Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases

BACKGROUND: Medical device adverse event reporting is an essential activity for mitigating device-related risks. Reporting of adverse events can be done by anyone like healthcare workers, patients, and others. However, for an individual to determine the reporting, he or she should recognize the current situation as an adverse event. The objective of this report is to share observed individual differences in the perception of a medical device adverse event, which may affect the judgment and the reporting of adverse events. METHODS: We trained twenty-three participants from twelve Asia-Pacific Economic Cooperation (APEC) member economies about international guidelines for medical device vigilance. We developed and used six virtual cases and six questions. We divided participants into six groups and compared their opinions. We also surveyed the country's opinion to investigate the beginning point of ‘patient use’. The phases of ‘patient use’ are divided into: 1) inspecting, 2) preparing, and 3) applying medical device. RESULTS: As for the question on the beginning point of ‘patient use,’ 28.6%, 35.7%, and 35.7% of participants provided answers regarding the first, second, and third phases, respectively. In training for applying international guidelines to virtual cases, only one of the six questions reached a consensus between the two groups in all six virtual cases. For the other five questions, different judgments were given in at least two groups. CONCLUSION: From training courses using virtual cases, we found that there was no consensus on ‘patient use’ point of view of medical devices. There was a significant difference in applying definitions of adverse events written in guidelines regarding the medical device associated incidents. Our results point out that international harmonization effort is needed not only to harmonize differences in regulations between countries but also to overcome diversity in perspectives existing at the site of medical device use.

Classification of Iris Colors and Patterns in Koreans / 대한의료정보학회지

OBJECTIVES: The iris is the part of the eye that is colored, and it is an important feature in making an artificial eye. To address the lack of information about the brown Korean irises, we classified the colors and patterns of the irises of 100 Korean eyes. METHODS: The iris colors were extracted from 100 different digital photographs of each eye using K-mean clustering image analysis. The RGB data of the extracted colors were converted to CIELAB color space data and analyzed to determine the representative color of the iris in each photograph. The color differences were calculated to form groups of similar colors by matching the 100 samples into several groups with minimum color differences among them. The average hue value for each group was calculated, and the corresponding representative color was selected from 2 to 3 colors in one group. RESULTS: The iris colors were classified into seven brown color groups with 2 to 3 colors in each group. The coloration of Koreans' eyes appears to vary in a similar hue with differences in chroma and lightness. In addition, the iris patterns were classified into three basic patterns, namely, crown, sunshine, and flower, as well as three complex patterns that are mixtures of two basic patterns. CONCLUSIONS: We classified Korean iris colors and patterns for application in the design of artificial eyes.

Factors Affecting Comsumer's Usage of Health Information on the Internet / 예방의학회지

OBJECTIVES: The purpose of the study was to identify a gap between consumer characteristics and utilization of health information on the Internet. METHODS: A telephone survey of nationally representative samples was conducted using structured questionnaires, and 1,000 of the 1,189 responses obtained were included in our analysis. The following variables were included in the analysis as potential predictors of health information use on the Internet: predisposing factors such as gender, age, and education status; enabling factors such as region and monthly household income; consumer need for health information; and attitude to health. Multiple logistic regression analysis was used to evaluate the association between utilization rate and the potential predictors. RESULTS: Thirty-nine percent of consumers had obtained health information on the Internet over a one-year period. The utilization rates were higher for consumers who were young, educated, worked in the office setting, had higher incomes, wanted health information, and were able to use the Internet. The utilization rate was 5.35 times higher in the younger group (20-30 years) than in the elderly group (95% CI=2.21-12.97); 2.21 times higher for office workers than for manual workers (95% CI=1.16-4.20); 3.61 times higher for college graduates than for middle school graduates and below (95% CI=1.07-11.59); 1.99 times higher for people with monthly household incomes over 3,000,000 won than for those with monthly household incomes below 1,500,000 won (95% CI=1.01-3.92). CONCLUSIONS: There needs to be a paradigm shift, with consideration of not only Internet accessibility in the digital age, but also consumer ability and attitudes toward utilization of health information.