Objective: Analysis of data from reports of medical device faults in drug-device combinations (DDCs) can prevent adverse events caused by errors and lead to improvements. However, there is a paucity of published articles reporting the analysis of data on faults in DDCs. The aim of this study was to analyze data of faults in these medical devices in Japan.Methods: The review summarized information from the Pharmaceuticals and Medical Devices Agency data on “case reports of suspected failures of the mechanical and instrumental parts of DDCs” reported between 25 November 2014 and 31 July 2022. Information was collected from public documents on “year reported”, “age”, “gender”, “trade name”, “generic name”, “mechanical device part name”, “mechanical device part failure status”, and “hazard” and “outcome”.Results: There were approximately 1,300 reports of medical device faults in DDCs over the study period, with the number increasing year by year. Five device parts (insulin pen injectors, pre-filled syringes, drug and vaccine injectors, disposable hypodermic needles, and intrauterine contraceptive devices) accounted for 90% of the reports. We found that there was a considerable amount of missing data on reportable items such as age and gender of the patient. Our analysis also showed that 90% of the medical device fault reports involving DDCs were related to malfunction or breakage.Conclusion: In order to use DDCs more safely and effectively it is important to review reports and analyse data of faults in these devices.

Objectives: Postmenopausal women with osteoporosis are frequently underdiagnosed. In Japan, general dental practitioners have begun using the cortical shape of the mandible on dental panoramic radiographs (PRs) to identify and refer women at risk of osteoporosis to medical professionals. It remains unclear whether dental students, after relevant education, possess the ability to identify these at-risk individuals. This study evaluated the ability of dental students to screen for osteoporosis on PRs. Methods: A cohort of 113 fifth-year dental students participated in a lecture on osteoporosis screening using PRs.The students then categorized the mandibular inferior cortex on PRs from 30 postmenopausal women (11 with osteoporosis) as normal, mildly to moderately eroded, or severely eroded. Interobserver agreement between the students and an expert oral radiologist using two cortical groups (normal to moderately eroded and severely eroded) was assessed through kappa statistics. Screening ability for osteoporosis detection by identifying severely eroded cortices was calculated and compared with that of the Osteoporosis Self-assessment Tool for Asians (OSTA). Results: Twenty-one (18.6%) students demonstrated moderate to substantial agreement with the expert. The mean sensitivity, specificity, and positive and negative predictive values for these students in identifying osteoporosis were 60.2%, 88.0%, 76.3%, and 80.0%, respectively. For the OSTA, sensitivity, specificity, and positive and negative predictive values were 27.3%, 68.4%, 33.3%, and 61.9%, respectively. Conclusions Even with minimal education, approximately one-fourth of dental students may accurately identify postmenopausal women with osteoporosis on PRs, outperforming questionnaire-based screening tools.

Objectives: Postmenopausal women with osteoporosis are frequently underdiagnosed. In Japan, general dental practitioners have begun using the cortical shape of the mandible on dental panoramic radiographs (PRs) to identify and refer women at risk of osteoporosis to medical professionals. It remains unclear whether dental students, after relevant education, possess the ability to identify these at-risk individuals. This study evaluated the ability of dental students to screen for osteoporosis on PRs. Methods: A cohort of 113 fifth-year dental students participated in a lecture on osteoporosis screening using PRs.The students then categorized the mandibular inferior cortex on PRs from 30 postmenopausal women (11 with osteoporosis) as normal, mildly to moderately eroded, or severely eroded. Interobserver agreement between the students and an expert oral radiologist using two cortical groups (normal to moderately eroded and severely eroded) was assessed through kappa statistics. Screening ability for osteoporosis detection by identifying severely eroded cortices was calculated and compared with that of the Osteoporosis Self-assessment Tool for Asians (OSTA). Results: Twenty-one (18.6%) students demonstrated moderate to substantial agreement with the expert. The mean sensitivity, specificity, and positive and negative predictive values for these students in identifying osteoporosis were 60.2%, 88.0%, 76.3%, and 80.0%, respectively. For the OSTA, sensitivity, specificity, and positive and negative predictive values were 27.3%, 68.4%, 33.3%, and 61.9%, respectively. Conclusions Even with minimal education, approximately one-fourth of dental students may accurately identify postmenopausal women with osteoporosis on PRs, outperforming questionnaire-based screening tools.

Objectives: Postmenopausal women with osteoporosis are frequently underdiagnosed. In Japan, general dental practitioners have begun using the cortical shape of the mandible on dental panoramic radiographs (PRs) to identify and refer women at risk of osteoporosis to medical professionals. It remains unclear whether dental students, after relevant education, possess the ability to identify these at-risk individuals. This study evaluated the ability of dental students to screen for osteoporosis on PRs. Methods: A cohort of 113 fifth-year dental students participated in a lecture on osteoporosis screening using PRs.The students then categorized the mandibular inferior cortex on PRs from 30 postmenopausal women (11 with osteoporosis) as normal, mildly to moderately eroded, or severely eroded. Interobserver agreement between the students and an expert oral radiologist using two cortical groups (normal to moderately eroded and severely eroded) was assessed through kappa statistics. Screening ability for osteoporosis detection by identifying severely eroded cortices was calculated and compared with that of the Osteoporosis Self-assessment Tool for Asians (OSTA). Results: Twenty-one (18.6%) students demonstrated moderate to substantial agreement with the expert. The mean sensitivity, specificity, and positive and negative predictive values for these students in identifying osteoporosis were 60.2%, 88.0%, 76.3%, and 80.0%, respectively. For the OSTA, sensitivity, specificity, and positive and negative predictive values were 27.3%, 68.4%, 33.3%, and 61.9%, respectively. Conclusions Even with minimal education, approximately one-fourth of dental students may accurately identify postmenopausal women with osteoporosis on PRs, outperforming questionnaire-based screening tools.

Objectives: Postmenopausal women with osteoporosis are frequently underdiagnosed. In Japan, general dental practitioners have begun using the cortical shape of the mandible on dental panoramic radiographs (PRs) to identify and refer women at risk of osteoporosis to medical professionals. It remains unclear whether dental students, after relevant education, possess the ability to identify these at-risk individuals. This study evaluated the ability of dental students to screen for osteoporosis on PRs. Methods: A cohort of 113 fifth-year dental students participated in a lecture on osteoporosis screening using PRs.The students then categorized the mandibular inferior cortex on PRs from 30 postmenopausal women (11 with osteoporosis) as normal, mildly to moderately eroded, or severely eroded. Interobserver agreement between the students and an expert oral radiologist using two cortical groups (normal to moderately eroded and severely eroded) was assessed through kappa statistics. Screening ability for osteoporosis detection by identifying severely eroded cortices was calculated and compared with that of the Osteoporosis Self-assessment Tool for Asians (OSTA). Results: Twenty-one (18.6%) students demonstrated moderate to substantial agreement with the expert. The mean sensitivity, specificity, and positive and negative predictive values for these students in identifying osteoporosis were 60.2%, 88.0%, 76.3%, and 80.0%, respectively. For the OSTA, sensitivity, specificity, and positive and negative predictive values were 27.3%, 68.4%, 33.3%, and 61.9%, respectively. Conclusions Even with minimal education, approximately one-fourth of dental students may accurately identify postmenopausal women with osteoporosis on PRs, outperforming questionnaire-based screening tools.