The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) stipulates the marketing and post market surveillance of IVD in the European Economic Area. In cases of issues and field corrective actions, the manufacturers have to inform the responsible Competent Authorities (CA). In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD, with a small subset of IVD for immune hematological and infectiological testing as well as tissue typing as specified in Annex II of the Directive, being within the responsibility of the Paul-Ehrlich-Institute (PEI). In this study, all issues regarding laboratory analyzers for infection testing and their consumables, but not reagents, kits and general culture media, reported to the BfArM between begin 1999 and end of 2007 were analyzed in respect to the sources of report, the underlying product failure and the performed corrective actions. Within the observation period a total of 1471 reports for IVD were received of which 73 related to the IVD for infection testing were included in our study. Reports were predominantly received from manufacturers (56) and competent authorities (15). Affected products were most frequently those for immunological analysis (42) whereas those based on culturing techniques (17) and molecular biological techniques (14) played only minor roles. In all these groups, laboratory analyzers (55) were more frequently affected than their consumables (18). Investigations of the manufacturers were able to identify the underlying root causes of product failures in 62 cases (84.9%). In 2 cases (2.7%) the root cause remained unclear and in 9 cases (12.3%) a product failure was excluded or a user error was the underlying cause. Product failures in laboratory analyzers were most frequently caused by software errors (31) and constructional faults (8) whereas the predominant cause of product failure in consumables were errors in production and quality control (8). Manufacturers issued corrective measures in 66 cases (90.4%) from which 49 and 17 were related to laboratory analyzers and their consumables, respectively. Based on the underlying root causes of product failures these were predominantly customer information (48), recalls (40), software-updates (30) and design changes (9) in the product group of laboratory analyzers as well as customer information (16), recalls (12) and modifications of production and quality management (11) in the group of consumables. The results and experiences obtained since 1999 suggest that the system for post marketing surveillance of IVD is an established tool to ensure product safety, even though the current system can be further enhanced.

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The European Directive 98/79/EC for in vitro diagnostic medical devices (IVD) regulates marketing and post marketing surveillance of IVD in the European Economic Area. Manufacturers have to inform the responsible Competent Authorities (CA) about incidents and field safety corrective actions (FSCA) related to IVD. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD, only few IVD as specified in Annex II of the Directive are under the responsibility of the Paul Ehrlich Institute (PEI). In case of a FSCA manufacturers have to inform customers by means of a Field Safety Notice (FSN) which should be sent to BfArM prior to release and is published on the BfArM home-page. Between beginning of 2005 and end of 2007 the BfArM received a total of 1025 reports regarding IVD. From these, 38 related to tests, reagents, calibrators, and control materials for infection testing, 13 related to analysers and general consumables (n = 8 and n = 5, respectively) based on culture techniques, and 7 related to analysers and general consumables (n = 5 and n = 2, respectively) based on molecular biological methods. FSCA were performed in Germany in 32 (84.2%) of all notifications related to tests reagents, calibrators, and control materials as well as in 13 (100%) and 7 (100%) of notifications related to analysers and consumables based on culture techniques and molecular biological methods, respectively. A number of relevant deficiencies regarding the quality of the FSN were separately demonstrated for FSN in German and English language. In brief, manufacturers often sent their FSN to the BfArM with delay. Additionally, a subset of FSN provided insufficient information on the product related risks or the measures to be performed by the customer to mitigate product related risks. Furthermore, customer confirmation forms often were missing in the FSN sent to the BfArM. Our data suggest that for IVD for infection testing FSCA and FSN are frequently performed. For better vigilance performance, manufacturers could shorten the time until release and improve the contents of FSN to ensure the safety of IVD in cases of product related corrective actions.

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