Zippel Claus, Bohnet-Joschko Sabine
Walcker Endowed Professor of Management and Innovation in Health Care, Faculty of Management and Economics, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448 Witten, Germany.
Walcker Endowed Professor of Management and Innovation in Health Care, Faculty of Management and Economics, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448 Witten, Germany.
Health Policy. 2017 Aug;121(8):880-886. doi: 10.1016/j.healthpol.2017.06.005. Epub 2017 Jun 24.
Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues.
医疗设备在疾病的诊断和治疗中发挥着核心作用，但也可能带来不良事件、危害或故障，给患者和使用者带来严重后果。因此，法律要求医疗设备制造商监测已获主管部门批准的医疗设备的性能（上市后监测）。为了探究上市后手段的使用现状，我们于2014年第二季度在德国医疗设备行业开展了一项全国性在线调查，共获得118个完整数据集，回复率为36%。该调查涵盖了不同规模、生产所有风险等级医疗设备的制造商。最常报告的上市后手段涵盖生产监测、质量管理以及文献观察、监管警戒系统、客户知识管理和市场观察领域，而上市后临床随访和卫生服务研究在产品监测中的使用较少。我们发现所生产的不同风险等级医疗设备与上市后手段的使用强度之间存在显著差异。公司规模与手段使用强度之间的差异几乎未被发现。研究结果很可能有助于设备监测的发展，而设备监测是识别与设备相关安全问题的政策和监管体系的关键要素。
