Eric Shaver

Human Factors Professional

Safety Information in Medical Device Labeling

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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

Design Best Practices for Medical Device Labeling Warnings

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Last month, I led a 90-minute webinar on Warnings and Safety Information in Device Labeling, Part 2: Design Best Practices for the AAMI University Distance Learning Program. Topics included:

  • Reviewing seven initial questions to ask before designing warnings and safety information in medical device labeling.
  • Discussing five overarching design considerations when developing warnings and safety information in medical device labeling.
  • Describing which features contribute to effective warnings and safety information for medical device labeling.
  • Identifying best practices of warnings and safety information in medical device labeling.
  • Providing resources for instructional designers to use when developing warnings and safety information for medical device labeling.

If you missed the two-part webinar, you can purchase access to the archived webinar here.

State of the Science of Medical Device Labeling Warnings

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warnings-and-safety-information-in-device-labeling-webinar

Last Thursday, I led a 90-minute webinar on Warnings and Safety Information in Device Labeling, Part 1: A Primer on the Science for the AAMI University Distance Learning program. Topics included:

  • Describing the purposes, parts, and pitfalls of warnings and safety information
  • Reviewing the state of the science of warnings and safety information, specifically as it pertains to medical device labeling
  • Examining how warnings and safety information development aligns with a typical usability engineering process
  • Explaining why warnings and safety information are not always effective
  • Discussing product liability challenges due to defective warnings and safety information

This week I will present Part 2 which will focus on medical device labeling design best practices. The webinar will be on November 10th from 11:00 am – 12:30 pm EST. If you’re interested in participating, you can register for the webinar here.

AAMI Warnings and Safety Information in Device Labeling Webinar

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aami-webinar-screenshot

On November 3rd and 10th, I’ll be presenting a two-part webinar on Warnings and Safety Information in Device Labeling for the AAMI University Distance Learning program.

Part I will introduce attendees to the science of warnings and safety information. Part II will focus on highlighting the best practices of designing and presenting warnings and safety information in device labeling. Each session will last 90 minutes and start at 11:00 am EST.

To learn more about the webinar, including how to register, visit the following link.