Does Customer Information Fulfill MEDDEV Criteria in Cases of Product Problems of In Vitro Diagnostics for Infection Testing?

Abstract

The European Directive 98/79/EC on in vitro diagnostics (IVD) regulates marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform responsible competent authority (CA) and public by field safety notices (FSN). We analyzed FSCA and FSN of IVD for infection testing (culture media, reagents, kits, control materials, as well as culture-based analyzers and their general consumables) published by the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany in 2005-2012 in regard to the European Regulatory Framework of Medical Devices (MEDDEV). One hundred and sixty-nine FSCA were published and German and English FSN were found in 157 and 154 cases, respectively. FSN were clearly characterized as FSN in 110 German and 134 English cases and product names were provided in 157 and 154 cases, respectively. Lot numbers and other information for product characterization were available in 146 and 137 cases, respectively. The information regarding FSCA and product malfunction was provided in 157 and 151 and 144 and 136 cases and that regarding the product related risks with continued use of affected IVD in 116 and 116 cases, respectively. In 156 German and 152 English cases, manufacturers provided the information for risk mitigation, including retesting in 69 and 75 cases, respectively. Requests to pass FSN to persons needing awareness were found in 108 and 87 cases, and contact data were provided in 127 and 131 cases, respectively. We conclude that most FSN fulfilled the MEDDEV criteria. However, type and content of FSN should be improved to ensure a better mitigation of risks due to product failure.

Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology

“…However, a critical non-compliance to the requirements of MEDDEV 2.12-1 rev 8 was found regarding the clarification of the potential hazard associated to continued use of the affected product (24/23 out of 36/35 German and English FSN, i.e., lack in about one third of FSN). These data are in accordance with the results of a previous study in IVD for infection testing (116/116 out of 157/154 German and English FSN (Hannig and Siekmeier 2015)). Such noticeable deviation from the requirements of the MEDDEV should be avoided as clear descriptions in these points serve as the basis for understanding the FSCA and required measures to be performed by the users for risk reduction.…”

“…No FSN included a recommendation of the manufacturer for control of the results or retesting. This observation stands in contrast to our previous publication for IVD for use in infection diagnostics where the recommendation for control of the results or retesting was frequently found (69/75 out of 157/154 German and English FSN) (Hannig and Siekmeier 2015). This difference can be explained by different types of included products in both studies.…”

“…However, irrespective to the importance of FSN the number of publications investigating their quality is sparse (Hannig and Siekmeier 2015;Siekmeier et al 2010 were received by the BfArM of which 45,938 were related to medical devices (active and non-active) and 4,115 to IVD (except IVD in the responsibility of the Paul-Ehrlich-Institute) resembling 91.8 % and 8.2 % of the notifications related to these product groups, respectively. The corresponding numbers of publicized FSCA were 6,465, 4,912, and 1,553 for all products, active and non-active medical devices and IVD, resembling the corresponding proportions of 76.0 % and 24.0 %, respectively.…”

“…Other medical devices, e.g., devices for use in otorhinolaryngology and intensive care medicine (e.g., respirators, masks, tracheal tubes and tracheostomae, and materials for bronchial drainage) were excluded from this analysis as those products are more frequently used by other clinicians than by pulmonologists. IVD (e.g., analyzers, consumables and reagents for blood gas analysis, and consumables and reagents for infection testing) were also excluded as they are typically used in laboratories (IVD for blood gas analyzes, IVD for infection testing) and intensive care units (IVD for blood gas analyzes), and in part were subject of prior studies (IVD for infection testing) (Hannig and Siekmeier 2015;Siekmeier et al 2010). FSN of the included FSCA were analyzed in respect to the criteria of MEDDEV 2.12-1 rev 8 ( 1 A clear title, with "Urgent field safety notice" followed by the commercial name of the affected product, an FSCAidentifier (e.g., date) and the type of action.…”

“…FSN play a central role for risk reduction in cases of product failure related to products already in the market. However, up to now there are little data analyzing the quality of FSN sent by the manufacturers in case of an FSCA even though requirements for FSN are described in MEDDEV 2.12-1 rev 8 (Siekmeier et al 2010; Guidelines on a Medical Devices Vigilance System 2013; Hannig and Siekmeier 2015). Therefore, aim of this study was the analysis of FSCA and FSN of medical devices serving for diagnostics or treatment in pulmonology in respect to the criteria of MEDDEV 2.12-1 rev 8.…”