Herstellerservices: Alles aus einer Hand

2016 ◽  
Vol 21 (09) ◽  
pp. 58-60
Author(s):  
Dirk Mewis
Keyword(s):  

Weltweit ist der Gesundheitsmarkt in Bewegung, Anbieter und Nachfrager rücken enger zusammen. Medizintechnikhersteller wie Siemens Healthcare, Medtronic, Philips oder Samsung HME beteiligen sich zunehmend an Forschungseinrichtungen oder bieten mittlerweile sogar Komplettlösungen an.

2017 ◽  
Vol 22 (12) ◽  
pp. 57-59
Author(s):  
Dirk Mewis
Keyword(s):  

Anbieter und Nachfrager rücken enger zusammen. Als Berater fungieren inzwischen auch Medizintechnikhersteller wie Siemens Healthcare, Medtronic oder Philips und beteiligen sich zunehmend an Forschungseinrichtungen.


2020 ◽  
Vol 21 (4) ◽  
pp. 290-303
Author(s):  
Z. Meziani ◽  
H. Hassaine ◽  
F. Belhachemi

Background: The significant increase in the use of implantable cardiac devices (ICDs) has been accompanied by biofilm formation and increase rate of infection on the devices. The purpose of our study is to describe the clinical and microbiological findings of infection of ICDs in the cardiology units of western Algeria hospitals. Methodology: All patients with clinical diagnosis of ICD infections or infective endocarditis upon removal of their ICDs from December 2012 to August 2014 in cardiology units of 4 Algerian hospitals were included in the study. Each element of the ICD pocket and lead was separately sonicated in sterile saline, inoculated onto Chapman and MacConkey agar plates and incubated aerobically at 37oC for colony count after 24 hours. Biochemical identification of the bacteria isolates was made by API 20E, API 20 NE and API Staph, and confirmed by Siemens Healthcare Diagnostics WalkAway® 96 Plus System. Antibiotic susceptibility testing on each isolate was performed by the disk diffusion method on Mueller Hinton agar. Biofilm formation was detected by Congo Red Agar (CRA) and Tissue Culture Plate (TCP) methods, and hydrophobicity of the bacterial cell was determined by the MATH protocol. Results: Over a period of twenty-one months, 17 ICDs were removed from patients with post-operative infections; 6 (35.3%) had early infection of ICD and 11 (64.7%) had late ICD infection. Fifty-four bacterial strains were isolated and identified, with coagulase-negative staphylococci being the predominant bacteria with 46.3% (25/54). There was no significant association between hydrophobicity and antimicrobial resistance in the 54 isolates but there is positive correlation between biofilm production and antimicrobial resistance, with the strongest biofilm producers resistant to more than one antibiotic. Four independent predictors of infection of resynchronization devices were reported; reoperation, multi-morbidity, long procedure, and ICD implantation. Conclusion: Our study is the first in Algeria to describe microbiological characteristics of ICD infection. The bacteria in the biofilm were protected, more resistant and tolerated high concentrations of antibiotics and thus played a major role in the development of ICD infections. Despite the improvements in ICD design and implantation techniques, ICD infection remains a serious challenge. Keywords: implantable cardiac devices, staphylococci, resistance, biofilm, hydrophobicity French title: Infections des dispositifs cardiaques implantables par des bactéries formant un biofilm dans les hôpitaux de l'ouest Algérien Contexte: L'augmentation significative de l'utilisation des dispositifs cardiaques implantables est un risque majeur d'augmentation du taux d'infection et donc du risque de formation d'un biofilm sur ce genre de dispositifs. L'objectif de notre étude est de décrire les résultats cliniques et microbiologiques de l'infection sur les dispositifs cardiaques implantables (DCI) dans les unités de cardiologie des hôpitaux de l'ouest Algérien. Méthodologie: Tous les patients cliniquement diagnostiqués avec une infection sur DCI, ou une endocardite infectieuse et ayant subit un retrait de leur dispositif cardiaque sont inclus dans cette étude et cela sur une période entre décembre 2012 et aout 2014 dans 4 unités de cardiologie. Chaque élément du DCI (boitier et sonde) est trempé séparément dans une solution saline stérile, ensemencé sur deux milieux de culture, un milieu de Chapman et un milieu MacConkey et incubé en aérobiose à 37°C pour la numération des colonies après 24 heures. L'identification biochimique des isolats de bactéries est effectuée par le API 20E, API 20 NE et API Staph, et confirmée par le système WalkAway® 96 Plus de Siemens Healthcare Diagnostics. Les tests de sensibilité aux antibiotiques de chaque isolat sont effectués par la méthode de diffusion des disques sur gélose de Mueller Hinton. La formation d'un biofilm est détectée par les méthodes de la gélose rouge du Congo (CRA) et de la plaque de culture tissulaire (TCP), et l'hydrophobicité de la cellule bactérienne est déterminée par le protocole MATH. Résultats: Sur une période de 21 mois, 17 DCI sont retirés de patients atteints d'infections postopératoires; 6 patients (35,3%) sont identifiés comme ayant une infection précoce sur leurs DCI et 11 patients (64,7%) ayant une infection tardive. Cinquante-quatre souches bactériennes sont isolées et identifiées, les staphylocoques à coagulase négative étant les bactéries prédominantes avec 46,3% (25/54). Il n'y a pas d'association significative entre l'hydrophobicité et la résistance aux antimicrobiens dans les 54 isolats, mais il existe une corrélation positive entre la production de biofilm et la résistance aux antimicrobiens, les plus puissants en biofilm sont résistant à plus d'un antibiotique. Quatre facteurs prédictifs indépendants d’infection des dispositifs cardiaques implantable sont retrouvés dans ce travail: ré-intervention, longue procédure, sujets multi-tarés, et implantation d’un DCI Conclusion: Notre étude est la première en Algérie à décrire les caractéristiques microbiologiques de l'infection des DCI. Les bactéries présentes dans le biofilm sont protégées, plus résistantes et tolèrent de fortes concentrations d'antibiotiques et jouent ainsi un rôle majeur dans le développement des infections par DCI. Malgré des améliorations dans les techniques de conception et d'implantation de DCI, l'infection des dispositifs cardiaques implantables reste un problème grave et très couteux. Mots-clés: dispositifs cardiaques implantables; staphylocoque; résistance; biofilm; hydrophobicité


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Hansen ◽  
C Bang ◽  
K G Lauridsen ◽  
C A Frederiksen ◽  
M Schmidt ◽  
...  

Abstract Introduction According to ESC guidelines, an acute myocardial infarction (MI) can be excluded without serial troponin measurements in patients presenting with a single high-sensitive troponin below the 99th percentile and chest pain starting >6 hours prior to admission. However, it is unclear if single-testing of high-sensitive troponin can rule-out MI in early presenters. Purpose To investigate the diagnostic performance of a single value of high-sensitive cardiac troponin I (hs-cTnI) at presentation for ruling-out MI in patients presenting with chest pain to the Emergency Department irrespective of chest pain onset. Methods We conducted a substudy of preliminary data from the RACING-MI trial. We included patients presenting with chest pain suggestive of MI to the Emergency Department of a Regional Hospital. We used the Siemens hs-cTnI (Siemens Healthcare, TNIH, Limit of detection: 2.21 ng/L) and a diagnostic cut-off value <3 ng/L to rule-out MI at presentation. Two physicians independently adjudicated the final diagnosis based on all clinical information. Patients were stratified based on time from chest pain onset to hospital admission as very early (0–3 hours), early (3–6 hours) and late presenters (>6 hours). Results We included 989 patients with available hs-cTnI results at admission. MI was confirmed in 82 (8.3%) patients. Using hs-cTnI <3 ng/L as diagnostic cut-off value at presentation, 302 (30.5%) patients without MI were classified as rule-out. Overall, the negative predictive value (NPV) for MI was 100% (95% CI 98.7–100). Based on chest pain onset, 33.8% of patients were classified as very early, 12.8% as early, and 42.7% as late presenters, with 10.7% patients with unreported/unknown onset. NPV was 100% (95% CI 96.5–100) for very early, 100% (95% CI 88.3–100) for early and 100% (95% CI 97.3–100) for late presenters. Conclusions Using a single hs-cTnI value <3ng/L as diagnostic cut-off to rule-out MI seems to be safe and to allow rapid rule-out of MI in patients presenting with chest pain to the emergency department, even in very early presenters. ClinicalTrials.gov Identifier: NCT03634384. Acknowledgement/Funding Randers Regional Hospital, A.P Møller Foundation, Boserup Foundation, Korning Foundation, Højmosegård Grant, Siemens Healthcare (TNIH assays), etc.


2017 ◽  
Vol 14 (02) ◽  
pp. 112-118
Author(s):  
Rüdiger Schulz-Wendtland ◽  
Sebastian Jud ◽  
Peter Fasching ◽  
Arndt Hartmann ◽  
Marcus Radicke ◽  
...  

Zusammenfassung Ziel Die Kombination verschiedener bildgebender Verfahren in Fusionsmaschinen verspricht, eine deutliche Verbesserung der Brustdiagnostik mit sich zu bringen. Hier wollen wir die Bildqualität und die klinische Anwendbarkeit eines Fusionsprototypen aus einem Standard-Mammografie/Tomosynthese-Gerät und einem Standard-3-D-Ultraschallkopf unter Zuhilfenahme einer neuen Methode der Brustkomprimierung evaluieren. Material und Methoden Für die Untersuchung an 5 Mastektomiepräparaten von Patientinnen mit histologisch gesichertem DCIS oder invasivem Mammakarzinom (BI-RADS™ 6) wurde an einem präklinischen Fusionsprototyp ein Ultraschallkopf eines ABVS-Systems aus einem Acuson S2000 in einen MAMMOMAT Inspiration (beide Siemens Healthcare GmbH) unter Zuhilfenahme einer neu entwickelten Kompressionsplatte integriert und digitale Mammografien und 3-D-Bilder per automatisiertem Ultraschall aufgenommen. Ergebnisse Die durch den Fusionsprototyp aufgenommenen digitalen Mammografien sind von vergleichbarer Qualität wie unter herkömmlicher Kompression entstandene Aufnahmen. Die neu entwickelte Kompressionsplatte hat keinen Einfluss auf die applizierte Röntgendosis. Der personelle und zeitliche Aufwand für die Mammografie unterscheidet sich nicht zur herkömmlichen Mammografie. Die Fusion aus Mammografie und Ultraschall lässt sich technisch umsetzen. Schlussfolgerung Die Fusion eines automatisierten 3-D-Ultraschallgeräts mit einem Standard-Mammografiegerät liefert an unseren wenigen Mastektomiepräparaten Mammografieaufnahmen von vergleichbarer Qualität. Darüber hinaus ermöglicht das Gerät den simultanen Ultraschall als 2. Bildmodalität der komplementären Mammadiagnostik ohne einen signifikanten Zeit- und zusätzlichen Untersucheraufwand.


2008 ◽  
Vol 13 (07) ◽  
pp. 11-11
Author(s):  
Jens Mau
Keyword(s):  

Das Forschungszentrum Jülich setzt neue Maßstäbe. Zurzeit installiert es einen Magnetresonanztomographen (MRT) mit einer Feldstärke von 9,4 Tesla – das entspricht beinahe dem 200.000-Fachen des Erdmagnetfeldes. Das Forschungszentrum hat das Großgerät mit dem Namen„9komma4“ gemeinsam mit Siemens Healthcare entwickelt.


Author(s):  
Madelon Noordegraaf ◽  
Albert Wolthuis ◽  
Frans Peters ◽  
Monique de Groot ◽  
Rein Hoedemakers

AbstractRheumatoid arthritis (RA) is a chronic inflammatory auto-immune disease affecting approximately 1%–2% of the population worldwide. RA is a potentially crippling disease since it results in malformation of the joints. RA is mostly diagnosed based on clinical manifestations but serological tests against autoantibodies, such as rheumatoid factor and anti-cyclic citrullinated peptides (aCCP), are available. The presence of aCCP antibodies is strongly associated with a more severe, destructive disease course. Recently, a new test for the measurement of aCCP antibodies on the IMMULITE 2000(XPi) platform was developed by Siemens Healthcare. In this study we investigated the performance characteristics of this new aCCP test in four different hospital laboratories and compared the new test with three different commercially available platforms.Samples were collected from patients presented to the hospital for aCCP measurement. Serum aCCP levels were determined by aCCP (Ig)G assay for IMMULITE 2000(XPi) systems (Siemens Healthcare), ImmunoScan RA enzyme-linked immunosorbent assay (ELISA) test (Eurodiagnostica), Immunocap 250 (Thermofisher) or aCCP IgG assay on the Modular system (Roche Diagnostics). The evaluation protocol consisted of within-run imprecision (20 sequential runs), between-run imprecision (16 workdays), comparison of serum and plasma measurement and method comparison.The within-run imprecision (n=20) for aCCP IgG assay on three different IMMULITE 2000(XPi) systems ranged from 3.0% to 6.9% at levels 3.2–171.2 U/mL. Between-run imprecision (n=16 days) ranged from 5.2% to 11% at levels of 3.2–106.9 U/mL. Method comparison showed good correlation when samples were measured on two different Immulite analyzers in two different hospital laboratories [0.21+0.96x (n=40)]. Method comparison of the IMMULITE 2000(XPi) aCCP test with aCCP on Immunoscan RA ELISA (n=112), Immunocap 250 (n=105) and the Modular system (n=289) resulted in a concordance of 90.2%, 93.3% and 94.8%, respectively. Correlation of serum versus heparin samples showed a correlation of 0.12+1.08x for the Immulite 2000(XPi) test.The aCCP assay on the IMMULITE 2000(XPi) has good performance characteristics and shows high level of concordance with the aCCP test on Immunoscan RA ELISA test, Immunocap 250 and the Modular systems.


2015 ◽  
Vol 20 (05) ◽  
pp. 59-59

Auf dem Kongress der Europäischen Gesellschaft für Radiologie (ECR) in Wien hat Siemens Healthcare ein neues PET-CT- Gerät präsentiert, das bei Untersuchungen ganz ohne „Stop-and-go“-Verfahren auskommt.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 20-20
Author(s):  
Brian F Poirier ◽  
Mary Robinson ◽  
Stefan Tiefenbacher ◽  
Erin McEwan ◽  
Caroline Cogswell ◽  
...  

Background:Emicizumab, a humanized bispecific antibody, has been approved for the prophylactic treatment of hemophilia A in patients with and without inhibitors. Both activated partial thromboplastin time (APTT) based FVIII:C and inhibitor assays, as well as select chromogenic FVIII:C assays have been reported to be affected in the presence of emicizumab. Aims:To assess the effect of emicizumab spiked at 0, 25, 50, and 100 ug/mL into congenital FVIII deficient plasma, containing FVIII inhibitor at 0, 1 and 5 BU, in seven commonly used APTT and chromogenic based FVIII:C assays. Samples were also tested in an APTT and chromogenic based FVIII Nijmegen inhibitor assay. Methods:Four IVD approved, APTT based FVIII:C assays and three chromogenic FVIII:C assays were evaluated (Table 1). In addition, FVIII inhibitor levels were measured by Nijmegen Bethesda assay using either APTT (Actin®FSL, Siemens Healthcare) or chromogenic based (FVIII Chromogenic Assay, Siemens Healthcare) FVIII:C assays. Results:Reagent and dose-dependent increases in FVIII:C were observed for all APTT reagents tested as well as for the BIOPHEN FVIII:C chromogenic assay. The presence of low or high titer inhibitors did not impact APTT based FVIII:C measured. Neither of the two chromogenic FVIII:C assays, using bovine based FX and FIXa (i.e. FVIII Chromogenic Assay and Coatest®SP4) demonstrated measurable FVIII levels at any of the emicizumab concentrations tested. FVIII Nijmegen Bethesda inhibitor results using APTT based FVIII:C, when tested in the presence of emicizumab, consistently produced false negative results (Table 1) whereas results determined using the FVIII Chromogenic Assay measured inhibitor titers at expected concentrations. Conclusion:Confirming previously published results, emicizumab interferes in the APTT based FVIII:C and Nijmegen Bethesda inhibitor assays. Even at low emicizumab concentrations, false negative inhibitor titers are measured in APTT based inhibitor assays. Using a bovine based chromogenic FVIII:C assay is imperative when measuring both FVIII:C and FVIII inhibitors in samples containing emicizumab. Disclosures Tiefenbacher: Laboratory Corporation of America Holdings:Current Employment, Current equity holder in private company;Novo Nordisk:Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Shire:Honoraria;Octapharma:Honoraria;Siemens Healthcare:Membership on an entity's Board of Directors or advisory committees;BioMarin:Membership on an entity's Board of Directors or advisory committees.


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