Antonela Šimunović, Croatian Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, 10000 Zagreb, Croatia,
Croat Med J. 2023 Aug 31;64(4):265-271. doi: 10.3325/cmj.2023.64.265.
To assess the quantity and quality of incident reports on medical devices by health care professionals from 2012 to 2021 and evaluate the effect of reporting on manufacturers' post-market surveillance.
Eighty-five incident reports were scored according to a self-developed evaluation system, and categorized as excellent, good, medium, qualified, and unqualified. The completeness of data in critical fields was assessed. For each report, the type and city of the reporter, and medical device risk class were extracted to calculate the frequency of report occurrence per risk class and outcomes for reportable reports.
The number of reports received from health care professionals was low; the highest number of reports in a year was 17. The majority of reports were deemed as unqualified (61.18%) and only 4.71% as excellent. Still, 67.65% of incident reports importantly affected the manufacturer's post-market surveillance, either as added information that contributes to risk monitoring or directly triggering a field safety corrective action.
The number of total reports and reports per year shows extensive underreporting in Croatia, and the quality of the provided reports is insufficient.
评估 2012 年至 2021 年期间医疗保健专业人员提交的医疗器械不良事件报告的数量和质量，并评估报告对制造商上市后监测的影响。
根据自行开发的评估系统对 85 份不良事件报告进行评分，并分为优秀、良好、中等、合格和不合格。评估关键字段中数据的完整性。对于每份报告，提取报告人所在的类型和城市以及医疗器械风险级别，以计算每个风险级别的报告发生率以及可报告报告的结果。
从医疗保健专业人员那里收到的报告数量较少；一年中报告数量最多的是 17 份。大多数报告被认为是不合格的（61.18%），只有 4.71%被评为优秀。然而，67.65%的不良事件报告重要地影响了制造商的上市后监测，要么作为有助于风险监测的附加信息，要么直接引发现场安全纠正措施。
总的报告数量和每年的报告数量表明克罗地亚存在广泛的漏报现象，并且提供的报告质量不足。
