an integral part of the product user interface and should be designed with the intended users in mind.