Presentation
MDD28 - Warm Up to Clarity: Iconography in Temperature Communication on Combination Products and Medical Devices
SessionPoster Session 2
DescriptionTopic: Communicating warm-up time and temperature of a product is an important topic for pharmaceutical manufacturers who are developing medications that need to be warmed up prior to use, and for users (patients, caregivers, healthcare providers) that need to warm a product prior to use.
Application: Learnings from this research may inform the design of device labeling and instructional materials related materials related to warming up medication.
Background: Some medications are refrigerated prior to use and are then required to be left out at room temperature to “warm up” prior to drug delivery. This process is done to ensure the medication works most effectively and the injection causes the patient the least amount of pain possible. AbbVie is investigating the use of temperature sensitive labels that will indicate to the user if the combination product has reached or not reached room temperature. An assessment of existing temperature-sensitivity iconography and temperature-indicator labels in on-market products and in standards and regulations supports this investigation.
Overview of Poster Presentation:
Introduction/Problem Statement
• The poster presentation will present an evaluation of temperature-sensitivity symbols and icons, and ways of communicating warm-up time to users from standards and regulations and from on-market products.
• Communicating the temperature of a product is important to supporting users in complying with instructions to warm a product prior to use.
Materials and Methods
• Methods: Description of the review and analysis approach and the methods used for exploring iconography and “warm-up time” communication.
• Materials: Standards/Regulations/Guidance for Temperature iconography and communicating warm-up time to users may include (as applicable)
o U.S. Food and Drug Administration (FDA), 21 CFR Part 820 - Quality System Regulation
o FDA Guidance Documents: "Applying Human Factors and Usability Engineering to Medical Devices", "Content and Format of Instructions for Use for Human Prescription Drug and Biological Products"
o International Organization for Standardization (ISO): ISO 15223-1:2021 - Medical Devices - Symbols to be Used with Information to be Supplied by the Manufacturer, ISO 11607-1:2019 - Packaging for Terminally Sterilized Medical Devices, ISO 62366-1:2015 - Medical Devices - Application of Usability Engineering to Medical Devices, IEC 60601-1-6:2010/AMD1:2013 - Medical Electrical Equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
o International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): ICH Q1A(R2) - Stability Testing of New Drug Substances and Products
o United States Pharmacopeia (USP): USP <659> Packaging and Storage Requirements, USP <1079> Good Storage and Distribution Practices for Drug Products
o International Electrotechnical Commission (IEC): IEC 60417 - Graphical Symbols for Use on Equipment
o American National Standards Institute (ANSI): ANSI Z535.4 - Product Safety Signs and Labels
o Clinical and Laboratory Standards Institute (CLSI): CLSI GP05-A2 - Laboratory Design for Optimal Performance
o European Union Medical Device Regulation (EU MDR)
o IEC 62366-1 - Medical Devices - Application of Usability Engineering to Medical Devices:
o AAMI Human Factors Engineering Guidelines (HE75)
o IEEE Standards: IEEE 11073-10417 - Health informatics - Personal health device communication - Glucose meter
• Review of notable on-market products that medications and combination products that include temperature-sensitive labels, icons, or symbols in their labeling to ensure proper storage and handling
o Insulin Products: Lantus, Humalog, NovoLog
o Vaccines: Influenza vaccines, Covid-19 Vaccines from Pfizer-BioNTech, Moderna), Zostavax
o Biologics: Enbrel, Humira
o Epogen/Procrit
o Avonex
o Orencia
o Herceptin
o Nuvarings
Results
• Key findings: symbols and icons that are used on-market, guidelines for use of these symbols and icons to communicate storage and handling prior to use
• Includes visual representations of the iconography for "warm" and "cool", and any challenges identified in communicating "warm-up time" to users.
Discussion
• Interpretation of the results: what the evaluation reveals about temperature-sensitive, warm-up compliance-related labels, in terms of guiding users on when a refrigerated medication has reached room temperature and is ready for use.
o Effective symbols and icons: (example: snowflakes, thermometers)
• Implications for practice: these findings can improve our communication surrounding storage and handling prior to use, especially regarding warm-up time for combination products.
o Enhanced Instructions for Use (IFU) and User Education
o Standardization
o Design Improvements
• Challenges faced:
o Testing prior to real-world use can be challenging to simulate; clinical validation improves outcomes in real-world settings
o Icon standardization for universal user understanding
o Technical implementation of these concepts can be complicated
Conclusion
• Key Findings and Take-Home Messages
o Temperature-sensitive labels and icons, such as those indicating "warm" and "cool," are effective tools for communicating storage and handling instructions for temperature-sensitive medications.
o The research identified a variety of on-market products, including insulin, vaccines, and biologics, that already incorporate these labels effectively.
o Clear and standardized temperature-sensitive labeling can improve compliance, ensure medication efficacy, and enhanced patient comfort and safety.
• Recommendations for Future Research or Practice Changes
o To be determined based on findings but may include usability research of these labels across different user demographics and product types to identify universally understood symbols and icons, regulatory advocacy, and new technology innovation.
Application: Learnings from this research may inform the design of device labeling and instructional materials related materials related to warming up medication.
Background: Some medications are refrigerated prior to use and are then required to be left out at room temperature to “warm up” prior to drug delivery. This process is done to ensure the medication works most effectively and the injection causes the patient the least amount of pain possible. AbbVie is investigating the use of temperature sensitive labels that will indicate to the user if the combination product has reached or not reached room temperature. An assessment of existing temperature-sensitivity iconography and temperature-indicator labels in on-market products and in standards and regulations supports this investigation.
Overview of Poster Presentation:
Introduction/Problem Statement
• The poster presentation will present an evaluation of temperature-sensitivity symbols and icons, and ways of communicating warm-up time to users from standards and regulations and from on-market products.
• Communicating the temperature of a product is important to supporting users in complying with instructions to warm a product prior to use.
Materials and Methods
• Methods: Description of the review and analysis approach and the methods used for exploring iconography and “warm-up time” communication.
• Materials: Standards/Regulations/Guidance for Temperature iconography and communicating warm-up time to users may include (as applicable)
o U.S. Food and Drug Administration (FDA), 21 CFR Part 820 - Quality System Regulation
o FDA Guidance Documents: "Applying Human Factors and Usability Engineering to Medical Devices", "Content and Format of Instructions for Use for Human Prescription Drug and Biological Products"
o International Organization for Standardization (ISO): ISO 15223-1:2021 - Medical Devices - Symbols to be Used with Information to be Supplied by the Manufacturer, ISO 11607-1:2019 - Packaging for Terminally Sterilized Medical Devices, ISO 62366-1:2015 - Medical Devices - Application of Usability Engineering to Medical Devices, IEC 60601-1-6:2010/AMD1:2013 - Medical Electrical Equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
o International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): ICH Q1A(R2) - Stability Testing of New Drug Substances and Products
o United States Pharmacopeia (USP): USP <659> Packaging and Storage Requirements, USP <1079> Good Storage and Distribution Practices for Drug Products
o International Electrotechnical Commission (IEC): IEC 60417 - Graphical Symbols for Use on Equipment
o American National Standards Institute (ANSI): ANSI Z535.4 - Product Safety Signs and Labels
o Clinical and Laboratory Standards Institute (CLSI): CLSI GP05-A2 - Laboratory Design for Optimal Performance
o European Union Medical Device Regulation (EU MDR)
o IEC 62366-1 - Medical Devices - Application of Usability Engineering to Medical Devices:
o AAMI Human Factors Engineering Guidelines (HE75)
o IEEE Standards: IEEE 11073-10417 - Health informatics - Personal health device communication - Glucose meter
• Review of notable on-market products that medications and combination products that include temperature-sensitive labels, icons, or symbols in their labeling to ensure proper storage and handling
o Insulin Products: Lantus, Humalog, NovoLog
o Vaccines: Influenza vaccines, Covid-19 Vaccines from Pfizer-BioNTech, Moderna), Zostavax
o Biologics: Enbrel, Humira
o Epogen/Procrit
o Avonex
o Orencia
o Herceptin
o Nuvarings
Results
• Key findings: symbols and icons that are used on-market, guidelines for use of these symbols and icons to communicate storage and handling prior to use
• Includes visual representations of the iconography for "warm" and "cool", and any challenges identified in communicating "warm-up time" to users.
Discussion
• Interpretation of the results: what the evaluation reveals about temperature-sensitive, warm-up compliance-related labels, in terms of guiding users on when a refrigerated medication has reached room temperature and is ready for use.
o Effective symbols and icons: (example: snowflakes, thermometers)
• Implications for practice: these findings can improve our communication surrounding storage and handling prior to use, especially regarding warm-up time for combination products.
o Enhanced Instructions for Use (IFU) and User Education
o Standardization
o Design Improvements
• Challenges faced:
o Testing prior to real-world use can be challenging to simulate; clinical validation improves outcomes in real-world settings
o Icon standardization for universal user understanding
o Technical implementation of these concepts can be complicated
Conclusion
• Key Findings and Take-Home Messages
o Temperature-sensitive labels and icons, such as those indicating "warm" and "cool," are effective tools for communicating storage and handling instructions for temperature-sensitive medications.
o The research identified a variety of on-market products, including insulin, vaccines, and biologics, that already incorporate these labels effectively.
o Clear and standardized temperature-sensitive labeling can improve compliance, ensure medication efficacy, and enhanced patient comfort and safety.
• Recommendations for Future Research or Practice Changes
o To be determined based on findings but may include usability research of these labels across different user demographics and product types to identify universally understood symbols and icons, regulatory advocacy, and new technology innovation.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer