Heuristic evaluation, when modified for medical devices, is a useful, efficient, and low cost method for evaluating patient safety features of medical devices through the identification of usability problems and their severities.
A study was carried out using four measures of effectiveness to compare product warnings that are consistent with the American National Standards Institute Product Safety Signs and Labels standard (ANSI 2535.4) to warnings that are not consistent with the standard. Inconsistent warnings were based on the format of existing product warnings. Two warnings, consistent and inconsistent, for each of ten different products were evaluated: cooking oil, trampoline, paint, dresser, airbag, seat belt, tire, sports utility vehicle, reclining seat and swimming pool. The four effectiveness criteria were judgments of noticeability, likelihood to read, understandability and likelihood of complying. Participants were 176 students with varied majors from five different universities. Results indicated higher levels of judged effectiveness for the warnings that were consistent with the ANSI standard. The differences were statistically significant for all four effectiveness measures for all ten products. While warnings that are consistent with the ANSI 2535.4 standard do not by themselves necessarily constitute an adequate warning system, these results indicate that the standard does have merit and utility and represents a good starting point in warning design.
Studies of juror decisions regarding pain and suffering awards in product liability litigation tend to show substantial variability across participants. A possible explanation is that jurors do not have a useful metric for assessing pain and suffering. A study was conducted to explore effects of providing day-rate suggestions on such decisions. Day rate refers to giving information about remaining life expectancy in days and suggesting a value to assign per day. Four scenarios describing product-related accidents were presented to 134 participants. Seven day-rate conditions were employed for each scenario: a no day-rate control; five day rates consisting of $1, $50, $100, $200 and $1000; and a multiple day rate condition that described four alternative rates. Results showed a significant day-rate effect, with higher rates resulting in higher awards. Variability of awards was greater in the no day-rate condition than in day-rate conditions with similar award levels. This finding is consistent with the notion that jurors are susceptible to monetary award suggestions. Implications for “biases” in pain and suffering award decisions are discussed.
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