Siekmeier Rüdiger, Lütz Johannes
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany.
Clin Chem Lab Med. 2007;45(3):396-401. doi: 10.1515/CCLM.2007.058.
The European Directive 98/79/EC on in-vitro diagnostic medical devices (IVDs) regulates IVD marketing practices and post-market surveillance. IVD manufacturers have to inform the responsible Competent Authorities of any issues. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for most IVDs, with a small subset of IVDs being within the responsibility of the Paul-Ehrlich-Institute (PEI).
All IVD notifications received by BfArM between 1999 and June 2006 were analysed in terms of the source of notification, underlying product defects and corrective actions.
A total of 773 notifications were received, 566 related to IVDs for professional use and 207 related to over-the-counter (OTC) products for lay use. The latter included systems for blood glucose testing (analysers, tests and control materials; n=166) or coagulation testing (n=13) and pregnancy tests (n=25). Most reports came from manufacturers (n=115; 55.6%) and users (n=72; 34.8%) mainly via pharmacies and the Drug Commission of the German Pharmaceutical Association. Manufacturer investigations for all lay IVD cases reported revealed underlying product defects in 53 cases (25.6%). Product failure was excluded in 80 cases (38.6%), which included a large number of user errors (n=34). Many cases (n=74, 35.7%) could not be clarified because the test strips and/or analysers were not returned to the manufacturer for further investigation. In most cases, product defects identified by manufacturer investigations were related to the test strips and not to the analysers. Because of the high proportion of cases without proven product failure, corrective actions were performed only in a subset (n=54, 26.1%) of the cases reported for IVDs specified for lay use.
The results show that the governmental system for post-marketing surveillance of IVDs is an established tool to ensure product safety. The proportion of notifications for OTC products indicates that they should be the focus for action by the competent surveillance authorities.
欧洲关于体外诊断医疗器械（IVD）的98/79/EC指令对IVD的营销行为和上市后监督进行了规范。IVD制造商必须将任何问题告知负责的主管当局。在德国，联邦药品和医疗器械研究所（BfArM）负责大多数IVD，一小部分IVD由保罗·埃利希研究所（PEI）负责。
对1999年至2006年6月期间BfArM收到的所有IVD通知进行分析，内容包括通知来源、潜在产品缺陷和纠正措施。
共收到773份通知，其中566份与专业用IVD有关，207份与非处方（OTC）家用产品有关。后者包括血糖检测系统（分析仪、检测试剂和质控材料；n = 166）、凝血检测系统（n = 13）和妊娠检测产品（n = 25）。大多数报告来自制造商（n = 115；55.6%）和用户（n = 72；34.8%），主要通过药店和德国制药协会药品委员会提交。对所有报告的家用IVD病例进行的制造商调查显示，53例（25.6%）存在潜在产品缺陷。80例（38.6%）排除了产品故障，其中包括大量用户错误（n = 34）。许多病例（n = 74，35.7%）无法澄清，因为试纸条和/或分析仪未返回给制造商进行进一步调查。在大多数情况下，制造商调查确定的产品缺陷与试纸条有关，而非分析仪。由于未证实产品故障的病例比例较高，仅对报告的家用IVD指定病例中的一部分（n = 54，26.1%）采取了纠正措施。
结果表明，政府对IVD的上市后监督系统是确保产品安全的既定工具。OTC产品的通知比例表明，它们应成为主管监督当局的行动重点。
