V O L 2 6 I S S U E 6 D E C E M B E R / J A N U A R Y 2 0 1 7 / 1 8 T H E E U R O P E A N F O R U M F O R T H O S E I N T H E B U S I N E S S O F M A K I N G H E A L T H C A R E W O R K RADIOLOGY Psychoradiology: brain MRI-mining 10-16 helps classify ADHD Optoacoustics: the sound of cells The DNA mismatch repair mechanism IT & TELEMEDICINE E-health developments in Spain Building an organisation’s 20-21 digital DNA The key to defeating cancer is knowledge dissemination Machine learning is promising Machine learning is playing an increasing role in computer-aided diagnosis, and Big Data is begin- ning to penetrate oncological imaging. However, some time may pass before it truly impacts on clinical practice, according to leading UK-based German researcher Professor Julia Schnabel, who spoke during the last ESMRMB annual meeting, Mélisande Rouger reports Machine learning techniques are start- ing to reach levels of human perfor- mance in challenging visual tasks. Tools such as the convolutional neural network (CNN or ConvNet), a class of deep neural networks that has been applied to analysing visual imagery, have become instrumental in segmentation tasks. Analysing such huge data is still a challenge However, a number of obstacles remain before adequate image analysis arrives, starting with the huge amount of data analysts must work with, according to Professor Schnabel, computational imaging expert at King’s College London. ‘In imaging, the challenges are that we work in 3-D or 4-D, and we have a lot of features to deal with. If we’re lucky, we deal with hundreds or thousands, but not millions of images, so we don’t have a high number of image data to work with. We have this whole sample size problem.’ The professor also identified the high associated cost and imperfec- tion of training data. Training data may be wrongly labelled, depend- ing on the expertise of the observer. Furthermore, machine learning is resource-intensive: only special- ists and consultants can perform special tasks. ‘I personally couldn’t distinguish a glass nodule from a semi-solid nodule. Only specialist consultants and expert radiologists Julia Schnabel PhD joined King’s College London, in the UK in July 2015 as Chair in Computational Imaging at the Division of Imaging Sciences & Biomedical Engineering, taking over the Directorship of the EPSRC Centre for Doctoral Training in Medical Imaging, which is jointly run by King’s College London and Imperial College London. She is also Visiting Professor in Engineering Science, at the University of Oxford. For segmentation in colorectal cancer with DCE MRI, Schnabel and team extracted variability of normalised signal intensity curves from the dataset using principal component analysis. ‘It’s a very sim- ple technique. We just looked at the mean signal intensity of curves embedded within an over-segmen- tation approach, called superpixels Continued on page 2 www.healthcare-in-europe.com CONTENTS NEWS & MANAGEMENT 1-5 SURGERY RADIOLOGY ULTRASOUND 6-9 10-16 17-19 IT & TELEMEDICINE 20-21 LABORATORY 22-23 DIGITAL PATHOLOGY 24 2-D view and 3-D volumetric rendering of contiguous perfusion-supervoxels for tumour parcellation defined on a 4-D dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) scan based on signal enhancement characteristics (Courtesy: Dr Ben Irving, ISMRM 2017) can do that,’ she pointed out. For a disease such as cancer, the image analysis team needs confirmation from pathology, which is often dif- ficult to obtain. For brain imaging, where different protocols exist, one sees different appearance of the same disease on different image protocols for the same patient and between patients. ‘Disease location and size of these pathologies may vary quite signifi- cantly, and the appearance of dis- ease may be very localised: it may be a very sharp “blob”, or it may be very diffused or infiltrated,’ she explained. Deep neural networks The professor shared practical advice on how to work with CNNs appropriately. She stressed the size of the receptive field of a CNN will determine the amount of informa- tion that will be obtained. ‘The size of patches used is important, since a large receptive field increases com- putation and memory requirements, and (max) pooling leads to loss of spatial information. In contrast , if you use very small patches, they are more susceptible to noise.’ As a solution, Schnabel points to using a multi-scale approach, i.e. having smaller patches operating on small filters and larger ones on larg- er filters, and putting them together in the end. Oncological image analysis brings challenges of its own. Machine learning-based segmentation often degrades when deployed in clini- cal scenarios. This is caused by differences between training and test data due to variations in scan- ner hardware and scanner protocols and sequences, Schnabel explained. ‘There is often an imbalance in the training or test data because of a dif- ferent ratio of healthy vs. pathologi- cal cases, individual patient variabil- ity and individual disease variability – also within the same patient. For example, lesions in the liver usually are a secondary cancer, caused by a primary cancer elsewhere, such as in the colorectum.’ Therefore, it is crucial to choose the appropriate network architec- ture. Currently three models in lit- erature are interesting: DeepMedic, FCN (in Deep Learning Toolkit) and U-Net, which owes its name to its ‘U’ shape. ‘These networks use different approaches and for all these, there is the good, the bad and the ugly,’ she pointed out. An ensemble of multiple models and architectures All three networks use CNN based approaches with good perfor- mance, but there are a lot of meta- parameters – more than input cases –, and the architecture and con- figuration influence performance and behaviour. The ugly part is that chosen models and parameters may be suboptimal of other data and applications. ‘Results and con- clusions may therefore be strongly biased,’ she said. One solution could be to use an ensemble of networks; one such example is ‘EMMA’ (ensemble of multiple models & architectures), for which performance is insensi- tive to suboptimal configuration and behaviour is unbiased by architec- ture and configuration.

N E W S & M A NAG E M E N T 3 New UK centre will develop light technologies A National Centre for Healthcare Photonics also be done by using time-resolved measurements of the spectrum.’ Other applications, Tom Harvey continued, include the opportunity to conduct skin cancer diagnosis without biopsy by using Optical Coherence Tomography and reflec- tance spectroscopy to image the suspect area on the skin; assessment of cardiovascular disease risk based on measurement of certain fluores- cent proteins in the skin; and in vitro and in-situ diagnosis of bacte- rial infections in the lung providing rapid diagnosis. In the United Kingdom, thermal imaging is already utilised to diag- nose problems with blood circula- tion or to detect inflammation in thyroid eye disease and to classify burns, whilst a project for in-vivo, in-situ imaging of bacterial infec- tions in the lung is at the clinical study phase. Further innovations are expected, Harvey said, as resolution of imag- ing systems improve, the trend for miniaturisation of optical systems continues, laser power increases as costs fall and Light Emitting Diodes become more powerful and avail- able with a wider range of emission wavelengths, further driving their adoption as a replacement to other light sources in medical use. The United Kingdom’s future National Centre for Photonics NCHP Experience the power of the Atellica Solution Eye examinations using photonics technologies can help to diagnose conditions early ods are non-contact and can be done in-vivo or in-vitro, with or without additional probes, contrast agents or other types of marker. ‘The aim is to help to improve the range and utility of photonic diagnostic methods available, with a focus on reducing the cost of manu- facture of those devices so as to be able to address established market trends, such as the move away from hospital-based and delivered services towards more local or per- sonal testing and diagnosis,’ Harvey said. ‘In general, the use of optical methods means less invasive and more accurate monitoring, diagnosis or location (imaging) of disease in the body. ‘In cancer diagnostics, differen- tiating between diseased and non- diseased tissues using non-contact optical imaging methods can be done in real time during laparo- scopic surgery by illuminating the target area with a diagnostic probe beam which measures the Raman or infra-red spectrum of the tissue, or by exciting and imaging fluorescent probes that bind to selected target tissue types. Tissue classification can Tom Harvey PhD is Strategic Programmes Manager responsible for Healthcare Photonics at the Centre for Process Innovation. His role aims to help companies with the translation of new photonic and printed electronic technologies into products and services for applications in Healthcare and Life Sciences. A Fellow of the Institute of Physics, he is an expert in these fields; before joining CPI he was employed in Industry for many years to develop displays, lenses, electronics and micro- fluidic components for a variety of uses. www.healthcare-in-europe.com Now available! Atellica® Solution:* Flexible, scalable, automation-ready immunoassay and chemistry analyzers engineered to deliver control and simplicity so you can drive better outcomes. A bi-directional magnetic sample transport that is 10 times faster than conventional sample conveyors The new standard in sample management—revolutionary technology that gives independent control over every sample An immunoassay analyzer that runs up to 440 tests per hour,† the industry’s highest productivity per square meter‡ Unprecedented flexibility with more than 300 customizable configurations including L and U shapes *Product availability will vary by country. †Dependent on test mix. ‡Versus leading IVD companies. Atellica is a trademark of Siemens Healthcare Diagnostics Inc. A91DX-9564-A2-4A00. © Siemens Healthcare Diagnostics Inc., 2017 siemens.com/atellicasolution

N E W S & M A NAG E M E N T 5 Advertorial Successful central patient monitoring Central alarm management of the Xenios console via the Philips IntelliVue MX800 patient monitoring sys- tem easily and efficiently achieves its goal through ‘a combination of safety and innovation,’ the manufactur- er reports. ‘The Barmherzige Brüder hospital in Regensburg and Xenios combine both in clinical practice.’ In clinical use since 2014, the console Xenios combines three therapies on one platform for the benefit of the patient and support of the user. After three years in clinical use, the Xenios console has estab- lished itself. However, those, who move around in daily clinical prac- tice will quickly realise that only everyday life defines the require- ments and poses new challenges, which can best be met by working hand in hand with users. Stephan Schroll MD PD, senior physician at the Barmherzige Brüder hospital in Regensburg, Germany, and Christian Hoff, clinical sup- port Xenios AG, are long-standing partners, who know and trust each other. This is the starting point for expertise and safety as shown with our example. The Barmherzige Brüder hospi- tal in Regensburg has a modern intensive care unit with 28 beds, which include 20 ventilation beds. Due to the historically grown situ- ation construction-wise, as well as the size of the intensive care unit, a central alarm registration is of great importance. the most ‘This also includes central mon- itoring of important parameters when performing an extra-corporal membrane oxygena- tion (ECMO) procedure,’ Stephan Scholl stresses. For this reason, a connection was installed between the Xenios console and the Philips IntelliVue MX800 central monitoring system. The connection can eas- ily be established via the interface of the central patient monitoring system (Philips Intellibridge EC10 Module) to the data interface of the console (Xenios console, iLA activve system). This ensures central moni- toring of the most important param- eters, such as blood flow and speed of the pump in the extracorporeal circuit at all times. Additionally, the most important pressure measurements are also centrally monitored in the ECMO system. By transferring the alarm settings of the Xenios console, no additional settings for central moni- toring are necessary. All settings are made automatically after connecting the interconnection cable. This a clear advantage, says Dr Stephan Scholl. ‘For us, the possibility of cen- trally monitoring important param- eters of the ECMO systems means additional safety for the patients and, at the same time, a reduced workload in everyday life of the intensive care unit.’ That is exactly one of the goals of Xenios AG, the company explains: ‘Safety in use and for the patient, bringing together innovation and support from experts for experts. From this, a continuous enhance- ment and progress results. In this concrete example, the alarm message is no longer optionally sent individually at the console in a room, but the messages are made accessible to the entire staff at a central point, for a whole team of therapists at the monitoring centre. ‘We, in clinical support, listen to the uses and bring the therapists’ experiences to our develop- ers and the entire Xenios team,’ Christian Hoff explains. ‘Hand in hand; together into a secure future; for the benefit of patients and for their safety.’ The Xenios console combines three therapies on one platform more precision and therefore, better outcomes.’ The conversion box does not impair the movement and zoom functionality of the endoscopes. Contact: http://www.medicaltek.biz/ Coming soon to a hospital near you? While some of the ‘Taiwan Excellence’ products are as yet only in the proto- type phase, others are already used in hospitals throughout Asia. Innovations such as the algorithm for tumour classification and the 3-D Conversion Box for endoscopes recently obtained FDA and CE clearance and thus will soon be admitted for use in USA and European hospitals. Many Taiwanese companies are actively seeking sales partners – no doubt, after Medica, some contacts will be eager to knock on Taiwanese doors. Taiwan External Trade Development Council Christina Lim, Tel: +886-2-2725-5200 E-mail: chlim@taitra.org.tw www.taiwanexcellence.org/index_en.html www.taiwantrade.com Taiwan Trade Center, Düsseldorf E-mail: dsdf@taitra.org.tw http://duesseldorf.taiwantrade.com Sonimage HSI has only eight buttons; everything else can be entered via the touchscreen ing room (OR) glasses, but a market launch is planned for 2018 because the necessary clinical studies have progressed well. Contact: http://www.surglasses.com/ Extra-dimension out of the box Technical innovations? Fair enough. However, they are of little value if hospitals do not have the neces- sary equipment to use them. This is where ‘MonoStereo’ by the ‘Taiwan Excellence’ winner MedicalTek comes in. This is a 3-D conversion box for endoscopes, as explained by Chairman Kai-Che (Jack) Liu. ‘The software we developed converts the monoscopic images from any current 2-D system and processes them in real-time to stereoscopic 3-D images.’ A strong point in favour of the product is the high degree of compat- ibility. ‘This is convenient for hospitals, because they already have all the necessary equipment,’ he points out. ‘Their endoscopy systems are simply connected to our conversion box. The depth is then perceived by the sur- geon via polarised 3-D glasses.’ 3-D endoscopic images not only improve visualisation of depth, they also flatten the learning curve. ‘Surgeons need to convert the 2-D endoscopic images to 3-D movements in their mind. For some, this takes up to two years to get used to,’ Liu explains. ‘Our system takes this addi- tional challenge away by adding depth to the images. This way, a surgeon only needs half an hour to get used to the endoscopic movement. Because it is a more natural way of percep- tion, the added depth also results in Germany. ‘Thermal technology is used, for example, in early warn- ing systems that are triggered when a critical temperature threshold is exceeded. Such a system, which uses cameras with integrated heat sen- sors, can detect infections in high- risk ICUs by identifying patients with fever. ‘Another potential field of applica- tion is monitoring hospital equip- ment: increased heat emission is often a sign of imminent failure, for example if there is mechanical fric- tion or when electrical components have a higher power consumption shortly before they break down. The system will detect and signal this unusual temperature increase early enough for maintenance work.’ ‘This Currently, thermal technology is being tested in a care facility in the Netherlands: a camera-controlled system warns the night watch staff of unexpected movement in patient rooms. technology makes repeated night watch rounds obso- lete’, says Lessmann, adding that this ‘increases flexibility and reduces pressure on the staff’. To ensure such a system respects patient pri- vacy, Mobotix designed a particular configuration. ‘All images recorded by the camera are pixelated. Only when the camera detects a potential emergency is the image recognisable and a signal is sent to the staff, who then check and decide whether an intervention is necessary.’ The initial feedback from a Dutch care facility is positive, above all ease of use and the practical help in daily routine are underlined. Thus the facility intends to expand the system. This seems to be another example where the approach ‘easy to use but customisable’ has borne fruit. www.healthcare-in-europe.com

S U RG E RY 7 VR glasses could ease trauma of waking up in an ICU A new therapy: virtual reality experiences Report: Madeleine van de Wouw A patient walks slowly into the Intensive Care Unit (ICU). He sits on a hospital bed, hears unfamiliar beeps and other sounds. Doctors and nurses arrive to talk about all the surrounding machines and how things work in an ICU. Everything is calm and without stress for the patient as he listens to them. Then the virtual reality (VR) glasses he is wearing are removed, and he returns to reality. The walkabout was a scenario. Its purpose was to deal with the traumatising effects of a sudden ICU admittance by having prior experience of being there. Dr Michel van Genderen, an intern at Erasmus MC, works at the Franciscus Gasthuis & Vlietland in Rotterdam, The Netherlands, where, in November 2017, he ini- tiated research into a method to help patients through Post Intensive Care Syndrome (PICS) by using VR. The project also includes Jolanda van der Wal, GZ-Psychologist at the same hospital, ICU specialists Evert-Jan Wils and Arjan Brouwers (Franciscus Gasthuis) and Jasper van Bommel (Erasmus MC). Why VR-Goggles? ‘Many patients are unexpectedly hospitalised and put into a coma in the ICU,’ van Genderen points out. ‘When they regain consciousness, patients speak of a “hole” in their memories. They awaken in an unfa- miliar surrounding with noises they don’t recognise; they see people they don’t know and are surrounded by equipment on which their basic existence depends. Besides that, the patient is unable to communicate, due to the use of a ventilator. Dr Elisabeth Le Prisé has been head of the radiation department at Eugène Marquis Cancer Centre in Rennes, France, since 2000. She has also presided over the Eugène Marquis management team since 2011. A former hospital resident, she is an oncologist and radiation therapist specialising in cancer centre medicine. ‘I’ve been working in this field for 30 years and, in the meantime, radiotherapy has taken a gigantic step ahead thanks to advances made in imaging and IT. The future will be MRI accelerators, and we would like to purchase one within the next three to four years,’ the radiologist added. improving For the time being, efforts should focus on software used for CyberKnife, she believes. ‘Definitions of regions of interest and treatment planning are time consuming compared with other conventional accelerators.’ www.healthcare-in-europe.com Michel van Genderen and a patient testing the glasses that could help treat Post Intensive Care Syndrome Research shows that many of them suffer from post intensive care syn- drome. They endure psychological problems, like anxieties, depression and returning nightmares. Physical complaints, such as fatigue and cog- nitive problems, like amnesia and concentration-problems also occur. These problems lead to a lower quality-of-life. ‘We think that, when a patient experiences the ICU through Virtual Reality he will be able to deal with all things that occurred in a better way, because he learns how he got into the ICU and what all the beeps mean. Virtual Reality is already being used to prepare patients for upcoming treatment, but for this project we use this technique as treatment after an unexpected event. Naturally one can’t prepare for such events.’ Post-intensive care syndrome ‘This is still relatively unknown and not much research has been done. The figures regarding the preven- tion of the Post Intensive Care Syndrome are not very reliable. International research shows that approximately 30 to 60 percent of ex-ICU patients have complaints. Research at the four hospitals in Rotterdam shows that 50 to 60 per- cent have serious issues. ‘We put two-and-a-half years in preliminary research before starting with VR. Initially we needed finan- cial resources. Luckily we received a fund of €45,000 from Stichting Coolsingel, which was used to develop the software.’ Other trauma processing methods ‘Sure, there are several forms like keeping a journal, reading brochures or watching information videos. This is not all very helpful to pro- cess the ICU treatment experience. A later visit to the ICU has shown to be more effective; however, that’s almost impossible to organise. With Cognitive Processing Therapy (CPT) and Eye-Movement Desensitisation Michel Egide van Genderen MD joined the ICU at Erasmus MC, Rotterdam, The Netherlands, in 2015, the same year in which he concluded his PhD. In 2016 he became an intern. In 2019 he will advance his training to become an intensivist. For his research, he aims to limit the impact of ICU re-admittance, and later to expand this understanding for other patient groups. He also wants to improve quality of care by training doctors and medical specialists to work with the technology he is using. and the images they see are of relax- ing surrounding, such as a forest, concert or other soothing scene or event. All patients receive the same personal guidance. Research results ‘We expect to have results by mid- 2018. If the results are positive, we can start to implement the meth- od in other hospitals. We want to do this regionally, in cooperation with and from the Erasmus MC. Most important is that we can help patients. ‘The fact that it is very effec- tive was shown with our first test patient, José Smit, aged 63. She developed psychological prob- lems after being committed to the ICU. After the treatment with the VR-exposure therapy she responded to have had a lot of help from it. She now sleeps and functions better. In the end, potentially it will reduce costs because patients will suffer less trauma. And there is the issue of the costs: aftercare will be less expensive. ‘Initially the hospitals must invest in this technology but, down the line, it’s also cost reductive for them. This research project might be a dif- ficult path for patients – but not as difficult as experiencing the trauma – and the potential outcome is big. If the research results show that VR can be used as a preventive means, the gain will be even larger. In a couple of years, this may become mainstream.’ and Reprocessing (EMDR) you are completely reliant on your own memory and associations, which are not there for these patients. ‘Using Virtual Reality is less dependent on memories and this may have a positive impact on patients. Many ex-patients have remarked that they feel out of con- trol and would like to be able to experience the ICU again, with the explanation and context. VR might give them back control.’ The research project This involves 50 patients at the Franciscus Gasthuis who were admitted to the intensive care unit (ICU) with sepsis (blood infection). On the fourth day after they are moved out of the ICU into a 16-bed ward, which provides five VR glass- es, the patients can request the use of VR-glasses for one week. They are randomly divided into two groups: 25 patients see images of the ICU. 25 are the ‘control’ group NOVALUNG KITS The integrated pressure sensors (IPS) elevate your patients’ safety to the next level. 1x1 Priming of the preconfigured kit requires just one person. Pump-driven priming in only two minutes. SAFE SIMPLE FAST L U N G A N D H E A R T T H S E I P A R E XENIOS AG | Im Zukunftspark 1 | 74076 Heilbronn, Germany Phone: +49 7131 2706-0 | Email: info@xenios-ag.com www.xenios-ag.com

S U RG E RY 9 Infection – defect – regeneration Joint infections are not to be underestimated can improve bone perfusion with the help of the Masquelet tech- nique,’ says the interim director of Heidelberg’s Clinic of Orthopaedics and Trauma Surgery. Today, due to periosteum induction bone defects of 20-25 cm heal well. ‘In addi- tion, locally applied high doses of antibiotics ensure that all bacteria are eradicated,’ Schmidmaier points out. ‘Masquelet used his technique solely for membrane induction and enhancement of perfusion, not to treat infections.’ Prior to the intervention cement is prepared in a bowl. ‘This makes the cement a bit more porous and the antibiotic is released better,’ Schmidmaier explains. Nonetheless, he also routinely works with ready-to-use products such as Copa G+V, for example in infected pseudarthrosis. ‘Bone cement loaded with a mixture of gentamicin and vancomycin,’ he explains, ‘catches up to 80 percent of all microbes.’ He recommends that, when plac- ing the bone cement, it makes sense to create irregularly shaped edges on the bone, ‘for the subsequent integration of the new bone, the bone cement should overlap onto the healthy bone material’. When the bone cement is removed after six to eight weeks, the objective is to spare the membrane. For harvesting graft material Schmidmaier favours RIA, a proce- dure that allows acquisition of large volumes (20-75 ml) of high-quality autologous bone tissue. ‘Research indicates,’ he points out that mor- bidity decreases with harvesting using the RIA technique.’ In conclusion, he says: ‘The Masquelet technique is suited for interventions with plates and nails but also in recent trauma. It makes sense from a biological point of view and the combination of gen- tamicin and vancomycin offers ben- efits. If a tissue sample is loaded with bacteria that do not respond to the antibiotics, the spacer can be replaced or a suitable antibiotic can be applied locally.’ Challenges in septic bone surgery k c o t s r e t t u h S / k n o w a r u B a h t t u S : e c r u o S RADBOOK The Guide to Imaging Technology The Guide to Imaging Technology and Informatics in Europe and Informatics in Europe and Informatics in Europe ment. In this, following thorough bone debridement and soft tissue coverage an antibiotic-loaded bone cement spacer is inserted into the bone defect. In a second interven- tion, the cement spacer is removed, without damaging the membrane, and the bone defect is filled with a mixture of BMP-7, tricalcium phosphate and endogenous bone. Bone tissue is harvested either from the iliac crest or via RIA tech- nique (Reamer-Irrigator-Aspirator). ‘Compared with other bone recon- struction methods the Masquelet technique is rather quick, even with large diaphyseal and metaphyseal femur or tibia defects,’ Marzi says. Unlike Masquelet himself, who did not apply antibiotics in order to avoid infection masking, Professor Gerhard Schmidmaier of the German University of Heidelberg uses the procedure to deliver bone cement and high doses of gentamicin and vancomycin. One advantage is improved per- fusion: ‘It’s amazing that today we www.healthcare-in-europe.com BOOK YOUR ENTRIES NOW! Showcase your products & solutions in our European guide to radiology equipment! Contact: https://european- hospital.com/contact/ index.html

R A D I O LO G Y 1 1 Multi-spectral optoacoustic tomography (MSOT) could help to detect cancer cells early Thus, liver studies, for example, are impossible. Ntziachristos’s colleague Razansky is particularly interested in the molecular level, the biochemical reaction in the cell. Whatever the individual research interests of the two scientists are, the overarching aim of the team is early detection of diseases and tracking of disease progression so as to save time-to- diagnosis and money and above all to help patients by improving prognosis. Additionally, the optoacoustic imaging pioneers think even further. They envisage new interdisciplinary fields of medical science and new areas of application, such as the diagnosis of inflammation or meta- bolic disorders and neurology. To test their ideas the research- ers successfully applied for Horizon 2020, the major European Union research and innovation programme for 2014 to 2020. Research carried out by Professor Vasilis Ntziachristos encompasses the development of new methods and devices for biological and medical imaging, focusing on innovative non-invasive approaches that visualise previously unseen physiological and molecular processes in tissues. His research also aims to translate these methods to advance biological discovery, accelerate drug development and offer efficient methods for diagnostics and theranostics. Ntziachristos studied electrical engineering at Aristotle University, Thessaloniki, Greece, and gained Master’s and doctoral degrees from the Bioengineering Department at the University of Pennsylvania, USA. He was assistant professor and director of the Laboratory for Bio-Optics and Molecular Imaging at Harvard University and Massachusetts General Hospital. He now directs the Biological and Medical Imaging Institute at Helmholtz Zentrum Munich, Germany. n e h c n ü M m u r t n e Z z t l o h m l e H – r a m O d a r u M : e c r u o S than four to five centimetres and the sound loses quality the deeper it moves into the tissue. ETIM 2018 After this year’s successful first congress about Emerging Technologies in Medicine (ETIM) in Essen, Germany, the organiz- ing committee sets the stage for the second edition on February, 16 and 17, 2018. The congress will again take place at the Lehr- und Lernzentrum of the medical faculty of University Hospital of Essen, Germany. The first day is dedicated to Artificial Intelligence and the second to Robotics. Key top- ics will include the role of artificial intelligence in diagnostics and the future of robot-assisted surgery. Advances in healthcare and medi- cal research are already strongly driven by information technology and engineering, the ETIM commit- tee points out. Technologies like individual genome sequencing or high-performance multiparamet- ric imaging generate exponentially growing datasets while contempo- rary data-mining techniques allow to extract valuable data from existing archives. These offer the opportunity for highly specific clinical decision making and personalized precision medicine. Further acceleration of medical innovation can be safely predicted. However, as complex chal- lenges often require complex solu- tions, these technologies demand an interdisciplinary approach between clinicians, computer scientists, engi- neers, researchers, healthcare provid- ers, legislators and many other disci- plines. The 2018 ETIM will therefore provide an opportunity for experts to get together. Detailed information is available at https://etim.uk-essen.de/. www.healthcare-in-europe.com Your Insight,Our SolutionsSonoVue® approved for detection of vesicoureteral reflux in paediatric patientsSUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT SonoVue 8 microlitres/mL powder and solvent for dispersion for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the dispersion contains 8 μL sulphur hexafluoride microbubbles, equivalent to 45 micrograms. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for dispersion for injection. White powder. Clear, colourless solvent. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications This medicinal product is for diagnostic use only. SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio. SonoVue should only be used in patients where study without contrast enhancement is inconclusive. Echocardiography SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or es-tablished cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation. Dop-pler of macrovasculature SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio. SonoVue increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment in adult patients. Doppler of microvasculature SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation. Ultrasonography of excretory urinary tract SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. For the limitation in the interpretation of a negative urosonography, see section 4.4 and 5.1. 4.2 Posology and method of administration This product should only be used by physicians experienced in diagnostic ultrasound imaging. Emergency equipment and personnel trained in its use must be readily available. Posology Intravenous use The recommended doses of SonoVue in adults are: B-mode imaging of cardiac chambers, at rest or with stress: 2 mL, Vascular Doppler imaging: 2.4 mL. During a single examination, a second injection of the recommended dose can be made when deemed necessary by the physician. Elderly Patients The dose recommenda-tions for intravenous administration also apply to elderly patients. Paediatric Patients The safety and efficacy of SonoVue in patients under 18 years of age has not been established for intravenous administration and use in echocardiography and vascular Doppler imaging. Intravesical use In paediatric patients the recommended dose of SonoVue is 1 mL. Method of administration For instructions on reconstitution of the me-dicinal product before administration see section 6.6. Intravenous use SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein. Every injection should be followed by a flush with 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection. Intravesical use After introduction of a sterile 6F-8F urinary catheter into the bladder under sterile conditions, the bladder is emptied of urine and then filled with saline (normal sterile 0.9% sodium chloride solution) to approximately one third or half of its predicted total volume [(age in years + 2) x 30] mL. SonoVue is then administered through the urinary catheter. Administration of SonoVue is followed by completion of bladder filling with saline until patient has the urge to micturate or there is the first slight sign of back pressure to the infusion. Ultrasound imaging of the bladder and kidneys is performed during filling and voiding of the bladder. Immediately following the first voiding, the bladder may be refilled with saline for a second cycle of voiding and imaging, without the need of a second SonoVue administration. A low mechanical index (≤ 0.4) is recom-mended for imaging the bladder, ureters, and kidney during ultrasonography of the urinary tract with contrast. 4.3 Contraindications Hypersen-sitivity to the active substance(s) or to any of the excipients listed in section 6.1. Intravenous use of SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome. SonoVue must not be used in combination with dobutamine in patients with conditions suggest-ing cardiovascular instability where dobutamine is contraindicated. 4.4 Special warnings and precautions for use Hypersensitivity reactions In the event of an anaphylactic reaction, beta blockers (including eye drop preparations) may aggravate the reaction. Patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. Intravenous use Patients with unstable cardiopulmonary status ECG monitoring should be performed in high-risk patients as clinically indicated. It is recommended to keep the patient under close medical supervision during and for at least 30 minutes following the administration of SonoVue. Use extreme caution when considering the administration of SonoVue in patients with recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarc-tion, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders because in these patients allergy like and/or vasodilatory reactions may lead to life threatening conditions. SonoVue should only be administered to such patients after careful risk/benefit assessment and a closely monitoring of vital signs should be performed during and after administration. It should be emphasised that stress echocardiography, which can mimic an ischaemic episode, could potentially increase the risk of SonoVue utilisation. Therefore, if SonoVue is to be used in conjunction with stress echocardiography patients must have a stable condition verified by absence of chest pain or ECG modification during the two preceding days. Moreover, ECG and blood pressure monitoring should be performed during SonoVue-enhanced echocardiography with a pharmacological stress (e.g. with dobu-tamine). Chronic obstructive pulmonary disease Caution is advised when SonoVue is administered to patients with clinically significant pulmo-nary disease, including severe chronic obstructive pulmonary disease. Other concomitant diseases Caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/or sepsis, hyperactive coagulation states and/or recent thromboembolism, and end-stage renal or hepatic disease, as the numbers of patients with those conditions who were exposed to Sono-Vue in the clinical trials were limited. Patients on mechanical ventilation or with unstable neurological diseases SonoVue is not suitable for use in ventilated patients, and those with unstable neurological diseases. Interpretation of voiding urosonography with SonoVue and limitations of use False negative cases can occur with voiding ultrasonography with SonoVue and have not been clarified (see section 5.1). Technical recom-mendation In animal studies, the application of echo-contrast agents revealed biological adverse reactions (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam. Although these biological side effects have not been reported in humans, the use of a low me-chanical index is recommended. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. 4.6 Pregnancy, lactation, and fertility Pregnancy No clinical data on exposed pregnancies are available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3 Preclinical safety data). As a precautionary measure, it is preferable to avoid the use of SonoVue during pregnancy. Breastfeeding It is not known if sulphur hexafluoride is excreted in human milk . However, based on its rapid elimination from the body via the expired air, it is considered that the breastfeeding can be resumed two to three hours after administration of SonoVue. Fertility No clinical data are available. Animal studies do not indicate harmful effects on fertility. 4.7 Effects on ability to drive and use machines SonoVue has no or negligible influence on the ability to drive and use machines. 4.8 Undesirable effects Adult population-Intravenous use The safety of SonoVue after intravenous administration was evaluated in 4653 adult patients who participated in 58 clinical trials. The undesirable effects reported with SonoVue after intravenous administration were, in general, non-serious, transient and resolved spontaneously without residual effects. In clinical trials, the most commonly reported adverse reac-tions after intravenous administration are: headache, injection site reaction, and nausea. The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < /100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).System Organ ClassAdverse Drug ReactionsFrequency CategoryUncommon (≥1/1,000 to <1/100)Rare (≥1/10,000 to <1/1000)Not known Cannot be estimated from available dataImmune system disordersHypersensitivity*Psychiatric disordersInsomniaNervous system disordersHeadache, paraesthesia, dizziness, dysgeusiaSinus headacheVasovagal reactionEye disordersVision blurredCardiac disordersMyocardial infarction**Myocardial ischemia**Vascular disordersFlushingHypotensionRespiratory, thoracic and mediastinal disordersPharyngitisGastrointestinal disordersNausea, Abdominal painSkin and subcutaneous tissue disordersPruritus, rashMusculoskeletal, connective tissue and bone disordersBack painGeneral disorders and administration site conditionsChest discomfort, injection site reaction, feeling hotChest pain, pain, fatigueInvestigationsBlood glucose increased*Cases suggestive of hypersensitivity may include: skin erythema, bradycardia, hypotension, dyspnoea, loss of consciousness, cardiac/cardio-respiratory arrest, anaphylactic reaction, anaphylactoid reaction or anaphylactic shock. **In some of the cases of hypersensitivity, in patients with underlying coronary artery disease, myocardial ischemia and/or myocardial infarctions were also reported.In very rare cases, fatal outcomes have been reported in temporal association with the use of SonoVue. In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome. Paediatric population - Intravesical use The safety of SonoVue after intravesical administration was based on evaluation of published literature involving use of SonoVue in over 6000 paediatric patients (age range 2 days to 18 years). No adverse reactions were reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 4.9 Overdose Since there have been no cases of overdose reported to date, neither signs nor symptoms of overdose have been identified. In a Phase I study doses up to 56 mL of SonoVue were administered to normal volunteers without serious adverse events being re-ported. In the event of overdose occurring, the patient should be observed and treated symptomatically. 5. PHARMACOLOGICAL PROPER-TIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Ultrasound contrast media. ATC code: VO8DA05. Sulphur hexafluor-ide is an inert, innocuous gas, poorly soluble in aqueous solutions. There are literature reports of the use of the gas in the study of respiratory physiology and in pneumatic retinopexy. The addition of sodium chloride 9 mg/mL (0.9%) solution for injection to the lyophilised powder followed by vigorous shaking results in the production of the microbubbles of sulphur hexafluoride. The microbubbles have a mean diameter of about 2.5 μm, with 90% having a diameter less than 6 μm and 99% having a diameter less than 11 μm. Each millilitre of SonoVue contains 8 μL of the microbubbles. The intensity of the reflected signal is dependent on concentration of the microbubbles and frequency of the ultrasound beam. The interface between the sulphur hexafluoride bubble and the aqueous medium acts as a reflector of the ultrasound beam thus enhanc-ing blood echogenicity and increasing contrast between the blood and the surrounding tissues. Intravenous use At the proposed clinical doses for intravenous administration, SonoVue has been shown to provide marked increase in signal intensity of more than 2 minutes for B-mode imaging in echocardiography and of 3 to 8 minutes for Doppler imaging of the macrovasculature and microvasculature. Intravesical use For ultrasonography of the excretory urinary tract in paediatric patients, after intravesical administration, SonoVue increases the signal intensity of fluids within the urethra, bladder, ureters, and renal pelvis, and facilitates the detection of reflux of fluid from the bladder into the ureters. The efficacy of SonoVue for detection/exclusion of vesicoureteral reflux was studied in two published open label single centre studies. The presence or absence of vesicoureteral reflux with SonoVue ultrasound was compared to the radiographic reference standard. In one study including 183 patients (366 kidney-ureter units), SonoVue ultrasound was correctly positive in 89 out 103 units with reflux and correctly negative in 226 out of 263 units without reflux. In the second study including 228 patients (463 kidney-ureter units), SonoVue ultrasound was correctly positive in 57 out of 71 units with reflux and correctly negative in 302 out of 392 units without reflux. 5.2 Pharmacokinetic properties The total amount of sulphur hexafluoride administered in a clinical dose is extremely small, (in a 2 mL dose the microbubbles contain 16 μL of gas). The sulphur hexafluoride dissolves in the blood and is subsequently exhaled. After a single intravenous injection of 0.03 or 0.3 mL of SonoVue/kg (ap-proximately 1 and 10 times the maximum clinical dose) to human volunteers, the sulphur hexafluoride was cleared rapidly. The mean terminal half-life was 12 minutes (range 2 to 33 minutes). More than 80% of the administered sulphur hexafluoride was recovered in exhaled air within 2 minutes after injection and almost 100% after 15 minutes.In patients with diffuse interstitial pulmonary fibrosis, the percent of dose recovered in expired air averaged 100% and the terminal half-life was similar to that measured in healthy volunteers. 5.3 Preclinical safety data Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction. Caecal lesions observed in some repeat-dose studies with rats, but not in monkeys, are not relevant for humans under normal conditions of administration. Intravesical local tolerance for SonoVue was also assessed. A single-dose study and a repeat-dose study, both followed by a treatment-free period, were performed in female rats with local toxicity evaluated through macroscopic and histopathological examination of both kidneys, ureters, the urinary bladder and urethra. It did not reveal any test item-related lesions in any of the examined or-gans, in particular in the urinary bladder, in both the single-dose and the repeat-dose studies. It was therefore concluded that SonoVue is well tolerated in the urinary tract in the rat. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Powder: Macrogol 4000, Distearoylphos-phatidylcholine, Dipalmitoylphosphatidylglycerol Sodium, Palmitic acid Solvent: Sodium chloride 9 mg/mL (0.9%) solution for injection. 6.2 Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 6.3 Shelf life 2 years. Once reconstituted, chemical and physical stability has been demonstrated for 6 hours. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user. 6.4 Special precautions for storage The medicinal product does not require any special storage conditions. For storage conditions after reconstitution of the medicinal product, see section 6.3. 6.5 Nature and contents of container Type I colourless glass vial containing 25 mg of dry, lyophilised powder in an atmosphere of sulphur hexafluoride closed with a grey butyl rubber stopper and sealed with an alu-minium crimp seal with a flip-off disc. A transfer system (MiniSpike). Type I clear glass pre-filled syringe containing 5 mL sodium chloride 9 mg/mL (0.9%) solution for injection. 6.6 Special precautions for disposal Before use examine the product to ensure that the container and clo-sure have not been damaged. SonoVue must be prepared before use by injecting through the septum 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to the contents of the vial. The vial is then shaken vigorously for twenty seconds after which the desired volume of the dispersion can be drawn into a syringe as follows: 1 Connect the plunger rod by screwing it clockwise into the syringe. 2 Open the MiniSpike transfer system blister and remove syringe tip cap. 3. Open the transfer system cap and connect the syringe to the transfer system by screwing it in clockwise. 4 Remove the protective disk from the vial. Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place. 5 Empty the contents of the syringe into the vial by pushing on the plunger rod. 6 Shake vigorously for 20 seconds to mix all the contents in the vial to obtain a white milky homogeneous liquid. 7 Invert the system and carefully withdraw SonoVue into the syringe. 8 Unscrew the syringe from the transfer system. Do not use if the liquid obtained is clear and/or if solid parts of the lyophilisate are seen in the suspension. SonoVue should be administered immediately by injection into a peripheral vein for use in echocardiography and in vascular Dop-pler imaging in adults or by intravesical administration for use in ultrasonography of the excretory urinary tract in paediatric patients. If SonoVue is not used immediately after reconstitution the microbubble dispersion should be shaken again before being drawn up into a syringe. Chemical and physical stability of the microbubble dispersion has been demonstrated for 6 hours. The vial is for a single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER Bracco International B.V. Strawinskylaan 3051 NL - 1077 ZX Amsterdam The Netherlands 8. MARKETING AUTHORISATION NUMBERS EU/1/01/177/002 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2001 Date of latest renewal: 24 April 2006 10. DATE OF REVISION OF THE TEXT 24/08/2017

R A D I O LO G Y In 335 high-risk lesions the system correctly diagnosed 97% as malignant Artificial Intelligence helps to detect breast cancer 1 3 ) L I A S C / n a m f r o D n o s a J : h p a r g o t o h P ( From left: Manisha Bahl MD is a breast imaging radiologist and director of the Breast Imaging Fellowship Program at Massachusetts General Hospital/Harvard Medical School in Boston, USA. After graduating from the Harvard School of Public Health with an MPH in Health Policy and Management, she completed a radiology residency and breast imaging fellowship at Duke University Medical Centre and joined the faculty at Massachusetts General Hospital/Harvard Medical School in July 2016. Regina Barzilay MD is a Delta Electronics Professor in the Department of Electrical Engineering and Computer Science and a member of the Computer Science and Artificial Intelligence Laboratory at the Massachusetts Institute of Technology. USA. Her research focuses on natural language processing, applications of deep learning to chemistry and oncology. Constance Lehman MD is a Professor at Harvard Medical School in Boston, USA, and chief of the Breast Imaging Division at MGH’s Department of Radiology. After graduating from Duke University and receiving medical and doctoral degrees at Yale University, she became Professor and vice chair of Radiology and division chief of Breast Imaging at the Seattle Cancer Care Alliance before her recent move to Massachusetts General Hospital. vide more targeted approaches to healthcare in general.’ It is hoped that MGH radiologists will begin incorporating the model into their clinical practice over the next year. ‘In the past, we might have recommended that all high- risk lesions be surgically excised, Lehman said. ‘But now, if the model determines that the lesion has a very low chance of being cancerous in a specific patient, we can have a more informed discussion with our patient about her options. It may be reasonable for some patients to have their lesions followed with imaging rather than surgically excised.’ The team – which also includ- ed Manisha Bahl, director of the Massachusetts General Hospital Breast Imaging Fellowship Program - says that they are working to fur- ther evolve the model and in future hope to incorporate the actual images from the mammograms and images of the pathology slides, as well as more extensive patient infor- mation from medical records. Scientists are using Artificial Intelligence to support more effective breast cancer detection. The researchers at Massachusetts Institute of Technology (MIT) Computer Science and Artificial Intelligence Laboratory (CSAIL), Massachusetts General Hospital (MGH), and Harvard Medical School, are using the machine learning system to predict whether breast lesions identified from a biopsy will turn out to be cancerous, Mark Nicholls reports The hope now is that this research could help reduce the number of unnecessary breast cancer surger- ies because it could pinpoint which lesions are cancerous more accu- rately and more efficiently. In the study, the system was information about trained on such lesions and looked for pat- terns among a range of data points, including demographics, family his- tory, biopsies and pathology reports. When tested on 335 high-risk lesions, it correctly diagnosed 97% as malignant. The researchers suggest that such levels of accuracy could lead to a reduction in the number of unnec- essary surgeries by more than 30%. While mammograms can detect cancers, there is also a risk of false positive results that can lead to unnecessary biopsies and surger- ies – often from ‘high-risk’ lesions that appear suspicious on mam- mograms and have abnormal cells when tested by needle biopsy. The researchers say patients have the lesion surgically removed but often it is benign and the operations were unnecessary. To address this, the team devel- oped the machine learning system to predict if a high-risk lesion identi- fied on needle biopsy after a mam- mogram will upgrade to cancer at surgery. ‘Because diagnostic tools are so inexact, there is an understand- able tendency for doctors to over- screen for breast cancer,’ Dr Regina Barzilay, MIT’s Delta Electronics Professor of Electrical Engineering and Computer Science, pointed out. ‘When there’s this much uncertainty in data, machine learning is exactly the tool that we need to improve detection and prevent over-treat- ment. ‘A model like this will work any- time you have lots of different fac- tors that correlate with a specific outcome. It hopefully will enable us to start to go beyond a one-size-fits- all approach to medical diagnosis.’ Using a method known as a ‘ran- dom-forest classifier’, the model resulted in fewer unnecessary sur- geries compared to the strategy of always doing surgery, while also being able to diagnose more cancer- ous lesions than the strategy of only doing surgery on traditional ‘high- risk lesions’. Dr Constance Lehman, Professor at Harvard Medical School and chief of the Breast Imaging Division at MGH’s Department of Radiology added: ‘To our knowledge, this is the first study to apply machine learning to the task of distinguishing high-risk lesions that need surgery from those that don’t. We believe this could support women to make more informed decisions about their treatment, and that we could pro- Elias A Zerhouni MD is a world re- nowned leader in radiology and medical research, who has helped change per- ceptions of the importance of imaging science within the global medical community, He is president of Global Research and Development at Sanofi, the Paris-based global pharmaceutical company in France. He has developed innovations in both computed tomography (CT) and magnetic resonance imaging (MRI) to improve diagnosis of cancer and cardiovascular disease. As director of the USA’s National Institutes of Health (NIH) from 2002 to 2008, Zerhouni launched the NIH Roadmap for Medical Research, an initiative designed to transform the translation of research into medical practice. in the 21st century. • Remain the key integrator that can improve healthcare for patients through imaging. • Participate in solving core scien- tific challenges of today. • Train and proactively mentor the next generation of radiologists, because they will represent the future of radiology in the 21st century. Dr Jonathan McNulty is Associate Dean for Graduate Taught Studies and Head of Subject, Radiography in the School of Medicine, University College Dublin, Ireland. He oversees more than 75 postgraduate programs and continuing professional development activities across the school. He is President of the European Federation of Radiographer Societies (EFRS), and Board Member since 2014. He chaired the Education Wing, a network of 59 educational institutions within the EFRS, and Vice- President from 2016-2017. imaging examinations and performing certain procedures traditionally done by medical doctors. ‘The impact radiographers can have on hospitals is dramatic. A lot of research shows that, when radiogra- phers take on advanced practices such as these, it can result in efficiencies, save time and money, and well trained radiographers have been shown to perform such tasks as well as radi- ologists. Ultimately radiographers may improve patient care by providing a more timely report in certain instanc- es,’ he said. Recognising radiographers’ skills could be pertinent in countries with an acute shortage of radiologists, based on the experience of coop- eration between radiographers and radiologists in the UK or Ireland, for example. In the end, a collaborative approach can only benefit healthcare, McNulty concludes. www.healthcare-in-europe.com

R A D I O LO G Y 1 5 Acceptance recognised in new recommendations MRI’s role in prostate cancer diagnosis A: Detection: Multiparametric MRI with T2-weighted image, ADC-map, high b-value image, and perfusion-map showing a large anterior prostate cancer in a patient with negative systematic biopsy B: Staging: Extensive seminal vesicle invasion and lymph node metastases on a coronal T2-weighted turbo spin echo (TSE) MR-image C: Active Surveillance: Tumour increase in size and aggressiveness (ADC-value decrease) in follow-up MRI in a patient with bioptic verified low-grad prostate cancer D: Recurrence: PSMA-PET/CT with parailiac lymph node metastasis on the left side Which diagnostic and imag- ing modalities do you use in PCa? ‘The PSA determination is the basic diagnostic tool for PCa check-up, but PSA is specific to the prostate gland and not prostate cancer. An elevation of PSA does not have to be associated with PCa, but when you use it wisely, it is an easy and excellent test for a preselection. ‘The role of PSA screening has been extensively discussed, especially in over diagnosis and over treatment, but trial results from large European studies have shown the relevance of this test. We are currently trying to figure out when it makes sense and in whom – in patients aged 40, 45, 50 or 55 years? ‘Ultrasound is the standard uro- logic imaging modality, but US has limitations in PCa detection. It is not so good for sensitivity or specificity, even combined with contrast agents. Currently none of these additional US-tools are recommended for pri- mary PCa detection. US is primarily used to guide biopsy. ‘Computed tomography (CT) only makes sense in combination with PSMA-PET, e.g. for PCa recurrence, or it may be chosen for pre-operative staging. CT is easily available and gives you an idea of metastases of bone lesion or lymph node metastasis in patients with extensive disease. But lymph nodes imaging is challenging, because they are often very small. CT is mostly not good at differentiating whether they are tumours or not in the prostate setting. ‘Mp-MRI is currently the best imag- ing tool for prostate cancer detec- tion, especially clinical relevant PCa. Qualitative mp-MRI is extremely promising for active surveillance and furthermore it is good for local stag- ing. It can also help in unclear cases or PCa recurrence. ‘PSMA-PET is the most promis- ing imaging tool for PCa-recurrence and may be used for detection in unclear cases with high PCa suspi- cion. Combination of PSMA-PET with MRI might be very nice, but PET/ MRI is rarely available and its clinical benefit remains to be demonstrated.’ Screening programs in Germany ‘The updated recommendation is that men of at least 45 years of age and a life expectancy of more than 10 years should be informed on the pos- sible benefits and drawbacks of early- detection measures of prostate cancer like PSA determination. ‘We are performing a huge national prospective multicentre randomised trial on early PSA screening in young men. Currently we have over 30,000 patients enrolled. The study is called PROBASE and we try to assess if it makes sense to measure baseline PSA for risk-adapting PSA screening. Screening must help lower mortal- ity. It only makes sense if you help people not to die or die later from that cancer. ‘PCa is most often a slow growing tumour, so that’s why screen- Lars Schimmöller MD is Associate Professor of radiology and head of the uroradiology working group at Düsseldorf University Hospital, Germany. His research fields include multiparametric magnetic resonance Imaging (MRI) of the prostate, image-guided prostate biopsy, hybrid imaging (e.g. PSMA-PET), urogenital radiology and cancer imaging. ing studies results need so long to show their value. You need at least 10 to 15 years approximately to show if a patient benefits from screening.’ What are PCa imaging risks? ‘Nationwide coverage of qualitative mp-MRI examinations and qualitative standardised reporting are two of the most important challenges in PCa imaging. Furthermore, the subsequent correct targeted biopsy is also a chal- lenge for urologists and radiologists. ‘A further issue is that the biology of prostate tumours is often multifocal and/or heterogeneous in histology, and sometimes hard to differentiate from inflammation or atypical stromal hyperplasia. It is also complex to determinate the possible metastatic clone with current technology. It’s cru- cial to differentiate tumours that are life limiting from those who are not. ‘Mortality in PCa is often due to late cancer detection or inaccurate diagnosis. But most tumours are not life limiting or can be treated. ‘Radiation risk, as a general limita- tion or challenge in radiology, is not a problem, because these patients are usually not young and MRI, as the best imaging tool, does not use radiation.’ LLars Schimmöller MD, associ- ate professor of radiology at Düsseldorf University Hospital, tackled current diagnosis of pros- tate cancer (PCa) and addressed tumour detection, staging, active surveillance and recurrence dur- ing the Medica Academy session on Imaging Update. He also high- lighted how MRI helps improve biopsies and avoid unnecessary surgery in PCa. Interview: Mélisande Rouger Asked about the latest advances in PCa diagnosis, Professor Lars Schimmöller spoke of ‘a remarkable change’ – the increasing role of magnetic resonance imaging (MRI) in routine clinical diagnosis. ‘In its updated guidelines, which will be published later this year, the German Society of Radiology notably insists on the importance of multiparametric MRI (mp-MRI) and MRI-guided biopsy for PCa diagnosis. ‘The new recommended technical approach is that mp-MRI can not only be used but also should be used in secondary PCa detection after nega- tive transrectal ultrasound (TRUS)- guided biopsy and before inclusion of patients for active surveillance, similar to international guidelines. Moreover, the German preliminary recommen- dations for 2017 state that mp-MRI can be used for primary PCa detection as long as quality standards are ful- filled. Based on these requirements, urologists can and should perform targeted biopsies of MRI suspicious lesions, by using either the cogni- tive approach (fusion of MRI and US in mind) with TRUS or software- based MRI-US fusion-guided biopsy approach. ‘Five to ten years ago, the standard was to just measure prostate-specific antigen (PSA) value, carry out digi- tal rectal examination, and then an ultrasound and US-guided systematic biopsy. The problem with systematic biopsy is that especially the anterior and apical parts of the prostate are not covered, and cancers missed or only partially captured with up to 50% false positive lower grade histology, so that you never know if higher- grade proportions of the tumour exist. ‘One of the big challenges in PCa is its biology. When you have multifocal tumour cells, which are quite com- mon, it’s hard to get the real imaging of where the index lesion is located. Performing an MRI-guided biopsy and an mp-MRI examination before biopsy to help prepare it enables it to hit a tumour with more precision. If you have quality mp-MRI, you can say with over 95% accuracy if there is clinical relevant cancer or not. ‘Also, if you carry out an MRI examination before you do a biopsy, you may discover the reason for high PSA value. Sometimes it may just be prostate enlargement or an infection. So carrying out an MRI scan may also avoid performing unnecessary biopsies. ‘Another significant advance in PCa diagnostics has been the use of prostate specific membrane antigen (PSMA) as a relatively new tracer to check PCa recurrence.’ www.healthcare-in-europe.com #MTF2018www.themedtechforum.euThe MedTech Forum is the biggest medical technology industry event in Europe. This three-day event brings together CEOs, healthcare disruptors and key opinion leaders to discuss future trends in the medical technology sector.''At MedTech vurope, the association representing the in vitro diagnostic (IVD) and medical devices (MD) industries in vurope, we are reshaping our annual Forum with the ambition of making it "the" vuropean medical technology event for health technology stakeholders.''Join us in Brussels ! Serge Bernasconi Chief Executive Officer, MedTech Europe

U LT R A S OU N D 1 7 The first ever guidelines on gastrointestinal ultrasound The EFSUMB’s nineteen GIUS recommendations The Past-President of EFSUMB and acting chair in the WFUMB Education Committee, Odd Helge Gilja MD, PhD, Director and Senior Consultant at National Centre for Ultrasound in Gastroenterology at Haukeland University Hospital, Bergen, Norway, is also a Professor at the University of Bergen. His interests are ultrasound, gastrointestinal (GI) motility, biomechanics of the GI tract, contrast-enhanced ultrasound, perfusion, registration of dynamic image sequences, advanced visualisation, medical imaging, functional dyspepsia, ultrasound microbubbles, targeted diagnosis and treatment. From 2001-07, he presided over the Norwegian Society for Diagnostic Ultrasound in Medicine. He has edited seven books and authored more than 230 scientific papers, as well as 60 popular science publications. ‘EFSUMB has ultrasound learning centres (ULCs) all across Europe, which are happy to take begin- ners, who can come to stay for two to four weeks and have training on ultrasound and specific topics, including GI tract ultrasound. The courses are designed for different levels - doctors need to update their skills constantly, even the most experienced professionals. ‘At UEG Week we provided post- graduate ultrasound courses, hands- on training sessions, and offer GI ultrasound specific training under supervision of an expert every day.’ GIUS training candidates ‘Anyone needs training who will use the modality, and that means radiol- ogists, radiographers, surgeons who can specialise in GI and internists – in some countries, internists also treat patients with GI disorders.’ noscopies by doing an ultrasound examination instead. It’s cheaper, safer, and you can obtain a lot of clinically useful information. ‘Doing endoscopy, you only see the surface, but with ultrasound you can see beyond the surface and estimate bowel wall thickness and what is beyond –lymph nodes, for example. ‘Avoiding colonoscopy means a more comfortable examination for the patient, and you can do ultra- sound beside or on an ambulatory basis. A first modality of choice, in some cases ‘The choice depends where you are in the world. In some African countries, doctors often use ultra- sound directly. In the USA, com- puted tomography tends to be the most widely used modality, whereas in Europe, the trend is to use ultra- sound first in a clinical setting. ‘There is a huge benefit in ultra- sound in that the clinician can do it immediately, without referring to a radiologist and subsequently hav- ing to wait for a report coming one week later. So you can gain a lot of information non-invasively directly at bedside.’ Bowel ultrasound needs training ‘Ultrasound of the GI tract is a little bit more advanced than liver and pancreas ultrasound. Air and bowel movement need specific training. So usually we recommend doing standard training on abdominal ultrasound first, and then progress to more advanced GI training. Ultrasound of the gastrointestinal (GI) tract is advancing with the development of elastography and con- trast agents. Odd Helge Gilja, director and senior consultant at the National Centre for Ultrasound in Gastroenterology at Haukeland University Hospital, Bergen, Norway, has worked with the technique for the past fifteen years. At UEG Week in Barcelona, Gilja presented new guidelines on GI ultrasound, now published by the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB). Mélisande Rouger reports A GI ultrasound examination usually starts in the right lower abdomen and often the appendix can be identified. In this image the appendix is shown behind the distal ileum and marked between the two green crosses with a diameter of 0.26 cm. If appendicitis is present, the diameter will increase above 0.6 cm. ject. Furthermore, EFSUMB is now updating both the CUES and general elastography guidelines.’ ‘There are many indications for ultrasound use here, but the main one would be inflammatory bowel disease, Crohn’s disease being the most important. US and the intestine: sparing invasive colonoscopies ‘You can spare a lot of invasive colo- The EFSUMB world’s first guide- lines on gastrointestinal ultrasound (GIUS) contain 19 recommendations on basic technical and clinical meth- ods to perform ultrasound of the GI tract including, for example, how to follow the small intestine, or how to use Doppler. ‘Elastography is well established in the breast, prostate, and most importantly the liver, for the diag- nosis of hepatitis B and C, and degree of fibrosis and cirrhosis,’ explains senior consultant and Professor Odd Helge Gilja, from Haukeland University Hospital, in Bergen, Norway. ‘Elastography is fairly new in GI tract, however. We use it to evalu- ate stiffness of tissue, and indicate if is more fibrotic or inflamma- tory, for instance in Crohn’s disease. Elastography will help us charac- terise and decide what treatment to chose: anti-inflammatory drugs when the tissue is soft, or to recom- mend surgery when there is pre- dominant fibrosis. ‘Contrast agents are also a rather new addition to GIUS. SonoVue has been used for almost twenty years in Europe, for the liver, pancreas and now GI tract. It gives a better understanding of blood perfusion of the GI tract in various diseases and enables depiction of vasculature or indicates inflammation in the tissue. Furthermore, it’s very helpful for abscess detection in and around the intestines. ‘Contrast agents and elastography are showing good results, so much that we can now give recommen- dations, and an increasing num- ber of papers support the use of these techniques, especially contrast agents. ‘New GIUS guidelines will be on Crohn’s disease and inflamma- tory bowel disease, and we have four more in the pipeline on GI conditions. It’s a really big pro- www.healthcare-in-europe.com

U LT R A S OU N D 1 9 Ultrasound device can now be smartphone size Emergency ultrasound training Training is at the heart of the biggest annual fair globally, thanks to the newly introduced Medica Academy sessions, i.e. full-day seminars that deal with practical questions, current techniques and advances in medicine. One of the hot topics tackled by the new format will be emergency ultrasound, with renowned experts such as Dr Wolfgang Heinz from Stuttgart giving hands-on training to use this modality. Dr Heinz training with ultrasound equipment Report: Mélisande Rouger In 2010 the German Society for Medical Ultrasound (DEGUM) intro- duced a curriculum on emergency ultrasound, a basic course for phy- sicians and medical staff with little to none experience in the modality. Seven years later, the program has become a reference in Germany, and about 60 courses are deliv- ered annually all across the coun- try – this year including Medica. Dr Wolfgang Heinz is head of inter- nal medicine at Clinic I, Karl-Olga Hospital GmbH in Stuttgart, and is among the DEGUM course instruc- tors. He chairs the seminar on Tuesday and invites every professional who has to deal with emergency patients to sign up, as ultrasound is central to emergency pathology diagnosis. ‘Ultrasound is particularly useful in detecting and differentiating condi- tions that could easily be missed were it not performed. It is a great tool for emergency physicians. For example in patients who are short of breath, one can differenti- ate within seconds whether pleural effusions, pulmonary oedema or pneumothorax is the cause. In the Fluid in the Douglas space after trauma Used in a rescue helicopter after trauma to rule out pneumothorax pre-hospital setting, ultrasound also helps to bring patients with free intra-abdominal fluid after trauma to the appropriate hospital,’ Heinz pointed out. The course offers both theoreti- cal and practical knowledge, and participants can immediately put in practice what they have learned, and to ask speakers questions. ‘Participants train by performing examinations on each other and car- rying out ultrasound-guided punc- ture using models. We teach them how to position the probe and share tips and useful content,’ Heinz said. The course adopts a practical approach and gives insight into protocols such as FAST, eFAST and FEEL, but also focus on various regions of the body – abdomen, thorax, etc. Emergency ultrasound is a very specific field, therefore Heinz rec- ommends physicians who are used to perform ultrasound examination in their daily practice to attend addi- tional emergency training. Ultrasound will often be key to support or question initial diagno- sis, and the general rule is to see as much as possible. ‘It’s become our motto as emergency physicians: the more you see, the more you know,’ Heinz said. You will definitely see more if you use ultrasound. It can give you core information and help you to use the right therapeutic approach because the diagnosis may be more accurate.’ According to Heinz, ultrasound is as mandatory as a laboratory test in an emergency patient – and it is the most available imaging modal- ity across all specialties. ‘You just need ultrasound when you meet the patient, and use it as an additional tool to broaden your diagnostic probability.’ Technology has prompted the widespread use of ultrasound in the emergency setting. Recent develop- ments have squeezed the size of the equipment to smartphone dimen- sions – and often found ways to insert it directly into a phone. ‘Ultrasound devices are so mobile and small that you can bring them anywhere – on a helicopter, sub- marine, cruise ship, at home, on Mount Kilimanjaro… wherever you want and for any situation. The patient does not have to come to be scanned with a big machine, but we can bring the equipment to the patient,’ he said. Notably, the German Air Rescue (DRF Luftrettung in German) has equipped its helicopter fleet with ultrasound devices. Also, for the past three years, its teams of doctors and paramedics have received train- ing through the DEGUM curriculum. Wolfgang Heinz MD heads internal medicine at Karl-Olga-Krankenhaus GmbH in Stuttgart, Germany, which he joined in 2014. His other interests include gastroenterology, diabetology, palliative care, infectious diseases, intensive care and emergency medicine and flight surgery. He is a DEGUM instructor for the Internal Medicine and Emergency Ultrasound level III course and represents the society’s working group on emergency ultrasound. For Heinz, it’s both challenging and motivating to teach such a wide variety of audiences. ‘It makes a big difference to teach experienced doc- tors or paramedics. The latter usu- ally don’t have deeper knowledge of human anatomy, so I have to explain things a bit differently.’ The DEGUM syllabus is a two- day training designed for everyone using emergency ultrasound – these may be orthopaedic and trauma sur- geons, anaesthesiologists who work within the ICU, internal doctors who work inside the emergency room, people who are underway as emer- gency physicians or part of a rescue team, paediatric doctors, and those in private practice. At Medica, participants only receive the first of the two-day train- ing, but may take the second day, which is entirely dedicated to echo- cardiography, on any other occa- sion, regardless of where or when. Typical emergency situation in Germany Mortality and morbidity reduction through AF ablation? CASTLE-AF has the answer! Learn more: www.castle-af.org Professor Dirk-André Clevert began his career at the MRI Diagnostics Institute Westend in the city of his birth, Berlin, Germany, and in the Department for Internal Medicine at the Waldkrankenhaus Gransee. He then worked as a specialist registrar in the Department of Radiology at Passau Hospital for three years. In 2003, he moved to Munich to join the newly founded (2004) Interdisciplinary Centre for Ultrasound at the Grosshadern Campus, University Hospital Munich. The centre coordinates all ultrasound activities in the hospital. As course director and congress president, he organises numerous national and international ultrasound courses and congresses. On the 80th founding anniversary of the Medical Faculty of Tbilisi State Medical University, as head of the Interdisciplinary Ultrasound Centre, the professor was awarded an honorary doctorate. ‘Sonography generates huge data volumes since we are dealing with moving images rather than stills. Consequently, in a first step, an image documentation standard has to be defined for the system to be able to learn anything at all. Furthermore the tumour classifications “benign” and “malignant” will not be sufficient to obtain valid results. A lot of work remains to be done!’ Neurologist Ignacio Hernández Medrano MD at Ramón y Cajal Hospital in Madrid, Spain, was elected one of the most influential healthcare professionals in 2016 by the specialised press for his work in HC systemic change due to information technology and big data use. He holds several masters in HC management, and he notably sits on the strategic board of Ramón y Cajal HC Research Institute. He gained a bachelor degree at the Singularity University (NASA, Silicon Valley) in 2014 and founded two emerging companies using artificial intelligence: Savana (electronic clinical records processing) and Mendelian (rare disease diagnosis and treatment). living conditions by using high impact technologies and a positive, exponential approach. ‘Technology is changing the lives of many people. Having an expo- nential approach means that we believe things will go much faster than we expect. This way of think- ing changed me; the future is much closer than what we believe. The future will come and it will be for the good; there will be associ- ated problems, of course, but it will improve people’s lives.’ Link: https://savanamed.com www.healthcare-in-europe.com

I T & T E L E M E D I C I N E 2 1 Knowledge dissemination is key to defeating cancer, says renowned expert Half of cancers can be avoided if institutions would exchange knowledge, according to Joxel García, executive director of the University of Texas MD Anderson Cancer Center in Houston, who opened the Center’s meeting in Madrid in October 2016. Report: Mélisande Rouger Technology has progressed enormously and there has never been that much knowledge of cancer to prevent it and find treatment tools. ‘We can prevent 50% of cancers approximately; and if we can’t do that, we can at least detect them in stage 1 or 2 instead of 3 or 4,’ Garcia stated in his inaugural lecture. But, he added, medicine is heterogeneous and its focus not well adjusted. ‘The current clinical care model is episodic, reactionary and very expensive; it varies from country to country. We concentrate on who finds the next cure and what is going to be the next silver bullet. In 20-30 years from now I think we’re going to look back and say: you guys did it wrong.’ For instance, health professionals know the cost of disease but do not have a value for a person’s health. ‘In population healthcare we can only talk of pathology; it’s a pathology- centric process. We have to combine the knowledge of scientists to be able to identify the real diagnosis and have people like me and others find a way to prevent that cancer from happen- ing.’ One way to do so is for healthcare providers to use models based on quality evidence-based decision sup- port, he argued. Editor-in-Chief: Brenda Marsh Art Director: Olaf Skrober Editorial team: Wolfgang Behrends, Lena Petzold, Marcel Rasch Senior Writer: John Brosky Executive Director: Daniela Zimmermann Founded by Heinz-Jürgen Witzke ISSN 0942-9085 Correspondents Austria: Michael Kraßnitzer, Christian Pruszinsky.China: Nat Whitney France: Jane MacDougall. Germany: Anja Behringer, Annette Bus, Walter Depner, Cornelia Wels-Maug, Holger Zorn. Great Britain: Brenda Marsh, Mark Nicholls. Malta: Moira Mizzi. Spain: Mélisande Rouger, Eduardo de la Sota. The Nether- lands: Madeleine van de Wouw. USA: Cynthia E. Keen, i.t. Communications, Lisa Chamoff. Subscriptions Liane Kaiser, Theodor-Althoff-Str. 45, 45133 Essen, Germany Subscription rate 6 issues: 42 Euro, Single copy: 7 Euro. Send order and cheque to: European Hospital Subscription Dept www.healthcare-in-europe.com across the world. One of the main issues in cancer research is knowledge dissemination. ‘There’s a lot of knowledge in a lot of pockets, but they do not exchange intelligence between them. Why don’t we share data and information?’ he suggested. A step in that direction, and a cur- rently highly discussed idea in popu- lation health, is to open clinical trials not only to people who can meet the criteria, but also to people who might have other diseases. Typically a medication approved by the FDA to go to a clinical trial comes out successfully in only two to three percent of patients who actually quali- fied for that trial, Garcia pointed out. ‘As soon as the drug goes into the market it has actually never been tested in people with asthma, diabetes or other chronic diseases. And then the drug fails and comes out of the market, and you’ve lost a billion dol- lars in research and 20 years of work.’ MD Anderson also plans to narrow the gap between providers to increase the number of available phenotypes. The centre’s US network tries to iden- tify locations that have other genomic pools to identify more mutations and see how those are affected in terms of phenotypes per se. Additionally, the institution is work- ing to create a digital platform for second opinion pathologists, because those specialists are cruelly lacking in many areas, including Africa, Asia, parts of Latin America and Eastern Europe, and the USA. ‘Several years ago we had areas in Connecticut where the diagnosis would come from a general surgeon. Endometriosis was diagnosed as ovarian carcinoma and A former four-star admiral in the USA’s Public Health Service Commissioned Corps and US assistant secretary for health in that service, since 2013 Dr Joxel García has been Executive Director of the MD Anderson Cancer Control and Prevention Platform in Houston, Texas, USA. He is also a member of the leadership team of the MD Anderson Moon Shots program. Prior to these endeavours, he served as president and dean at the Ponce School of Medicine and Health Sciences in Puerto Rico. a patient would have had three to four different chemotherapies, she was cured after six months… but she never had cancer. This should not happen in a community.’ Having predictive models compris- ing people’s genotypes and identify- ing which factors can amplify cancer risk, such as living area, are the future of medicine, not only in cancer but also chronic diseases, García believes. Screening services will have to adapt to the needs of a particular person, unlike the ‘utopic idea that people should have mammograms at this age, or a PSA test at this time. A lot of biomarkers will help and change the way we practice medicine,’ he believes. However policy makers must back up institutions so that communities can have more access to up-to-date healthcare. From left: Dr Joseph Khoury with Dr Juan Fernando García García MD, from the Anderson Cancer Center Madrid and Joxel García, MD Anderson Cancer Center Houston. MD Anderson’s Moon Shots pro- gram is an initiative that uses a trans- disciplinary approach to speed up the development of new treatments, diag- nostic methods and prevention pro- grams from scientific discoveries. The centre, which collaborates with com- munity hospitals and health systems in the USA and has a local branch in Madrid, has 13 moon shots, each dedicated to a particular cancer area. ‘If the knowledge we have today was applied effectively, it would reduce cancer mortality within the next five to 10 years of initiation of a moon shot project,’ García said quot- ing Ronald DePinho, president of MD Anderson Cancer Center. ‘What he meant is that our goal is to do what currently takes eight to 10 years in three to five years.’ The centre’s Moon Shots program notably inspired former US President Barack Obama, who announced a national cancer moon shot to cure cancer. On the US level the centre has managed to influence change in some states’ legislation regarding minors’ protection, for instance by forbidding youngsters’ access to tanning beds, a known risk factor for melanoma in younger populations. This remains a significant challenge in the US, according to García. ‘We have a trillion dollar system which is very ineffective; there’s a huge dispar- ity of knowledge, one of which is among physicians.’ One of the organisation’s aims is to help spread knowledge to non-spe- cialised centres through their network. The centre also cooperates with the WHO on prevention and control, and provides community based services and teleconsulting in nutrition, exer- cise, smoking, prevention, UV protec- tion and vaccination at various sites Solid IT hard ware and communication firm emphasises that it also ensures support for customers who want to integrate the medical product solutions into their own medical systems. ‘Adlink products also support multiple operating systems and include comprehensive and easy-to- use software packages and services,’ the manufacturer confirms. Medical panel computers The medical panel computers and monitors have been designed with optimum viewing capabilities and hygienic fully-sealed and eas- ily cleanable housings, suitable for patient vital sign monitoring, nurs- ing care, clinical diagnosis, PACS, anaesthesia monitoring and OR documentation. ‘The MLC 5 medical panel com- puter is designed for digitally inte- grated operating theatres to enable easy access to PACS images, EHRS and other relevant patient data. The device allows surgeons to man- age the patient’s vital parameters and other critical information dur- ing surgery’, Adlink explains. ‘The MLC 5 therefore is ideally used to simplify surgi- cal patient data monitoring with superior graphic processing capa- bilities.’ When Taiwan-based Adlink acquired Penta, the buyer benefited from 20 year’s experience in design and hard- ware manufacturing. Today, Adlink provides state-of-the-art computing products such as advanced TCA pro- cessor blades and platforms, com- pact PCI/PlusIO, VPX blades, indus- trial SBCs, motherboards and chas- sis, plus embedded flash storage, computer-on-modules, rugged small form factor SBCs & systems, fan-less embedded computer, wireless inter- net gateways, and SEMA cloud. The firm’s IMPS product lines include industrial mobile handheld com- puters, smart panels, smart touch computers, industrial & panel PCs, medical PCs & dis- play. All these products and components are governed by strict revision control, medical regu- lations and risk analy- sis, and the Printed by: WVD, Möhrfelden, Germany Publication frequency: bi-monthly Representatives China & Hongkong: Gavin Hua, Sun China Media Co, Ltd. 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L A B O R AT O RY 2 3 orders is important and indeed has been mandatory since 2005 because its long-term benefit EBM is well established. Similarly, LC-MS/MS has long been considered gold standard and indispensable in therapeutic drug monitoring and drug analytics. A more recent field of application is steroid analytics (e.g. cortisol, testosterone, 17-hydroxy-progester- one). Since cross-reactions, a well- known problem with the routinely used immunoassays, do not occur in tandem mass spectrometry, this procedure yields much better results and unambiguous clinically relevant information. LC-MS/MS is also use- ful for proteomic, metabolomic and steroid profiling in clinical routine and will surely enable the clinician to arrive not only at a faster but a more precise diagnosis. Increased precision On possible future applications in analytics, Weber said, ‘We already use conventional LC-MS/MS systems routinely for qualitative questions such as haemoglobin differentia- tion, thus closing an underreported diagnostic gap. Moreover, a num- ber of tumour markers and panels were described that can be detected with high sensitivity and specific- ity in plasma or urine with LC-MS/ MS. Synthetic peptides and metabo- lites, even in stable isotope-labelled forms, are easily available today, which is a precondition for wide- spread use of these methods in the short term. In my opinion, the increased use of mass spectrometry methods will significantly increase diagnostic precision.’ Dr Matthias Weber is a Consultant in Laboratory Medicine and General Medicine, as well as Clinical Mass Spectrometry in Karlsruhe, Germany. ometry early days of tandem mass spec- trometry (LC-MS/MS), the combina- tion of liquid chromatography (LC) and two mass analysers in mass spectrometry (MS/MS), he passed away before this technology con- quered clinical routine. High-performance tandem mass spectrometry The technique entails combining chromatographic separation with subsequent highly specific and sen- sitive detection. One crucial advantage of this meth- od is that, depending on the method, several values can be determined in one run. Other widely used meth- ods, such as immunoassays (ELISA, RIA), photometry or convention- al liquid chromatography (HPLC), are all highly specific and do not possess the same high degree of substrate specificity as LC-MS/MS. When used properly, the capital expense is quickly amortised, since high-performance analytical meth- ods can be established quickly with low operating costs for supplies and chemicals. Efficiency can be further increased by using fast UHPLC sepa- ration and commercially available open automatisation platforms. Newborn screening and drug monitoring What are the current and future fields of application of tandem mass spectrometry? According to Dr Matthias Weber, LaborDiagnostik, Karlsruhe, Germany (matthias. weber@labor-karlsruhe.de), new- born screening for metabolic dis- Christian Hötzl is founder and shareholder of Teco Medical Instruments, Production + Trading. Following an apprenticeship as a physics laboratory technician, he completed a degree course in medical technology at the Medical Technical Academy Esslingen, Germany. For the next six years, he worked for a medical devices manufacturer in Munich, Germany, initially as international head of service and later entered sales and development, his last role being acting production manager for coagulation analysers. In 1990, by buying the coagulation division, he founded Teco GmbH and has since successfully focused on worldwide distribution of his products. we may be accused of not having done enough against any predictable anomalous use.’ Therefore, the company has gone on the offensive and has developed a closed system for its own products. ‘Our devices only allow the use of certified, original cuvettes. After delivery to the end user these are scanned via a barcode system, or an RFID-tag. This identification prevents the use of other products.’ Risk analysis and safeguarding against any misuse may amount to a heavy workload, but Hötzl is opti- mistic. ‘We have more than twenty- five years’ experience in the market and will master this, despite all the bureaucracy.’ www.healthcare-in-europe.com www.gbo.com/preanalyticsGreiner Bio-One GmbH | Bad Haller Straße 32 | A-4550 KremsmünsterPhone: (+43) 75 83 67 91-0 | Fax: (+43) 75 83 63 18 | E-mail: office@at.gbo.com Simple sampling for different patient groups Easy sample transfer with integrated blood collection scoop No accessories necessary, such as capillaries or funnels Leakproof caps for safe transport Complete version particularly for automated analysis of the sampleEvery Drop CountsMiniCollect® Capillary Blood Collection System*System is currently not available on the U.S. market