Designing an IFU for Usability – Not Vanity
Consider a time when you opened up a new product. Maybe you just bought an IKEA desk, and you are super excited to get to using your new “FOLUBAN.” You open the box, pull out the pieces, and a paper falls out with drawings of tiny people guiding you on how to assemble your desk.
This is probably what you think of when you hear “instructions for use.” However, for other products, and especially medical devices, these instructions actually encompass much more. The FDA defines Instructions for Use (IFU) as a part of labeling, which includes all the documentation of the product, its certifications, a guide for users on how to use the product, and much more. The goal of the IFU, and in fact all product labeling, is to provide someone with little to no understanding of the product with all the information necessary to use the device in the most safe and effective manner possible.
What is an IFU? Why does my medical device need it?
You may be thinking, that sounds like a lot of information! An IFU truly encompasses every component of the product that contributes to user experience. On top of that, IFU’s have to pass through the same regulatory controls that allow a device pass through FDA regulations.
Consider: Who will be reading this IFU?
In addition to FDA regulations, IFUs are important for the usability of the device. Different portions of the IFU face different “users.”
The first is, of course, the person who will actually use the device for its intended purpose. For example, for an ultrasound device, the person delivering the ultrasound is the operator. On top of their medical expertise, they would need to know how to operate this specific ultrasound machine.
After an ultrasound is performed, the device will need to be sterilized and stored. This may be a secondary operator who needs to know how to store the device, what conditions it needs to be stored under, how to clean the device and what types of chemicals are acceptable to use.
Another “operator” who could benefit from a well-written IFU are the suppliers of the device. They refer to the labels on the device and packaging in order to understand how the device needs to be packaged and shipped, how long disposable components can stay “on the shelf,” and which environmental conditions may effect the device while it is being shipped or stored.
All the components of the IFU feed into the usability of the device and its components, which feed into the User Experience, which feeds into the users’ ability to use the device safely and effectively.
Components of an IFU
So what goes into an IFU? There are different requirements for the components of an IFU depending on if it will be cleared (510(k)) or approved (PMA) by the FDA. This also depends on what the device actually is and does. Is it software? Surgical equipment? A home-health device?
Let’s break down some of the most important sections of an IFU:
1 | Quick Reference Instructions (QRI)
The Quick Reference Instructions or Quick Reference Guide is the part of the IFU that users will see the most. It is the instructions as most people view them: how to set up and use a device. It includes step by step instructions which can be supplemented by images or diagrams. Today, many quick reference instructions are available digitally (although you have to make a printable version available).
First Time Use and Setup
- Includes the device setup, first time use, and regular use. These instructions should be tested to ensure that they are easy to understand and that users perform tasks correctly and consistently.
User Assistance Information
- Table of contents
- General warnings and cautions
- Address/contact info for help
2 | Prescribing Information (PI)
Why would this device be used? Under what circumstances, how frequently, and by whom is the device being used? These are all aspects of the PI. Any small change in verbage in this section could designate that a device has more risk of harm to a user, and therefore could lead to more regulatory controls.
Distribution, Dosage, and Administration
- Is there a consumable or disposable element of the product that has a shelf life?
Description of the device
The level of specificity of these two phrases could determine the classification of the device:
- Indications for use:
- The conditions that might lead to the device needing to be used.
- Intended use:
- What the device labeling defines as the purpose of the device.
3 | User Manual
The user manual is kind of the “behind the scenes” use. How to clean, store, and maintain the device. All the use cases outside of the most common workflow would be contained in this section.
- Include specific instructions on how the product should be disposed or cleaned. Many cleaning products are not suitable for certain plastics and may cause the product to prematurely degrade.
Maintenance: How, Where, and by Whom
- In some cases, sterile processing departments are tested on their knowledge of the IFU. This means that the IFU has to be written for the operator of the device, and the maintenance instructions may have to be written for another user.
4 | Packaging
Shipping, Storage, Shelf life
- The packaging must undergo testing for the durability of the packaging for shipping. Other components of the labeling are important for understanding shelf life of both the packaging itself as well as its contents.
Sterile vs. Clean Packaging
- In medical devices, there are many different levels of sanitation requirements for packaging, and only some manufacturers are qualified to produce packaging that qualifies as sterile or clean because they requires a “clean room.”
Branding and Quality
- Is the packaging for a disposable or for the product itself? Will someone open this quickly and throw the packaging away, or will the packaging be for a home use device where the device may be on display at a POS?
5 | Labels
These are the actual labels that go on the product and shipping container. They may include information or symbols relating to:
- Any conditions that effect use, such as temperature, humidity, light, etc.
Handling and storage conditions
- Are there any storage conditions that may effect use? Does the device need someone to pre-program something into the device before or after storage? If it is a single-use or short term use product, what happens at its end-of-life?
Symbols and certifications
- (UL, FCC, ROHS, REACH, WEEE, etc.)
6 | Training
In-person Training? Video Training?
- Any training required in order to operate the device specifically; this could be in person or through a video.
Making a Usable IFU
Aside from the components that need to be in an IFU, there is more to consider in order to make these components usable and understandable. Design can feed into brand image, as well as the safety of the device, so let’s look at some primary considerations to make the design of the IFU usable and functional:
1 | Material Selection
Environment of Use
- Choose materials that are appropriate for the environment in which they will be used. This could mean the IFU is available in paper form as well as digitally, or it could mean that frequently referenced instructional materials are printed on a more durable material. For labeling, it could mean choosing materials that will pass through rigorous regulatory testing.
- This also refers to packaging materials. If any part of the IFU will be printed directly on the packaging, these materials must be taken into consideration as well. Where will it be stored? Do all the materials have to remain sterile?
2 | Type
Consistent Typeface and Font
- Keep text formatting consistent.
- Use typefaces that are legible. Consider the person who will be reading the instructions, will they be in a dark room? Is the IFU for a home health device for people above the age of 60 who may have impaired vision?
- Consistent and correct page and figure numbers is pivotal.
- Use a consistent hierarchy to help guide the depth of information. For example: One IFU may use a larger, bold, green text style for section titles; a slightly smaller, bold text for headings; and finally a regular weight text for the body.
Clear and Concise Writing Style
- Keep everything short and to the point, be specific.
- Make sure instructions cannot be interpreted or misinterpreted. Making “false” claims to the FDA are considered “misbranding,” as the product would not do what it says it can do.
- Say negatives at the beginning. Ex. “Do not …”, “Users should not …”, “Never …”, “…place the device in direct sunlight.”
3 | Tips and Tricks Section
- Separate the regulatory information and the information that the operators are really going to use, but make sure both are consistent and both are easy enough to understand.
- Pretty self-explanatory, but anyone who has ever used an FAQ section knows how useful they can be.
An Icon Glossary
- This should contain notable hazards and risks icons, icons specific to the IFU, and product-specific icon descriptions.
4 | Diagrams and Images
- Have a consistent style for all images and diagrams. This includes color, illustration style, line weight, etc.
- Be considerate of whether the IFU will be printed or digital.
Label Diagrams and Images
- Make sure diagrams are clearly labelled with a figure name. Extensive IFUs may even contain a figure index.
Most Instructions for Use documents are long and tedious, but it is important to include this information in order to both pass through FDA regulations and also to ensure safety and effectiveness of the medical device throughout its use.
A good IFU can mean that the device easily passes through the FDA – and makes the difference between a usable product and one that isn’t.