2 M O N D AY @ M E D I C A POCT – clinical application, IT and technology Moving towards deeper diagnostics Just two decades ago, even though promising, point-of-care testing (POCT) was only used in hospitals and surgeries by a small number of specialists. Today POCT is in use throughout healthcare. During the third POCT- Symposium initiated and directed by Professor Peter B. Luppa, from Rechts der Isar Hospital, at Munich’s Technical University, EH asked him to forecast developments within the next decade. Looking to the future, Professor Peter Luppa said: ‘One clear trend is infectiology and, above all, molecu- lar diagnostics for infectious agents. Another major topic, already inten- sively discussed, is the continuous measurement of metabolites. This not only includes glucose but also other parameters that must be con- tinuously monitored on the intensive care ward.’ The Munich symposium focused on nine subjects, which included point of care management for chronic diseases, and POCT in developing countries. ‘Technical’ topics included advanced POCT technologies and applications, and Regulations and norms for POCT equipment. Is there a trend here? ‘The most important topic is clinical application. IT is important during the implementation of the clinical applications. Vice versa, we need the IT regulations to improve the avail- ability of POCT for the users. The regulatory aspect is therefore very important so that the developers can assess what’s possible; not every- thing that’s being developed can be used immediately for patients.’ Does this mean that new devices, procedures, solutions etc. should be developed in cooperation with the respective industries? ‘Yes. Any developments within the medical devices industry should in close cooperation, synchronously, so to speak, with the users, to verify the advantages of the technol- ogy and procedures. It is essential that the benefits and outcome for patients are taken into considera- tion and are clearly evi- dent.’ The two previous sym- posia (2012, 2014) were predominantly German events. This year saw greater inter- nationalism – languages were German as well as occur F K E f o y s e t r u o C English, over three days, speak- ers from nine different countries held lectures, and the exhibition was also international. During the symposium, it became apparent that two speakers, Dr H. Stekel, from Linz in Austria, and Dr R. Fried, from Zurich, Switzerland, spoke about national issues when it came to regulatory require- ments for POCT. Their respec- tive contributions were enti- tled requirements for POCT in Switzerland, and ISO 22870 in Austrian Practice. Is there still con- siderable work to do in Europe on the development of unified standards, definitions and values etc.? ‘Some European guidelines exist already. For example, the ISO 22870 is now not only used in all European countries but also world- wide. However, when it comes to the respective translation and imple- mentation into national laws there can be inconsistencies. This is why we took a closer look at these two countries. We saw that the ring trials carried out for quality assurance, for instance, are organised on a national level, i.e. EU law is being converted into national law. In some other countries, such as France, we can see that the conversion is organised in a different way. Is there European or international cooperation, for example work- ing groups, commissions, or com- mittees? ‘There are many active European and international committees in this field. It has become apparent that the Asian region needs to reposition itself, and we are working inten- sively on this. In the past, Asia has almost exclusively aligned itself with the FDA, based on the motto that whatever they approve automatically becomes licensed in Asia. But there has been a change here recently: both India and China, for instance, have now also developed analogue and national systems. ‘International cooperation is in good shape. The ISO norms are an excel- lent example here as, once they have been introduced, a country cannot really opt out again. However, the D O N ’ T M I S S MEDICA’S LABMED FORUM Wednesday, 15 Nov 2017 11.15 – 11.30 a.m. The lab comes to (and into) the patient Professor Peter B. Luppa Institut für Klinische Chemie und Pathobiochemie Klinikum rechts der Isar der TU München application is not compulsory, which means that national requirements can still be considered. In any case, it’s beneficial that ISO norms are now used as a foundation worldwide. ‘This trend is reinforced by the fact that the industry, which revolves only around a small number of manu- facturers here, is not interested in national solo efforts.’ During Medica, Professor Georg Hoffmann, from Trillium Verlag, will hold a four-day ‘LabMed e w a r b o t S . M : e c r u o S Professor Peter B. Luppa is head of the Central Laboratory and Blood Bank at the Rechts der Isar Hospital in Munich’s Technical University in Germany. His main scientific interest lies in the regulation of steroid metabolism and biosensorics, aiming to develop improved analytical- diagnostic procedures for autoimmune diseases. From this, POCT in the hospital developed as a further focus. He has published more than 125 contributions in is a co-editor of the first German specialist book on point-of-care testing (now in its 3rd edition). journals and international Forum Medica’. On 15 November you will preside over the topic ‘From point-of-care-testing to continuous monitoring’. Will this focus exclusively on POCT for dia- betes? ‘Obviously the focus will be on dia- betology, but we are not limiting ourselves and can also accommodate the interests of our participants. The event will be held for the first time and we are curious about how it will develop. Previously at Medica sev- eral working groups and symposia focused on POCT, when diagnostics still played an important part at this Düsseldorf-based event. That’s why we will now observe developments and draw our conclusions. ‘So, this time, we will mainly focus on continuous glucose monitoring. For other parameters that can be continuously monitored, such as lac- tate or other cardiac markers, the applications are still more straight- forward.’ Advancing lateral flow immunoassays ‘Lateral flow immunoassays (LFIs) have evolved rapidly in the past 30 years, from the original crude and simple qualitative tests, to more complex multi-analyte and quantita- tive assays,’ reports BBI Solutions, a firm that has been raising the per- formance of lateral flow tests with the development of technologies for next generation diagnostics. Award-winning signal enhancement technology ‘Developments in component mate- rials, antibody design, sample matrix handling and test fabrication have hugely expanded the potential of next generation diagnostics,’ the firm points out. ‘The launch of BBI Solutions Morffi signal enhancement technology significantly boosts signal intensity and increases the limit of detection, up to ten-fold, to achieve a shorter time-to-result. This award- winning technology is helping BBI’s customers to create the next genera- tion of high performance lateral flow immunoassays.’ BBI Solutions is now poised to enhance its diagnostic capabilities for lateral flow testing with smartphone readers pioneered by Novarum DX, the report continues. Revolutionising POCT Lateral flow immunoassays are ideal for point-of-care testing (POCT), allowing a simple and visual inter- pretation of results. However, the firm underlines, poor eyesight, inad- equate lighting or human error can result in false positives or negatives and this establishes the need for a more reliable and accurate way to assess test results. Acquired by BBI Group in 2016, Novarum set out to address this issue by harnessing the power of today’s smartphone technology to revolu- tionise POCT and the interpretation of diagnostic results. ‘Novarum works with diagnostic firms and pharmaceutical companies to develop mobile medical apps spe- cific to each POC test, using patented image-capture software to transform a patient’s smartphone into an accu- rate test reader. Results can also be shared with healthcare professionals, safely and securely, enabling early diagnosis and empowering patients to manage conditions from their own home.’ Shaping the future of lateral flow Combining full traceability and lab- quality results with advanced data BBI Solutions is at Medica Hall 3A / Stand 3AB02-1 Left: Image-capture software transforms a patient’s smartphone into an accurate test reader Lateral flow immunoassays have evolved rapidly in the past 30 years, from simple qualitative tests to more complex multi- analyte and quantitative assays sharing is expanding the potential of POC testing, and offers a future of improved, customercentred health- care, supported by the smartphones we carry in our pockets. Developing this technology is the next step in BBI’s commitment to helping cus- tomers to embrace the evolution of lateral flow immunoassays, and deliver solutions that enhance POC diagnostic testing. EH @ MEDICA No 1 2017 Made in Francewww.ecmscan.comECHO CONTROL MEDICALPortable ultrasound Hall 9 Stand B 47

4 M O N D AY @ M E D I C A ‘We must act now – or we may run out of options’ Antibiotics don’t generate large profits of open borders and changes in travel habits. Holidays abroad and working on different continents have become the norm. However, this also means that locally occurring infec- tions no longer remain local. Beniam Ghebremedhin MD is a Specialist in Microbiology, Virology and Infection Epidemiology at the University Hospital Wuppertal, Germany. He is also a member of the German Committee on Antimicrobial Susceptibility Testing (NAK), which is a national subdivision of the European Committee on Antimicrobial Susceptibility Testing (EUCAST). Where some substances used to be effective for up to ten years, this is now wishful thinking.’ Is the pharmaceutical industry active in this area? ‘Not as much as we’d like it to be; unlike cancer drugs, antibiotics don’t generate large profits. Investment in studies is expensive, and treat- ment with antibiotics is not always comprehensive enough to regain the money invested.’ Another major problem: violation of hospital guidelines on infec- tion prevention and control. ‘Correct – and hand hygiene is criti- cal here. This could help avoid a third of all transmissions of pathogens. Many places now have specially trained nurses who work in this field. Unfortunately, they have to fight obstinate colleagues on a daily basis. However, hygiene knows no hierar- chy and a bacterium is not interested in chains of command. We must act now – otherwise we may well run out of options in the fight against multiresistance.’ tubes or funnels is in the past, thanks to this system because the blood collection scoop is integrated into the wide tube opening. ‘The sample comes into contact with the addi- tive immediately,’ the manufacturer reports. ‘The caps are completely sealed, meet the highest standards and can easily be sent via pneumatic dispatch or other transport systems without losing any sample material.’ Carrier tubes and combined filling volumes The MiniCollect capillary blood collection system EH @ MEDICA No 1 2017 During our European Hospital interview with specialist in microbiology, virology and infection epidemiology Beniam Ghebremedhin MD, from the University Hospital Wuppertal, spoke about the impact of migration on infections, and ways to tackle the problem of multiresistant pathogens ‘There is a lack of specialists in infectious diseases, for direct patient care on hospital wards as well as in the field of infectiology and diagnos- tics,’ infections specialist Dr Beniam Ghebremedhin agreed. ‘We are also short of specialists in infection prevention and control, along with microbiologists and virologists. In these times of multiresistant bacteria and large-scale microbial infections we should be promoting and sup- porting a new generation of spe- cialists to strengthen research and diagnostics.’ This June, the EU published guide- lines on dealing with antibiotics to help contain the spread of resistance. Could this help? ‘The topic is of great importance as there are still many areas where anti-infectives are prescribed too quickly and not in a targeted man- ner. Due to time constraints in out- patient care for instance, antibiotics D O N ’ T M I S S MEDICA’S LABMED FORUM Thursday, 16 Nov 2017 02.50 p.m. – 03.15 p.m. Detection tools for carbapenemase-producing gram-negative bacteria Dr Beniam Ghebremedhin Universität Witten/Herdecke, HELIOS Universitätsklinikum Wuppertal k c o t s r e t t u h S / a v o k h s e P : e c r u o S Worldwide migration of viruses and bacteria is on the rise partly because taking holidays abroad and working on different continents has become the norm are often prescribed so that patients can be treated as quickly as possible. However, Amoxycillin or Cefuroxim are the wrong drugs to treat viral infections. There should be much more emphasis on treating patients with more precision, and on adapt- ing treatment to their individual risk factors. ‘Apart from the EU guidelines, there are already other recommen- dations on how adequate treat- ment should commence, such as the “Tarragona Strategy”. This is the basic concept for adequate, initial treatment of bacterial infections with antibiotics. It includes the recom- mendation that the patient should receive a systematic examination if there is a lack of relevant informa- tion, such as where the patient is from and their local epidemiology (frequency of infections and resist- ance), because appropriate treatment cannot be given when these factors are not known. The focus should be on the dose, length of treat- ment and monitoring, along with the severity of the disease, all of which also requires as much information as possible about the patient. It is criti- cal for the prognosis that adequate treatment commences without delay and with a high dose.’ At Medica 2017 you will focus on ‘Emerging pathogens and mul- tiresistance in the age of migra- tion’. Why? ‘Viruses and bacteria know no bor- ders. Worldwide migration is very much on the increase, not only as waves of refugees but also because A pathogen such as an influen- za virus can quickly spread globally. Bacteria are carried from one country to another in suitcases. If we want to treat patients correctly we therefore need to know where they are from, which pathogens they could have brought with them, or which multi- resistant pathogens they may have been exposed to. ‘This is of particular importance in the case of multire- sistant pathogens. In my lecture, I will talk about gram-negative bacteria such as Escherichia coli, Klebsiella pneumoniae or Acinetobacter bau- mannii, all of which have taken on greater significance. The latter in particular has made the headlines, in Kiel for instance and in Stuttgart at the beginning of this year.’ What can be done against multi- resistant pathogens? ‘This is a very important and also difficult question. Germany must definitely improve its procedures for infection prevention and detection. Infected patients need to be isolated earlier. In the Netherlands, the isola- tion of risk patients on admission is standard practice, in Germany; how- ever, the capacities for isolation pro- cedures are often insufficient. This is a strong point of criticism, as things are getting serious: the last weapons we can utilise in the fight against multiresistant pathogens are becom- ing ever blunter. New anti-infectives are rarely approved and only have specific effects. Around thirty new substanc- es are currently being examined in studies, but only four or five of those are likely to make it to the market. However, rather than multi-purpose weapons, these will be substances working against very specific patho- gens only. Furthermore, resistance is developing much more quickly now. Refined capillary blood collection Small tubes, great impact Drives of the Future FULL DRIVE POWER WITH THE NEW a i l o t o F - o t o h p 9 7 2 @ MEGAMAT 12 • High safety level by self-locking • Easy and safe automized cleaning and decontamination • Easy use of safety functions such as integrated emergency release • High comfort thanks to a silent operation JOIN DEWERT AT MEDICA: HALL 14, STAND D34 The capillary blood collection system not only benefits geriatric patients, or those who need regular blood sam- pling, but also burns victims and oth- ers, including the youngest patients. All need a gentle approach. To that end, Austrian firm Greiner Bio-One has developed and optimised its MiniCollect system. No more tubes and funnels The cumbersome process of transfer- ring the drop of blood using capillary Greiner Bio-one is at Medica Hall 03 / Stand F72

6 M O N D AY @ M E D I C A Ultrasound device can now be smartphone size Emergency ultrasound training Training is at the heart of the biggest annual fair in the world, 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. Report: Mélisande Rouger In 2010 the German Society for Medical Ultrasound (DEGUM) intro- duced a curriculum on emergency ultrasound, a basic course for physi- cians and medical staff with little to none experience in the modal- ity. 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 Fluid in the Douglas space after trauma Lung contusion after trauma 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 differentiate within seconds whether pleural effusions, pulmo- nary oedema or pneumothorax is the cause. In the pre-hospital set- ting, ultrasound also helps to bring patients with free intra-abdominal fluid after trauma to the appropriate hospital,’ Heinz pointed out. The course offers both theoretical and practical knowledge, and partici- pants 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 pro- tocols 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 recom- Dr Wolfgang Heinz giving hands-on training with ultrasound equipment Prehospital ultrasound in rescue helicopter after trauma to rule out pneumothorax mends 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 diagnosis, 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 addition- al 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 YOU NEED RELIABLE PATIENT INFORMATION. WE PROVIDE IT SECURELY, ANYTIME & ANYWHERE VISIT KONICA MINOLTA IN HALL 9 – BOOTH D68 Ultrasound Business Process Optimization Immunoassay Digital X-ray Wound care Mobotix Konica Minolta Business Solutions Europe GmbH / medica.konicaminolta.eu Wolfgang Heinz MD is head of internal medicine at Karl-Olga-Krankenhaus GmbH in Stuttgart, Germany, where he worked since 2014. Beyond internal medicine, his 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 III course and a representative of the society’s working group on emergency ultrasound. level insert it directly into a phone. ‘Ultrasound devices are so mobile and small that you can bring them anywhere – on a helicopter, subma- rine, 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 training through the DEGUM curriculum. 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 occasion, regardless of where or when. Typical emergency situation in Germany EH @ MEDICA No 1 2017

8 M O N D AY @ M E D I C A Acceptance recognised in new recommendations MRI’s role in prostate cancer diagnosis Lars Schimmöller MD, associate professor of radiology at Düsseldorf University Hospital, will tackle current diagnosis of prostate cancer (PCa) and address tumour detection, staging, active surveillance and recurrence during the Medica Academy session on Imaging Update. He will also highlight how MRI helps improve biopsies and avoid unnecessary surgery in PCa. Interview: Mélisande Rouger Asked about the latest advanc- es in PCa diagnosis, Professor Lars Schimmöller spoke of ‘a remarkable change’ – the increasing role of mag- netic resonance imaging (MRI) in rou- tine 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 recommenda- tions for 2017 state that mp-MRI can be used for primary PCa detection as long as quality standards are fulfilled. Based on these requirements, urolo- gists can and should perform targeted biopsies of MRI suspicious lesions, by using either the cognitive approach (fusion of MRI and US in mind) with TRUS or software-based MRI-US 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 fusion-guided biopsy approach. ‘Five to ten years ago, the stand- ard was to just measure prostate- specific antigen (PSA) value, carry out digital 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 histol- ogy, 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.’ Which diagnostic and imaging 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 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. 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 prom- ising for active surveillance and fur- thermore it is good for local staging. 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 suspicion. 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 nation- al 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 mortality. 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 screening stud- ies 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 multifo- cal and/or heterogeneous in histology, and sometimes hard to differentiate from inflammation or atypical stromal hyperplasia. It is also complex to deter- minate the possible metastatic clone with current technology. It’s crucial 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.’ EH @ MEDICA No 1 2017

1 0 M O N D AY @ M E D I C A ‘It’s popping up everywhere. Is this a good thing?’ Bring your own ultrasound Pocket ultrasound accelerates diagnosis at the point-of-care reducing the role of the radiologist, John Brosky observes e t i s o n o S f o y s e t r u o C You can buy a pocket ultrasound probe online, download an app to your smart phone and start making your own diagnoses of joints and organs. ‘It’s popping up everywhere. But is this a good thing?’ asked Michael Bachmann Nielsen, a radiologist at the Rigshospitalet in Copenhagen, during a session dedicated to hand- held ultrasound at the European Congress of Radiology (ECR). Helmut Prosch, a radiologist with Medical University of Vienna, added that pocket probes are ‘used by many, but understood by few. As radiolo- gists we don’t see the usefulness of these devices, yet we are surrounded by colleagues using them.’ The chairman of the special ECR session, Michel Claudon, from the University Hospital in Nancy, France, suggested: ‘Our goal is not to stop people from buying, but to train them in how to use their device.’ Quick answers to specific questions Point of care ultrasound (POC) exams can quickly answer a specific clinical question, to send patients along care pathways rapidly. Examples of already established exams include focused assessment with sonography in trau- ma (FAST), bedside lung ultrasound in emergency (BLUE), and the focused echocardiography in emergency life support (FEEL). The handheld portable ultrasound device segment is expected to be the fastest-growing niche in the over- all ultrasound market, increasing at a 13.1% compound annual growth rate through 2022. Enabling the trend toward pocket ultrasound is the wide acceptance in healthcare for bring-your-own-device (BYOD). Changes in device design According to a study by IT network provider Cisco Systems Inc, based in San Jose, California, by 2013 some 88% of healthcare workers used their smart phones or tablets at work, with the tacit agreement of their institu- tion. This has led to a key shift among device design to throw out dedi- cated ultrasound viewers and enable scans to be viewed on personal BYO de vices, which most often have a higher resolution of the image. Bachmann Nielsen provided an overview of the leading devices used in the western world, noting he did not include the surge in such devices coming out of Asia. Courtesy of GE Device overview The Vscan from GE Healthcare is one of the original devices in the segment, and the company holds the leading market share. The 14-ounce Vscan Extend is the latest version, intro- duced in 2016 with a five-inch touch screen for the dedicated viewer a per- manently attached probe. The Vscan Extend offers, in a single handle, dual transducers, a phased or linear array enabling either shallow views of tissue or a deeper look into organs. In 2014, Philips Healthcare intro- duced the Lumify smart-device ultra- sound that is compatible with any handheld computer or phone run- ning the Android operating system. The commercial USA launch came in 2015. The BYOD approach offered by Philips includes a subscription model for $199 per month for qualified healthcare professionals to scale their ultrasound solution to meet their needs without having to purchase imaging equipment. Pre-set exams in the app and three different probes enable use in acute and emergency care, internal medicine, or muscu- loskeletal exams for orthopaedics, sports medicine and podiatry, as well as rou- tine medical office practice. Clarius Mobile Health is riding the BYOD wave offering the first mobile ultrasound scanner with an application for both iOS and Android devices. At ECR the company was launching its commercialisation in the European Union of the handheld, wireless Clarius C3 and the Clarius L7 multipurpose ultrasound transducers that talk to the everyday technology onboard personal, off-the-shelf smart devices. ‘We take advantage of the latest screen technology available on mobile devices, which has an appeal for radiologists with the high quality resolution and display,’ said Neena Rahemtulla, the vice president for marketing. Fujifilm SonoSite offers the iViz, a seven-inch tablet with two cabled transducers that stands out for its one-hand navigation of the touch screen and a superior 1900 by 1200 pixel image user interface, though it is hefty at 20 ounces. Mobisante offers the Mobus SP1 System viewer that weighs less than 12 ounces as a dedicated system of transducer, cable and viewer, but also introduced the Mobius PE, that can run on any Windows-based device. s p i l i h P f o y s e t r u o C Capturing precise colour and image detail in surgery The new MKC medical grade camera platform A new MKC 4K Camera platform is on show at Medica this year. ‘This includes a newly designed CCU to drive a 4K native 1-CMOS head, and additionally several different 4K and HD heads, such as the 3-CMOS 4K, 3-CMOS Full-HD and a unique 4-CMOS 4K camera head for ICG applications,’ reports manufacturer Ikegami. ‘The first camera in Ikegami´s series of medical cameras based on the MKC 4K Camera platform is a 4K-native progressive-scan 1-CMOS model with an ultra-compact head designed to be operated from a remote CCU,’ the firm explains. ‘Features include ultra-high sensitiv- ity, dynamic contrast correction, plus image correction. This marks the beginning of Ikegami´s new cam- era generation for microscopy and endoscopy in native 4K resolution.’ The CCU incorporates a com- pletely new processing board with very compact measurements, requir- ing much smaller space in integrated solutions, the report continues. ‘This board size reduction, combined with the ability to drive several different camera heads in 4K and Full HD reso- lution, makes Ikegami’s new camera platform an ideal product for a vari- ety of OEM applications. ‘In addition, the unique construc- tion of the output boards allows maximal flexibility in the creation of OEM camera solutions based on the MKC 4K camera platform. OEM designers have complete freedom to create either one universal CCU serv- ing different heads, even in hot-plug configuration, or to serve several cameras with fixed heads. The new platform provides flexible choice of 4K monitors connectivity ahead of an industry standard for 4K output being defined. ‘Besides known 4K outputs, such as 4xHD-SDI and HDMI 2.0, Ikegami´s new MKC 4K camera platform also provides 4K output in 12G SDI. This signal format comes from the profes- sional broadcast sector and allows 4K connection over a single coax Ikegami is at Medica Hall 10 / Stand B12 EH @ MEDICA No 1 2017

1 2 M O N D AY @ M E D I C A Down to earth devices On sale now: a novel monitoring patch tried and tested in the International Space Station. John Brosky reports Moussay explained. Space missions are famous for driv- ing innovation, from Mylar blankets to microchips. So when French scien- tists learned one of their compatriots would be aboard the Soyuz MS-03 spacecraft to reach the International Space Station (ISS), they gathered cutting edge technologies for him to carry into orbit. On 17 November 2016 the European Space Agency (ESA) astro- naut Thomas Pesquet was launched into space with NASA astronaut Peggy Whitson and Russian cosmo- naut commander Oleg Novitsky for the six-month Proxima Mission. Inside Pesquet’s space gear were equipment and materials for two assignments, the Matiss project designed by the French National Centre for Space Studies (CNES), and the ESA’s EveryWear program. The EveryWear tablet computer serves as the data platform for two devices from BodyCap, a start-up based in Caen, France, which col- laborated on a zero-gravity study of wearable technology with the CNES laboratory focusing on microgravity science and the Swiss Institute for Space Medicine and Physiology. Monitoring sensors A sensor in the e-TACT patch worn by astronaut Pesquet combines activ- ity tracking, skin temperature moni- toring and body position detection; data is sent wirelessly in real time or stored on the device for subsequent analysis. The patch can be worn on any body area for some time, monitoring chronic diseases, sleep disorders and overweight people, for example. ‘As there is no gravity in the ISS, the astronaut needs to be attached to the bed to avoid drifting around the capsule, which makes it difficult to sleep. What becomes important is an ability to quantify movement during his sleep, as this is a very good indi- cator of sleep quality, a measure of whether he is truly sleeping or is rest- less,’ explained Sébastien Moussay MD, a co-founder of BodyCap. The other device from BodyCap is the Blood Pulse Wave sensor finger- worn device to detect changes in the blood pulse of the carotid artery when the astronaut presses his fin- ger against his neck. This tonometer is being used as part of a study of modifications to astronaut Pesquet’s cardiovascular system during long- term exposure to microgravity. Without the resistance of gravity, Moussay said, the heart does not need to force blood flow to the brain and it progressively weakens, requir- ing a period of therapy for recovery once Pesquet returned to earth in May 2017. The pulse wave sensor is a work- in-progress, Moussay pointed out, but e-TACT is a CE-approved product with down-to-earth medical appli- cations in programs for the obese and diabetic patients where physical activity is a vital measure, as well as for sleep labs. An example is patient compliance to prescribed physical therapy routines in the period follow- ing bariatric surgery. Connected watches and other activity trackers popular with con- sumers do not make the grade with clinicians, he said. ‘What’s very important for doctors and medical staff is a measurement of metabolic change linked to activi- ties such as walking and swimming. They are less interested in measuring hand movements of someone play- ing a video game, which is the data provided by connected watches,’ Finger-worn Blood Pulse Wave sensor is a tonometer that checks on modifications to the cardiovascular system A S E / A S A N © The Matiss project is a test of smart surfaces to resist bacterial colo- nisation inside the spacecraft with an eye on the future. ‘If we are going to send people to Mars, we don’t want them to get sick on the way, nor do we want them scrubbing and cleaning all the time,’ said Guillaume Nonglaton, the pro- ject manager for the Matiss experi- ment at the Grenoble-based Leti research institute. Housekeeping in the space station takes up an inordinate amount of the astronauts’ time, which could be bet- ter spent performing their scientific mission. Keen housekeeping is a vital task installed four Astronaut Pesquet plaques in spots regularly frequented by fellow astronauts, such as the kitchen area. Each plaque holds 20 different samples of hydrophobic materials that will be exposed to the air in order to come in contact with water droplets circulating within it, each possibly carrying bacteria. The sample surfaces were each designed to repel the droplets so that they remain in the air and can be fil- tered, rather than being absorbed on a surface where they may take root. Advanced materials developed for the experiment include a fluorinated thin layer, an organic silica and a biocompatible polymer, all chosen for their hydrophobicity, and ability to be manufactured on an industrial scale. The materials also have practical benefits back on Earth for germ-free medical device surfaces and even elevator buttons. Nonglaton: ‘One never knows where the next good idea for prac- tical applications will come from; perhaps this time it will come down from space.’ Augmented Reality in the operating theatre Virtual data merges with a r Report: Anja Behringer Medical Augmented Reality (AR) assistance systems overlay information onto a surgeon’s field of view. However this technology is complex and expen- sive. Therefore, the procedure must offer a big advantage compared to conventional treatment and diagnostic methods to qualify for standard use. The objective is a system that shows Getting a grip on dermatology diagnostics An LED lamp with optional full HD camera Skin deep precision The right kind of light DTR Medical is at Medica Hall 16 / Stand F42 Stainless steel 175mm Gillies Skin Hooks are the latest release in DTR Medical’s extensive dermatology sin- gle-use instruments range. To ensure effective grip when retracting skin, these offer a choice of sharp or semi sharp tips. Stainless steel forceps The company has now also produced high quality, sterile, single-use, sharp angled epilation forceps, designed with correctly sprung handles adjust- ed with the right amount of tension for greater control to increase vis- ibility. ‘With pointed ends to enable precision in epilation and the removal of fat deposits, they are the per- fect solution when it comes to deli- cate procedures,’ the manufacturer explains. The new dermatology catalogue also features sterile, stainless steel, single-use, skin biopsy packs, includ- ing a choice of four, five or seven instruments. The copy of DTR’s new dermatol- ogy catalogue is available now. in the Italy, Manufactured STARLED3 NX lamp, based on next generation LED technol- ogy, provides cold, shadow- less light, long life and low energy consumption, and directs light beams accord- ing to needs, so is suitable for diagnosis, gynaecology, dermatology, general medicine and surgery. ‘Its next generation LEDs produce an unparalleled qual- ity of light with a colour tem- perature (CCT) of 4.500 °K and a colour rendering index (CRI) of 95,’ the manufacturer Acem explains. ‘The lamp has a light intensity of 130.000 lux with a low energy consumption of 69W. The life cycle of its LEDs is about 50.000 hours. ‘Three reflectors produce a well- blended and intense cone of light focus- able through the automatic adjust- ment of the light spot diameter. Its slim, practical and compact design makes it perfect for several uses.’ Ergonomical and easy to move and position the lamp suits the laminar flows of an operating room. STARLED3 NX ENDO function also offers light for endoscopy and minimally invasive surgery, the company adds. The entire system, including the I-SENSE control panel, has been designed for easy cleaning and sterilisation. The device also can be mount- ed on a ceiling (single, double con- figuration, or with other STARLED NX lamps), wall, or trolley. An Special LED optics produce homogeneous, shadowless light Acem is at Medica Hall 10 / Stand E31 EH @ MEDICA No 1 2017 t. +44 (0)2920 767 800e. info@susl.co.ukFollow usFind us in Hall 16 Stand F42The widest range of single use suctions.www.susl.co.uk

1 4 M O N D AY @ M E D I C A Robotic-assisted visceral surgery The advantages are obvious dle holder, but inside the abdomen. This is brilliant.’ More ‘radicality’ A further advantage of robot-assist- ed surgery in oncology is immuno- fluorescence. These fluorescent dyes, injected by the anaesthetist, can stain the lymphoid tissue or other vessels and structures during surgery, either to protect them or remove them even more precisely with the respec- tive radicality. The prescribed number of lymph nodes to be removed for certain types of tumour surgery can be significantly increased with the da Vinci system. ‘During open surgery, the dyeing is very complex because there isn’t normally a camera system available, which is why it’s not usu- ally done. ‘For a long time, it was quite con- troversial whether tumour surgery should actually be carried out with the minimally invasive procedure at all,’ Krüger points out. ‘There was always the claim that it is not suf- ficiently radical. However, this has been scientifically refuted. It obvi- ously always depends on the exper- tise of the surgeon, but the proce- dure achieves at least the same, and sometimes even more radicality, and at the same time allows the patient to benefit from the advantages of minimally invasive surgery.’ Costs and viability Only a few patients in Germany cur- rently benefit from robotics in pan- creatic surgery. Last year, 43 surgical departments had access to one of the 87 systems currently available in that country. The number of depart- ments for visceral surgery and cen- tres that treat a noteworthy number of patients with robotics is consider- ably lower still; Krüger estimates it to be around 10-15 centres. This can most probably be attri- buted to the increased costs of the procedure, which are €1,000- €1,500 higher than the costs of conventional surgery and therefore still not always viable, despite short- er in-patient stays. The discussion as to whether these systems are really required, or not, is still very heated and affected by jealousy. On the other hand, there are currently almost exclusively only studies that confirm the feasibility, and only very few studies that confirm a clinical advantage of robotics compared to Editor-in-Chief: Brenda Marsh Art Director: Olaf Skrober Editorial team: Wolfgang Behrends, Lena Petzold, Marcel Rasch minimally invasive surgery. ‘However, this is to be expected at the moment, as we require a critical number of users and data to confirm clinical superiority. Method studies are dif- ficult to carry out anyway, and often only individual parameters are exam- ined. We don’t generally compare the minimally invasive procedure with robotics, so it is difficult to evaluate this,’ he explains. Krüger is establishing the first centre for robotic-assisted visceral surgery in Brandenburg, and plans to carry out his own studies. With gynaecological and urological col- leagues he aims to achieve full capa- city for the da Vinci-SI with around 500-600 interventions annually in one to two years’ time. Financial easing could occur from 2018/19 when large manufacturers will break the current monopoly held by Intuitive by releasing their own equipment, and when competition will regulate the prices for acquisi- tion and maintenance. Krüger is sure that ‘in five years’ time the costs will settle down around the level of those currently expected for a complex laparoscopy’. In April 2017, Dr Colin M Krüger MBA, Dipl.oec, became a senior consultant at the Department for Surgery at the Immanuel Hospital, Rüdersdorf, Germany, near Berlin since April 2017. Earlier, as a specialist for general, visceral and vascular surgery and emergency medicine at Vivantes GmbH, he also headed the visceral surgery programme for ‘Robot-assisted, minimally invasive Surgery (Da Vinci)’. From October 2016, he was senior consultant at the Centre for Robotics and Minimally Invasive Surgery in the Department for Surgery, Vivantes Humboldt Hospital, Berlin. Krüger also holds a MBA in Health Economics, is a medical advisor at Intuitive Europe and is currently writing his habilitation at the University of Greifswald on the risk stratification in pancreatic surgery. Britain: Mark Nicholls. Malta: Moira Mizzi. Spain: Mélisande Rouger, Eduardo de la Sota. The Netherlands: 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 Report: Brigitte Dinkloh The implementation of minimally invasive technology in the 1990s was a milestone for visceral surgery. A further chapter of innovation began about five years ago with advances in robotics, which were able to address certain technological shortcomings of minimally invasive surgery in the fields of optics, instrument technol- ogy and reconstruction. If nothing else, pancreatic surgery has benefitted from these develop- ments. ‘It ranks amongst the most complex interventions in abdominal surgery and opens up an impor- tant perspective to be able to offer these complicated and very time con- suming interventions, which have been carried out almost exclusively with conventional surgery, with an assistance system and minimal inva- sion,’ explains Colin M Krüger MD, Dipl.oec, Senior Consultant at the Department for Surgery, Immanuel Hospital Rüdersdorf, near Berlin. A lower rate of complications First studies and analyses confirm that the quality of organ removal and partial removal is more or less com- parable for both procedures, but also that the rate of complications asso- ciated with the intervention is sig- nificantly lower for minimally invasive procedures than for open surgery. Therefore, minimally invasive surgery, whilst achieving the same surgical outcome, has clear advantages. But, which patients and indica- tions are suitable for robotic surgery? ‘Basically, all patients who are oper- able and fulfil the surgical entry cri- teria,’ Krüger responds. ‘If the diag- nosis confirms that a patient is likely to benefit from surgery, then this can also be done with minimally invasive procedures, or, in the best case, with robotic surgery, such as the da Vinci Surgical System.’ Krüger does not foresee a consid- erably better perspective for patients with pancreatic cancer as 70-80% of them are only diagnosed once the tumour has already spread and is considered inoperable. However, there are other pan- creatic diseases with a less negative prognosis, where surgical interven- tion is worthwhile. These include hormone producing tumours, as well as all types of chronic pancreatitis s a a M & x i r B © Colin Krüger is establishing the first centre for robotic-assisted, visceral surgery in Rüdersdorf, near Berlin such as those that may develop due to chronic alcohol abuse or as a result of autoimmune diseases, where the body tries to fight its own pancreatic tissue. The resulting inflammatory changes can cause jaundice, gastro- paresis and, most importantly, chron- ic pain. This is an area of application for robot-assisted surgery. Improved optics and a higher degree of freedom One essential advantage of the da Vinci Surgical System is the improved visibility over the operating area. ‘Unlike conventional laparoscopy, which only offers 2-D visualisation, it facilitates 3-D HD visualisation in the same way as open surgery does. The surgical structures can be enlarged up to tenfold, which means more precision during preparation,’ the Berlin-based surgeon emphases. The same applies to handling, with much more freedom when guiding the instruments in the abdo- men compared to conventional lapa- roscopic surgery. ‘The instruments have up to seven degrees of free- dom,’ Krüger points out. ‘When you work with double-joint technology the instruments carry out their own hand movements. This is the prin- ciple of the surgical robot – it con- trols the manipulators, and the hand movements carried out outside of the operating area are implemented 1:1 to the instrument working inside the abdomen. You sew externally, with the manipulator in your hands, and the robot sews with the needle, which you hold in the external nee- Medica’s Connected Health- care Forum Technological innovations are the drivers and ena- blers for new approaches that will revolutionise tomor- row’s medical world. Solutions for connected and mobile healthcare take part in these changes. Medica’s Connected Healthcare Forum and the correspond- ing exhibition area provide a platform for all those innovative products and systems that strengthen the networking of players, processes and systems within the healthcare sector. The forum takes place in hall 15 (Stand 15C24). The conference language is English. Focal Topics in 2017 include: Wearable Technologies in Sports & Healthcare Enabling Tech for Healthcare Devices Innovative Start-ups Pitching Their Medical Solutions Patient Centered IoT Solutions Connected Health Platforms Medical Mobile Solutions + 6th Medica App COMPETITION Healthcare Certification & Standards Disruptive Technologies in Healthcare Senior Writer: John Brosky Printed by: druckpartner, Essen, Germany Executive Director: Daniela Zimmermann Publication frequency: bi-monthly 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, Brigitte Dinkloh, Cornelia Wels-Maug, Holger Zorn. Great Representatives China & Hongkong: Gavin Hua, Sun China Media Co, Ltd. Phone: +86-0755-81 324 036 E-Mail: gavin_hua@163.com Germany, Austria, Switzerland: Ralf Mateblowski Phone: +49 6735 912 993, E-Mail: rm@european-hospital.com EH @ MEDICA No 1 2017

Yizhe Building, Yuquan RoadShenzhen, 518051, ChinaTel: 86-755-26722890Fax: 86-755-26722850E-mail: Market@sonoscape.netwww.sonoscape.netCaring for Lifethrough InnovationP50Define your visionSONOSCAPE MEDICAL CORP.10G04 in Hall 109E25 in Hall 9