How to Develop Better Instructions For Use (IFU) and Common Pitfalls
The instructions that come with prescription combination drug products and medical devices are called Instructions For Use (IFU). An IFU, which provides detailed patient-use instructions, is a form of product labeling that is included with medications or devices that are given to end-users, typically patients or caregivers. An IFU guides patient understanding of how to use medical devices, software as a medical device (SaMD), or combination products (e.g., insulin injector pens, prefilled syringes, transdermal patches, digital therapeutics) by outlining step-by-step instructions, safety warnings, detailed illustrations and other key information to guide proper usage and prevent harm such as injury or even death.
Similarly, an IFU may be provided to healthcare providers that are using complex medical devices, such as respirators or endoscopes. As patients, we want our healthcare providers to understand the instructions and know how to operate these devices, so that we can have safe and effective healthcare.
Note: An IFU is distinct from a Package Insert or Patient Leaflet. While Package Inserts provide comprehensive details about prescription medications or medical devices, Patient Leaflets offer simplified information aimed at patients. Both focus on medication-related information, whereas the IFU is specifically designed to ensure proper use of medical devices and the delivery system to administer drugs (e.g., combination drug/device products).
Pitfalls and considerations when developing an IFU
Design flaws in products can lead to use errors that can have serious consequences for patients and healthcare providers. Several key considerations should be kept in mind to ensure clarity, safety, and compliance.
Here are some common pitfalls some developers and stakeholders often encounter when developing an IFU, along with considerations and suggestions on how to address them and enhance the overall quality of your IFU.
Lack of Clarity
- Use clear, simple, and concise language. The IFU should be understandable by the intended user, whether they are healthcare professionals or laypersons. Whether the user is experienced or inexperienced with the device or product, they should be able to understand the instructions.
- The FDA recommends that the reading level of medical device patient labeling “should be no higher than an eighth-grade level, the average reading level among adults”1.
- Avoid inconsistent terminology, technical jargon, or overly complex terms, as this might confuse the user resulting in misuse of the product.
Inadequate Formatting and Organization
- There should be a logical sequential flow to the content of the IFU, with a clear structure that guides the user step-by-step through the setup, operation, maintenance, and troubleshooting of the product.
Lack of Warnings and Caution
- Warning labels contain critical information to reduce potential use errors and/or harm to the user. Highlight warnings and precautions prominently by using clear symbols and standardized formats to draw attention to critical information.
- Bright colors, large text, or recognizable visuals can also be used to help draw attention to warnings and cautions.
Inadequate Consideration of User Characteristics
- The IFU should be tailored to the specific needs and skills of the intended users, whether they are patients, healthcare providers, technicians, or lay people.
- The intended users of the product may have visual, cognitive, or physical impairments, which might prompt the IFU to have larger fonts, high-contrast colors, or audio versions.
Lack of User Testing
- Conduct usability testing with actual users to identify potential issues in the IFU. The IFU should be tested for clarity, ease of understanding, and effectiveness.
- Design the IFU to minimize the risk of user error. This includes providing clear instructions for complex procedures and emphasizing critical steps.
- The FDA could require a label comprehension (LC) study to be conducted for nonprescription drug products2. These studies are intended to evaluate product labeling for user comprehension, which can identify areas on the label that would benefit from clearer or simpler presentation of important information.
Poor Translation or Localization
- If the product will be used in multiple geographic regions, the IFU will need to have a clear and accurate translation that will maintain the original intent and clarity of the instructions.
Lack of Regulatory Compliance
- The IFU will need to be compliant with the regulations of the relevant authorities (e.g., FDA, EMA, or other global regulatory bodies). Each market may have specific requirements for IFU content and format.
- For approval in the U.S., applicants must “submit true representations of both the content and format of the IFU, including page layout, graphic design, and color, for FDA’s review and approval”3.
- The IFU will also need to be in compliance with labeling standards, such as IEC 62366 for usability engineering processes4.
Insufficient Visual Aids
- Clear and accurate diagrams and images should be used to support the text. These visuals should be consistent with the instructions and be easy to interpret.
Lack of Emphasis on Critical Steps
- There should be detailed, sequential, step-by-step instructions with clear headings and subheadings. It is helpful to include visuals like diagrams or photos to enhance understanding.
Printing and Packaging
- The IFU should be easy to locate, open, and read.
- An IFU’s effectiveness can be compromised if it is overlooked, hard to find, confused with other documents (i.e., the Package Insert), or printed in small, unreadable text. It should be prominently integrated into the packaging and designed for easy visibility and access.
- Avoid complex legal language in the IFU or Package Insert, as it may deter users from reading it.
Why choose Improvita for developing your IFU?
A clear, easy-to-find, and easy-to-understand IFU can minimize risks associated with human error, help users make informed decisions about their health, and improve user’s health by using the product correctly. Human Factors principles and user testing can be utilized to develop a well-designed user interface that will prevent users from making decisions based on incorrect information that could lead to harm.
Improvita has extensive experience with writing and testing IFUs for medical devices, combination drug products, and software as a medical device (SaMD). Our experience with labeling and the risks associated with the use of labeling allow us to guide our clients through the Human Factors and FDA approval process.
Developing an IFU involves many considerations, and it’s crucial to thoroughly examine these factors and regulatory requirements before pursuing a direction that may not align with FDA approval or your corporate goals.
To learn more about how we can help, please contact our team of experts. In addition, connect with us on LinkedIn!
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