2 Visceral imaging Endosonography: AI takes on the “supreme discipline” E H @ M E D I C A Endoscopic Ultrasound (EUS) is considered a "supreme discipline" in imaging, requiring great diagnostic skill. From left: B-mode EUS, contrast-enhanced EUS, elastography, EUS fine-needle aspiration. h c i r t e i D f o r P © about AI assistants. In order to put the discussion about the pros and cons of the new technology on a solid foundation, Dietrich is currently working together with a group of 25 experts on a ‘position paper’ of the World Federation for Ultrasound in Medicine and Biology (WFUMB) – a document intended to guide the handling of the new technology in an orderly manner: ‘On the one hand, it is a matter of overcoming limits with the help of AI and being open to the new possibilities. Ethical and legal aspects On the other hand, it is important to consider the ethical and legal aspects that arise from the use of this technology, especially in terms s c i t s o n g a i D , . l a t e a k u z o n o T © ) 0 4 . Y B C C ( 1 2 0 2 AI-based analysis as shown in a gradient-weighted class activation mapping (Grad- CAM): The left image is a representative original endoscopic ultrasound image. The right is a Grad-CAM image displaying the regions recognized as being important. of data security. In short, we need to know the game this game is  played by.’ Report: Wolfgang Behrends Wednesday 11:00-12:20: Future hospitals and care centers • New tech for hospitals and care centers • Decarbonization in healthcare Monday 11:00-13:00: Connected medical things – IoT technologies • Smart connected medical things – from wearables to medtech devices to im- plants • Interoperability in the Internet of Medical Things infrastructure • Connectivity options – 5G, low power connectivity and more • Cybersecurity and data privacy 13:00-15:00: 14th Healthcare Innovation World Cup pitch • Top12 Health Techpreneurs 2022 pitching their solutions • Categories: IoMT devices, wearables, digital biomarkers, smart patches, smart implants • Panel discussion: HealthTech trends 2022 – What’s next? • Award ceremony – Announcement of the Top3 Health Techpreneurs 2022 12:20-14:00: Health metaverse • Immersive environments for educational, assistive and therapeutic purposes • AR/VR/Mixed reality • Digital twins for new insights into health decision making 14:00-15:00: MEDICA DISRUPT – future of therapy • Therapeuticals and new treatment approaches • Chronic disease treatment • Tech to watch 15:00-15:30: Digitalization of the German Federal Health Ministry • Electronic patient record • European Health Database • DiGA 15:00-17:00: AI & Big Data • AI-guided medical devices • Real-time analytics • Precision medicine • Personalization of treatment with AI Tuesday 11:00-12:00: Robotics • Autonomous robots • Robot-assisted surgery • Robotic solutions in hospitals and care centers 12:00-13:00: Healthcare accelerators • Scaling up future health innovations 13:00-15:00: 11th MEDICA Start-up competition pitch • Top12 Medical Start-ups 2022 pitching their solutions • Categories: AI in healthcare, health apps, lab diagnostics, robotics & others • Panel discussion: Successful health innovations – Key drivers and disruptors 2022 • Award ceremony: Announcement of the Top3 Medical Start-ups 2022 15:00-17:00: MEDICA DISRUPT – Preventing chronic diseases • Diagnostics and health monitoring • Mobile health 15:30-16:20: Certifications & market access • Access to healthcare markets • Certifications and regulations 16:20-17:00: Tackling future pandemic • Covid-19 learnings in digital health • Best practice in tech • Solutions for prevention and control Thursday 11:00-12:00: • MEDICA DISRUPT - Taiwanese Start-up showcase 12:00-14:00: • MEDICA DISRUPT - Pushing the frontiers of diagnosics 14:00-15:00: • MEDICA DISRUPT - Understanding the brain and mental health 15:00-17:00: • MEDICA DISRUPT - Improving health equity of vulnerable populations » Hall 12 / E37 EH @ MEDICA 2022 for example, an automatic assess- ment of the setting parameters could ensure that the ultrasound signal achieves sufficient penetra- tion depth and improved validity. AI-supported segmentation of ana- tomical structures could serve as a navigation aid and specifically point out structures that deviate from the norm. these Overcoming reservations Currently, applications are still in the experimental and research stages. However, Prof Dietrich is confident that in the future, medical practitioners will be able to benefit from the assistance provided by AI: ‘Currently, we are still at the very beginning. Still, it is important to look at the possi- bilities of the technology at this point, to approach the methods of independent learning, pattern recognition and what added value they can have for our patients.’ This process will likely be subject to reservations, the expert predicts; especially seasoned physicians who have been using endosono- graphy with conventional methods for many years tend to be sceptical DON’T MISS! Connected Healthcare Forum Endosonography poses unique challenges for medical profes- sionals, because two demanding disciplines have to be mastered at the same time. The use of artificial intelligence (AI) could help speed up the notoriously slow learning curve of the pro- cedure, says Prof Dr Christoph F. Dietrich. At the Visceral Medicine Congress in Hamburg, the expert explained how AI can help endo- sonography achieve faster and better diagnoses, standardisa- tion of images and better veri- fiability of findings – and which hurdles still stand in the way of introducing the technology into clinical practice. ‘In a way, endosonography is the supreme discipline, as it combines endoscopy and ultrasound at the highest level,’ says the head physi- cian of the Department of General Internal Medicine at the Hirslanden Beau-Site, Salem and Permanence hospitals in Bern, Switzerland. ‘The procedure is not easy to learn, because many parameters are not standardised and the assess- ment criteria for some diseases – especially concerning the pancreas – are difficult. Artificial intelligence could help to set standardised sec- tions and establish quality para- meters for presentability and assessability.’ One example is decision support for diffuse abnormalities in pan- creas imaging: Here, early forms of fibrosis with inflammation can indicate degenerative processes in the sense of chronic pancreatitis. However, these changes are hardly visible to the naked eye. AI could provide valuable additional infor- mation to identify and classify such findings at an early stage. A watchful eye on elasticity and perfusion Other potential areas of application concern elastography, where the AI registers unusual stiffness in the tissue and specifically points out these suspicious areas to the physician. An analysis of vascu- larity and perfusion behaviour in contrast-enhanced sonography could also benefit from algorithms, Dietrich explains – and gives some examples: ‘A lower accumulation of the contrast agent in the pan- creatic parenchyma might point towards a ductal adenocarcinoma, as this usually has only one third of the normal vessel density. On the other hand, greater vascularisation usually indicates an inflammatory or benign neoplastic process, as these are associated with dilated or additional vessels.’ Incidentally, the elastography indicators do not only apply to the pancreas, but can in principle be used for all organs, from the thyroid to the mamma and the liver, the expert adds. Soft tissue serves as an exclusion mark- er of pancreatic carcinoma. AI could also be a valuable aid for inexperienced diagnosticians:

4 E H @ M E D I C A Tissue-engineered glioblastoma model shows proliferation and drug resistance of malignant cells 3D brain tumour in a dish to personalize cancer treatment It is the size of a common pencil eraser, but it could have a huge impact on the therapy of glio- blastoma: Scientists in Virginia have developed a novel 3D tissue- engineered model of the brain tumour microenvironment, which can be used to assess how the glioma cell invades healthy tissue, proliferates, and reacts to chemotherapy drugs. Glioblastoma, the most common and most malignant form of brain cancer, is notoriously difficult to treat, due in part to its invasion into surrounding tissue where the tumour cells become more resis- tant to therapy. Median patient sur- vival is five months. Tumour microenvironments (TMEs) – the tissue that surrounds a tumour – are known to contri- bute to cancer progression. The brain TME contains cells speci- fic to the central nervous system, including astrocytes and microglia. Understanding how TME functions and how glioblastoma tumour cells grow, and being able to control, manipulate, and tune its elements, may help enable the development of more effective, individualized therapies for glioblastoma patients. The 3D model developed by Jennifer M. Munson, PhD, an asso- ciate professor of biomedical engi- neering at the Fralin Biomedical Research Institute of Virginia Tech h c e T a i n i g r i V , z t e M n o t y a l C © Gabriela Mendes, a postdoctoral associate in the Jennifer Munson lab of the Virginia Tech Fralin Biomedical Research Institute, holds an example of the 3D model of the glioblastoma tumour microenvironment the lab developed to study how different people’s cancers respond to different therapies. in Roanoke, is an accurate re- creation of TMEs: It contains cells unique to the central nervous sys- tem, in ratios based on those found in patients, as well as glioblastoma stem cells and interstitial fluid flow, the movement of fluid between and around cells in tissues. Dr Munson and a multi-institutional team of researchers describe the model’s detailed composition and what they learned from it in an article published in NPJ Precision Oncology (https://doi.org/10.1038/ s41698-022-00290-8). ‘Our goal is ultimately to develop a personal- ized medicine approach in which we can take a patient’s tumour, build a model of that tumour in a dish, test drugs on it, and tell a clinician which therapy will work best to treat it,’ said the expert. Inter-patient differences have huge impact The research team examined indi- vidual and synergistic effects of the cellular and biophysical glio- blastoma microenvironment on patient-derived glioma stem cell outcomes, bidirectional intercellu- lar communication between glioma and glial cells, and the effectiveness of various chemotherapy drugs on destruction of tumour cells. They determined that: • Invasive regions primarily contain neural astrocytes and microglia; • Glioma cell invasion is patient specific and depends on the TME context. Inter-patient differences are the greatest contributor to invasion. The addition of glial cells or a combination of glia and interstitial fluid flow can mean- ingfully influence glioblastoma stem cell invasion either positive- ly or negatively; • The proliferation of tumour cells is highly dependent upon a patient’s glioblastoma stem cell line(s) and how a specific cell line interacts with fluid flow; • CCL2, a chemokine which guides a variety of immune/inflammato- ry cells to the site of a tumour, plays a role in TME-driven enhancements to glioma malig- nancy and may impact individu- alized cancer responses; • Therapeutic drug response exhibited in the model could partially predict responses seen in in-vitro tests on laboratory mice. Further testing is required to expand on these findings and incorporate other important fac- tors, such as the blood-brain bar- rier (BBB), which impacts drug transport and provides important pro-tumour signalling. ‘Results of our testing varied wide- ly,’ Munson said. ‘This highlights the importance of a personalized medicine approach to glioblastoma and the value of being able to re- create an individual patient’s tumour microenvironment.’ The team is working to obtain more patient data and establish more academic-clinical collabo- rations to better identify which model components and metrics are needed to establish transformative Jennifer M. Munson Jennifer M. Munson, PhD, is an asso- ciate professor in tissue engineering in the Biomedical Engineering and Mechanics Department of the Virginia Tech College of Engineering. She is director of the Munson Lab at VT’s Fralin Biomedical Research Institute, and a co-director of the Virginia Tech Cancer Research Alliance. Munson began to develop 3D tissue-engi- neered models for cancer research in 2014. She collaborates with engineers and biologists throughout the world. predictive power in glioma therapy. Munson told European Hospital that the team is also leveraging the tunability and ease of implementa- tion of this system to use it to iden- tify new therapeutic targets and to understand the complex interac- tions between the cells in the brain and tumour cells in disease.  Report: Cynthia E Keen Sponsored · 3D single-port surgery and 3D endoscopic sleeve gastroplasty Keep 2D endoscopy but see 3D vision One of the world’s leading endo- scopic imaging system companies, MedicalTek (MDTK) from Taiwan, launches its brand new endoscop- ic visualization system, Darwin MS-301. While keeping the main feature – conversion of 2D endo- scopic images to 3D – from its predecessor MonoStereo, Darwin delivers the twice-better perfor- mance, more intuitive control, and Rigid and Flexible scope modes. The conversion feature, called "Keep-2D-See-3D", has become an acceptable and efficient meth- od to help doctors gain spatial vision during surgery and gastro- intestinal endoscopic procedures for years. The system has been installed in hospitals around the world since 2017. Two of the hun- dreds of Darwin 3D Endoscopic Visualization System users, Dr Miguel Afonso from Portugal and Dr Cheng-Ming Peng from Taiwan, share their unique experiences with the Darwin 3D system. Application in Portugal Dr Miguel Afonso from Gastroclinic in Lisbon, Portugal, applies the Darwin 3D Endoscopic Visualization System in every endo- scopic sleeve gastroplasty to obtain the better visualization and depth perception, without the 3D effect causing nausea. ‘It’s not possible c e T l a c i d e M © to drive our car with only one eye. In fact, it is the binocular vision or two-eye vision that gives us depth perception. Being able to see the inner side of a stomach in 3D helps us understand not only the distance, width, and length, but also the depth. 3D view is already available for laparoscopy. The novelty of the Endoscopic Visualization System is that the gastroenterologists can now have an identical system in endos- copy. This is really a great progress in gastroenterology,’ said Afonso. Experiences from Taiwan In Asia, Dr Cheng-Ming Peng from Chung Shan Medical University Hospital in Taiwan is amazed by the 3D vision brought by MedicalTek’s Darwin system during single-port laparoscopy with a scope of 5 mm diameter and 46 cm length. He states that before the operation, he thought the image would be too dark since the light source usu- ally does not project far enough through such a long and thin scope for him to observe the deeper tis- sues in patient’s abdomen; with an added darkening effect from the 3D glasses. The gamma cor- rection function, which enhances both the brightness and contrast of the image, in the Darwin system, compensates the disadvantage of the thin laparoscope and brings clearer sight for him to conduct the single-port laparoscopy with depth perception. Peng has sought 3D solution with longer and thinner telescopes for single-Port and NOTES (Natural Orifice Transluminal Endoscopic Surgery) for long; for him, the operation with big dual-lens 3D scopes proved is challenging due to collisions between the scope and surgical tools. Now, thanks to the depth perception brought by the Darwin 3D vision available for the long and narrow space, single-port surgeries are easier to conduct and less time-consum- ing. Patients also benefit from the scarless surgeries with less pain and faster recovery. The Darwin system does improve the way that Peng conducts single port and port-less laparoscopy. Apart from that, MedicalTek’s newly-launched Lascaux (MS-300) 4K/3D/HD Recorder supports dual-inputs, allowing not only single-signal but also dual-signal 3D recording, e.g. during robotic surgery. With this new device, the audience in the conferences can now watch the live 3D robotic surgery image. incubated by MedicalTek was IRCAD-Taiwan. Prof Jacques Marescaux brought many brilliant ideas during the product devel- opment. Furthermore, in order to bring a better 4K3D image to doctors, MedicalTek is in partner- ship with the world-famous display manufacturer, AUO Display Plus. MedicalTek is planning to launch its own 4K3D medical monitor. With this integration, the Darwin 3D Endoscopic Visualization System will be more affordable while taking the quality to next level, the company announces. » Hall 10 / B03 EH @ MEDICA 2022

6 Overheard at AACC E H @ M E D I C A The complexities of drug testing in urine and hair Urine screening tests using only immunoassays are the most common procedures used to identify drug abuse. They are inexpensive, automated, and pro- duce rapid results. But they may generate false-positive or false- negative results, which vary based on the drug, drug class, and the assay used. Hair toxicol- ogy analysis is another form of drug testing which, unlike urine tests, enable analysis of drug use over a period of time. Hair tox- icology tests complement urine tests but can be just as challeng- ing to interpret. Mass spectrometry, specifically liq- uid chromatography with tandem mass spectrometry (LC-MS/MS), is a powerful tool for toxicolo- gy analysis. Although more labour intensive, more time consuming, and much more expensive than hair and urine tests, LC-MS/MS is recommended for drug confirma- tion testing following a positive or inconclusive immunoassay screen. It is highly complex and requires significant expertise but provides definitive results due to its superior sensitivity and specificity. At the 2022 AACC Annual Scientific Meeting Joe M. El-Khoury, PhD, director of the Clinical Chemistry Laboratory at Yale-New Haven Health, discussed the challenges of interpreting com- plex urine toxicology cases. in Chicago, ‘When in doubt, mass spec it out’ El-Khoury discussed a routine urine test ordered for a patient prescribed opioids and other med- ications for multiple, chronic, and complex medical problems. Her physician wanted to verify that this patient was not taking addi- tional types of painkillers. The test results were positive for heroine, but other findings were contradic- tory and confusing. ‘Immunoassay screening may not produce accu- rate results, because antibodies used in the assays for the targeted Publisher Mediengruppe Oberfranken – Fachverlage GmbH & Co. KG E.-C.-Baumann-Str. 5 95326 Kulmbach/Germany Phone +49 9221 949-311 Fax +49 9221 949-377 Editor and Production Manager: Sonja Buske (SB) Editorial team: Wolfgang Behrends (WB) Sascha Keutel (SKE) Managing Directors: Walter Schweinsberg, Bernd Müller Founded by Heinz-Jürgen Witzke ISSN 0942-9085 Correspondents Austria: Michael Krassnitzer (MK) France: Jane MacDougall (JMD) m o c . k c o t S e b o d A – n o i t c u d o r P a i d e M k c o t S © drug may exhibit cross-reactivity toward other closely related com- pounds,’ said El-Khoury. ‘Patients maintained on chronic opioids are often at risk of false positives. The LC-MS/MS test determined that the patient was only taking exactly what she’d been prescribed. When in doubt, mass spec it out.’ He noted that patients taking Suboxone, a drug widely used for treatment of patients with opi- oid use disorder, are high-risk, and may attempt to stimulate compliance by spiking the pill in urine to pass the screening test. Immunoassays are not spe- cific enough to detect this sample adulteration and patients may get away with it. El-Khoury recom- mends that quantitative LC-MS/MS testing be the only method used for assessing adherence in patients taking Suboxone. When concentra- tions of drugs in urine are high, he advised the audience to make sure to rule out pharmaceutical impuri- ties, and to rule out enzyme inhi- bitors when metabolite patterns are unusual. Jacqueline Hubbard, PhD, the Laboratory Director of Three Rivers Diagnostics in Pittsburgh, Pennsylvania, gave deeper insights into hair toxicology analysis. Hair grows an average of 1 cm each month. When hair samples are seg- mented into sections, it is possible to obtain a detailed historic profile of an individual’s drug exposure over a specified amount of time. However, the accuracy of the anal- ysis may be impacted by ultravi- olet light exposure and diffusion of sweat, which may occur at any time. Cosmetic hair treatments may strip analytes or increase environ- mental contamination. Melanin must be considered A person with higher melanin may show a greater accumulation of drugs compared to a person with low melanin, so this needs to be considered when testing dark hair. Hubbard explained that the Society of Hair Testing (SHT) recommends that hair first be segmented prior to decontamination. The Society re- commends use of aqueous washes and an organic solvent to remove oil and external contaminants from the hair. But these processes may still be insufficient. Recent research has suggested that such proce- dures may lead to the swelling of the hair and may promote incor- poration of analytes into the hair itself. Cleansed hair samples need to be cut, ground, and pulverized before they are analysed. ‘When drugs are detected in a panel, I recommend metabolite detection to confirm ingestion,’ she said. ‘The detected presence of drugs in hair may be due to ingestion, incidental exposure from contaminated sur- faces, impurities found in the drug, Germany: Cornelia Wels-Maug (CWM) Dr Christina Czeschik (CC) Great Britain: Mark Nicholls (MN) Spain: Mélisande Rouger (MR) The Netherlands: Madeleine van de Wouw (MvW) USA: Cynthia E. Keen (CEK) Subscriptions Simone Sesselmann kundenservice@mgo-fachverlage.de Subscription rate 8 Euro Printed by: mgo360 GmbH & Co. KG, Bamberg, Germany Representatives Germany, Austria, Switzerland: Ralf Mateblowski Phone: +49 201 17755094 E-Mail: r.mateblowski@mgo-fachverlage.de France, Italy, Spain: Eric Jund Phone: +33 493 58 77 43 E-Mail: jund@european-hospital.com GB, Scandinavia, BeNeLux: Simon Kramer Phone: +31 180 6200 20 E-Mail: kramer@european-hospital.com Taiwan: Charles Yang Phone: +886 4 232 236 33 E-Mail: medianet@ms13.hinet.net USA & Canada: Hanna Politis, Media International Phone: +1 301 869 66 10 E-Mail: hanna@media-intl.com Maria Kaiser Phone: +1 250 726 4007 E-Mail: mkads@mac.com All company, brand and product names in this publication are the property of their respective holders. Users must obtain permission from those holders before copying or using the owner’s trademarks, product and company names or logos. and/or decomposition products of drugs.’ ‘Hair toxicology interpretation to determine the frequency of use and if a person used specific drugs is not that simple. The amount of drugs detected in hair may not be equivalent to the actual con- centration present in hair, and the relationship between the concen- tration in hair and the amount ingested is not well established,’ cautioned Hubbard. ‘Drugs in hair are indicative of repeated use and/ or exposure, and not of a single use or recent use. Hair as a matrix for toxicology testing has impli- cit biases, including seeing higher drug concentrations in pigmented toxicology analysis showed that the child had ingested two drugs, including methamphetamine. A two-year-old boy was admitted to a hospital emergency department with acute encephalopathy and seizures. His urine and lab tests were negative, but when the hair toxicology reports became availa- ble 30 days later, they had tested positive for exposure to oxycodone and methamphetamine ‘Hair toxi- cology helped identify an unstable home situation from drug use for both children. For the boy, whose parents were separated, it provided definitive evidence that the mother of the child was a drug abuser, enabling the child to stay with his m o c . k c o t S e b o d A – y l f y t t i k © father. These tests can be invalu- able in help keeping vulnerable children safe,’ she concluded.  Report: Cynthia E. Keen versus non-pigmented hair after the same systemic exposure. This test frequently has a longer turn- around time compared to urine tests. But it may be useful to identify if children who have unex- plained conditions or may be expe- riencing developmental delays are living in unhealthy situations,’ she said. Hubbard described two cases that demonstrate the utility of hair toxicology testing. A malnourished two-year-old girl showing signs of neglect and developmental delays had a negative urine drug screen- ing test for 11 drugs. However, hair Jacqueline Hubbard Joe El-Khoury Jacqueline Hubbard, PhD, joined QualiTox Laboratories, now Three Rivers Diagnostics, in 2022 as its Laboratory Director. Her interests include toxicology interpretations, test utilization, and mass spectrometry. She also serves as an MSACL Practical Training scientific committee member and is actively involved in training new users on mass spectrometry. Her research has also focused on devel- oping and validating drugs of abuse assays, driving under the influence of marijuana, and Covid-19 serology research. Joe El-Khoury, PhD, is Director of the Clinical Chemistry Laboratory at Yale New Haven Health in New Haven, Connecticut, and Associate Professor of Laboratory Medicine at Yale University School of Medicine. A fellow of the AACC Academy, his research interests include indicators for monitoring clinical laboratory per- formance, investigating biomarkers of acute kidney injury and chronic kid- ney disease, and development of new mass spectrometry-based methods for the measurement of markers in bio- logical fluids. EH @ MEDICA 2022

8 E H @ M E D I C A Multi-cancer early detection New MCED blood tests could shake up cancer screening New tests can identify over 50 types of cancer and boost detec- tion of traditionally elusive can- cers from tumour DNA in blood, researchers showed at the ESMO congress in September. These multi-cancer early detection (MCED) tests in development can spot common cancer signals across over 50 types of cancer and predict where the signal comes from in the body, results from a prospective investigation reported at the conference sug- gest. In the study, MCED testing, which collects the signal arising from small sequences of circulating tumour DNA in the blood, detected a cancer signal in 1.4 % of partici- pants aged 50 years and over who were not known to have cancer. Carcinoma was confirmed in 38 % of those with a positive test. The researchers also found that 99.1 % of the 6,290 participants who were cancer-free received a negative test result. The time to reach a diagno- sis for those with a positive test result was an average of 79 days. For 73 % of participants with a po- sitive screening test, that time was only three months. These results are an encouraging first step for early cancer detection tests, according to study senior author Deb Schrag, MD, MPH, a medical oncologist at Memorial Sloan Kettering Cancer Center, New York, USA. ‘The study showed a good detection rate for people who had cancer and an excellent spe- cificity rate for those who did not have it,’ she said. ‘In people with a positive test, it took less than two months to confirm the diagnosis if they had cancer and a bit longer if they didn’t have cancer prima- rily, because physicians opted to perform imaging studies and then m o c . e b o d a . k c o t s – o c e d o l l e g n a © repeat them a second time several months later to investigate the pos- sibility of a cancer diagnosis.’ Screening options for previously unscreenable cancers Another important aspect was that only few participants with a false positive screening test required multiple invasive procedures such as endoscopies and biopsies, Schrag pointed out. ‘This finding should help to allay concerns that these tests could cause harm by generating unnecessary procedures in people who are well,’ she said. Schrag stressed the importance of continued standard screening for cancers such as breast and colorec- tal cancer, while MCED tests are being refined and validated for cancers such as pancreatic, small bowel and stomach cancer, where there are currently no screen- ing options. ‘This study indicates that hope is on the horizon for detecting cancers that are currently unscreenable, but of course much more work is needed, and, with experience and larger samples, these assays will improve,’ she said. Impact on future cancer screening programmes The PATHFINDER study is the first prospective investigation to show that an MCED test can detect cancer in patients with undiag- nosed cancer, as previous studies used tests only in patients already known to have cancer. The new results may have major implications for future cancer care Fabrice André Deb Schrag Deb Schrag, MD, MPH, is Chair of the Department of Medicine and George J. Bosl Chair at Memorial Sloan Kettering Cancer Center, New York, USA. Dr Schrag is a medical oncolo- gist and health services researcher at the Dana-Farber Cancer Institute. She is Chief of the Division of Population Sciences and a Professor at Harvard Medical School in Boston and has a longstanding focus on gastrointestinal cancers, particularly colorectal cancer. across all types of cancer are need- ed to find out if having an early detection test affects morbidity and mortality and how the procedure benefits patients, he suggested. ‘In addition, we need to know more about the small proportion of false positive tests (…) We need some of these answers before we can calcu- late the cost impact of introducing MCED tests in routine clinical prac- tice,’ he concluded.  Report: Mélisande Rouger Fabrice André, MD, PhD, is Director of Research at Gustave Roussy Cancer Center, Villejuif, France, and the newly elected future president of the European Society of Medical Oncology (ESMO) for the 2025 – 2026 term. Prof André is a medical oncologist specia- lizing in breast cancer and a Professor of Medicine at Paris-Saclay University. provision, according to Professor Fabrice André, ESMO 2022 Scientific Co-Chair. ‘Within the next five years, we will need more doc- tors, surgeons and nurses, together with more diagnostic and treat- ment infrastructure, to care for the rising number of people who will be identified by multi-cancer early detection tests,’ he explained. All stakeholders must be involved in deciding new pathways of care and must agree on who will be tested and when and where tests will be carried out, André added. ‘We need to anticipate the changes that will happen as a result of these tests, for example in the diagnosis and treatment of people with pan- creatic and other cancers that are usually diagnosed at a much later stage,’ he said. Comparative trials Stereoscopic viewing and virtual work Passive 3D stereo monitors in medical applications Volumetric 3D images and 3D models are becoming increasingly important in medical technology. Schneider Digital's high-resolution 3D PluraView stereo monitors are a perfect fit for 3D stereo display of medical data, especially from CT and MRI scanners. The 3D PluraView monitor is com- patible with all leading 3D-enabled medical software applications, such as Siemens Syngo, Brainlab Stereotaxy, Vertual Vert, Forsina, Vived Anatomy, Vesalius 3D, Paskal 3D, ThermoFisher Amira or 3D Slicer. Compared to other 2D and 3D mo- nitors, PluraView systems have two screens with passive 'BeamSplitter' technology that provide a realistic 3D experience, but with brightness suitable for daylight. Combined with the appropriate medical soft- ware and a powerful graphics card, they provide turnkey 3D work- station solutions that analyze and present volumetric medical data comfortably and efficiently – in the highest resolution, flicker-free, even in normal, bright workstation environments. Areas of use and application: • Surgery planning and prepara- tion • 3D computed tomography (CT) • 3D imaging (MRI, ultrasound) • Preparation for medical 3D print- ing • Evaluation of visual medical data • Education & Training  » Hall 10 / C45 i l a t i g D r e d i e n h c S © EH @ MEDICA 2022

1 0 E H @ M E D I C A Implementing the electronic patient record in the hospital Step by step into the digital future In Europe, Germany has been bringing up the rear in imple- menting the electronic patient record (EPR) for years. While the EMRAM score of German hospi- tals continues to be negligible – on the international as well as on the European level – there are signs of progress that give reason for hope. Far too often, paper records still dominate daily routine in German hospitals despite the fact that the EPR is the linchpin of digitalisation. Under the new so-called Future of Hospitals law in Germany, substan- tial funding is earmarked for EPR implementation. Financial support is provided above all for the digita- lisation of documentation (clinical and care) and medication as well as for linking patients to a digital portal before and after their hos- pital stay. An analysis by Curacon shows that 54 percent of the grant applications aim at expanding di- gital documentation. The fact that suddenly EPR is becoming top priority can be easily explained: in the future, hospitals that do not introduce EPR will be sanctioned. By 2023, implementation progress has to be shown via the so-called digital radar. Since this is a rather tight time frame for such a complex project, hospitals are under severe pressure. Experience shows that the introduction of the EPR is a demanding task, mostly because almost all members of the clini- cal and care teams are involved. Moreover, in the different depart- ments and wards different docu- mentation standards have evolved which have to be harmonized when introducing the EPR. Most importantly, however, the docu- mentation process itself will have to change since maintaining paper records is very different from main- taining electronic ones. Case in point: Much data will be trans- ferred from the medical devices or from the lab directly into the EPR and no physical records have to be searched for or picked up. On the other hand, digital documentation can be more time consuming, e.g. with medication, since the product has to be selected and the dosage has to be determined in detail. Last but not the least, a technical infra- structure has to be put in place that gives everybody access to the EPR SPOT ON INNOVATION from anywhere. The following four steps help to successfully imple- ment the EPR: 1. Create the technological founda- tion In many German hospitals, the infrastructure is outdated and not all institutions are equipped with WiFi, which is a basic requirement for using mobile peripherals such as tables, carts, as well as smart- phones and mobile medical devi- ces. Updating the infrastructure with WiFi, however, is expensive since cabling and access points have to be installed. These basic technology and network structures have to be created prior to any EPR implementation. Since this time-consuming task cannot always be handled by the internal tech- nical and IT teams in addition to their other responsibilities, external service providers might have to be contracted. In a next step, all medical devi- ces have to be integrated into the network either by cable or WiFi in order to be able to transfer all diagnostic results of the medical equipment directly into the EPR. Obviously, it needs to be ascer- tained that all medical devices are indeed network-enabled. If not, modern replacements need to be purchased – an investment item which has to be included in the budget. Moreover, since the nec- essary peripherals are part of the technological foundation, the pro- vider of the hospital information system (HIS) has to be consulted as to the most suitable tablets, smart- phones and carts. 2. Develop a documentation stand- ard Parallel to creating the technolo- gical foundation, a common doc- umentation standard should be developed. Many hospitals simply follow their hospital information system but each HIS uses its own documentation philosophy. Many systems are configurable which means the customer has to set the parameters. This is often done by pilot departments and pilot wards which – consciously or not – cre- ate the rough frame for the doc- umentation standard. When EPR implementation is planned, many hospitals are tempted to simply transfer the paper record 1:1 into Arvato Systems turns TI into a service To connect to the telematics infrastructure (TI), the digital healthcare network in Germany, a connector is required. Until now, this was located on-site in doctors' offices, pharmacies, etc. With flexTI, Arvato Systems is moving the connectors to its own secure data centers. This offers users more flexibility in their daily work and a low-cost, low-threshold entry option. In addition, higher availabili- ty is achieved – an indispensable quality feature for ser- vice providers who are working around the clock. Arvato Systems is thus taking another important step toward telematics infrastructure 2.0. Hall 10 / G20 m o c . e b o d a . k c o t s – n e n i a l a s e v o r e t © the digital version. This is a crucial mistake since many of the exist- ing structures and processes are shaped by the paper approach and are unsuitable for digitalisation. It is therefore strongly recommend- ed to establish a multi-disciplinary team of clinical and nursing staff to define a single, unified docu- mentation standard for the entire institution. It makes little sense to task the IT department with the leadership and control of such a project. Rather, the documentation standard, which includes patient vital signs, medication and the clin- ical and care documentation, has to be shaped by the professions and professionals who will use it on a daily basis. 3. Clear project organisation and responsibility The objective of implementing the EPR is the full digitalisation of all patient data. In order to achieve this goal, all documentation pro- cesses have to be re-thought since a 1:1 transfer of analogue processes will never bring about the EPR’s potential increase in efficiency and reduction of work load. With the focus being on the processes, the project should not be led by the IT department unless that department is in charge of process development across the institution. If the hos- pital has a dedicated department responsible for process develop- ment, it should be in charge of the implementation project. If no such department exists, a specialist for documentation and clinical and care processes needs to be identified. If there is no person with this specific job profile, experienced nursing or clinical staff with a strong interest in IT and in such an implementation project are a good choice. It is important to squarely place the project in a transparent pro- ject organisation. We recommend a 3-level approach encompassing three subprojects, project manage- ment and a steering committee. One subproject is tasked with creating the technological/IT preconditions, a second one with developing the documentation standards. These two subprojects should work in parallel. When they have reached a certain point, the third subproject – implementation – can start. The project manager should be a person who is familiar with the documentation processes and the documentation contents. The task is to manage the project and con- trol project progress. The steering committee, which is made up of representatives of the core decision-making units of the hospital or the hospital group, will be regularly informed about progress and problems and decide on important measures to be taken in case there is a deviation from the plan. With such a structure, the implementation process can be controlled and enforced. 4. Migration and schedule Very often, EPR is implemented as a pilot on a single ward or in a single department. Then, imple- mentation is expanded step by step across the institution. The underly- ing idea is that specific documenta- tion requirements can thus be inte- grated step by step as well. While this approach is frequently chosen because no unified documentation standard has been established prior to the implementation, it exposes the project to two risks: Firstly, when new requirements regarding more and more topics are constant- ly added, the unified documenta- tion standard is weakened and the entire process tends to develop into a 1:1 transfer of the analogue patient record. Secondly, the step- by-step approach becomes pro- blematic when a patient is moved from an already digitalised ward to a non-digitalised one. At that point, all documents have to be printed out and turned into a paper-based record. In view of these risks we strongly recommend to establish a comprehensive documentation standard prior to implementation. This standard can then be tested on one or two wards/departments. In a next step, it is implemented in all other departments. The EPR is adjusted only when urgently needed data have not yet been saved. These changes have to be approved by the subproject team in charge of the documentation standard. In order to reduce the complexity of the implementation and training processes, the differ- ent modules can be implemen- ted one after the other. Such an approach ensures that all wards and departments are at the same stage throughout the process and can support each other. Outlook and challenges ahead In view of the sanctions for failing to implement the EPR, the HIS soft- ware providers will most likely face short-term bottlenecks. The short- age of IT professionals will fur- ther exacerbate the problem since all hospitals will try to meet the compliance deadline. At the same time, the hospitals might have to conduct complex public tenders in order to be able to spend the funds that were made available for EPR implementation. In addition, introducing the EPR will temporar- ily increase the work load of the hospital staff. Institutions that are already struggling with staff short- ages and teams that are already putting in extra hours will suffer. Nevertheless, introducing the EPR is vital since it will improve patient care and will enable a more effec- tive control of the processes in the hospital. And: digitalisation is an important factor that makes a hos-  pital attractive for new staff. Report: Dr Christian Heitmann and Dominik Weis, Curacon EH @ MEDICA 2022

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