Presentation
Use-Related Risk Analysis of Complex Interconnected Medical Devices
Event Type
Oral Presentations
TimeThursday, June 9th11:30am - 12:00pm EDT
Location
DescriptionPreparing a comprehensive use-related risk analysis for a complex interconnected medical device can be a daunting task. Understanding important components and inputs to this process can make it more manageable. UserWise regularly supports clients in preparing their use-related risk analyses and will present our best practices and helpful hints in approaching this task in the usability engineering process.
In this presentation we will review the expectations and requirements for a use-related risk analysis based on current standards and guidances:
• 2016 FDA HF Guidance
• IEC 62366-1
• ISO 14971
We will outline our typical process for creating a use-related risk analysis at UserWise.
• Important team member involvement
• Preparation of a product workflow
• Inputs to consider during the risk analysis process (e.g., Use Specification, Known Use Problems (MAUDE, social media/web information, articles), Standards)
• Leveraging Hazard Analysis information for the product
• Documentation of hazard-related use scenarios and risks that lead to hazardous situations utilizing perception, cognition, action analysis techniques
• Setting appropriate severity scales to help identify critical tasks for usability testing
• Assessment of risks
• Implementation of Risk Control Measures based on hierarchy
• Standardization of terminology across the use-related risk analysis and other risk analyses
• Listing assumptions and reference documentation
We will share considerations for complex interconnected devices including how to determine what is “in” versus “out” of scope for the use-related risk analysis.
We will present some examples of risks to consider for different types of products and corresponding risk measures that can be considered:
Products with foot pedals
• Users or others inadvertently depressing the foot pedal while the product is positioned outside the patient or positioned incorrectly within the patient.
• Users pressing an incorrect foot pedal (e.g., product foot pedal instead of fluoro foot pedal or vice versa)
Ablation systems
• Users misunderstanding ablation zone size/shape
• Use in an inappropriate use environment (e.g., oxygen rich)
Products requiring teams
• Incorrect energy settings due to miscommunication between team members
• Inappropriate product hand-offs (e.g., breach of sterility)
Products with multiple GUIs in different locations
• Unavailability of critical information at the appropriate point of use
Finally, we will present best practices for handling common questions related to the use-related risk analysis for complex products:
• How do we consider 3rd party products that are cross-labeled or sold with the product under development?
• How do we consider 3rd party products for which a variety of brands may be used with the product under development?
• Should we create an individual risk analysis for each device within the system (e.g., a risk table for the catheter and another for the generator for an ablation system)?
In this presentation we will review the expectations and requirements for a use-related risk analysis based on current standards and guidances:
• 2016 FDA HF Guidance
• IEC 62366-1
• ISO 14971
We will outline our typical process for creating a use-related risk analysis at UserWise.
• Important team member involvement
• Preparation of a product workflow
• Inputs to consider during the risk analysis process (e.g., Use Specification, Known Use Problems (MAUDE, social media/web information, articles), Standards)
• Leveraging Hazard Analysis information for the product
• Documentation of hazard-related use scenarios and risks that lead to hazardous situations utilizing perception, cognition, action analysis techniques
• Setting appropriate severity scales to help identify critical tasks for usability testing
• Assessment of risks
• Implementation of Risk Control Measures based on hierarchy
• Standardization of terminology across the use-related risk analysis and other risk analyses
• Listing assumptions and reference documentation
We will share considerations for complex interconnected devices including how to determine what is “in” versus “out” of scope for the use-related risk analysis.
We will present some examples of risks to consider for different types of products and corresponding risk measures that can be considered:
Products with foot pedals
• Users or others inadvertently depressing the foot pedal while the product is positioned outside the patient or positioned incorrectly within the patient.
• Users pressing an incorrect foot pedal (e.g., product foot pedal instead of fluoro foot pedal or vice versa)
Ablation systems
• Users misunderstanding ablation zone size/shape
• Use in an inappropriate use environment (e.g., oxygen rich)
Products requiring teams
• Incorrect energy settings due to miscommunication between team members
• Inappropriate product hand-offs (e.g., breach of sterility)
Products with multiple GUIs in different locations
• Unavailability of critical information at the appropriate point of use
Finally, we will present best practices for handling common questions related to the use-related risk analysis for complex products:
• How do we consider 3rd party products that are cross-labeled or sold with the product under development?
• How do we consider 3rd party products for which a variety of brands may be used with the product under development?
• Should we create an individual risk analysis for each device within the system (e.g., a risk table for the catheter and another for the generator for an ablation system)?
Authors
