Creating clear Instructions for Use (IFUs) is crucial for ensuring the safe and accurate usage of medical devices. Yet many IFUs are plagued by complex language, poor organisation, and inadequate visuals. This can cause user confusion and safety risks. To bridge this gap, it is essential to adopt a user-centred approach that enhances readability, usability, and compliance. In this article, we will explore 11 essential tips for crafting IFUs that people will actually read, understand, and follow. This could contribute to better user safety and satisfaction.

1. Focus on clear communication by simplifying language.

• Use simple, clear, and concise language. Do not use technical jargon or complex medical terms. When technical terms are necessary, provide explanations or a glossary.

  
  

• Address the user directly by using active voice and direct instructions, such as "Press the power button" instead of "The power button should be pressed".

  
  

• Make sure there is consistency in terminology. Use consistent terms for device components and actions throughout the IFU.

2. Improve Organisation and Layout

• Arrange instructions so that they follow a logical flow that mirrors the actual process of using the product.

• Make sure there are clear headings and subheadings. Use descriptive and hierarchical headings for easy navigation.

  
  

• Use bullet points for lists and numbered steps for sequential actions to enhance readability.

• Keep adequate white space so that there is no visual clutter and improve appeal.

3. Incorporate Visuals that have an Effect

• Use clear, high-resolution images and diagrams to support complex procedures.

  
  

• Label images clearly with consistent terminology.

  
  

• Provide step-by-step visual guides, especially for assembly, operation, and maintenance.

  
  

• Use standardised medical symbols, such as ISO 15223, to aid understanding, ensuring symbols are culturally appropriate and universally recognized.

4. Ensure Complete and Accurate of Information

• Include all necessary steps, from setup to operation, maintenance, troubleshooting, and disposal.

  
  

• Clearly highlight safety warnings and contraindications using visual cues like colour coding or icons.

5. Enhance Accessibility and Usability

• Provide translations for non-English-speaking users, ensuring cultural and linguistic accuracy.

  
  

• Use large, legible fonts and accessible colour contrasts for users with low vision.

  
  

• Offer digital alternative formats, such as interactive PDFs and videos to enhance accessibility and user engagement.

6. Maintain Consistency in Terminology and Formatting

• Maintain consistent terminology throughout the document to prevent confusion.

  
  

• Use a consistent style guide for fonts, bullet points, numbering systems, and colour schemes.

7. Emphasise Safety and Troubleshooting Information

• Place critical safety warnings in prominent locations with attention-grabbing visuals.

  
  

• Include detailed troubleshooting guides for common issues, supported by step-by-step visuals or flowcharts.

8. Ensure Regulatory Compliance and Up-to-Date Information

• Regularly update the IFU to reflect new safety information, regulatory changes, or device updates.

9. Incorporate User Testing and Feedback

• Conduct usability testing with representative participants. These could include patients, caregivers, and healthcare professionals.

  
  

• Gather and incorporate user feedback for continuous improvement of the IFU.

  
  

• Apply human factors engineering principles to minimise user errors and improve safety.

10. Consider Cultural and Contextual Relevance

• Make sure content, symbols, and images are culturally appropriate and do not cause misunderstandings.

  
  

• Tailor instructions to reflect the specific usage context, such as home care versus clinical settings.

  
  

11.  Digital Enhancements

• Consider digital aids such as QR codes linking to instructional videos or augmented reality (AR) guides, as well as linking to multilingual content.

• Provide access on IFUs to user training materials, support hotlines, or digital help centres.

Improving medical device IFUs requires a user-centred approach, compliance with regulatory standards, and continuous feedback integration. By simplifying language, optimizing layout, enhancing visuals, ensuring completeness, maintaining consistency, and emphasising safety, medical device manufacturers can significantly improve usability, safety, and overall user satisfaction.

Thank you for reading!

Mark Gibson, Leeds, United Kingdom, March 2025