Presentation
Decoding Medical Device Symbols Where Space Is Limited: Lay User Comprehension of Stand-Alone Symbols on Medical Device Packaging
SessionPoster Session 1
DescriptionIn September 2016, the Food and Drug Administration (FDA or the Agency) issued a final rule revising its medical device and certain biological product labeling regulations. This revision explicitly allows for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to as “stand-alone symbols”) if certain requirements are met. One of these requirements is the stand-alone symbol must be explained in a paper or electronic symbols glossary included in the labeling for the device.
Imagine you are using a medical device and encounter a symbol on its packaging. Without a glossary at hand, would you understand its meaning? This poster delves into this very challenge, building on previous research with healthcare professionals (Seo DC, Ladoni M, Brunk E, et al. Do healthcare professionals comprehend standardized symbols present on medical device packaging?: an important factor in the fight over label space. Packaging Technology and Science, 2017;30:61–73.), and explores whether lay users can comprehend seven standardized symbols found on medical device packaging, where the glossary is not available.
The symbols selected were those that are commonly used as risk control measures on packaging and/or have been seen to cause confusion in some lay users during human factors research. The selected seven symbols (descriptions are included below) are standardized internationally, notably by the ISO 15223-1 standard. They are permitted by FDA and the EU's Medical Device Regulation (MDR).
- Caution, consult accompanying documents
- Consult instructions for use
- Use by Date (Date added to the symbol for context)
- Date of manufacture (Date added to the symbol for context)
- Do not re-use
- Temperature limitation (Temperatures added to the symbol for context)
- Do not use if packaging is damaged
Lay users were presented these symbols in a survey and asked, “Imagine you saw this symbol on the packaging for a medical device you use, what do you think it means?”. Their open-ended responses were assessed in the same way as done by Seo, et al. allowing for comparison across the data sets. Responses have been categorized into the same five levels of comprehension: correct, wrong, opposite, don’t know, or no response. Symbols receiving response rates of ≥85% in the correct category are considered successfully comprehended and responses categorized as opposite at ≥5%, symbols are considered ‘critically confusing.’
Our findings reveal which symbols are easily understood as they are and which require additional explanation. We will further explore whether additional iconography, minimal explanatory text, or full descriptions are necessary to improve comprehension.
This poster presents the results of our survey, further explorations, and recommendations for manufacturers on the most effective ways to present these symbols on their packaging.
Imagine you are using a medical device and encounter a symbol on its packaging. Without a glossary at hand, would you understand its meaning? This poster delves into this very challenge, building on previous research with healthcare professionals (Seo DC, Ladoni M, Brunk E, et al. Do healthcare professionals comprehend standardized symbols present on medical device packaging?: an important factor in the fight over label space. Packaging Technology and Science, 2017;30:61–73.), and explores whether lay users can comprehend seven standardized symbols found on medical device packaging, where the glossary is not available.
The symbols selected were those that are commonly used as risk control measures on packaging and/or have been seen to cause confusion in some lay users during human factors research. The selected seven symbols (descriptions are included below) are standardized internationally, notably by the ISO 15223-1 standard. They are permitted by FDA and the EU's Medical Device Regulation (MDR).
- Caution, consult accompanying documents
- Consult instructions for use
- Use by Date (Date added to the symbol for context)
- Date of manufacture (Date added to the symbol for context)
- Do not re-use
- Temperature limitation (Temperatures added to the symbol for context)
- Do not use if packaging is damaged
Lay users were presented these symbols in a survey and asked, “Imagine you saw this symbol on the packaging for a medical device you use, what do you think it means?”. Their open-ended responses were assessed in the same way as done by Seo, et al. allowing for comparison across the data sets. Responses have been categorized into the same five levels of comprehension: correct, wrong, opposite, don’t know, or no response. Symbols receiving response rates of ≥85% in the correct category are considered successfully comprehended and responses categorized as opposite at ≥5%, symbols are considered ‘critically confusing.’
Our findings reveal which symbols are easily understood as they are and which require additional explanation. We will further explore whether additional iconography, minimal explanatory text, or full descriptions are necessary to improve comprehension.
This poster presents the results of our survey, further explorations, and recommendations for manufacturers on the most effective ways to present these symbols on their packaging.
Event Type
Poster Presentation
TimeMonday, March 234:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices