news & management needed: an umbrella organisation an independent and transparent event robots will never replace the first spanish oncology forum robots that perform cleaning or transport tasks, or distribute medi- cation or meals, are now often indis- pensable in hospitals and clinics, contributing significantly to smooth operations behind the scenes. a robot offered by medical technol- ogy provider xenex, for example, disinfects the environment with uv rays. according to the manufacturer the device can handle 64 rooms a day, calculating its route carefully so as to cover every nook and cranny. the robot is an important aid in the on-going battle against hospital- acquired infections (hais) by help- ing to contain infections caused by pathogens such as clostridium dif- ficile or mrsa. japan’s technology research for the past few years japanese companies, such as panasonic and toyota, and many research institutes have driven the development of care robots, due to the rise in the country’s aged population and the shortage of care staff, which is even more pronounced than in germany, for example. panasonic developed the roboticbed, which not only lifts a patient but can also transform into a wheelchair. from the same firm comes the hospi-rimo, a tele-pres- ence robot enabling communication between patient and physician. in hospital trials ‘hospi’ also distrib- uted medication. toyota motor launched the care assist robot, which lifts hospital and care home patients from the bed or takes them to the toilet. riken, another japan-based com- pany, follows a similar approach with robear. drawback: currently, none of these technologies is marketable because the development and acqui- sition costs are prohibitive. robots – a very distant switch from human caregivers there is no mass market yet for electronic patient care and the use of robots in clinical routine is still pie in the sky, since none of the high-tech devices recognises emo- tions or responds to them. while humanoid robots can indeed simulate emotions, they lack the ‘social skills’ to interact with patients. this is a major issue, as professor birgit wilkes, head of the institute of facility telematics at the technical university wildau, germany, points out: ‘in my opin- ion, the use of care robots can contribute greatly to facilitate lifting actions. however, it is incredibly dif- ficult to programme sensitivity into robots so they don’t hurt patients. they simply lack empathy and this is where today’s robots clearly hit the wall.’ technical assist systems support care staff technical assist systems are quite a different story: they can improve difficult working conditions in in- patient care, be it in hospital or geri- report: mélisande rouger there are many oncology meetings in spain, including the annual meeting of the spanish society of oncology medicine. what’s differ- ent about your event? ‘all these meetings are financed by the pharmaceutical industry. the forum is not; it is a completely independent and transparent event, organised by and for oncologists. ‘we wanted to offer frankly objec- tive information on the most fre- quent tumours without being con- ditioned by industry-related aspects. our speakers are free to present what they think are the most appro- priate aspects of cancer therapy. ‘there is neither industry sympo- sium nor technical exhibits at the conference, but the industry is more than welcome to participate and attend sessions. ‘we had around 350 registrations, mainly oncology physicians but also nurses, pharmacists and people from the oncology industry. the forum is open to anyone interested in oncology. we’ll try to make it an annual event.’ is oncology care good in spain, particularly regarding personal- ised medicine? ‘the field is doing very well here. the national level is very high, also in personalised medicine. ‘cutting-edge centres include vall d’hebron hospital in barcelona, clínico hospital in valencia and ramon y cajal hospital in madrid, among others. they all need more resources to continue to do things properly. ‘spanish oncologists are involved in numerous international stud- ies; for instance at ramon y cajal hospital we participate in various studies on immunotherapy drugs and targeted therapy.’ precision medicine is another important trend. is this the case in spain? ‘we’ve been talking about precision medicine for many years because we’ve been trying to treat patients more precisely, according to the nature of their disease, to improve both diagnosis and treatment. ‘however, to do so, we need more and better-designed clinical studies. these must be carried out everywhere, because cancer is a worldwide disease, but especially in centres of excellence, which have all the latest available therapies. as the number of patients and people requiring care increases, exacerbating the shortage of care staff for in- and out-patients, care robots might solve the problem. for menial tasks, many devices can contribute well; however, at the complex interactive human level of care, the idea that advancing technologies could replace human caregivers to alleviate staff shortages is clearly simplistic. overview: melanie günther when two spanish oncologists launched the first independent spanish oncology forum this may in madrid, european hospital’s cor- respondent spoke with dr javier cortés, co-organiser of the event, to find out more about its expected impact in their field did the programme tackle every aspect of oncology? ‘yes. we aimed to review cancer management over three days, by presenting the latest advances in diagnosis and treatment of all kinds of tumours. with dr enrique grande, who co-organised the event, we invited over 60 oncolo- gists as speakers and moderators to ensure we covered every aspect of tumour management. what about the two slots dedi- cated to lung cancer? ‘lung cancer, one of the most com- mon cancers, is the leading cause of cancer death in spain and incidence is rising. 26,715 people were diag- nosed with the disease in 2012 and experts predict it will affect over 40,000 individuals by 2035 in our country, according to the spanish association against cancer. ‘we presented all the newest developments – in personalised medicine, knowledge of mutations in risk factors, molecular biology and immunotherapy – in both local- ised and advanced lung cancer.’ care-o-bot shows how to handle the haemodynamometer continued from page 1 britain and brexit © fraunhofer © panasonic argument goes, withholding that would end our precious respect for democracy! some diehards among the ‘remain- ers’ also speak of a renegotiation of britain’s eu membership terms (despite what other eu countries might petulantly think); others are simply stiffening upper lips and proclaiming ‘we’ve done it; now we must just get on with it’ what those in british healthcare are focused on is further renegotia- tion to ensure the free movement of qualified eu medical workers to take up british nhs employment. it has been said that this could prove difficult in the future – but not for some time. much is already afoot: the pre- sent chief executive of the general medical council, niall dickson, commented: ‘withdrawing from europe will have implications for the way we regulate doctors but we understand that the vote to leave the eu will have no impact on the regis- tration status of any doctor already on the register. ‘we will now explore how doctors from the eu will be granted access to the uk medical register and how any concerns about those doctors will be shared between us and other countries. ‘we will also seek to understand the implications for uk doctors wishing to work in the eu once the uk is no longer a member state.’ how to achieve ‘leave’ the process of a eu exit runs in several stages. first, the european council - without the uk - must agree guidelines for negotiations and then the european commission is to negotiate an agreement on behalf of the eu. the agreement would need to be approved by britain as well as 20 of the 27 remaining member states, represent- ing 65% of those states’ population. (why did we not adopt that before the referendum?!) the european parliament (ep) then would need to approve the agreement with a simple majority. british members of the ep could vote. not surprisingly, the process needs two years to complete – after article 50 is initiated, unless surpris- ingly britain repeals the european communities act of 1972, but that would breach treaty obligations under international law. leaving could, according to the uk government, take ‘up to a dec- ade or more’ just to negotiate exit from the eu, the trade deals, and more. even then a state that has left the eu could request re-joining. in a nutshell, for now britain has its eu healthcare staff, and we need to do all we can to show our gratitude and to retain them – as well as, in the interim period before an actual brexit, to encourage oth- ers to work alongside us. we also need to influence whatever future government and medical institution leaders we have, to exercise their greatest efforts to ensure freedom of movement of qualified medical professional eu and other health- care migrants. so far, a laudable number of par- liamentarians are calling for guaran- tees to cover eu nationals’ employ- ment in british healthcare. 2 european hospital vol 25 issue 3/16

management & laboratory professional and ethical challenges no shortage of labs in malta report: moira mizzi nowadays, the variety of clinical labo- ratories in a hospital setting is end- less, especially due to the constant advent of new technology and scien- tific discovery; this places a cutting- edge professional and ethical chal- lenge on both the clinician and the laboratory specialist to give the best service to the patient in the realm of diagnosis and prevention. despite its minuscule size, malta still boasts of a hub of state owned laboratories and a number of much smaller private enterprises in the field. virologist dr christopher barbara, chairman of the pathology department at mater dei hospital, describes the particular challenges of the only state-owned laboratory service on the island. ‘we cater for a large number of tests, almost 22,000 in a single day, coming from dif- ferent sectors in the hospital, other public hospitals and clinics around the island and even from private labs that use our services in certain circumstances,’ he explains. ‘we offer these services on a 24/7 basis irrespective of the cost.’ the labs are also a national focal point that forms part of an interna- tional network (ecdc, who) focus- ing on disease surveillance and pre- vention. having to cater for such a large number of samples from different sources puts to test service qual- ity, particularly where blood collec- tion and transport are concerned. ‘quality has been a major priority for me during the seven years i’ve been in charge of the labs,’ barbara says. ‘thus i insist on having a clear visibility of things to ensure account- ability and efficiency.’ in his opinion this must start at a pre-analytical level so that the accuracy of the result is not jeopard- ised. in fact, the pathology depart- ment at mater dei has gone through major quality-centred changes for this purpose, with the aim to gain a much coveted iso certification; these include the installation of a harmonised lab information system (lis) software that ensures the acqui- sition of ‘clean data’ from sampling to result, putting in place standard operating procedures and quality manuals, the setting up of a coagula- tion clinic at all the outside clinics with a point of care (poc) testing facility, connected through the latest software to the haematology depart- ment, and the use of sample bottles with gel separators. phlebotomy was also relegated to staff members on a lower salary scale, who were specifically trained for the job to avoid sampling prob- lems – usually rampant with junior medical staff. this shift in tasks also allowed a parallel shift of funds, which could then be used in the acquisition of necessary state-of-the- art equipment. capital expenditure is in fact another major challenge faced by labs every day. barbara believes much can be done if unnecessary cost is curbed and funds are then used in a more profitable way. ‘at the moment we are planning to get an automatic sorter from the money saved from vetting unnecessary tests,’ he explains, excitedly. ‘in turn, this will save on human resources and extra wages, improve turn-around times, which then can be used to acquire other analysers, such as the guthrie test. although the challeng- es and demands are never ending, there’is a lot we can do to give the best service to the patient.’ for a private lab, giving the best service to patients is not just an exercise in quality control and cost- effectiveness but also having to con- tend with the ever-looming shadow of reputability, especially in a small market where competition is tight and patients have been accustomed to free medical service for decades. paul sultana, head of medical laboratory services (mls), the pri- vate laboratory at st. james hospital, in sliema, describes how this focus on quality of service, especially where timing and reliability of results and availability of a wide range of tests is concerned, put his lab among the forerunners in diagnostics for patients and clinicians. ‘the advan- tage of running a private lab is the paucity of the bureaucracy that often limits state-owned labs,’ he observes. ‘for example, we immediately intro- duced liquid based cytology five years ago, whilst at mater dei, there malta has a hub of state owned laboratories and a number of much smaller private enterprises paul sultana is head of medical laboratory services at st. james hospital, sliema transplants: beating organ rejection cell-free dna offers several the worldwide problem for transplan- tation is the lack of donor organs. ‘therefore,’ professor michael oellerich explains,‘we have to expand the range of donors in transplant med- icine and must also use organs from marginal donors under considerations of the risks involved. the rate of transplant rejection within the first year is up to 20% for liver transplants, 27% for lung trans- plants and 29% for heart transplants. for the latter, 11% of deaths within the first three years are due to rejection, which therefore poses a significant risk. ‘the survival time of transplants is important for long-term outcome. for the liver and kidney the average is 13 years. the average survival of patients with heart transplants is 11 years. if we could extend the half-life many more people would benefit from a new transplant and the general short- age could be overcome, not to men- tion the costs. ‘the limiting factors are the irre- versible chronic rejection on one hand and, on the other, side effects, such as nephrotoxicity, cardiovascu- lar disease, infections and malignant tumours. secondary complications are also dangerous and clearly contribute to the difficult prognosis. the problem we continue to deal with is over- and under-immunosuppression. ‘measuring the cell-free dna allows us to continuously monitor the integ- rity of the transplanted organ and so to reduce the number of rejec- tions whilst lowering the side effects through optimisation of immunosup- pression,’ oellerich explains. the procedure ‘if a patient has been under-immuno- suppressed after a kidney transplant, for a period of time, for instance, he can develop donor-specific antibod- ies, which will destroy the organ in the course of time. drug monitoring allows us to detect the toxicity bet- ter, i.e. the over-immunosuppression. however, the procedure is less suit- able to assessment of immunosup- pression effectiveness, meaning the minimum exposure required cannot be safely predicted. ‘to escape this dilemma we need a parameter that can reveal something about the state of the transplant at any given time. there are no reliable conventional markers for rejection as yet: liver enzymes are not sufficiently specific, there are no suitable non- invasive markers for the heart and lungs and the kidneys can already be affected by a fifty percent loss of func- tion before a rise in creatinine can be detected. ‘in other words, we’d like to improve and personalise immunosuppression through early detection of rejection so that we can also diagnose slow, continuous damage to the transplant at the subclinical stage and prevent chronic loss. we need a test that’s practicable and can be quickly carried out at a reasonable cost. ‘cell-free dna is extremely suitable for this. the cell nucleus of a dam- aged cell releases dna into the blood which can be used as a marker for cell necrosis or apoptosis; it is a marker which indicates the destruction of the tissue. if, for instance, a liver cell dies and the cell nucleus is destroyed, the nucleosomes are flushed into the blood. in the case of necrosis these show up as large fragments and as smaller ones in apoptosis. ‘against the background that organ transplants are always also genome transplants, i.e. that the donor and recipient genomes are different, there is a fantastic opportunity to detect the genomic dna of the donor in the recipient’s blood, even though it is present in much smaller quantities. if we detect an increased amount of cell-free donor dna in the blood we know that the transplanted organ is not doing well.’ how the test works ‘circulating cell-free dna in the blood has a very short half-life of four to 30 minutes. in studies, we have examined patients’ stable phases to determine a ratio as to how high the fraction of the circulating donor dna can be. we then use this as a threshold above which it indicated that the organ becomes damaged. ‘the fraction of donor dna is very high immediately after a transplanta- tion because of the ischemia/reperfu- sion damage, but it quickly decreases. if the values rise significantly again over time this is a sign of rejection or other damage to the organ (severe ischemia, for instance). ‘a method has been developed based on droplet digital pcr, which allows cost-effective monitoring of graft-derived circulating cell-free dna with same-day turnaround. donor- and recipient dna are amplified in the droplets and quantified in a flow cytometer via the emission of different fluorescence signals. this procedure has quickly proved itself of value in molecular diagnostics. ‘the particular advantage is that we require no donor material for our test. we use e.g. streck cell-free dna bct tubes for the blood test, which keep the sample stable for up to seven days at room temperature through stabilisers. the donor dna can then be extracted from the sample and the recipient dna is determined via the white blood cells. using pre- selected single nucleotide polymor- phisms (snps) it is possible to obtain respectively heterologous, homozy- as part of a national, joint research project in cooperation with chronix biomedical (san jose, ca/usa/ göttingen/germany), professor michael oellerich md is on new biomarkers in organ transplantation, aiming to develop personalised immunosuppression for patients.this also entails the development of molecular test pro- cedures, among others for the early detection of rejection.the keyword here is cell-free dna (cfdna). graft-derived cell-free dna (gcfdna) is released from kidney, liver, heart or pancreas transplants into the recipient’s blood. it accounts for a small fraction of total circulating cfdna. small cell-free dna fragments from the recipient’s blood circulation can be filtered through the glomerular barrier and appear in the urine. (reprinted from gielis em et al, am j transplant 2015; 15: 2541-2551) 4 european hospital vol 25 issue 3/16

www.kugel-medical.de c o lo r u p yo u r l a b equipment for histo-pathology labs azg_km_european-hospital_103x133.indd 1 11.02.16 09:32 laboratory paediatric laboratory medicine the orphan stoppin device hossam haick is a professor in the department of chemical engineering and russell berrie nanotechnology institute in haifa, israel paediatric labo- ratory medicine plays a minor role in the large clinical laboratory field. this may be due to the low incidence of rare dis- eases, which are a major task of paediatric medicine, but also to the small number paediatric samples in routine laboratory medicine overall. since most diagnostic laboratories do receive paediatric samples, now and then, it is essential that there are primary sources of information and networks to answer questions arising around paediatric laboratory medicine. the challenge in paediatric labo- ratory medicine starts in pre-analyt- ics: the small blood collection tubes with capillary blood samples are not compatible with automated tube handling of pre-analytical solutions in high throughput core laborato- ries. in view of the fact that pre-term neonates can have a total blood volume of less than 80 ml, it is understandable that neonatologists are reluctant to draw more blood than absolutely necessary. thus, the paediatric laboratory has to collect manually even the last drop of plas- ma for diagnostic purposes to pre- vent a transfusion of erythrocytes. among the main challenges in paediatric laboratory medicine are inborn diseases, which individu- ally are rare but, in their multitude, lead to a large number of paediatric patients. the wide field of inborn errors of metabolism, inborn endo- crine disorders, and inborn immu- nological defects mainly pertains to the paediatric population. for these diseases paediatric laboratory medicine offers many analyses to support diagnosis and follow-up. for example, paediatric laboratories offer several targeted metabolomic profile analyses that may lead to the investigation of a specific enzyme defect, followed by genetic confirmation of the rare monogenic disease. whilst most paediatric laboratories offer target- ed metabolomic profile analysis, enzymatic and genetic analysis are available only in specialised centres for inborn errors of metabolism that have the necessary diagnostic experience for a limited number of diseases. communication between the pae- diatric laboratories and the special- ised centres enables the diagnosis of many rare or orphan diseases. networking support is provided by orphanet (www.orpha.net), an ini- tiative that allows searching for orphan diseases and directly lists the specialised paediatric laborato- ries offering the appropriate diag- nostic procedures. however, the current list of orphan diseases is incomplete and novel orphan dis- eases are discovered every week. thus, paediatric laboratories need to adapt their metabolomics pro- file analyses constantly in order to cover all newly discovered diseases. it is reasonable to assume that these metabolomic profile analy- ses will become crucial also for adult patients since life expectancy of paediatric patients with inborn errors of metabolism is increasing and more of these patients will reach adulthood due to new drugs and better treatment in general even routine paediatric labora- tory medicine can be challenging because children are not just small adults but have a distinct physiol- ogy that moreover changes during development from neonate to young adult. this is particularly obvious in analytes such as alkaline phos- phatase during growth and in sex hormones during puberty, which require interpretation and reference intervals. due to the rapid changes of refer- ence intervals during development, paediatric laboratories would prefer implementing continuous reference intervals rather than displaying the categorical age groups that most laboratory information systems sup- port today. in order to be able to develop con- tinuous reference intervals, we need solid reference data over the entire developmental period from the neo- nate to the young adult. while these data were not available in the past, several working groups within the ifcc in northern europe and in canada have contributed recently to the establishment of solid refer- ence intervals in the paediatric and adolescent age range. for example, the large children and adolescent health study (kinder- und jugend- gesundheitsstudie – www.kiggs.de) in germany established reference intervals for routine clinical chem- istry and haematology; in addition, the canadian caliper study (www. caliperdatabase.com) provided ref- erence intervals for endocrinology. those studies now allow the diag- nosis of orphan diseases detected with routine diagnostics such as hypophosphatasia or hypoalphali- poproteinemia, which both need lower reference levels for alkaline phosphatase and hdl cholesterol, respectively. these initiatives for the estab- lishment of solid reference inter- vals are supported and coordinated by the task force for paediatric laboratory medicine of the ifcc. this task force also organises the triannual ‘international congress on paediatric laboratory medicine’ (icplm) as a satellite meeting of the ifcc worldlab. * the next icplm will take place on 20 to 22 october 2017 in durban, south africa. congresses such as icplm allow networking between professionals in paediatric laboratories and pro- vide clinical and scientific further education for these professionals. in addition, these events offer labo- ratory professionals who handle paediatric samples now and then insights into paediatric laboratory medicine and serve as a commu- nication forum with profes- sionals in pae- diatric labora- tory medicine. interview: walter depner according to dr peter liese (cdu), speaker for health issues for the european people’s party (epp group), the largest parliamentary group, this is an important step for europeans who have long awaited appropriate consequences to follow scandals such as poor quality breast implants, stents or unsafe hiv tests. due to extremely complex issues, it took several years to reach an agreement, according to liese, who suggested that certain ministers in some countries obviously did not consider this a top priority issue. eh asked the healthcare speaker to outline the draft regulation and expected effects the vdgh, the association rep- resenting the ivd industry in germany, expects – or rather fears – that eu law will once again place a high financial and time burden on manufactur- ers, mainly due to the increased administrative requirements. is this fear justified? peter liese: ‘i do understand the concerns of vdgh. the council’s position, as defined last year, indeed overshoots the mark. pressured by the european parliament, we revised the text. after long negotiations the council finally agreed to reduce overly bureaucratic requirements in many areas. i’m confident, that we will have a good compromise.’ paediatric laboratory medicine plays a minor role in the large clinical laboratory field. this may be due to the low incidence of rare diseases, which are a major task of paediatric medicine, but also to the small number of paediatric samples in routine laboratory medicine overall. since most diagnostic laboratories do receive paediatric samples now and then, it is essential that there are primary sources of informa- tion and networks to answer questions arising around paediatric laboratory medicine, explains professor martin hersberger, head of the division of clinical chemistry and biochemistry at the children’s university hospital in zurich, switzerland the european parliament, the council and t a compromise draft regulation covering med following more than 42 months of negotiati company banishes white from medical interiors colour up your lab! a month later, at the german pavilion at arab lab 2016 in dubai, the firm was presenting lab personnel with this concept and reports: ‘we received a lot of questions: what’s high pressure laminate? what makes it eco-friendly? what kind of lab- oratory furniture can be colour matched? why is it antibacterial?’ along with a ‘colour up your lab’ leaflet, the company showed its his- to-pathology equipment, e.g. gross- ing tables, staining tables, prepara- tion cabinets, stainless steel furni- ture and more, and also presented a new brochure about exhaust sys- tems for histo-pathologies. however, kugel medical was keen to point out that it not only manufactures this equipment but also provides planning. ‘no matter if you’re looking for a partner for a sophisticated furnishing of an entire building complex or a partial fit out, we are your point of contact concerning designing, developing and planning.’ kugel medical is encouraging medical personnel to leave those tra- ditional sterile white worlds behind, stating that the ‘design possibilities are almost endless. the combination of different materials like wood with granite or the mixture of cold and warm tones gives your laboratory design that little extra something. ‘we do not limit ourselves to labo- ratory furniture and laboratory table plates, but rather we also colour match our preparation cabinets with the corporate identity of your labo- ratory. all woods and raw materials that we use for our eco-friendly high pressure laminate solution come from sustainable managed forests with pefc and fsc certificates. ‘additionally, daily adjustments of production processes guarantee that 10 times less water and 40% less energy are used and 75 % of the waste is recycled or recovered. ‘during production of high-pres- sure laminate, fine paper layers as well as a thin eco-friendly mela- mine resin film are applied on top and bottom of a wooden base plate. then, the different layers are pressed together under high pres- sure of 75 kg/cm² and temperature of approximately 150°c, making the this january, kugel medical, from regensburg, germany, announced an interesting new venture. although a leading manufacturer of equip- ment for pathology, histology and the laboratory for over 20 years, the firm launched its new colour up your lab design service. color concepts in laboratories instead of sterile white 6 european hospital vol 25 issue 3/16 azg_km_european-hospital_103x133.indd 111.02.1609:32

digital path0logy medical devices. ‘there also will be an additional procedure for high- risk devices such as implants, where not only the notified bodies but also an expert group will assess product conformity.’ are there figures regarding how many medical devices and ivd launched each year will be affect- ed by these changes? ‘there are somewhere between 3,000 and 5,000 ivd products and more than 100,000 medical devices.’ the so-called genetic technol- ogy products are also governed by this new regulation. what is the situation in the different eu member states? ‘the european parliament demands special rules for dna tests. obviously we do need strict rules for all diagnostic tests to guarantee the quality of the products as such. dna tests are a special case as they deal with highly sensitive infor- mation. therefore the european parliament suggested that such tests only be performed after expert counselling and explicit consent of the patient. in some countries – but not all member states – this is already standard operating proce- dure. since, for ivd manufacturers many things will change, we agreed on a five-year transition period.’ meaning a transition period to allow all stakeholders to under- stand and implement the new rules? ‘exactly! there will be a transition period of five years for ivds after the regulation’s entry comes into force.’ thank you – hopefully the new regulation will increase patient safety with regard to medical devices and ivd for all of us, throughout the eu. continued from page 7 stopping unsafe medical device production mobile technology could enhance digital pathology mobile digital microscopes are in development for many years pathology has moved more slowly than other fields that have embraced digitisation primar- ily due to costs and scale of the equipment, according to professor johan lundin, research director of finland’s institute for molecular medicine (fimm), at the university of helsinki. an inability to take digital micros- copy out of the laboratory as a port- able tool has also been a consid- eration, which is about to change, however, with a number of mobile digital microscopes in development. among these is lundin’s research group at fimm and karolinska institute in stockholm, which is pio- neering the momic portable scan- ner, currently undergoing tests in finland and tanzania. ‘having the microscope closer to a patient, or where the samples are obtained, would improve the way you can perform diagnostics, mak- ing it more rapid and more acces- sible,’ lundin pointed out. it would improve the workflow of diagnos- tics, not just in pathology but also microbiology, cytology and forensic medicine.’ the low-cost, easily transported mobile microscope and scanner developed by the finnish research- ers, which enables the use of rapid, computer-assisted remote diagnos- tics, uses cheap components origi- nally intended for mobile phones and connects wirelessly to a cloud server to which it transmits images for machine vision analysis. ‘digital pathology, and digi- tal microbiology, can make much use of technology from the mobile phone industry if combined with the optical components you need for microscopy,’ added professor lundin, who is chairing sessions at the 13th european congress on digital pathology (held in berlin - 25-28 may 2016). momic is still an academic study, but what differentiates it from simi- lar mobile microscopy projects is the scanner facility it incorporates, which is vital because it enables the digitisation of the whole sample. ‘if you cannot digitise the whole sample it’s very difficult to use it for medical diagnostics because it’s extremely difficult to control where the important part of the sample is on the slide,’ lundin explained. the advantage of momic is that it becomes a point-of-care (poc) device and can attain laboratory- levels of microscopic resolution and scan a sufficient area of a sample to enable diagnosis. once a sample is obtained it can facilitate faster digital diagnosis, or the ability to consult remotely. lundin said the momic project began with the goal of creating an instrument for low resource set- tings and currently five prototypes are being tested. field studies are under way in a small hospital in a provincial area of tanzania, a coun- try where there are less than 20 pathologists among a population of 45 million people. in the three-year pilot programme, patient samples will be diagnosed both on location and remotely based on the digitised sample. in such countries, he believes momic will impact on diagnoses of cancer, infectious diseases, includ- ing malaria, tuberculosis, and stool parasites. other tests are under way in finland for cancer diagnosis dur- ing surgery, using the device away from the laboratory for pathologists on the spot to view samples taken, to check tumour margins and to ensure the lymph nodes are clear of cancer. the next steps, supported by a government innovation grant, are to establish routes to commerciali- sation with partners identified, to transform the prototypes into a product, with large-scale validation studies planned for next year. lundin also sees portable digital pathology microscopy being used in parallel with larger high throughput scanners, supporting single patholo- gists in smaller units, a move which he believes would open the world of digital pathology to more prac- titioners. the professor also believes the mobile microscope would suit research work, including the study of tissue and cell samples to iden- tify the expression of biomarkers in cancer research. mobile technology could prove an important catalyst in helping to raise digital pathology to a new level in delivering clinical diagnostics, mark nicholls reports professor johan lundin is research director at finland’s institute for molecular medicine (fimm) hosted by the university of helsinki and guest professor in medical technology at the karolinska institute, in stockholm. he is also associate professor in biomedical informatics at the university of helsinki. his key research aims are to fully utilise development within information and communication technologies to improve diagnostics and individual care of patients. 8 european hospital vol 25 issue 3/16

i-scan 1 – surface enhancement i-scan 2 – tone enhancement i-scan 3 – optical enhancement endoscopy & surgery international endoscopic r&d bring distinct rewards new devices deliver exceptional clarity after gaining his phd in mechanical engineering at the georgia institute of technology mike drexel phd held senior research engineering positions at ge global research, michelin and the georgia institute of technology, before joining pentax medical in 2012. there, as chief technology officer, he leads the $500 million medical device firm’s international technology efforts, coordinating the activities of 60 research scientists and engineers based in munich and boston. dr drexel is also responsible for initiating partnerships with universities and industrial concerns. joining pentax medical five years ago, dr mike drexel immediately began to globalise the firm’s r&d process. ‘originally we didn’t have any facilities for r&d beyond japan, which meant our local market expertise was not as strong as it could be. in the last five years we have established further facilities in the us (montvale and boston), and germany, to work closely with local mar- kets throughout our r&d pro- cesses. ‘this globalisation project has resulted in four r&d sites across three continents generating local market data and working with regional kol (key opinion leader) groups, made up of internation- ally recognised clinicians within the key endoscopic application areas. i believe this global approach to endoscopic r&d is a market first; pentax medical is the only manu- facturer to work on this global/ regional level.’ how are clinical needs estab- lished before new product devel- opment? ‘we have an ethos at pentax medical which involves bringing together the elements needed to deeply under- stand exactly what unmet needs are in the market. the first step is to identify the need by looking at data sets and talking to our global net- work of clinicians. it’s important to consider the market requirement in this process alongside the practical capabilities of the physicians. ‘through our consultation with our kol network, we have now recognised a suitable unmet need, but what does the solution need? sometimes consultant clinicians are specific in their requirements and sometimes a consultant can identify the need, but we have to consider the technology best employed to meet that need; it’s a two-way pro- cess. we are now defining the prop- osition in-line with all the applica- tion requirements. ‘once we’ve identified an unmet need where we feel we could engi- neer an effective solution, and then decided on possible solutions, we must consider the product definition – which technologies are best suited to that application. the suitable technologies would be incorporated into prototypes, which then would be bench tested using a number of trials designed to evaluate its performance against a range of parameters. here, our kol network plays an important role because fur- ther in-the-field testing is conducted through multi-centre studies. ‘by analysing all the data from the rigorous testing procedure and looking at the data and consultants’ feedback, we can now down-select from our prototypes. multiple units of the chosen prototype are pro- duced featuring our further defined technology and distributed to our kol network to see if we now sat- isfy the unmet need. ‘all previous data gathering, con- sultations, bench and field testing make up the research stage. as we start development, we liaise heavily with all departments within our organisation, clinical specialists, sourcing and quality management. ‘we particularly work closely with our quality management and sourc- ing teams to ensure high stand- ards of quality engineering and of components.’ how do you evaluate and vali- date a new product? ‘with the full specification now complete we can produce a pro- totype that is so close to a final production model that hopefully consultants can’t notice much dif- ference. these final prototypes are then handed to our kol networks for final evaluation. as part of our continuous development we are further enhancing our kol pro- gramme with the introduction of the blackbox innovations project, which looks to build on our existing relationships with kols, allowing us to work even more closely and enhance our working relationships. ‘this year will see the benefit of our global approach with the intro- duction of a number of key products across three areas of specialism. one key product brings together two technologies, digital and optical enhancement, i-scan and i-scan oe.’ pentax medical is now keen to see the market response to the optivista epk-i7010 video processor, its unique product launched in may. ‘our kols were clear on the need to identify both vascular and mucosal patterns better, with each technology (digital and opti- cal enhancements) having strengths in the two different applications,’ drexel points out. ‘there wasn’t a video processor that could offer this, so we understood there was a clear benefit for physicians to be able to employ both technologies through the same device.’ believing the future of endoscopy lies in ever-closer union between manufacturer and consultant com- munities, the firm is further evolv- ing its research and development process by introducing a blackbox innovations project. in 2016, ten kols will visit pentax r&d world in augsburg, germany, to share confi- dential material on its latest research and discuss the way forward. this year pentax medical launches three premium products for use in gastroenterology, ear nose and throat (ent) and bronchoscopy. these result from highly focused global research and development, for which mike drexel, the company’s chief technology officer, is responsible. in our european hospital interview he discusses how the firm’s globalised approach to product research and development has taken shape. application reports the optivista epk-i7010 video processor, which features both digital (i-scan surface and tone enhancements) and optical enhancement (i-scan oe), with the new optical filter producing bandwidth-limiting light. this unique enhancement combination delivers detailed information for more accurate endoscopic in vivo diagnosis through improved vessel and mucosal pattern characterisation; for example, the surface structures of blood vessels, glandular ducts and mucosal membrane are displayed in higher contrasts than white light. (images courtesy of dr federico buffoli, ospedale di cremona, italy) internationally-renowned experts have tested optivista and switched seamlessly in real time amongst hd+ white light and i-scan 1 (se), i-scan 2 (te) and i-scan 3 (oe), to view multiple aspects of tissue structure. their initial findings have confirmed the clinical value of this unique system, when moving through the clinical pathway for endoscopic evaluation. professor pradeep bhandari (queen alexandra hospital, portsmouth) concluded: ‘the pentax high definition white light image is a major advance, but when i switch i-scan 1 (se) on then the image becomes sharper and crisper without losing any other attribute of the image so i don’t see any reason why i-scan 1 (se) should not be left on at all times. once i find a subtle abnormality, or any obvious lesion, then i switch on i-scan 2 (te) and that really highlights the lesion from the surrounding normal mucosa. ‘once the presence of neoplasia is confirmed then i switch to i-scan oe to evaluate finely the surface and vessel patterns of the lesion (to differentiate neoplastic from non-neoplastic lesion) and identify the exact margins of the lesion. the recent addition of i-scan oe to the pentax family has been a major step forward in evaluation and characterisation of gastrointestinal neoplasia.’ dr michael häfner, at the elisabethinen hospital, vienna, confirmed: ‘i-scan oe combines the versatility and flexibility of i-scan with ever sharper and crisper pictures. while i-scan 1 (se) is my standard setting during every procedure because it gives you the extra bit of contrast and detail to detect even very subtle changes of the mucosa, i-scan oe offers an extremely sharp view of the surface pattern, for example in barrett’s oesophagus. combine it with the capabilities of the optical zoom endoscopes and you get the ultimate diagnostic tool in both lower and upper gi tract.’ dr rehan haidry used the i-scan oe combined with optical zoom endoscopy to help diagnose early squamous cell carcinoma, as well as visualise an early neoplastic lesion arising from the barrett’s mucosa. ‘over the past six months i have been using newer optical enhancements that pentax have developed above and beyond the conventional i-scan. i have particularly liked i-scan oe, because the filtering technology provides a very distinct and lighter image of the vascularity and mucosal pit patterns that become disordered in early cancer. in my practice, this coupled with i-scan se have become the two most common enhanced imaging modalities that i use.’ images on discs and films, a slower but significantly cheaper alternative. ‘the point is to use something that is economically relevant to store the huge amount of information and images we need today,’ he said. pathologists can also use low cost vendor-neutral archive (vna) systems to store images in a reposi- tory cheaper than the one used for radiology images. several com- panies, including agfa healthcare, carestream health, ge healthcare and merge healthcare, now offer vna products either in-house or through acquisitions. another possibility is to erase the images after a given period of time. pictures do not need to be saved forever; the paraffin block, from which images and slices can be generated anytime, always remains as a back up for future investigation in molecular pathology or genomics. twenty-five public hospitals are equipped with digital pathology scanners in spain, but only five use them in clinical practice: gh jerez de la frontera, university hospital arnau de vilanova in lerida, university hospital in ciudad real, and barcelona’s del mar hospital and university hospital clínic. the latter leads the way, with up to 300 preparations a day. several digitisation projects for private clinical practice are under- way across spain. santa lucia university hospital in murcia offers telepathology services to the rest of the country. ‘spanish digital pathology is doing well,’ rojo observes. ‘almost every pathology department now digitises preparations. sweden, norway and the netherlands are still leaders in clinical practice, but the situa- tion across europe is very irregular. we’re doing what we can to stay ahead of the curve.’ continued from page 9 ‘we’re staying ahead of the curve‘ 10 european hospital vol 25 issue 3/16

endoscopy & surgery natural orifice transluminal endoscopic surgery notes – an emerging trans-disciplinary treatment bringing a sharper image to surgery jose ramon armengol miro heads the gastrointestinal surgery department at hospital vall d’hebron and the gastrointestinal endoscopy department at quiron clinic, in barcelona. he is also associate professor at the medical faculty of autónoma university, in barcelona. he is founder and president of the catalan society of medico-surgical digestive endoscopy. additionally, armengol-miro is vice-president of the world organisation of digestive endoscopy. what exactly is natural orifice transluminal endoscopy surgery? ‘notes represents an emerging trans-disciplinary treatment based on disruptive technology. it is the paradigm between open abdomi- nal surgery, laparoscopic surgery and surgery carried out through natural orifices. in 2000, dr sergey kantsevoy and anthony kalloo, from baltimore, presented their work on transgastric laparoscopy, to avoid abdominal incisions. it’s the the conversion will not happen over- night, but 4k is a natural next step for improving visualisation during surgery, according to john herman, the european marketing manager for surgical solutions at sony medical. standard definition (sd) video gave surgeons a view that was measured in 680 pixels by 480 pix- els. over the past eight years hos- pitals have progressively converted to high definition (full-hd) video that gives a sharper view, with 1920 pixels by 1080 pixels. ‘if you asked a surgeon whether he would be will- them greater diagnostic confidence in what they are seeing, and a greater confidence in making surgi- cal gestures and actions,’ he added. ‘4k also offers an enhanced colour range, providing surgeons with true colour reproduction. this should then lead to better patient outcomes through a visually enhanced pro- cedure.’ like hd, next-generation 4k imaging is created in a tightly linked video chain from source to final display. in the operating theatre, a video signal is created by a camera in an endoscope, surgical microscope, or one mounted on a boom arm suspended above the operating table for open surgery procedures. ‘with 4k sources you need 4x the bandwidth to transmit the signal compared to hd. standard video cables are just not practical to transmit 4k images effectively, as four cables would be needed. so we designed a new plat- form to convert the video signal to ip format and to transmit secure 4k content via a single cable,’ herman explained. the content can be sent anywhere within a hospital, through the lan, to be shared or stored. to view the image, the data is con- verted again to a video format, and while it can be displayed on hd or 4k devices, it is only on a 4k display monitor that the original resolution and sharpness of the image can be appreciated. this end-to-end chain becomes critical in the operating theatre (ot), where there can be no delay in the processing chain, and here is where sony medical brings unique expertise and capabilities from its live broadcasting division. ‘the surgeon working with an endoscopic camera cannot toler- ate any latency in display of the image, otherwise the movement of the surgeon’s hands, while viewing the image, would not be co-ordinat- ed,’ herman pointed out. ‘any vis- ible delay would mean the surgeon would not be able to perform the operation.’ in the surgical imaging indus- try, sony medical is the only com- pany that provides each link in the 4k chain, he said. ‘certainly there is competition in the differ- ent segments for surgical monitors, or for surgical recorders, but in the 4k chain from image acqui- sition through image processing, recording, and to image display, our proposition is unique. we are the only company to have a complete 4k workflow and there is no other company with this breadth of com- plementary products.’ ‘we were the first to launch 4k medical-grade monitors, and the first to launch a 4k surgical record- ing system. we have just introduced a 4k content management system and soon we will also introduce our 4k video over ip system,’ herman said. outside the operating theatre, sony has a huge range of market leading 4k devices for training and education, from 4k lcd displays, to 4k laser projectors and 4k video presentation solutions. sony is a global leader in image sensors and image processing tech- nology, he explained, adding that the camera modules found inside many of the leading endoscopes are from sony. at the same time, he added that a premiere feature of the sony 4k ip system is that it is an open architecture built on industry- accepted standards (standardisation process ongoing), with no propri- etary requirement, giving hospitals the flexibility to connect any input device or any display device they choose for best purpose. sony medical holds a strong pres- ence in operating theatres going back over 30 years, ‘to the point where i would guess that the vast majority of hospitals in europe have some sony equipment in their oper- ating theatres,’ the marketing man- ager surmised. thanks to the infrastructure required in the conversion to full- hd, many hospitals are ready to share content from a server or cms system. and the demands for digital capabilities in other areas of healthcare, such as pacs systems and electronic records, mean that most hospitals have a standardised it infrastructure that can support video over ip. there are two areas where a conversion to 4k will present chal- lenges that need to be incorporated into planning. many hospitals have already faced difficulties in archive planning for hd video files and with 4k these problems will only become greater, as 4k files can be over four times larger than hd. however, using sony’s xavc-s codec format, 4k file sizes can be reduced by a factor of three, depending on image quality settings. this can translate into savings in archive costs and savings in computing hardware needed to edit. the next area is within the ot. whereas hd images pass through a video cable, fibre optic cabling is an absolute requirement for 4k, in order to maintain real-time display of the surgery being performed. incorporating this into an exist- ing or requires special care and expertise. upgrading to 4k within the operating theatre opens the pos- sibilities for surgeons to gain access to more information when they need it, with the ability to share images from multiple sources such as ct or mri scans from pacs sys- tems, patient vital data or even pre- surgical planning data on a single large 4k monitor. herman expects that the surgeons’ drive for 4k visualisation may be the trigger for a decision to make the move. beyond enhancing the view for endoscopic surgery, herman said that sony is collaborating with com- panies investigating the potential for 4k in surgical microscopy. for the fine work required in neu- ro-surgery or ophthalmic surgery, the surgeon today views the target bent over a microscope, sometimes for hours. 4k camera module tech- nology is compact enough to be integrated inside the microscope to provide a crystal clear 4k image to a 4k surgical monitor, giving a heads- up view, where the surgeon can watch his hands working instead of through the binocular eyepiece. ‘there is a potential that, with 4k, we can unlock innovative ways of performing surgeries,’ herman is convinced, ‘because the image is that good.’ so-called perfect cosmetic surgery with no scar, less infection risks, quick recovery without pain, quick recovery of the paralytic ileus, less adherence issues and better access in obesity indications. ‘basically it consists of pinch- ing the stomach, dilating an inci- sion with a balloon, introducing the endoscope into the peritoneal cavity and closing the dilated gastric incision. access is fundamental; it can be trans-gastric, trans-colonic or trans-vaginal. many indications have emerged in humans since 2000: lap- aroscopy, appendectomy and trump ligature. in animals we are using notes in hysterectomy, cholecys- tectomy, gastrojejunostomy, splenec- tomy, gastric reduction, herniogra- phy and hepatic resection. ‘advances have focused main- ly on basic but essential aspects: suture, endoluminal anastomosis, transluminal drainage and complete tumour resection in gastrointesti- nal tube and achalasia treatment with peroral endoscopic myotomy (poem) technique; and other appli- cations of submucous tunnelling, such as pyloric stenosis etc. also the introduction of robotics.’ ‘notes was introduced in june 2007, after attending the first d-notes course organised by dr j hochberger. in 1986, at vall d’hebron hospital, barcelona, a team successfully treated two patients with large pancreatic pseu- do cysts by performing cystogas- tronomy and post dilatation of the puncture area with post-cystosco- py, with complete cleansing of the detritus inside the pseudo cysts. these cases were the foundation of notes in our country. originally we had a few experimental centres that jose ramon armengol-miro has directed the world institute for digestive endoscopy research (wider) since 2007. there, he leads the investigation of natural orifice transluminal endoscopic surgery (notes). the technique was introduced to gastrointestinal endoscopy over ten years ago. speaking with mélisande rouger the expert assessed its use and value today sony medical offers an end-to-end video processing chain for medi- cal-grade 4k surgical visualisation, john brosky reports the sony 4k surgical monitors are available in two sizes: 55” for big screen surgery, or 31” typically used on an endoscopic cart system. the sony medical 4k over ip complete workflow solution provides all the necessary end-to-end technology to capture 4k surgical images right through to sharing 4k content for clinical education and training. continued on page 14 ing to go back a step and give up hd, he would say absolutely not, he’d argue that sd no longer meets the required standard of care, and that it may even pose a risk for the patient,’ said herman. in the same way, he said sur- geons will be ready to embrace the ultra-high definition resolution of 4k, which is four times greater than what they are using today with full-hd. ‘it gives a much clearer picture with a greater sense of depth, and for surgeons this means an abil- ity to better distinguish blood ves- sels or minute structures. it gives 12 european hospital vol 25 issue 3/16

endoscopy & surgery robots for neurosurgery? the brain is a delicate place their parts are simply too big ‘an autonomously working robot in the operating theatre will continue to be a vision of the future for a long time to come,’ according to professor uwe spetzger, clinical director and neurosurgery specialist at karlsruhe city hospital. at the same time, he is calling for political support for the development and promotion of these innovative technologies and asking funding bodies to rethink their strat- egies. ‘the topic obviously easily lends itself to ethical discussions,’ he adds, ‘but, in some cases, an assis- tance system can actually be more reliable than a human colleague.’ a setback for science the big boom in robotic medical technology in germany occurred around 15 years ago. at the end of the 1990s to the early 2000s robots conquered operating thea- tres, carrying out hip replacements more or less autonomously – often with little success. why? because those robot-assisted operations failed due to mistakes. ‘the errors were human and actually quite banal, because the robots were often not programmed correctly; calculations were carried out wrongly and user errors occurred,’ spetzger explains. ‘in principle the robots were very precise and performed good work on components. however, they had not been specifically manufactured for the medical market but mostly rather adapted from the automotive industry.’ ‘what followed was a general loss of trust and a setback for robot assist- ed surgery. ‘this not only resulted in harm for some of the patients treated but also in enormous damage for tested notes in animals to help develop the technique and train our teams in carrying out procedures. ‘now the most active institutions are the centre of minimal invasion surgery jesús uson in cáceres (ccmiju), the centre of training in endoscopic surgery in santander (cendos) and wider, where we are working on procedures for clini- cal practice. we also launched an international course, celebrating its 10th anniversary this year. ‘there are many more centres, but only for investigation. many other centres perform hybrid notes, i.e. endo- scopic surgery assisted by lapa- roscopy, for digestive, urology and obesity surgery.’ ‘notes requires tight coop- eration between endoscopic and laparoscopic surgeons in physio- logical research, new instruments development, personnel training. cooperation trials are absolutely mandatory for the development of the technique.’ ‘benefits potentially include signifi- cant post-surgery comfort, less pain during surgery, less inflammatory response, less intraperitoneal adher- ence, less parietal complications, reductions in hospital stays and incapacity for work. disadvantages are risks related to surgery, intraperitoneal infection, visceral parietal haemorrhage in the portal entry, visceral parietal suture dehiscence, adjacent visceral lesions in the entry and dissection, and dif- ficulty in complications control. ‘ why is notes not used as exten- sively as previously thought? ‘it’s true; the technique has not delivered everything we hoped for. the crisis clearly had an impact on investment from cutting edge industry. ‘notes is now being used to develop treatment of digestive tube tumours, sub mucosa dissection, subserosal dissection and thickness resection with complete endoscopic suture. in echo endoscopy com- bined with ercp, it is also used in biliopancreatic pathology and in anastomosis between viscera, stom- ach liver, bile ducts and intestine. ‘we still face many challenges in pneumoperitoneal gastric overture, orientation and navigation, charac- teristics of the endoscope, sterility, tissue manipulation, triangulation, haemostasis, gastric closure, qual- ity visceral sutures and ergonomic work platforms.’ how might notes develop and what may change? ‘we must continue to evaluate notes development and viability in animal experiments. new technolo- gies will be needed to meet objec- tives we set ourselves. notes has already led to great advances in con- ventional endoscopic surgery and fibre, tube endoluminal endoscopy. ‘this new paradigm will change our conception of conventional endoscopy teaching, in diagnosis and therapy. specialist training will be multidisciplinary and require in- depth knowledge of gastroenterolo- gy and laparoscopic surgery, notes will change medico-surgical special- ist training in digestive endoscopy. ‘its evolution will require true innovation and cooperation between endoscopic and laparoscopic sur- geons through experimental work and physiological research, and the development of new instruments, accessories, procedures and coop- eration trials. science per se because, consequent- ly, not one single eu or german research foundation (dfg) applica- tion was approved that included the word robotics.’ da vinci: outstanding for mis interest in robot-assisted surgery is now slowly re-awakening. at karlsruhe city hospital the da vinci surgical system, developed in the usa and largely based on remotely- controlled assistance systems that aimed at guiding small camera sys- tems and small instruments directly to where needed is mainly used by urologists, specialists in abdominal surgery and gynaecologists. ‘the sys- tem is outstandingly suitable for min- imally invasive surgery (mis) in the abdominal cavity,’ explains spetzger, whilst also limiting the advantages. ‘however, for neurosurgeons the sys- tem is of no use. the basic problem is the access needed to the surgical site. you would have to drill four or five holes into a patient’s head to place a camera, a mounting system and the actuator arm into position and into the brain. that would be a catastrophe.’ nonetheless, neurosurgery could actually benefit from further devel- opments of this technology as it pre- dominantly uses mounting fixtures for endoscopes or instruments. ‘for this application, a robot is almost more reliable than a human col- league because it always works based on exact calculations and with high precision, and it doesn’t shake, which is a big advantage particularly for the brain,’ spetzger emphasises. neurosurgery is based on image- guided operations; each intervention is carried out under navigation, so computer assistance is already stand- ard nowadays. ‘therefore, it’s not actually that far to go towards partial automation,’ spetzger points out. most assistance systems are still currently far too big and not easy enough to handle. ‘and, above all, they are too expensive,’ the neuro- surgeon emphasises. ‘the da vinci system, for instance, works with disposable instruments, which must be discarded after each operation. this creates additional costs in the region of €2,500 – essentially an amount usually spent on care, medi- cation and hosting the patient after the operation. this clearly needs rectifying.’ the need for future improve- ment spetzger believes that politicians and funding bodies need to up their game and hopes for restructuring. ‘there are many companies which have been developing innovations in the field of robotics. this should be promoted, he suggests. he cannot conceive of a further setback such as that experienced 15 years ago with robot assisted hip surgery. ‘modern assistance sys- tems do not work autonomously,’ he explains. ‘even then it wasn’t actually the devices that went wrong – there were simply calculation and user errors. working with robots in medicine requires solid training and continuing education.’ the specialist, who also lectures at the department of robotics at the karlsruhe institute for technology (kit), does not believe there will be a quick development towards completely autonomous assistance an assistance system for minimally invasive spinal surgery: robot-assisted positioning of screws on a model of the lumbar vertebrae at the research project centre for sensor systems (zess), university of siegen and neurosurgery karlsruhe continued from page 12 notes – an emerging trans-disciplinary treatment maintaining hygiene in xi and si robotic instruments have an ultrasonic bath the trison 4000 ultrasonic bath from berlin manufacturer bandelin elec- tronic is reported to make repro- cessing of highly sensitive robotic instruments even easier and exceeds any manual cleaning effectiveness. for best results, during pre-cleaning, the device combines ultrasound, moving of all instrument axes and individual channel rinsing. ultrasonic cavitation reaches dif- ficult to access areas, joints and bowden cables, and mechanical damages, such as scratches, are avoided due to electronic brushing. the new trison twist is report- ed to be the first to move all instru- ment axes of up to four robotic instruments separately – for an improved ultrasonic effect. this is available as a si or xi version, in respect of instrument types, the manufacturer reports, adding: ‘a new ergonomic innovation is the new pivot mounted arm trison lift. it allows a simple con- nection of the instruments and a comfortable lowering of the trison twist into the ultrasonic tank.’ an alternating suction and pressure rinsing of every instrument lumen, combined with an individual examina- tion, completes the cleaning process. 14 european hospital vol 25 issue 3/16

helping scie led lamp for operating room starled7 nx medical lighting system bologna – italy tel +39 051 721844 info@acem.it - www.acem.it surgery live-streaming robotic cancer surgery doctors and students participate worldwide the 3-d brain t tas qureshi is a consultant surgeon at poole hospital nhs trust with a recognised expertise for embracing the latest techniques in laparoscopic surgery. he specialises in minimally invasive surgery (mis) for bowel cancer, inflammatory bowel disease, hernias and gallstones, amongst other conditions. he is the first general surgeon in dorset and one of the first in the south of england trained in robotic surgery for these procedures. report: mark nicholls uk-based surgeons have taken a sig- nificant step that they believe could have major implications for the development of robotic tele-surgery. rectal cancer surgery - using a da vinci robot and conducted by tas qureshi, consultant surgeon and robotic lead at poole hospital nhs foundation trust - was beamed live from his operating theatre by satel- lite to an international conference of specialist doctors, student doc- tors and to a worldwide audience via multimedia platforms with live audio and twitter feedback. the stream – part of an educational programme by poole hospital nhs trust at its international symposium of minimal invasive surgery for rectal cancer – offered a 360-degree perspective of the operating theatre, as well as a ‘robots-eye-view’ of the inside of the 60-year-old patient. ‘the live stream, the first ever for a robotic case, enabled surgeons to have the opportunity to listen to lectures from the international sym- posium from recognised authorities in the field,’ qureshi said. ‘they also witnessed live surgery performed on a patient with rectal cancer, with the opportunity to interact with us in real time. ‘in addition, through an affiliation with the university of portsmouth, the case was recorded using virtual reality technology, allowing any- one with a smart phone to have an “immersive experience” of the thea- tre environment, a world first for a robotic case, we believe. ‘therefore, this event provided a huge learning opportunity for people with no access to the robot both in terms of the latest evidence from lectures and live surgery from experts.’ surgeons believe the mode of transmission of the live stream using satellite rather than physical isdn lines has implications, not just for real-time teaching, but also for the potential of robotic tele-surgery in the future. potentially, they say, a special- ist can operate remotely from an identical console on a patient from anywhere in the world or even assist a colleague on a similar console in the operating theatre remotely. the surgeons suggest the cur- rent constraint for robotic tele- surgery is a physical reliance on the internet with its potential to slow down transmission, especially during times where an unforeseen peak in social media may sud- denly devour redundant bandwidth. point-to-point satellite overcomes this potential hurdle. ‘it will be exciting to see this technology develop further in the coming years, providing a fantas- tic teaching and training platform, and perhaps allowing patients to be operated on remotely, all over the world, by the best surgeons,’ qureshi enthused. he was assisted in the operation by professor amjad parvaiz, a spe- cialist colorectal surgeon professor of surgery at poole, head of minimal access and robotic colorectal surgery at the champalimaud foundation in lisbon, portugal and a founding director of the european academy of robotic colorectal surgery (earcs), for the procedure. ‘historically, the robot has been used almost exclusively for pros- tate cancer surgery by urologists. currently, there are very few gen- eral surgeons like us who perform robotic resections on rectal cancer,’ qureshi continued. ‘in fact, how- ever, general surgeons have been sceptical about the prediction from experts in the field that the number of general surgeons wishing to have access to a robot will increase sig- nificantly as they develop an under- standing of what is possible and as new evidence starts to appear in medical literature.’ the symposium drew many of the world’s leading authorities in this field to poole hospital, which has recently named as the european epi- centre for robotic colorectal surgery. qureshi: ‘this means da vinci recognise the quality in poole and have appointed us as their preferred “epicentre” or centre of excellence in europe for robotic colorectal surgery, meaning any surgeon in the uk and europe approaching da vinci wanting exposure to robotic surgery will be directed to our unit for “observerships”. ‘those surgeons who already have access to a robotic system, but are finding it difficult to start operat- ing, or are unable to progress, will also be directed to poole to attend master classes that we run.’ the da vinci robot used for the surgery provides high definition 3-d images with sophisticated instru- ments, allowing for greater preci- sion, which in turn deliver significant benefits for patients in the short and long term, such as reduced trauma to the body, reduced post-operative pain, shorter hospital stay and faster recovery. the da vinci system has been designed to improve upon conven- tional laparoscopy, in which the sur- geon operates while standing, using hand-held, long-shafted instruments, which have no mechanical wrists. in contrast, the da vinci system’s design allows the surgeon to oper- ate from a seated position at the console, with eyes and hands posi- tioned in line with the instruments and using controls at the console to move the instruments and camera. surgeons can also sit at dual con- soles and remotely work collabora- tively to assist one another. commenting on the enhanced performance of the robot, qureshi said: ‘traditional laparoscopic sur- gery has instruments with very primitive movements. the robot provides me with 3-d high defini- tion views and wristed instruments able to perform seven degrees of movement - the human hand has only six. ‘this means i can very precisely access difficult areas in the body and take cancers out with bet- ter precision and with much more confidence that the whole cancer can be taken out,’ tas qureshi con- firmed, adding: ‘this hopefully will mean patients require less radio- therapy and chemotherapy.’ report: mark nicholls 3-d printed tumour-like constructs will be used by a research team at scotland’s heriot-watt university in edinburgh, to raise research to a new level and successfully lead to new treatment options. the project brings together tumour biologist dr nick leslie, at heriot-watt university’s institute of biological chemistry, biophysics and bioengineering, with 3-d print- ing expert dr will shu as well as neuropathologists and neurosur- geons, engineers and clinicians. the collaborators have developed working together: surgeon’s sit at dual controls to remotely work collaboratively to assist one-another. the robot provides 3-d high-def views and instruments wristed and able to perform seven degrees of movement – the hand has six 16 european hospital vol 25 issue 3/16 tel +39051721844 info@acem.it - www.acem.it

radiology we need to assess ir efficacy compared to surgery ‘interventional radiology has become fashionable!’ fernando lópez zárraga is a member of the executive board of the spanish society of vascular and interventional radiology (servei). in an interview with mélisande rouger he explains issues facing interventional radiology in spain and why this is becoming an increasingly attractive field an interventional radiologist since 1997, fernando lópez zárraga was instrumental in establishing the vascular and interventional radiology department at santiago apostol hospital, now part of álava university hospital. he is also second chair of the executive committee of the spanish society of vascular and interventional radiology, as well as president of the society’s annual congress in 2017 to be held in vitoria – gasteis. he was part of the working group for quality in a radio-diagnosis programme for the iso 9001 (iqn – aenor) certificate and helped to establish protocols for on call security in álava and the codigo ictus. rouger: how did the audience respond to the central interven- tional radiology (ir) theme at the recent meeting of the spanish society of radiology? fernando lópez zárraga: ‘pretty well, judging from attendance. the interventional committee held ten sessions and every other commit- tee (thorax, abdomen imaging, etc.) organised at least one session on ir. one of the three pre-courses before the meeting was dedicated to ir, and even radiographers sessions featured a session on embolisation. it seems ir has become fashionable! ‘many sessions focused on drain- age; but there are many general radiologists who already perform liver or breast radiofrequency, or are interested in puncturing with fine needles or thick probes. we can see that people are overcoming their fear of needles, at least within their own area, which is very positive. ‘in spain the newest applica- tion is probably thermo-abla- tion with microwave, cryoablation and nanoknife; it’s showing good therapeutic results in liver metas- tasis and kidney tumours smaller than 2 cm. these techniques should be performed more often, but we need more experiments and pro- spective methodological studies. cryoablation is very interesting for patients who are not candidates for surgery. ‘radiofrequency in thyroidal nod- ule has been around for many years and some surgeons even prefer this option to avoid complications in the neck, a delicate area. ‘next should come embolisation of the haemorrhoidal arteries and percutaneous creation of arterio- venous fistula for haemodialysis. ‘prostate embolisation is an inter- esting option for patients who usu- ally wear a urinary bag; it’s an estab- lished procedure in portugal, even if urologists have recently questioned it.’ spain has a long research tradi- tion. are there interesting pro- jects in this field at the moment? ‘various studies are underway; teams at navarra university and la fe hospital, in valencia, are assessing the impact of ytrio 90 radio-embo- lisation in hepatic tumour. other researchers at hospital reina sofia in cordoba are leading a study on stem cells in peripheral revasculari- sation; they have already obtained good results and helped reduce the number of amputations of lower limbs with significant ischemia. in zaragoza, dr gregorio is leading a multicentre registry on vena cava filters.’ could bariatric arterial embo- lisation (bae) gain ground in obesity treatment? ‘in the vitoria area surgeons treat morbid obesity; they are not really asking for our participation.’ ‘bae is co-adjuvant to surgery; it helps to prepare a patient by cutting the production of satiety hormone ghrelin and helps avoid complica- tions during surgery. ‘interventional radiologists can place prosthesis inside the digestive track, to secure suture or for the embolisation of potential haemor- rhage in post surgery. ‘now we need to convince sur- geons of our efficacy!’ might ir applications also increase in oncology? ‘spain has one of the leading hos- pitals in liver cancer treatment: the hospital clínico in barcelona. ir applications here are growing, espe- cially in thermo-ablation or thermo therapy. some specialists also per- form ytrio 90 radio-embolisation and a many work with electropo- ration nanoknife and microwaves in pancreatic cancer and kidney tumours.’ how many interventional radi- ologists are there in spain? ‘servei has 327 members; there are potentially more interventional radiologists in spain. on average every centre has three to four spe- cialists.’ are there issues with contrast products or devices? ‘recently an important company had to take off one of its diagnostic catheters because of a series of bad events. the cause of this problem still needs clarification.’ what are the challenges in ir? ‘we need good registries to assess our own activity and ir therapeutic efficacy compared to surgery. ‘obtaining subspecialty certifi- cation would be another impor- tant step forward. we also need to become more visible to the patient. we are not regarded as interven- tionists; the referring clinician is. we must succeed in following up patients before and after an inter- vention. we are like navy seals: they only want us when things are going really badly!’ how can you rouse general radi- ologists’ interest in ir? ‘a part of training should be dedi- cated to learning basic interven- tional procedures. this is a chal- lenge now with the ‘core training’ scheme, which fuses radiology and nuclear medicine during the first two years; but, if we succeed in being recognised as a subspecialty, students may have the opportunity to spend some time in our operating room (or). ‘the fellows programme, being developed at 25 centres, and which can certificate ir in spain, is a potential hotbed.’ other specialists perform their own interventional proce- dures. what is the added value of being radiologists? ‘we know imaging of all the body; we work not just on pathology but also everything around it. we have a sort of integrated gps in our brain; this enables us to improve intervention quality significantly. it’s a strength we should use. also we know how to adapt and work with other medical professionals; col- laboration is in our genes.’ add us or to synthesis to report: mark nicholls italian-led research has highlighted the value of utilising additional screening technologies to help diag- nose breast cancer in some women. interim analysis from the adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts (astound) study has deliv- ered evidence of the potential ben- efit of adding either ultrasound or tomosynthesis to standard mam- mograms for screening women with dense breasts. heading the team of researchers, radiologist dr alberto tagliafico, assistant professor of human anatomy at the university of genoa, italy, explained that interim analysis showed that ultrasound had better incremental breast cancer detection than tomosynthesis in mammog- raphy-negative dense breasts at a similar fp-recall (false positive) rate. however, he pointed out that future application of adjunct screen- ing should consider that tomos- ynthesis detected more than fifty percent of the additional breast cancers in these women and could potentially be the primary screening modality. it is the first time the addition of ultrasound or tomosynthesis – which can detect breast cancer in mam- mography-negative dense breasts – have been directly compared when added to standard mammograms in prospective trials and comes at a time of on-going debate on screen- ing in women with dense breasts. for the prospective multicentre study, eligible women had tomos- ynthesis and physician-performed mediolateral oblique views of right breast in 49-year-old woman. a, mammogram was reported as n image shows an architectural distorsion not visible in the standard mammography. ultrasound and m underwent vacuum assissted breast biopsy under tomosynthesis guidance and the result of the histo was considered a false positive for tomosynthesis mediolateral oblique views of left breast in a 67-year-old woman. a, mammogram shows normal find distorsion (white oval). c, ultrasound image demonstrates a small irregular hypoechoic mass with ind an 5-mm invasive ductal carcinoma was diagnosed at histologic examination. note that on dbt the i radiat­ ing lines that converge to the lesion site. this case was considered a true-positive for tomosyn 18 european hospital vol 25 issue 3/16

radiology from qualitative to quantitative imaging seram president bets on education and professionalism magnetic resonance fingerprinting e-learning could help and certify radiologists after gaining an electrical engineering and it degree at karlsruhe institute of technology, germany, reto merges dipl.-ing began his career at siemens, developing segmentation algorithms for coronary artery segmentation on ct data. based in china for four years, he built up an organisation for research collaboration for the ct division in greater china and south korea. within the magnetic resonance business line, merges has held various positions in global marketing, which included heading the clinical marketing team, before he was appointed director of scientific marketing in early 2015. in this role he focuses on innovations, education and the future of value-based imaging. from the beginning of mri scien- tists dreamed of not only translat- ing data sets into images, but also classifying tissue directly. five years ago this would still have been inconceivable. however, mr fingerprinting might now make it possible to diagnose a disease from a distinctive combination of information about the tissue. this original technology is being largely driven by case western reserve university and cleveland university hospitals, ohio, with research support from siemens healthineers. reto merges, head of scientific marketing for the magnetic resonance business line, discussed the technique and how it could change mri diagnos- tics in the future. report: karoline laarmann just as each person has a unique fin- gerprint, each body tissue, whether diseased or healthy, also has an indi- vidual, physical pattern. this pattern is encrypted in signals sent by the tissue during an mri scan. to date, it has only been possible to measure different signal intensities, which are then represented as light/dark con- trasts on the mri image. however, this qualitative and relative measure- ment alone does not allow for straight forward conclusions as to whether the tissue is healthy or diseased. however, mr fingerprinting (mrf) ‘education is a top priority,’ said dr angel gayete cara, newly appointed president of the spanish society of radiology when asked about his agenda for seram. ‘we are betting on e-learning to help and certify radiologists, both specialists and residents. we also offer transversal courses, for instance in publication and management, and are working on a university master [degree] in quality in radiology management. ‘radiographers want homologa- tion at the european level and we absolutely support this claim. recently we published a manual for their attention. we try to integrate them as much as possible in our activities. ‘eu member states must transpose council directive 2013/59/euratom into national law by 6 february 2018; this directive will change sub- stantially the way we register dose and dose value levels. we are work- ing together with the industry and health ministries and other scien- could open up entirely new opportu- nities for quantitative measurements, explains reto merges: ‘this procedure now could make it possible to obtain quantified information about a tissue section without having to consult reference values. with this method tific societies to help integrate these aspects in daily practice. ‘we are also very concerned about technical obsolescence, as spain has some of the oldest imaging equip- we do not record the signal intensi- ties of individual image sequences or weightings that can vary accord- ing to the device and data acquisi- tion. instead, we record the signal evolution from one single pseudo- randomized sequence that contains ment in europe. ‘additionally, we work to improve professionalism by publishing good practice guidelines and tack- ling issues related to management, quality, risk planning or informed consent. we are developing mod- els for imaging equipment contests together with the industry and radio physicians to help radiologists in this complex task. a multitude of parameters that can be characteristic for a certain type of tissue. these signal evolutions are correlated with simulations in a digital mrf dictionary, similar to a finger- print, which is fed into a database to find out to which person it belongs.’ currently this database, devel- oped by researchers at case western reserve university and the university hospitals, contains simulations for all t-1 and t-2 weightings. the aim is to successively add simulations for other tissue features, such as relative spin density, b0 or diffision. the procedure is already delivering the first promis- ing results, which radiologist vikas gulani and physicist mark griswold along with their us research team already presented in nature magazine in 2013, attracting worldwide atten- tion. at the moment the particular focus of clinical trials is on oncologi- cal applications for the head, prostate, breast and liver, but also for cardiac examinations and multiple sclerosis. mrf advantages compared to conventional proce- dures for quantification mrf has the potential to offer some decisive advantages, merges confirms. ‘firstly, the procedure is very fast. the vari- ous parameters are not consecutively recorded in different sequences but captured simultaneously. this not only shortens the examination peri- od to just five minutes, but it also makes the procedure more robust. if a patient moves during a conventional mri examination the entire aquisition sequence that has just been run can lose its diagnostic relevance. with the fingerprinting procedure the signal evolution measured up to that point remains useable.’ the procedure also copes very well with field inhomogeneities; whether or not a signal is a little stronger or weaker is not that important for the ‘furthermore, we plan to organise meetings with professionals from partner disciplines to determine ways to assess treatment response and potentially publish guidelines together. we are also considering the possibility of acting as media- tors between research groups and the industry, by helping them get in touch and following up on their projects. we see ourselves as a pos- sible intermediary between both parties.’ rouger: general elections will soon be repeated in spain but the ‘core training’, in which radiology and nuclear medicine are fused for the first two years of a four- year plan, is going ahead. what is seram’s position on this matter? ‘we can’t legislate but we can opine. we have representatives who work on the issue with the authori- ties. it’s an important challenge; depending on how the situation evolves, radiologists’ training may change a lot in the near future. the number of places available for radiologists may be reduced and tutors would need to be trained adequately. ‘but we don’t want to assume that it will be two years of core training and two years of specialisation in radiology. the ministry itself said that skills first need to be evaluated, so this is what we’ll do, bearing in mind that the european recommen- dation is a five-year training plan.’ how did the society’s meeting go and what can you tell us about general pattern of the signal evolu- tion. a further strength of mrf, along with its speed, is its great consist- ency. ‘we are currently experiment- ing with transferring the procedure to different mri scanners and field strengths,’ merges explains. ‘the tech- nology is now at a point where we have also been able to trial it in other international centres, such as essen university hospital and the medical university of vienna from the begin- ning of this year. ‘phantom measurements carried out with all of our clinical cooperation partners, have already shown that fin- gerprinting delivers consistent, com- parable results measured on different devices and in different locations. this is an important step towards introducing mrf into clinical imag- ing. however, we currently cannot say exactly when this will be.’ the next? ‘we had 1,933 participants this time, 122 more than last year, and 35 industry exhibitors. we hope to have more delegates during our next gathering, to be held in pamplona in two years. we are just begin- ning to decide on the programme. certainly there will be contents on the increasing role of imaging in treatment response evaluation in oncology and other fields of person- alised medicine.’ are spanish radiologists coping better with austerity and short- ages? ‘we are coping with difficulty, patience and compromise! staff shortage and terrible contracts mean there is work overload for act- ing radiologists to manage waiting lists. coupled with technical obso- lescence, this can be a challenge for patient safety and it generates inequity in assistance. the situation is more precarious in some regions than others, and each has its own problems; for some it is radiother- apy, others pet/ct, etc. the situa- tion is heterogeneous and definitely improvable.’ what are today’s biggest radiol- ogy challenges? ‘with the growing number of clini- cal applications, tools and mini- mally invasive procedures in both diagnosis and treatment our role is increasingly clinical. long gone are the days when radiologists sat alone in a basement! we are now 1.5t mr fingerprinting t1 and t2 map of high grade glioma. mrf promises the possibility to differentiate solid part of tumour, central necrosis, lower grade part of tumour, surrounding oedema and tumour infiltration from normal appearing white matter. (courtesy of medical university of vienna. mr fingerprinting of the brain) dr angel gayete cara took over the reins of the spanish society of radiology (seram) in may, immediately after the society’s meeting in bilbao. in an exclusive interview with mélisande rouger he revealed his vision for the next two years and how he means to help radiolo- gists in their increasingly clinical role 3-t mr fingerprinting t1 and t2 map of a biopsy confirmed low grade prostate cancer. (courtesy of university hospital essen, germany. mr fingerprinting of the prostate) from left to right: dr. ángel gayete (seram president), dr. cosme naveda (bizkaya, board of doctors president), mikel alvarez (bilbao city councilor), iñaki berraondo (basque country health planning and evaluation director), dr. josé luis del cura (seram immediate past president), dr. arsenio martínez pérez (seram meeting local organizing committee chairman), and dr. josé carmelo albillos (seram meeting scientific committee president) 20 european hospital vol 25 issue 3/16

it & telemedicine a universal platform at the heart of communication cardiac it made simple when michael ziller, head of it at the bethanien hospital in moers, germany, was looking for a provider of cardiac it applications that not only offered standard applications for ecgs as well as long-term ecgs and long-term blood pressure measurements, he realised there was not much on the market. ‘we had an additional challenge for this project in that we wanted all data to run via just one server,’ he explains. the hospital opted for a product called sema supplied by schiller ag, which allowed us to customise and further evolve it the development of a healthcare it infrastructure in european hospi- tals faces two major hurdles, ben giese reports: ‘contradictory return on investment (roi) reports and the unquantifiable risk of security breaches’ michael ziller has worked in the information technology department at the bethanien hospital in moers, germany, for 14 years. over the last decade, as head of the department, he has been responsible for all it processes in the hospital. the particular feature of an it project at bethanien hospital was that there was no comparable solution availa- ble based on using just one commu- nication server, until schiller’s intro- duction of sema 3, michael ziller, the hospital’s it head, explained: ‘the implementation at bethanien hospital was basically a joint effort as both parties could mutually bene- fit from their respective experience.’ the platform covers everything sema 3 is a platform that covers all needs, from measuring to evaluat- ing ecgs, including resting and stress ecgs. additionally, the data collected can also be evaluated with the standard it sub-systems used in cardiology. the big advantage is that sema 3 is a collection point for all ecgs recorded in the hospital. ‘this applies to pc-based ecgs as well as those measured on mobile devices,’ ziller explains. ‘mobility and mobile devices are increasingly important for us. we have an additional six mobile devices next to our five pc-ecgs. these are tablets we can use to access the ecgs from any location in the building.’ the ecgs can be directly meas- ured via the corresponding sema- client without needing to com- municate with the server. younger generation doctors particularly take advantage of this benefit. ‘we’ve found that old-school cardiologists prefer to work with known tem- plates. the generational change is clearly visible and we have to adapt technologically,’ ziller believes. it is a clear advantage that both options can be implemented with schiller’s technology. organised chaos the 510-bed bethanien hospital needs to organise patient flow and data volumes well. ‘in our case this means duplicate data management,’ ziller points out. ‘doctors receive patient data via an interface on the his and it is processed via hl7. this means the doctor makes a request, which also appears on the sema client, i.e. on the individual ecg devices. to ensure there are no mix-ups each ecg device has its own name.’ then the respective patient only appears on the allocated ecg device because only one device is individu- ally accessed. this avoids chaos in the database. ‘no other procedure is conceivable given the large patient flow in our hospital and the enor- mous volume of ecg data,’ ziller explains. a big advantage: one viewer after the completion of an ecg measurement the data is sent direct- ly into the pacs as dicom data. ‘all non-dicom data is visualised with jivex. the advantage is that this pacs-viewer allows the visualisation of data from several systems at the same time and next to one another. we can assess ecgs, cardiac param- eters or cardiac catheters together, without needing different versions or viewers,’ ziller reports. ‘ultimately, this was why we chose sema 3. it was also impor- tant for me that all modalities that can transmit images, from c-arms to ecgs to endoscopies, are organised via one viewer and that doctors don’t have to view different moni- tors and specialist software. ‘we obviously also save on soft- ware licensing fees in this way.’ a further advantage is that all recorded ecgs can be re-measured via jivex. ziller: ‘maybe this is not as cleverly done as it is with sema but, for our purposes, it’s perfectly adequate.’ updates and upgrades updates carried out over the last few years have also all been suc- cessful. after all, it is not custom- ary that updates are carried out on individual devices little by little. ‘normally all clients need to be directly updated once the server has already received a new version,’ he explains. ‘this would be difficult to do in day-to-day hospital operation. with sema 3 we can upgrade the devices individually to the new ver- sions, depending on which client is available at the time. even if the server has already been upgraded the clients can still work with the old version.’ for ziller, this leaves nothing to be desired for the future. ‘the sys- tem is running continuously and we are more than satisfied with it. if the diagnosis client was also run via the web this would enhance mobil- ity in the hospital even further.’ to maximise it benefits team insecurities must be overcome fear defeats progress known and quantifiable – industry will pitch to clinicians and adminis- trators the ever-increasing benefits of it implementation within multi- functional institutions or individual private practices. indeed, the accu- rate, easily accessible flow of all healthcare delivery data can provide benefits. for example, lead poi- soning of the public water source in flint stands out. paediatrician dr mona hanna-attisha utilised the searchable electronic records database of epic systems to dis- cover parameters indicating popu- lation poisoning – impossible to demonstrate otherwise. however, such solutions carry impressive price tags. the wide-ranging deal between the mayo clinic and epic broke the billion-dollar threshold. even smaller medical systems face impressive bills from electron- ic medical record (emr) vendors, plus poor results and internal strife. england’s cambridge university hospital engaged with two promi- nent vendors to overhaul its it systems – cost £200 million. the implementation is not going well. the bbc reported that multiple high-level departures began within a year into the 1o-year deal. the institution received poor quality control (qc) ratings, e.g. emr operability is insufficient, par- tially due to the new system’s roll- out. in new england, the south- coast health group cited its new emr implementation costs forced the lay off nearly 100 staff members in march. these, say industry providers, are isolated examples appearing as ‘front and centre’ exceptions to a generally successful but rarely headline-grabbing service. however, many of europe’s segmented, small- er, conservative hospital systems use that negativity as evidence that full scale digitisation is not worth the cost, especially if economies of scale cannot be realised at individ- ual institutions. both are somewhat correct. if an institution is tied to short term roi and that success is measured in immediate procedural efficiencies alone, the investment will not be worthwhile. if success is measured more holistically and contains much harder to quantify parameters, including overall popu- lation health, reduction of errors, and a database of medical records accessible by a range of users for research and predictive analytics, the investment is entirely justified. the unknown and unknowable hospitals are increasingly influ- enced by and driven towards it reliance – whether internally sanc- tioned or mandated by regulatory bodies. hospitals have had plug- and-play operating systems for years and use of networked devices is exponential. hospital employees access multiple interfaces concur- rently, creating massive challenges in authentication and open portals to large swaths of data. highlighting this danger, an nhs report found that 72% of logins had no time limit, 87% of staff could log into multiple units and 44% had no unique login whatsoever. in patient data security alone there is an open invitation to nefarious intentions. in reality, individuals and organi- sations view healthcare systems as a prime target for cyber-attacks, for they fulfil a checklist of characteris- tics that make them vulnerable and attractive. security is not part of a mentality born of open scientific research. to be effective, communi- cation systems and patient records need real-time access and manipula- tion by many staff members. legacy devices, from multiple ven- dors, employ myriad operating plat- forms and, paradoxically, the maker is responsible for their security. yet, these systems control life and death and hospitals are targets considered worth the time of hackers. progress directors need to help produce a comprehensive risk assessment and mitigation plan – alongside hospital it specialists and all higher admin- istrator levels, enabling everyone to discover and admit on-going deficiencies, engage with outside consultants, and most important- ly, become aware of and report on possible vulnerabilities in their existing responsibilities. this goes well beyond the medical staff – the costliest data breach in history, credit card data theft at us ‘target stores’, originated with a hack in a networked hvac unit. initially survey hardware, software and data it departments should be able to identify data sources from net- worked devices and data entry, the types of data transferred and stored, and the channels and loca- tions through which the informa- tion is transferred and stored. this is the foundation of protection. any mitigation is based on an accurate catalogue of assets – both physical and digital. intermediate term – risk evaluation many european hospitals have no dedicated it security employee, but the evaluation should be devel- oped in conjunction with knowing risks to the individual systems. thus an outside expert should evalu- ate the initial it infrastructure sur- vey and provide an accurate risk assessment. this will involve an outcomes assessment following a malicious attack and the likelihood of a breach. for example, at one extreme, if a networked ventilator is easily hacked, it is top priority. or, what can wait is a staff member perhaps accessing the emr of a past romance, although against protocol this happens more than any admin- istrator wants to admit. action an evaluation and recommenda- tion report must be generated and shared with stakeholders, to ensure awareness of potential threats and agree to an action plan. this crucial step ensures clear understanding of a threat, actions taken, every- one’s responsibilities and any risk remaining. the proactive stance this process achieves allows institutions to maximise existing systems effi- ciency, now free of the paranoia of not knowing an actual risk level. as an added benefit, purchasing deci- sions are simplified with vendors by concisely communicating the secu- rity expectations in new device and software acquisition, implementa- tion and use. the on-going discussion of data management efficacy within institu- tions remains dynamic. an evalua- tion of existing and future systems, plus costs and benefits, cannot be accurately achieved unless the par- allel issue of security is managed in a holistic and honest discourse, with agreed action plans. over a longer period this will add overall cost though a patchwork of reactive security measures. innovation will also suffer as hospitals develop a bunker mentality towards a threat, which, although real and perma- nent, is manageable. assessing ecgs, cardiac parame- ters or cardiac catheters together on one viewer 22 european hospital vol 25 issue 3/16

it & telemedicine editor-in-chief: brenda marsh art director: olaf skrober managing editor: sylvia schulz editorial team: sascha keutel, marcel rasch senior writer: john brosky executive director: daniela zimmermann founded by heinz-jürgen witzke correspondents austria: michael kraßnitzer, christian pruszinsky. china: nat whitney france: annick chapoy, jane macdougall. germany: anja behringer, annette bus, walter depner, bettina döbereiner, matthias simon, axel viola, cornelia wels-maug, holger zorn. great britain: brenda marsh, mark nicholls. malta: moira mizzi. poland: pjotr szoblik. russia: olga ostrovskaya, alla astachova. spain: mélisande rouger, eduardo de la sota. switzerland: dr. andré weissen. usa: cynthia e. keen, i.t. communications, nat whitney. subscriptions janka hoppe, european hospital, 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 printed by: wvd, mörfelden-walldorf, germany publication frequency: bi-monthly european hospital issn 0942-9085 representatives china & hongkong: gavin hua, sun china media co, ltd. phone: +86-0755-81 324 036 e-mail: gh@european-hospital.com germany, austria, switzerland: ralf mateblowski phone: +49 6735 912 993, e-mail: rm@european-hospital.com france, italy, spain: eric jund phone: +33 493 58 77 43, e-mail: ej@european-hospital.com gb, scandinavia, benelux: simon kramer phone/fax: +31 180 6200 20 e-mail: sk@european-hospital.com israel: hannah wizer, international media dep. of el-ron adv. & pr co., ltd., phone: +972-3-6 955 367 e-mail: hw@european-hospital.com south korea: ch park, mci phone: +82 2 730 1234, e-mail: chp@european-hospital.com usa & canada: hanna politis, media international tel: +1 301 869 66 10, e-mail: hp@european-hospital.com nhs england adopts translational medical information server (tmis) integrating imaging and metadata on any device ot efficiency impacts on quality care england’s nhs has received an advanced medical imaging and genomic data integration platform from a global healthcare informa- tion systems specialist, mark nicholls reports given mounting financial pressure, a hospital needs greater effi- ciency in medical service structures. staff and materials for operating theatres (ots) account for about a third of the overall expenditure. working closely with all other hospital departments, ot efficiency can affect a hospital’s overall efficiency and costs, reports cornelia wels-maug founder and ceo of kanteron systems, jorge cortell lived in new york, but moved to london with his family to personally support and manage the collaboration with the nhs. kanteron systems has offices in new york, london, lima, as well as a european hq in valencia. professor martin schuster md, head of the department of anaesthesiology, intensive medicine, emergency medicine and pain management, at the fürst- stirum-klinik, bruchsal, germany shawn larson is a senior project manager at the health and social care information centre and creator of the openpacs project. following 18 years in frontline diagnostic imaging, he spent time in industry and private healthcare before joining government healthcare it where he has been involved in a variety of national projects. a translational medical information server (tmis) that aims to prevent adverse medication events, assist in pre-operative genomic screening and establish telemedicine networks is being adopted by nhs england’s open source and code 4 health programmes. developed by kanteron systems (founded 2005), the tmis platform integrates genomics, pharmacog- enomics, digital pathology, radiol- ogy, biosensors, and analytics into a single unified workflow at the point of care. the system can, for example, allow oncologists to access radi- ologists’ images and studies, pathol- ogists’ biopsies and reports, lab genomics sequences, pharmacog- enomics databases, and biosensors’ readings and combines all that information to enable analytics via single-sign on, single interface, and single point of access. shawn larson, senior project manager at the health and social care information centre and creator of the openpacs project, explained the agreement with kanteron brings the nhs a set of ‘quality, cutting edge and medical device certified diagnostics’ combining, he added, imaging genomics and pathology into a single system. accessed via nhs england’s open source/code 4 health repository and managed on an on-going basis by a clinically led nhs custodian group, this will take nhs infor- matics capability to a new level, with open source now a ‘genuinely viable and affordable alternative to proprietary solutions.’ the company reports that the national health service will make financial savings by improving patient outcomes via improve- ments in the diagnosis of conditions including cardiovascular disease, cancer, obesity and diabetes; sup- port personalised therapies; and deliver more focused medication. founder and ceo of kanteron systems, jorge cortell, said that, as a complete personalised medicine operating theatre management was established to ensure better deploy- ment of theatre resources by • ensuring patient safety during surgery • ensuring that all clinical depart- ments have access to the or-facilities • maximising the use of theatre resources • minimising waiting times for surgical procedures • enhancing satisfaction among patients and staff. however, to measure the effi- ciency of a given ot, as well as the quality of its performance clearly defined, measurable indicators are needed to establish a reliable set of benchmarks as opposed to rely- ing on qualitative impressions as to how well or badly the perioperative process has been executed. professor martin schuster md, head of the department of anaesthesiology, intensive medicine, emergency medicine and pain management, at the fürst-stirum- klinik, bruchsal, germany, was among a group of physicians and ot managers who set up a bench- marking programme for periopera- tive process data: ‘it’s really hard to know how many resources are used per patient per surgery,’ he explained. ‘for this, you need to know all the different processes involved in a procedure, from enter- ing the pre-operative unit all the way to leaving the operating thea- solution, tmis integrates ‘silos’ cur- rently existing in many hospitals such as genomics, pharmacogenom- ics, digital pathology, radiology, biosensors, and analytics into a single unified workflow to produce a complete visualisation with deep integration, enabling researchers and clinicians to reach precise diag- nostics with ease and speed. ‘while any of those components provide all the functionality needed by each area, when we connect them, tre- mendous synergies and efficien- cies are enabled, such as virtual multidisciplinary collaboration, adverse medication event detection, radiomics analysis,’ he added. nhs institutions gain unlimited access to kanteron’s tmis plat- form source code and free use. for kanteron this entails close nhs collaboration to co-develop specific tools and functions needed by the clinicians. the system works via a web browser and runs either on-prem or in the cloud to provide data (including imaging and metadata) storage, management, integration, collaboration, normalisation, as well as visualisation. tre. to obtain reliable, reproducible data, a group of hospitals has united to define the different underlying processes and agree on indicators to build up a repository for bench- marking data.’ beginning in 2009, with 20 hos- pitals and about 192,000 data sets, there are now (in 2016) 220 par- ticipating hospitals, which produce more than 1.5 million data sets per year. although the definition of the key indicators for the benchmark- ing platform are handled by a clini- cal consortium consisting of the working group on key figures of the association of ot management (vopm), the german association of anaesthesiology and intensive medicine (dgai), the professional association of german anaesthetists (bda) and the professional association of german surgeons (bdc), all aspects associated with the collection of data are taken care of by hamburg-based digmed. this company is responsible for ensuring that the used infrastruc- ture is compliant with current safety and privacy legislation. ‘at the very beginning, we handled the data our- selves at göttingen university hospi- tal,’ schuster added, ‘but when this became too contentious, we decided to transfer the job to a neutral inter- mediary − digmed.’ hospitals transmit the data elec- tronically to digmed. those meas- urements have already been gener- ated as part of a hospital’s routine documentation of each ot case and reside in its hospital information system. however, the data transfer is not in real-time, but typically occurs once a month. in turn, the hamburg firm performs a centralised plausi- bility test of the data, e.g. ‘anaes- currently with customers in 15 countries, kanteron reports that the key benefits for the nhs in terms of workflow, cost and clinical outcome will be increased interoperability, enhanced collaboration, faster diag- noses, improved diagnostic tools, flexibility, better control of the data, avoidance of vendor lock-in, and considerable savings. cortell: ‘our experience in other countries is that patients benefit thesia administered prior to incision time’ points to a problem in the data set and the reporting hospital is asked to check its data. designated users of all registered hospitals can access the database via an internet portal to look at their institutions’ data and compare them to the overall benchmark. ‘the data is used to generate reports as well as benchmarks. we also offer the option to compare an institu- tion with its peers. for example, a university hospital can measure its performance with that of other university hospitals’, schuster points out. however, the data is not accessi- ble for non-participating institutions. ‘modifications and the achievement of objectives can be monitored con- tinuously and made generally avail- able by means of an adequate com- munication structure’, he stresses. to ensure a high rate of accept- ance among hospitals, the bench- marking process is governed by the underlying principles of ‘origin and quality of data’, ‘usefulness and benefit’ and ‘safety and acceptance’. the actual set of key indicators for process efficiency presently com- prises 38 measurements, among them ‘start-time tardiness’, suture- to-incision time’, ‘changing time’, ‘incision-to-suture time’, ‘degree of ot capacity utilisation’, ‘number of surgical interventions’, ‘total inci- sion-to-suture minutes per case’ and ‘staff costs per surgical intervention/ incision-to-suture minute’. schuster calls attention to the fact that distri- bution curves are often more mean- ingful than absolute values and shares some snippets of the insights from the benchmarking exercise. ‘delays in transporting the patient to the operating theatre are the from faster diagnosis, access to their own data (if hospital administra- tors allow it), reduced errors from identification to double data entry or adverse medication event, and overall improved outcomes.’ other areas it will be particu- larly beneficial are those involving complex cases and a multitude of tests, exams, images and reports in oncology, cardiology, neurology and so on, will particularly benefit most from the integrated platform. work with nhs pilots currently using the in-built development plat- forms to enhance and innovate the system is continuing, as well as progression in existing relationships with higher education institutions, schools of radiology and universities to create a unified diagnostics solu- tion, and to continue to promote the growth and adoption of open source in the nhs. number one cause for tardiness of surgeries. ‘additionally, there is often no positive linear relationship between the frequency with which an opera- tion is performed and the time the procedure takes.’ by using the data provided by digmed, participating hospitals have the tools to render their ot pro- cesses more efficient, hence, creat- ing additional value for their institu- tions. however, as useful these key indicators may be, schuster also warns: ‘they are important tools, but there are pitfalls associated with them because one needs to know exactly how to interpret them, espe- cially around utilisation rates and turnover times.’ as the quality of the benchmark is positively linked to the number of participating hospitals, it will be important, for the future, to win additional institutions and, with it, additional data sets. this will also open the door for applying analyt- ics to the data to uncover hitherto undetected relationships between the process times and the quality of medical care. 24 european hospital vol 25 issue 3/16 phone: 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