Understanding the need: Any machinery released in the market is packed with its IFU as this includes information for the user to understand the product’s purpose, instructions to use it correctly and also precautions when installing or using it.
IFU or Instructions for Use is prepared by the manufacturer and it gets reviewed and approved by the FDA. IFU content structure varies widely as it depends on the product’s complexity and risks that can occur while handling it. These are needed across industrial machinery, household appliances and medical device labelling industries the most.
Where is it needed?
IFUs are used mostly in the medical industry. These are prepared to instruct the user about medical devices and prescription drugs.
An ideal format for IFU which is generally accepted by the FDA would include the following in sequential order:
- Table of contents
- Glossary
- Purpose of the device
- Setup instructions
- Operating instructions
- The need to monitor device activity
- Cleaning instructions
- Storage instructions
- Information for troubleshooting
- Index
How does a good IFU help?
- It ensures safety: As safety instructions are correctly given in the IFU, users can easily understand how to install and handle the particular medical device safely. Thus, any damage or injury is avoided.
- Mitigates liability risks: Clearly laid out instructions can help in minimizing risks for the manufacturer. IFUs are prepared in a manner to ensure the user gets complete idea of handling the device.
- Less errors: With everything explained to the user, the chances of committing errors on the user’s part are considerably reduced. Be it a prescription drug or a medical device, the correct dosage or the instructions to setup the device is mentioned accurately.
- Easy to adopt for the user: IFUs are user-friendly and they provide a hassle-free experience of adopting the device. They also aid in better usage and facilitate word-of-mouth facility,
- Educational document for anyone: IFUs are essentially educational by nature and they are useful for caregivers, healthcare professionals and patients. Anyone adhering to the instructions given in an IFU will understand how to correctly use the device/ product.
- Enhances user experience: When the user can follow instructions without any difficulty, they find the device/ product easy to handle or use. This instills trust in the manufacturer as it proves how much the manufacturer commits to user experience and safety by providing the smallest details.
What to consider before preparing an IFU
Writing and organizing an IFU format and content needs a systematic process. The manufacturer should think of the following to before preparing directions or instructions for use:
- Intended use of the IFU for a device
- Engineering design process
- Methods to manage risks
- Disposal instructions (depending on the product)
- Troubleshooting guide
- Standard format of documents
- General safety
- Cleaning instructions
- Product requirements
- Legal requirements
It is not a user manual
It is important for manufacturers or authors to note that an IFU is not a user manual. While a user manual is more of a comprehensive approach to operating and maintaining a product, an IFU is focused on accomplishing a particular task. A IFU is prepared putting focus on how to perform tasks for safe and accurate handling of a medical device/ product.
Joyeeta Writes 