I have started a series for the Human Factors MD blog on the design, presentation, and evaluation of safety information (warnings, precautions, and contraindications) in medical device labeling.
Last week I posted the first in the series that provided an overview of the challenges medical device companies face when developing safety information for their products. Yesterday, I posted the second in the series that discussed the four components (signal word, identification of the hazard, information on how to avoid the hazard, and consequences for failing to avoid the hazard) typically included when developing safety information.
Some of the additional topics that will be covered in the series include:
- Purpose of safety information
- When safety information is required
- Challenges developing safety information
- Why safety information isn’t always effective
- Questions to ask when developing safety information
- Design considerations when developing safety information
- Issues seen in device labeling safety information