Abstract
The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) regulates the marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents 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. In this study all notifications regarding IVD (tests, calibrators, kits, and control materials, except laboratory analyzers) for tumor diagnostics received by the BfArM between begin 1999 until end of 2010 were analyzed. All notifications were analyzed in respect to the type of product, the source of notification, the underlying product defects and the corrective actions performed. In the observation period, a total of 2,851 notifications were received of which 84 were related to IVD for tumor diagnostics included in this study (clinical chemistry – 63, histology – 6, molecular biology – 3, rapid tests – 12). Reports were received from manufacturers (68 cases), CA (8 cases), users (4 cases) and other sources (4 cases). In the group of IVD based on clinical chemistry means, the affected products were mostly those for the measurement of prostate specific antigen (PSA, 14 cases), human chorion gonadotropine (13 cases), carcino embryonic antigen (6 cases), CA 19–9 (6 cases), α1-fetoprotein (6 cases) and CA 125 (5 cases), whereas in test strips 9 out of the 12 notifications were related to PSA. Investigations of the manufacturers were able to identify the underlying root causes of product failures in 66 cases (78.6%). In 10 cases (11.9%) the root cause remained unclear and in 6 cases and 2 cases (7.1% and 2.4%) a product failure was excluded or a user error was the underlying cause. Most common root causes of product failures were material defects (24 cases) and manufacturing errors (15 cases). Corrective actions were performed by the manufacturers in 64 cases (76.2%) and were predominantly (multiple entries possible) customer information (62 cases, mandatory in case of a recall), recalls (45 cases), modifications in production or quality management (45 cases) and design changes (14 cases). The obtained results suggest that the system for post marketing surveillance of IVD is an established tool to enhance product safety and provides valuable information on product specific problems serving for improvement of product safety.
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References
Bornhak, H., Dörr, V., Halbauer, J., Meyer-Lüerßen, D., Odenthal, J., Siekmeier, R., & Will, H. G. (2002). Die Anforderungen der Medizinprodukte-Sicherheitsplanverordnung für in-vitro-Diagnostika im Rahmen des Medizinproduktegesetzes. MedizinProdukteRecht, 4, 120–133.
Directive 98/79/EC of the European Parliament and of the Council of 27 October (1998) on in vitro diagnostic medical devices. Official Journal L 331 : 1–37 / Internet: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0079:EN:HTML
Guidelines on a medical devices vigilance system. (2007). (MEDDEV 2.12-1 rev). 5 / Internet: http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/
Halbauer, J., Siekmeier, R., & Funk, M. (2009). Die Sicherheit von Hochrisiko-in-vitro-Diagnostika. Internationale und nationale Maßnahmen. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 52, 610–618.
Medical devices post market surveillance. (2006). National competent authority report exchange criteria and report form. (GHTF/SG2/N79R8:2006) / Internet: www.ghtf.org
Medizinproduktegesetz in der Fassung der Bekanntmachung vom 7. August 2002 (BGBl. I S. 3146), geändert durch Artikel 1 des Gesetzes vom 14. Juni 2007 (BGBl. I S. 1066), zuletzt geändert durch Artikel 6 des Gesetzes vom 29. Juli 2009 (BGBl. I S. 2326) / Internet: http://bundesrecht.juris.de/mpg/index.html
Ogino, S., Galon, J., Fuchs, C. S., & Dranoff, G. (2011). Cancer immunology-analysis of host and tumor factors for personalized medicine. Nature Reviews Clinical Oncology. doi:10.1038/nrclinonc.2011.122. Epub ahead of print.
Siekmeier, R., & Lütz, J. (2007a). Safety of in-vitro-diagnostics for hematology and coagulation testing – Analysis of the reports to the German Competent Authority (BfArM). Transfusion Medicine and Hemotherapy, 34, 353–361.
Siekmeier, R., & Lütz, J. (2007b). Experience with post-market surveillance of in-vitro diagnostic medical devices for lay use in Germany. Clinical Chemistry and Laboratory Medicine, 45, 396–401.
Siekmeier, R., Halbauer, J., Mientus, W., & Wetzel, D. (2008). Safety of reagents for infection testing: Results of the market surveillance by the Federal Institute for Drugs and Medicinal Devices until end 2006. Journal of Physiology and Pharmacology, 59(Suppl. 6), 629–643.
Siekmeier, R., Halbauer, J., Mientus, W., & Wetzel, D. (2009). Safety of laboratory analyzers for infection testing – Results of the market surveillance by the BfArM until end 2007. European Journal of Medical Research, 14(Suppl. IV), 216–226.
Siekmeier, R., Lisson, K., & Wetzel, D. (2010). Field safety notices related by manufacturers in cases of failure of products for infection testing: Analysis of cases reported to the BfArM between 2005 and 2007. European Journal of Medical Research, 15(Suppl. II), 175–183.
Spitzenberger, F., Edelhäuser, R., Funk, M., & Halbauer, J. (2007). Vigilance experience for high-risk IVDs in Europe. Regulatory Affairs Journal Devices, 15, 157–164.
Verordnung über die Erfassung, Bewertung und Abwehr von Risiken bei Medizinprodukten (Medizinprodukte-Sicherheitsplanverordnung – MPSV) vom 24. Juni 2002 (BGBl. I S. 2131), zuletzt geändert durch Artikel 3 des Gesetzes vom 29. Juli 2009 (BGBl. I S. 2326) / Internet: http://www.gesetze-im-internet.de/mpsv/index.html
Conflicts of interest: The authors declare no conflicts of interest in relation to this article.
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Siekmeier, R., Wetzel, D. (2013). Market Surveillance of In Vitro Diagnostics by the BfArM Until End 2010: How Safe Are Products for Tumor Diagnostics?. In: Pokorski, M. (eds) Respiratory Regulation - Clinical Advances. Advances in Experimental Medicine and Biology, vol 755. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-4546-9_49
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DOI: https://doi.org/10.1007/978-94-007-4546-9_49
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