Presentation
MDD3 - “The Pharmacy Would Never Give Me an Expired Product!”: Checking the Expiration Date as an Observation Task and Managing Residual Risk
SessionPoster Session 1
DescriptionChecking a combination product or medical device for its expiration date has undoubtedly been assessed in human factors (HF) studies tens of thousands of times in the past two decades. Manufacturers and HF consultants understand why – failure to check an expiration date can have far-ranging consequences including lack of drug efficacy to patient exposure to toxic substances, equipment failure due to the breakdown of device plastics, or loss of sterility. However, to manufacturer’s and consultant’s chagrin, whether a patient chooses to check an expiration date is often a matter of personal preference, current habits, or beliefs about the importance of expiration dates. Could it be that observing whether or not people check the expiration date has been “human factored” to death? Is there anything to gain from continuing to assess this observation task in human factors summative studies? What can manufacturers do to encourage users to check their product’s expiration date?
The current research consists of retrospective review of several human factors studies in which checking the expiration date was assessed as an observation task. Studies conducted by Core Human Factors, Inc. in the past 13 years were included in the review. Assessments for both combination products and medical devices were gathered and analyzed. The research first categorizes and describes success or failure to check the expiration date by user group (e.g., do healthcare professionals check the expiration date more often than lay adults?) and device type (e.g., are participants more likely to check the expiration date for a combination product than a medical device?) Root causes for failure to check were analyzed and categorized to understand whether the failure was due only to a participant’s preferences, habits, or beliefs or whether the product user interface contributed to failure to check. The current research seeks to understand what user interface design knowledge, if any, manufacturers and consultants gain by continually assessing this task.
If checking the expiration date is considered a critical task in a product’s use-related risk analysis, it should be assessed in HF studies. However, if a percentage of the population will always fail to check regardless of the product’s user interface, can manufacturers leverage other HF study assessments to build a strong case for acceptable residual risk? This research provides suggestions for manufacturers and consultants to better understand participants’ understanding and comprehension of the expiration date, regardless of spontaneous checking behaviors.
The current research consists of retrospective review of several human factors studies in which checking the expiration date was assessed as an observation task. Studies conducted by Core Human Factors, Inc. in the past 13 years were included in the review. Assessments for both combination products and medical devices were gathered and analyzed. The research first categorizes and describes success or failure to check the expiration date by user group (e.g., do healthcare professionals check the expiration date more often than lay adults?) and device type (e.g., are participants more likely to check the expiration date for a combination product than a medical device?) Root causes for failure to check were analyzed and categorized to understand whether the failure was due only to a participant’s preferences, habits, or beliefs or whether the product user interface contributed to failure to check. The current research seeks to understand what user interface design knowledge, if any, manufacturers and consultants gain by continually assessing this task.
If checking the expiration date is considered a critical task in a product’s use-related risk analysis, it should be assessed in HF studies. However, if a percentage of the population will always fail to check regardless of the product’s user interface, can manufacturers leverage other HF study assessments to build a strong case for acceptable residual risk? This research provides suggestions for manufacturers and consultants to better understand participants’ understanding and comprehension of the expiration date, regardless of spontaneous checking behaviors.
Event Type
Poster Presentation
TimeMonday, March 314:45pm - 6:15pm EDT
LocationFrontenac Foyer
Digital Health (DH)
Simulation and Education (SE)
Hospital Environments (HE)
Medical and Drug Delivery Devices (MDD)
Patient Safety and Research Initiatives (PS)