Division of Nephrology, Department of Internal Medicine, Soonchunhyang University College of Medicine, 170, Jomaru-Ro, Bucheon, 14584, Republic of Korea.
Center for Medical Device Safety Information Monitoring, Soonchunhyang University Bucheon Hospital, 170, Jomaru-Ro, Bucheon, 14584, Republic of Korea.
BMC Health Serv Res. 2024 Nov 14;24(1):1402. doi: 10.1186/s12913-024-11885-1.
The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events.
An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases.
All 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders.
We identified the diversification in terminology and code selection for reporting MDAEs.
医疗器械不良事件报告是上市后监测的起点，也是最初安全信号的最常见来源。由于医疗器械不良事件（AE）在全球范围内发生，并涉及备受瞩目的国际公共卫生危机，国际监管机构为 MDAE 报告植入了标准代码。本研究旨在通过提供虚拟事件示例来评估 MDAE 术语和代码的应用。
对参加医疗器械监管机构培训计划的人员进行了在线调查，该计划提供了国际医疗器械监管者论坛（IMDRF）不良事件术语和代码，以及六个虚拟 MDAE 案例。
72 名参与者中的 29 名全部为监管人员。在所有情况下，大多数参与者选择了广泛的（级别 1）代码，而不是详细的（级别 2 或级别 3）代码。虽然在案例 1 中，应答者为所有附件选择了各种代码，但在案例 6 中，超过 50%的应答者选择了预期的代码。在设备问题、组件和健康影响方面，用于原因调查的代码比其他附件更频繁地被选中。不同利益相关者之间在代码选择上没有差异。
我们确定了报告 MDAE 时术语和代码选择的多样化。
