On April 29 and 30, the FDA will hold 2 days of public hearings specifically focusing on the growing need for clear medical device labeling. (Learn more.)
Healthcare providers and consumers have similar instructional needs
Research done in preparation for these hearings makes it clear that device users—healthcare providers and consumers—seek information and instructions that are clearly written and illustrated to support ease of use.1 2 Both groups want instructions to be available in multiple formats, such as quick reference guides and DVDs, and both groups want multichannel access, including print and digital. Check out our infographic (below) to learn more.
At HealthEd, we are excited to see this issue being explored in a more public forum. Having developed and tested numerous Patient Instructions for Use documents and device training kits, we have come to the same conclusion. Users are users, whether they are providers or patients. And our experience has shown that all users want to understand quickly how to operate a device and incorporate its use into their personal or work routine. Read more about our approach in our learning paper Solutions for Success: Clear Instructions Can Benefit All Users.
HealthEd will be listening to the hearing to add to our knowledge. By doing so, we continue to turn learning into doing to benefit clients, healthcare providers, and patients.
- RTI International. Medical Device Labeling for Healthcare Practitioners Focus Group Study. https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM335197.pdf. Accessed April 1, 2013.
- National Family Caregivers Association. Consumer Survey: Feedback on Medical Equipment Labeling/Instruction Information. https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM335198.pdf. Accessed April 1, 2013.
Laura Wilson, MEd