IFU – Instructions For Use

The IFU/User Manual is usually one of the last tasks performed for a medical device submission.

It should be fast and easy.

I’m David Freedman, a technical writer specializing in User Manuals/Instructions for Use for medical devices in Israel.

I’ve written hundreds of User Manuals, for CE and FDA approval. For more than 70 companies in Israel.

Maybe your company can be next?

If your medical device is of normal complexity and your design is final or close to final, I can take your IFU from concept to completion in less than a month.

Of course every device is different. I’ll be happy to discuss your medical device and how I can write the shortest, simplest UM that does the job and passes FDA/CE inspection.

You can contact me at 0526.512251, or David@IFU.co.il.

Let’s talk today!

After the User Manual has been written and approved, but before we send it as part of the submission to the FDA or CE, we have to be sure it is correct.

Remember that the User Manual is the “gold standard” for how to use a device. It  is is critical to the device’s safety and success . It must be clear, complete, and cover all device features, no matter how obscure or infrequently used. If it’s in the device, it must be in the User Manual.

But short of a full-blown usability test with a one-way mirror and several users, how can we check that the User Manual/IFU is accurate and clear?

A simple but effective approach is the User Manual Verification.

To perform a Verification, a new user (not a developer or system expert) sits down with the medical device and the User Manual — and that’s it. With no assistance from the experts who have developed the system, the user has the User Manual and only the User Manual as a step-by-step guide to using the medical device.

Does the IFU pass the test? Are the instructions correct, complete, and unambiguous? To answer these questions, the user fills out a Verification Protocol. A sample entry from a Protocol table might look like this:

Section	Function	Expected Results	Actual Results	Pass/Fail
7.7	Generate report	Add comments and see generated report.	Text says to press Save after entering a comment, but I don’t see a Save button. Instead, comments are automatically saved when you press the back button.	Fail

As you can see, Section 7.7 of the IFU fails this part of the Verification.

The Verification Report can also point out items that could use improvement. This is provided in the Recommended Improvements section, for example:

Section	Problem	Assessment
3.4 System Overview	USABILITY	There is no “What’s in the Box” section, showing the user what they see in the newly-opened box.

Of course, we can’t always test all aspects of a medical device — we certainly don’t perform a heart catherization or back surgery as part of our test! But within reasonable limits, and using phantoms or simulations where possible, we can check out most or all features of a typical medical device.

In summary, although a User Manual Verification is not a substitute for a formal usability test, it can be an excellent check that the instructions are accurate and complete, and easily understood by a qualified user who is not previously familiar with the device.

I strongly recommend a User Manual Verification as part of your normal validation process.

Borrowed from the world of software validation, a Traceability Matrix is a simple cross-reference to make sure that all User Manual-related risks are properly handled.

Let’s say that the Risk Analysis has this entry:

Mode/Hazard	Cause of Failure	Risk Reduction
Electrical	Electrical fault	User Manual instructs user to replace device

How do we know that the User Manual is correct for this risk?

One good cross-check is to create a Traceability Matrix. This is a table that tells where in the User Manual the risk is mitigated.

Mode/Hazard	Cause of Failure	Risk Reduction	Section of User Manual
Electrical	Electrical fault	User Manual instructs user to replace device	Section 4.3 Safety Instructions

In this way we can be sure that we haven’t missed any User Manual-related risks.

The Traceability Matrix is an excellent way of double-checking that the User Manual is accurate and complete. It’s one of the essential steps we take to make sure your IFU is correct and compliant.