Eric Shaver

Human Factors Professional

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.

MedBuild 2016 Summit is November 9th

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MedBuild 2016 SummitOn November 9th, The Core will host the MedBuild 2016 Summit.  The second annual summit is being held at Boise State University and seeks to connect innovators, companies, and investors with the intent of growing the nascent medical technology industry in Idaho.

The two-track summit will feature a keynote address by Debra Beresini and have educational sessions focusing on investing, reimbursements, and working with startups and universities.  There will also be company spotlight presentations, where I’ll be speaking about the capabilities of Human Factors MD.  The day will end with a networking reception.

For those interested in attending, you can purchase tickets 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.

HFES 2017 Health Care Symposium is March 5th – 8th

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2017 HFES Health Care SymposiumOn March 5th – 8th, the Human Factors and Ergonomics Society (@HFES) will hold the 2017 International Symposium on Human Factors and Ergonomics in Health Care at the Sheraton New Orleans Hotel in New Orleans, Louisiana.

The keynote speaker is Rafael Grossmann, MD (@ZGJR) – “The world’s first surgeon to use Google Glass during live surgery.”

The symposium will include lectures, panels, and posters in four program tracks:

  • Consumer and Clinical Health Care IT
  • Hospital Environments
  • Medical and Drug-Delivery Devices
  • Patient Safety Research and Initiatives

It should be another great opportunity to meet, reconnect, and learn from practitioners, industry representatives, researchers, students, and the human factors staff at the FDA. Hope to see you in New Orleans!

6 Safety Questions to Ask During the Medical Device Development Lifecycle

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endoscope on a tableIn an earlier post, I identified ten questions that are important to answer when developing innovative medical devices. These are general questions that cover a wide variety of topics, without initially diving too deep. But, it’s also necessary to drill down and answer more specific safety-related questions.

Whitmore (2012) has identified six questions that are a good starting point for addressing potential risks associated with medical devices. They include:

  1. Have all the safety risks been identified for normal use of the device?
  2. Have all the safety risks been identified for foreseeable misuse of the device?
  3. To what extent are the identified risks minimized through routine design development procedures, product testing, and application of industry standards?
  4. To what extent will warnings and anticipated adherence to those warnings minimize the hazard?
  5. Could an alternative, lower-risk design be used?
  6. Given the identified risks of the product, do you, the manufacturer, consider the device to be reasonably safe?

References

Whitmore, E. (2012). Development of FDA-regulated medical products: A translational approach (2nd ed). Milwaukee, WI: ASQ Quality Press.