Healthcare TecDoc in the Wild: How Users Perceive What We're Offering Them
- Presentation
- Legal Requirements and Standards
- 05. November
- 15:00 - 15:45 PM (CET)
- C5.1
-
Stephanie Schwenke
- Use-Lab GmbH
-
Torsten Gruchmann
- Use-Lab GmbH
Contents
The European Commission, ISO, IEC, FDA, MDCG and others put a lot of work into regulating and guiding the documents available to medical device users. But do users want what regulators do? We explore this question along three examples:
A longitudinal study on how healthcare professionals interact with instructions for use – what they want to see, why they use the IFUs, what formats they prefer – starts us off. (An update to data presented 2023 in our presentation "Feedback aus dem Feld.")
We then turn to a new-ish EU document: The SSCP (summary of safety and clinical performance). The MDCG 2019-9 gives us a framework for producing the document, but no information on how users will interact with it. We asked users about their expectations before and after interacting with an SSCP to better understand how the document can be improved with in the given framework.
Symbols, like documents and text are subject to regulation and guidance, but not necessarily usable. We finish with a look at the "blue man reading" symbol. Healthcare professionals in a recent study gave feedback on their interpretation of this symbol.
We end with a discussion of what the data from all three studies means practically. How can we use this knowledge to make documents that support users.
Takeaways
- Learn what healthcare professionals want in Instructions for Use (IFUs) and their preferred formats.
- Understand user interactions with the Summary of Safety and Clinical Performance (SSCP) and ways to enhance its usability.