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Microorganisms are intentionally added at different stages of the food and feed chain (food or feed additive, novel food or plant protection product) and are subjected to regulation and safety assessment by the European Food Safety Authority. Safety evaluation is based on application dossiers for market authorisation to the European Commission. The qualified presumption of safety (QPS) concept was developed in 20031 to provide a harmonised generic safety pre-appraisal of the above microorganisms. Unambiguously defined biological taxonomic units (TUs) are assessed for their body of knowledge, their safety and their end use. Identified safety concerns for a certain TU can be, where reasonable in number and not universally present, reflected as 'qualifications.' Strains belonging to TUs having QPS status may benefit of a fast track evaluation. The lowest TU for which the QPS status is granted is the species level for bacteria and yeasts and the family for viruses. The QPS concept is also applicable to genetically modified microorganisms used for production purposes. Based on the current body of knowledge and/or the ambiguous taxonomic position, some TUs, such as filamentous fungi, bacteriophages, Enterococcus faecium, Escherichia coli, Streptomyces spp. and Oomycetes, are not considered liable for QPS status.

Salmonellae are a major cause of food-borne outbreaks in Europe, with eggs and egg products being identified as major sources. Due to the low levels of salmonellae in eggs and egg products, direct quantification is difficult. In the present study, enrichment quantitative real-time PCR (qPCR) was employed for enumeration of salmonellae in different matrices: table eggs, pasteurized egg products, and egg-containing dishes. Salmonella enterica serovar Enteritidis and S. enterica serovar Tennessee were used to artificially contaminate these matrices. The results showed a linear regression between the numbers of salmonellae and the quantification cycle (Cq) values for all matrices used, with the exception of pasteurized egg white. Standard curves were constructed by using both stationary-phase cells and heat-stressed cells, with similar results. Finally, this method was used to evaluate the fate of salmonellae in two egg-containing dishes, long egg and tiramisu, at abused refrigeration temperatures, and results indicated the growth of bacteria over a 1-week period. In conclusion, enrichment qPCR was shown to be reliable for enumeration of salmonellae in different egg products.

Purpose: There is a growing discrepancy between the demand for renal transplants and the number of transplants conducted. For the many patients on the renal transplant waiting list, this means increased dialysis-associated morbidity, mortality and a reduced quality of life. The aim of this study was to ascertain whether it is justifiable for transplant centers to reject cadaveric donor organs on hand of marginal organ quality., Methods: We identified 110 kidneys that were primarily rejected for transplantation at Charité Universitätsmedizin Berlin, Campus Mitte, and later transplanted at another center within the Eurotransplant zone. Using data from the Collaborative Transplant Study, we analyzed various demographic donor data including cold ischemia times, as well as graft and recipient outcomes., Results: The median follow-up was 54 months. The cold ischemia time averaged 16 h. The organs that were primarily rejected by our center and then transplanted at other Eurotransplant centers showed 31 % of recipients had creatinine levels under 1.47 mg/dl and 94 % had levels under 2.97 mg/dl at 3-year follow-up. The mean death-censored graft survival was 71.4 months. The mean renal transplant recipient survival was 87.5 months., Conclusions: Based on our findings, we propose that acceptance criteria for marginal donor kidneys need to be widened.

For specific production lines, European retail companies demand exclusively female pork meat. To control the quality of their suppliers the identification and a quantitative detection of the animal sex origin of the meat is therefore of importance for meat processors. To enable a fast and reliable detection of male pig meat, a real time-PCR-system was designed in the present study. This was based on the genes AMEL-X and AMEL-Y. The real time-PCR assay allowed the detection of male pig meat at a concentration of 1% yielding a detection probability of 100% while the detection probability investigating meat samples containing 0.1% male pig meat was 44.4%. The analytic sensitivity of this system was assessed to be <5 pg DNA per PCR reaction. The assessment of the accuracy of the real time-PCR assay to correctly identify sex individuals was investigated with 62 pigs including males (n=29) and females (n=33) belonging to different breeds/lines. With the newly designed test all analysed animals were correctly sexed. No amplification was obtained with cow, goat, sheep, turkey and chicken genomic DNA. The presented assay can be used for sex diagnosis, for the detection of male pig meat and for meat quality control., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

The recent crises in the meat industry due to meat-associated risks such as salmonella, nitrofen and dioxin prove that the traditional ante- and post mortem inspection of slaughter animals and carcasses is not any longer able to recognise and prevent the risks of today. Therefore, the EU Commission has issued Reg. (EC) 853/2004 and Reg. (EC) 854/2004 that regulate the transition of the traditional meat inspection, which demands inspecting each individual carcass in the same way, to a risk-based meat inspection, which is using relevant pieces of information about the previous production stages for making risk-based decisions on the intensity of the inspection of slaughter pig batches. The new EU legislation is not any longer prescribing exactly the inspection procedure, but defines the food safety goals. The consequence is that there are still various ideas and opinions on how to implement a reasonable risk-based meat inspection, and, in particular, on how to design the "relevant food chain information". The present paper is describing the legal framework and the objectives of the risk-based meat inspection, and proposals for designing the food chain information for the implementation of the risk-based ante- and post-mortem meat inspection are made and discussed.

Appropriate and inappropriate therapies of implantable cardioverter defibrillators (ICDs) have a major impact on morbidity and quality of life in ICD recipients. The recently introduced home monitoring of ICD devices is a promising new technique which remotely offers information about the status of the system. Stored intracardiac electrograms (IEGMs), which are essential for correct classification of appropriate and inappropriate ICD discharges, have until now not been available with ICD home monitoring on a day-by-day basis because of limitations of transferable data. We demonstrate the first compressed IEGMs daily transferable via home monitoring (IEGM-online). Validation of these electrograms will be performed in the Reliability of IEGM-Online Interpretation (RIONI) study. A total of 210 episodes of stored IEGMs will be collected by at least 12 European centres. The primary endpoint of this study is to investigate whether the IEGM-online based evaluation of the appropriateness of the ICDs therapeutic decision following episode detection is equivalent to the evaluation based on the complete ICD episode Holter extracted from the IEGM stored. The evaluation is independently done by an expert board of three experienced ICD investigators. The equivalence of the two methods is accepted if the evaluations yield a different conclusion for <10% of all evaluated IEGMs. The conclusion of the study is expected at the beginning of 2007. If RIONI successfully validates IEGMs transmitted via home monitoring, a strong basis for the use of this promising technique will be established.

Objectives: This review article aims to highlight the importance of standards for effective communication and provides an overview of international standardization activities., Methods: This article is based on the experience of the author of European standardization in CEN, which he leads, and the global work of ISO, where he is leading the security working group, and an overview of the work of DICOM, IEEE and HL7, partly using their web presentations., Results: Health communication is highly dependent of the general development of information technology with standards coming from ISO/IEC JTCI, ITU and several other organizations e.g. IETF, the World Wide Web consortium and Open group. A number of standardization initiatives have been in progress for more than ten years with the aim to facilitate different aspects of the exchange of health information. Electronic record architecture, Message structures, Concept representation, Device communication including imaging and Security are the main areas., Conclusions: Important results have been achieved, and in some fields and parts of the world, standards are widely used today. Unfortunately, we are still facing the fact that most healthcare information systems cannot exchange information with all systems for which this would be desired. Either the existing standards are not sufficiently implemented, or the required standards and necessary national implementation guidelines do not yet exist. This causes unacceptable risks to patients, inefficient use of healthcare resources, and sub-optimal development of medical knowledge. Fortunately, the different bodies are now largely co-operating to achieve global consensus.