Evaluating Varied Label Designs for Use with Medical Devices: Optimized Labels Outperform Existing Labels in the Correct Selection of Devices and Time to Select

Abstract

PurposeEffective standardization of medical device labels requires objective study of varied designs. Insufficient empirical evidence exists regarding how practitioners utilize and view labeling.ObjectiveMeasure the effect of graphic elements (boxing information, grouping information, symbol use and color-coding) to optimize a label for comparison with those typical of commercial medical devices.DesignParticipants viewed 54 trials on a computer screen. Trials were comprised of two labels that were identical with regard to graphics, but differed in one aspect of information (e.g., one had latex, the other did not). Participants were instructed to select the label along a given criteria (e.g., latex containing) as quickly as possible. Dependent variables were binary (correct selection) and continuous (time to correct selection).ParticipantsEighty-nine healthcare professionals were recruited at Association of Surgical Technologists (AST) conferences, and using a targeted e-mail of AST members.ResultsSymbol presence, color coding and grouping critical pieces of information all significantly improved selection rates and sped time to correct selection (α = 0.05). Conversely, when critical information was graphically boxed, probability of correct selection and time to selection were impaired (α = 0.05). Subsequently, responses from trials containing optimal treatments (color coded, critical information grouped with symbols) were compared to two labels created based on a review of those commercially available. Optimal labels yielded a significant positive benefit regarding the probability of correct choice ((P<0.0001) LSM; UCL, LCL: 97.3%; 98.4%, 95.5%)), as compared to the two labels we created based on commercial designs (92.0%; 94.7%, 87.9% and 89.8%; 93.0%, 85.3%) and time to selection.ConclusionsOur study provides data regarding design factors, namely: color coding, symbol use and grouping of critical information that can be used to significantly enhance the performance of medical device labels.

Paramedic interactions with the packaging of medications and medical supplies: Poor package design has the potential to impact patient outcomes

“…The limited work that has been done to understand how packaging performs in healthcare contexts has focused on perioperative environments [ 27 , 34 , 35 ]. Many of the published findings conducted in these more controlled contexts of care indicate improvements in packaging are needed, parallel to the findings we present here.…”

“…Many of the published findings conducted in these more controlled contexts of care indicate improvements in packaging are needed, parallel to the findings we present here. Published studies using perioperative contexts have concluded that packages are: “hard to open” [ 35 , 36 ] and employ “crowded label contents” which make crucial information difficult to locate [ 27 , 34 , 35 ]. While our survey of paramedics echoed the difficulties voiced by perioperative personnel, they also expressed problems, and coping strategies, that were uniquely their own.…”

A novel strategy to optimize critical information on over the counter labels for older adults

“…Power estimates were based on our prior work investigating medical device labeling in which participants made a speeded selection between two packages given a criterion (i.e., was latex free). 32 Across trials, critical information (latex, expiration date, sterility, etc.) was highlighted or not.…”