How to Write Comprehensive Instructions for Use for Medical Devices

The rate of chronic diseases constantly grows with early diagnosis and treatment. It all leads to an increasing number of patients undergoing diagnostics and surgical procedures. Such a rise is fueling the demand for medical devices. And medical devices, in their turn, become more sophisticated and complex; at the same time, they require users to understand specific information about such devices. Of course, ideally, the devices must be as intuitive as possible sometimes, but usually, it is not the case. Therefore, the manufacturers must rely on instructional materials to convey important information. Such materials, i.e., Instructions For Use (IFU), are considered part of the product user interface.

What Is an IFU and an eIFU for Medical Devices?

The instructions for use are delivered with every new medical device and enable careful use of the piece. Since medical devices impact patients’ safety, IFU are mandatory for use.

Traditionally IFU for medical devices have been paper-based, but the evolution of electronic technologies allowed to digitize these instructions.

Replacement of the paper-based manuals with electronic Instructions for Use (eIFU) gives certain benefits for end-users. Paper IFU is typically difficult to read, unattractive, and not user-friendly since manufacturers try to jam data onto the smallest booklets as much as possible. Considering that the booklets also include translations into different languages with the same information, the task becomes almost impossible. Plus, readers are wasting time searching for the relevant sections across multiple pages. With eIFU, layout limitations are no longer a problem as manufacturers have the space they need. The focus dislocates to improving the user experience by making the information easier to read and allowing language selections by the end-user. Read our article on medical technical writing to find out the peculiarities of being a medical writer.

Instructions for Use Types

All medical devices in the United States are regulated by the Food and Drug Administration (FDA). The FDA determines if a device is safe and effective before being sold in the U.S. The review extent depends upon the class of medical device. There are three such classes:

1. PMA (Premarket approval) IFU. Class 3 medical devices have the most rigorous review. Such review includes a medical device for life support or sustainment, a device implanted within the patient or poses a high risk of harm to the patient if it is ineffective. Examples include pacemakers, implanted prosthetics, orthopedic screws, and defibrillators. Class 3 medical devices undergo the Premarket Approval (PMA) process. A PMA is the most thorough review process with extensive testing and clinical trials, and IFU approval and review. IFU approved means that the FDA considers such IFU as sufficient for the safe use of the medical device.
2. Reviewed IFU. This type of IFU is supplied with Class 2 medical devices. This class presents a moderate risk of harm since it is similar to another device already used in healthcare facilities (a predicate device). Class 2 medical devices include infusion pumps, some surgical instrumentation, and biological indicators. Some Class 2 medical devices are used in the sterile processing department to process other medical devices. Most medical devices of Class 2 undergo the 510(k) review process. This process requires testing submission to demonstrate that the new medical device is similar to a medical device currently being sold in the U.S and as safe. Class 2 510(k) testing is typically limited to a performance comparison, and clinical trials are not usually required. The FDA confirms that all required sections have been completed and that the device is substantially equivalent to comparable products. At the same time, the FDA does not approve the IFU for the Class 2 review process; it only reviews them.
3. Manufacturer-controlled IFU. The third type of IFU applies to Class 1 medical devices, which include, for example, elastic bandages and exam gloves. Devices in this category are deemed to present minimal risk to the patient and are exempt from the FDA review. Therefore, they have the most negligible regulatory supervision. Manufacturers are expected to perform appropriate testing and develop IFU based on the most current recommendations, but the FDA does not review the supporting testing or the IFU. It is up to the manufacturer to ensure that appropriate measures have been taken.
   Regardless of the amount of oversight provided by the FDA, all medical device IFU have specific information that must be provided.

IFU Requirements for Medical Devices

There are a lot of requirements on instructions for use for medical devices. The top things to consider when writing IFU for medical devices are:

1. The intended use. It is what you as a manufacturer have to say about your medical device.
2. Standards. Use the FDA guidance documents on labeling and writing IFU according to best practices. They include the standards to look at when creating IFU.
3. The risk management process. This process aims to ensure that the medical device can be used without any undesirable risks. It covers all life-cycle phases and aspects of the medical device.
4. The usability engineering process. A subset of the risk management process that focuses on the user interface and optimizes the usability of a medical device regarding safety.
5. General safety and performance requirements contain several sections specifying information found in the IFU. For example, the manufacturer’s registered trademark, the address of its registered place of business, or an indication that the device contains or incorporates. See the complete list in Annex I of the Medical Device Regulation.
6. Legal requirements include various disclaimers relevant to the legal relationship between the customer and the legal manufacturer.
7. Product requirements. The product specification may include such design inputs as weight, operating temperatures, size, or other technical qualities.

Don’t forget to adjust the language to the relevant audience. If your users are doctors, you should use a different language than if your medical device is intended to be used by a non-specialist. Get some ideas on how to do it smoothly in our blog post – Medical Writer Guide Into Profession.

Tips for Creating IFU for Medical Devices

A focus on usability induces technical writers to spend some quality time and resources to author, review, and verify the instructions for use. Since the IFU are considered part of the product user interface, it is crucial to create worthy instructions for use. So, here are some tips that can help:

• Keep in mind your users. To effectively design instructional materials, you must learn about your users. Use focus groups, interviews, field research, contextual inquiries, and literature reviews to research your target audience. Also, consider what users already know.
• Consider the design. Usable IFU involves selecting appropriate textual content, layout, organization, font, contrast, and graphics.
• Use short, action-based sentences. One item should include one step. It helps to avoid missing steps.
• Describe the expected outcomes of actions so users can see they have performed the steps correctly.
• Be careful with technical terms. Define any obligatory technical words, and then introduce them in parenthesis.
• Identify consequences or potential risks of misuse to motivate users to comply with instructions.
• Use appropriate symbols. Symbols with ordinal meaning (e.g., “1, 2, 3”) should be used for lists where the order of action matters and apply symbols without ordinal meaning (e.g., dots) when the order of actions does not matter.
• Test your instructions. Before IFU reach the actual users, you should conduct usability testing. It can reveal issues that users may encounter when using instructional materials and identify what aspects of the IFU caused the errors of use. Such testing can help evaluate the IFU efficiency and confirm that they do not cause any errors or difficulties.

Conclusion

Medical devices can be complex and require users to understand specific storage, use, or disposal information. Although it is optimal to have the most intuitive design possible, manufacturers must rely on instructional materials to convey critical information supporting safe and effective product use.

Good luck with your technical writing!
ClickHelp Team
Author, host and deliver documentation across platforms and devices