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Archive for category: Featured Articles

Featured Articles

Disaster medicine: French lessons in the age of terror

, 26 August 2020/in Featured Articles /by 3wmedia

It is now clear that casualties after the November 2015 terror attacks in Paris were reduced by a superbly conceived and coordinated response.
While 130 people died in the tragedy, another number deserves attention, too. As many as 302 people were wounded, several seriously. They were triaged, treated on site and then shifted to hospital. Of these, two died during transport and another two in the first 10 days after admission. In other words, the casualty rate in the aftermath of terror was less than 1.5%.

by Ashutosh Sheshabalaya and Antonio Bras Monteiro

Plan Blanc – a collaborative blueprint for disaster medicine
Much of the credit for such an achievement goes to France’s ‘Plan Blanc’ (White Plan), created to respond to disasters. In Paris, the White Plan was activated within an hour after the first incident, namely the bomb explosions at the Stade de France. It mobilized some 40 hospitals, 200 operating rooms, 22,000 beds and 100,000 health professionals.
The White Plan is essentially a collaborative blueprint for disaster medicine. Although its conceptual roots go back several decades, November 2015 was the first time it was put to use.
The White Plan effectively places the entire French hospital system on a war footing, with the ability to pool resources on demand. It establishes a lean/quick-response command, control, communication and information system, mobilizing and synchronizing hospital/clinic bed and staff availability to anticipated victim inflows, postponing chronic surgeries and interventions while readying operating rooms, and providing rolling plans for augmenting resources – both human and material. The White Plan also establishes a specialized unit for informing families and communicating with the media.

No surprise about French leadership
According to us, France is among the world’s best prepared countries to deal medically with the aftermath of a terrorist attack. This laurel should be no surprise, given that the concept of ‘disaster medicine’ (médecine de catastrophe) was developed in the 1980s by three French physicians – René Noto, Alain Larcan and Pierre Huguenard. The French Society of Disaster Medicine/Société Française de Médecine de Catastrophe (SFMC) was founded in 1983.

Emergency medicine versus disaster medicine
Both emergency medicine and disaster medicine deal with the kind of challenges seen in Paris: gunshot wounds, blast wounds caused by explosions with organ and tissue damage, contusion and embolisms, multiple penetrations, pulmonary damage, and last but not least, shock.
The key difference between the two, however, involves the subject for medical attention. In emergency medicine, the subject is an individual patient, while disaster medicine deals with a group of patients. Disaster medicine begins on site and, given extreme constraints in human resources and equipment, is devoid of any element of personal medical care. It also uses specialized equipment, such as portable ultrasound and minimalist lightweight stretchers, while first responders are trained to improvise – for instance, carrying patients by their arms and legs. All this was evident in Paris.

Specialized military medical practices
What also was seen in Paris was a full range of specialized techniques. Some of these are derived direct from military medicine – hemorrhage control with tourniquets, hypotensive resuscitation and hypothermia prevention.
Another battlefield practice deployed in Paris (and debated subsequently by clinicians in many other countries) was to let the blood pressure of thoracic primary blast injury victims fall to levels which avoided exsanguination, but not below that required to maintain perfusion.

Anticipating frictions
Although considerable attention was paid to the White Plan, other Plans too rolled into place in the immediate aftermath of the first attack in Paris. Taken together, they highlight how potential conflicts on roles and responsibilities, jurisdiction etc. between different sets of professionals, in a period of extreme personal and systemic stress, had been anticipated, with interdisciplinary protocols already in place to minimize confusion between the police, the fire brigade, ambulance drivers, physicians and other hospital staff as well as the media and the public.
The police, for example, provided perimetric security and crowd control, taking charge of  clearing and organizing pathways to and from incident scenes. The fire brigade was responsible for victim search and extraction as well as certain types of emergency first aid. Though based in principle at field stations, doctors and nurses attended on site as and when required to the severely wounded, conducting triage and handing over patients for transport to ambulance drivers. On their part, specialist Red Cross teams had set up counselling services for victims and their families by midnight – in other words, within just 2-3 hours of the attacks.
The impact of such preparation cannot be under-estimated. In many cases, it allowed BRI special police forces to ignore pleas for help from victims, without disrupting their conscience or composure. Knowing that qualified medical professionals would shortly be taking responsibility for the wounded, the armed intervention teams instead concentrated on their job – to neutralize the terrorists.
All this, it must be underlined, was undertaken in the face of anticipated dislocations due to a strike by thousands of medical professionals protesting a health reform bill in the French Parliament on the very same day as the terrorist attacks. The strike was subsequently called off.

Other plans also implemented
The Alpha Red Plan is designed to deal with extreme emergencies at multiple sites. It sets up an ad-hoc, quick-operational chain of command which pools the full range of emergency services. These include public and private ambulances, the fire brigade and civil protection as well as the Red Cross – to provide evacuation and support. Hospitals outside the region are also placed on standby, if required.
In an interview with the ‘New England Journal of Medicine’, France’s Director-General for Health, Benoit Vallet, said that he had activated emergency protocols in areas outside Paris, including a request for helicopters to be on standby to transport victims. Vallet also noted that military hospitals treated some of the victims: “[Their] surgeons’ experience in war surgery was, unfortunately, exactly what was needed.”
The Red Plan focuses on pre-hospital care in the field. It is based on the principle of extracting and grouping the injured in a field medical facility, triaging them and then providing care on a need basis. Care is based on prioritizing treatment to what is strictly necessary for survival, managing extreme pain and transporting victims without worsening their condition.
Indeed, a key factor behind the success of the Paris response in November was the pre-hospital system. Within an hour of activation of the Red Plan, eight coordinating units dispatched 45 medical teams – each consisting of a doctor, a paramedical assistant and a driver – to six incident sites.

Lessons from France: the US case
The lessons from the French response to terror are being studied in many parts of the world. One of the first questions being asked is whether other countries would have managed as well.

Such a topic seems to be particularly charged in the US, for several reasons.
A key hurdle is that it is not easy to compare the US and French disaster response systems. The US system is built around mainly private hospitals, and is bottom-up and decentralized, while the French system is based largely on public sector hospitals, and is top-down and centralized.
Nevertheless, critics of hospital disaster preparedness in the US complain that decentralization simply means far too many federal initiatives, which leaves considerable scope for confusion about  lines of authority and responsibility in a crisis.

The US National Disaster Medical System
The point organization for overseeing a US federal medical response to disaster is the National Disaster Medical System (NDMS). NDMS is staffed by more than 8,000 civilian volunteer medical personnel. It is tasked with supplementing medical professionals and equipment should local medical resources become overwhelmed. It also has the responsibility to move injured patients to areas unaffected by a disaster.
NDMS was originally under the Department of Health and Human Services (HHS) but was moved as a result of the 9-11 terror attacks to the Federal Emergency Management Agency (FEMA), which is part of the Department of Homeland Security.
After Hurricane Katrina in 2005, amidst allegations of mismanagement, NDMS was removed from FEMA and sent back to HHS, where it now remains parked within the Office of Preparedness and Emergency Operations (OPEO). OPEO is responsible for developing operational plans, analysis and training to respond to public health emergencies and acts of terror.

HHS versus Homeland Security: Turf wars and more
It is evident that there is room for considerable conflict between OPEO and NDMS’s original parent, FEMA. One of the supra-entities tasked with overseeing a disaster response is The National Response Framework, a multi-agency initiative run by FEMA for the Department of Homeland Security.
As Beltway insiders know, the rivalry between Homeland Security and HSS is considerable.

In 2005, a then-confidential report prepared for the Secretary of Homeland Security evaluated US disaster medical readiness. The 103-page report found that “the nation’s medical leadership works in isolation, its medical response capability is fragmented and ill-prepared to deal with a mass casualty event and … HHS lacks an adequate medical support capability for its field operating units.”

NDMS was specifically targeted, as lacking the medical leadership and oversight “to effectively develop, prepare for, employ, and sustain deployable medical assets,” relying on an overtaxed volunteer network and experiencing “critical shortfalls in doctrine, training, logistics support and coordination” with other emergency responders and federal agencies.

ER capacity shortfalls in the US ‘truly alarming’
The impact of such inter-departmental rivalry and the seriousness of the allegations drew the attention of a Congressional Committee a few years later. The Committee chose a very specific target, namely emergency room (ER) capacity in cities considered to be at greatest risk of a terror attack.
Its findings, released in May 2008, were described as “truly alarming”. The hospitals surveyed did not have “sufficient ER capacity to treat a sudden influx of victims from a terrorist bombing.” The situation in Washington DC and Los Angeles were described as being “particularly dire.”
Aside from capacity, the Congressional investigation also revealed what appeared to be “a complete breakdown in communications between the Department of Homeland Security and the Department of Health and Human Services.” When the Committee requested information on hospital emergency surge capacity, “neither department was able to produce a single document.”

In France, some ironies too
There are several lessons to be learned from the French response to the November 13 terror attacks. The most salutary one brims with irony.
The French ‘system’, in the Anglo-Saxon mind, is believed to be statist, bureaucratic, top-heavy and inflexible. The White Plan response in November was based largely on the Parisian APHP, Assistance Publique – Hôpitaux de Paris, Europe’s largest hospital system.
Many critics have questioned the concept of the APHP, particularly its enormous size, as “an obstacle to adaptation in a rapidly changing technological, medical, and social context.” However, the rapid response of the APHP after the Paris terror attacks negates such criticism.
According to APHP Director General Martin Hirsch: “We sensed … that the size of the [APHP] could be an advantage in times of disaster. This advantage has now been demonstrated. No lack of coordination has been identified. No leakage or delay has occurred. No limit was reached.”
“At no time during the emergency was there a shortage of personnel.”

The authors
Ashutosh Sheshabalaya and Antonio Bras Monteiro
SolvX Solutions
Email: office@solvx.com

SolvX provides security and risk consulting services out of offices in Europe, the Middle East and Asia

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Cardiovit AT-1 G2

, 26 August 2020/in Featured Articles /by 3wmedia
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Medica, Duesseldorf, Nov 14-16 2016

, 26 August 2020/in Featured Articles /by 3wmedia
https://interhospi.com/wp-content/uploads/sites/3/2020/08/47048_2016_07_25_MEDICA_2016_International_KH_OP_Aerzte_92_x_270mm_IHE_International_Hospital_4c_4892.jpg 1000 341 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:18:122021-01-08 12:30:52Medica, Duesseldorf, Nov 14-16 2016

3D medical printing – the promise of personalization

, 26 August 2020/in Featured Articles /by 3wmedia

Three-dimensional (3D) printing for medical applications has grown in recent years at a feverish pace. The technology has long made a significant impact in manufacturing and is also revolutionizing healthcare. For some of its proponents, this would be rather like the Gutenberg printing press did with publishing. Indeed, the respected Gartner Group estimates that 30percent of internal medical implants and devices will be 3D printed by 2020.
3D printing was founded in the 1980s as stereo-lithography’ (STL) and the first commercial 3D printer came to market in 1988. Since the 1990s, manufacturers have used the technique principally for rapid prototyping, or the production of models and moulds.

Implants and prosthetics
Medical 3D printing took off in the early 2000s for producing dental implants and custom prosthetics, with a rapid pace of acceptance in areas such as hearing aids and dental braces. Currently, almost all hearing aids fitted into the ear in industrialiZed countries are made with 3D printers and orthodontic braces, too, are almost entirely 3D printed.
CustomiZed 3D-printed prosthetics and implants were made possible by translation of CT and MRI scans into digital STL print files, and imaging continues to play a central role in medical 3D printing.

Orthopedics and neurosurgery applications
The customization offered by 3D printing also quickly made its case for orthopedic patients being fitted with a standardized hip or spinal prostheses, which required the cumbersome process of shaving of pieces of metal and plastic with scalpels and drills afterwards, in order to achieve best fit.
Neurosurgeons too quickly saw the potential of 3D printing to address the drawbacks of variation in skull shape and the difficulties in using standard cranial implants. In head injury victims, for example, it is important to remove bone to provide space for the brain room to swell and the cranial plate must be perfect in fit.

In situ, in the OR
In the operating room, 3D printing has thoroughly transformed the manufacture of patient models to facilitate planning of surgical procedures. In 2016, a 3D printed model was used by Blythedale Children’s Hospital in Westchester in a 27-hour operation to separate twins conjoined at the head. According to many reports, recovery of the infants was accelerated due to the 3D model.
At the University of Michigan, CT images of a patient’s airway were used with a 3D printer to fabricate a precisely modelled, bioresorbable tracheal splint that was surgically implanted in a baby. The baby recovered, and full resorption of the splint is expected to occur within three years.
3D printing has also been used for making surgical tools such as forceps, hemostats, scalpel handles and clamps. They are formed sterile, and some estimates report that they cost only a tenth of a stainless steel equivalent.
In situ printing, by which implants, tissue (and eventually organs) are 3D printed in the human body during operations is anticipated in the future trend. Such a trend is being reinforced by rapid developments in miniaturized robotic bioprinters and robot-assisted surgery.

Personalized pills
3D printing technologies are also used for personalized medicine, with precision in dose (matched to patient profile and response). Some firms are experimenting with complex drug-release profiles, such as poly-pills with multiple active ingredients in a multilayered form.
This is seen as promising new standards of care for patients with several chronic diseases. Extended to one poly-pill per day for everyday medications, such a step would reduce a bane of medical practitioners – namely patient non-compliance.
In 2016, Spritam levetiracetam, a new drug to control seizures brought on by epilepsy, was approved by the US Food and Drug Administration (FDA). The pill, the world’s first to be 3D printed, is based on a trademarked ZipDose technology developed by Ohio-based Aprecia, and provides more porosity than alternative dosage forms.
Industry experts foresee drugs manufacturing being done eventually at the point-of-care, with physicians emailing medication formulations to pharmacies for on-demand drug printing.

Post-industrial production
The logic of 3D printing is in some ways truly revolutionary. What it brings is an end to the idea that there is commercial sense in only large runs of standardized products, a cornerstone of 19th/20th century manufacturing tradition as well as the Industrial Revolution. The first 3D manufactured product, in other words, costs approximately the same as the next one.
3D printing also reduces cost in certain cases. For example, a 5-mg pharmaceutical tablet can be custom-fabricated on demand as a smaller and less expensive 2.5-mg tablet rather than being broken up and left unused.

Speed
Speed too is a major asset of medical 3D manufacturing, and a spin-off from the fact that large production runs are not required. Customized products like prosthetics and implants, in particular, can be made within hours.
As with pharmacy pills, some expect on-site 3D printing at, or adjacent to, a hospital, to eventually emerge, for making patient-specific products.

Basic technology
The basic technique of 3D printing, which is also known as additive manufacturing, involves the successive deposit of layers of materials, typically plastic and ceramics or metal and powders, to make the final product.
One of the most exciting innovations, however, consists of using live cells as the printing material.

Types of 3D printer
The type of 3D printer chosen for an application often depends on the material used and the method for bonding the layers in the final product. Key technologies for medical applications include selective laser sintering (SLS) and thermal inkjet (TIJ) printing. Another widely-used 3D printing technology is fused deposition modelling (FDM).

Though relatively basic and inexpensive, FDM was one of the earliest examples of successful medical 3D printing in the late 1990s/early 2000s when it was used to construct cranial implants. FDM remains widely used for rapid modelling and prototyping in orthopedics and dentistry.
FDM printers use a print-head similar to an inkjet printer. Rather than ink, however, beads of thermoplastic (similar to those used in injection moulding) are released to form a thin layer. The process is repeated continuously. Since the plastic is heated, it fuses to the layers below, and then hardens as it cools to create the final product.

More complex medical uses of 3D printing are based on SLS and TIJ.
SLS uses metal, plastic or ceramics as material. A laser draws out the shape of the object and this is then fused to a powdered metal substrate. The process is repeated until the product is formed. The degree of detail in SLS is directly linked to the precision of the laser and the powder’s fineness.

On its part, TIJ uses thermal (as well as electromagnetic or piezoelectric) technology to deposit tiny droplets of ink or even cells (bio-ink) on a substrate. Unlike office inkjet printers, 3D TIJ heats a print-head to create collapsing air bubbles, which in turn create pressure pulses to eject the droplets from nozzles. The size of the droplets can be adjusted by temperature, pulse frequency or material viscosity and volumes can be as little as 10-20 picolitres. Multiple-head TIJ is especially promising for producing tissue and simple organs in the process of bioprinting’ (discussed below). Other applications under study include drug delivery and gene transfection.

Bioprinting – the final frontier
While implants and prosthetics have convincingly demonstrated the real-world relevance of 3D printing, the maximum excitement is currently focused on its use in tissue and organ fabrication.
Ageing, accidents, disease and birth problems often cause tissue and organ failure. Treatment is largely based on donor transplants. However, there is a chronic shortage of supply, not least of suitable donors (e.g. with matching tissue). In addition, surgery and follow-up is complex and expensive.
One recent approach to finding a solution consists of tissue engineering and regenerative medicine, based on mixing growth factors into isolated stem cells, multiplying them in a lab and then seeding the cells on scaffolds which transform direct cell proliferation and differentiation into functioning tissues.

Beyond regenerative medicine
Bioprinting takes traditional regenerative technologies further than scaffold support alone by using 3D printing technology to produce layers of cells, biomaterials, and cell-laden biomaterials. This is then precisely placed by the printer in tissue-like structures. As mentioned previously, inkjet-based bioprinting is the most commonly used technique for bioprinting.

Tissues and organs
German researchers have been developing skin cell bioprinting since 2010. In January 2017, a team from Spain’s Universidad Carlos III de Madrid (UC3M) reported in the journal Biofabrication’ they had developed 3D-printed human skin adequate for transplant into patients, and for testing drugs and cosmetics. Their product is currently undergoing European approval. Meanwhile, in the US, Organovo too has developed 3D-printed skin. Demonstrating the potential of such markets, French cosmetics giant L’Oreal has begun collaborating with Organovo.
Researchers have so far also successfully printed a knee meniscus, heart valves, bone and an artificial liver. In 2016, scientists at Cambridge University’s Centre for Brain Repair reported the 3D printing of a retina using a piezoelectric TIJ printer.
One application area is to use 3D printing to create tissues and organs for medical research, and rapidly screen candidate drugs, cutting research costs and time. Organovo is developing strips of printed kidney and liver tissue for exactly such a purpose, while Russia’s 3D Bioprinting Solution has 3D printed a functional thyroid in a mouse and claims to be ready to do the same in humans.

20 years to a 3D-printed heart?
Nevertheless, most bio-printed organs have so far been relatively small and simple, with no vascularity or nerve system and nourishment provided wholly by diffusion from the host vasculature. Such diffusion seems to suffice for thicknesses of 150-200 micrometers. Beyond it, there is none. In future, the bioprinting of 3D organs such as an entire kidney or heart will require precise multicellular structures with full vascular network integration.
Such a process may not be that far away. Collaborators from a network of academic institutions, including the Harvard University, Stanford University, the Massachusetts Institute of Technology and the University of Sydney recently announced they had bioprinted a perfusable network of capillaries, marking a significant stride toward overcoming the limits to diffusion.
According to some projections, we may be less than 20 years from a fully functioning printable heart.

Challenges ahead
As with many other frontiers of medicine, an immediate challenge for medical 3D printing consists of regulatory acceptance. Though a hundred-odd 3D-printed products had been approved in the US and Europe by the end of 2016, these consist almost entirely of prosthetics, surgical tools and artificial bone replacement.
Fulfilling regulatory requirements for more complex products is likely to be much more demanding. Included here are the need for large randomized controlled trials, which require funding and time – for instance to determine the biocompatibility of several of the new materials being used.

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Point-of-care testing – enhancing throughput in emergency departments

, 26 August 2020/in Featured Articles /by 3wmedia

Point-of-care testing (POCT) refers to diagnostic tests which are performed physically close to a patient, with the results obtained on site. They are conducted at primary care centres and at hospital bed sides (increasingly, in emergency departments and intensive care units, too).
POCTs are also used in the field in settings such as natural or man-made disasters, and accompanied by telemedicine, in patients’ homes.

Saving time and space
While traditional diagnostic tests involve taking patient specimens, transporting them to a laboratory for analysis and then returning the results to a physician, POCTs cut out both the transport and laboratory. As a result, they provide quicker turnaround time (TAT), sometimes near-instantaneously.
In the past, the traditional laboratory-centric process was unavoidable due to the sheer size of equipment required for diagnostic tests. In recent years, technology developments – especially in terms of miniaturization – have made it possible to perform a growing number of tests outside of the laboratory. One recent book on biomedical engineering (D. Issadore and R.M. Westervelt (eds.), Point-of-Care Diagnostics on a Chip, Biological and Medical Physics, Biomedical Engineering’, Springer-Verlag, Berlin 2013) notes the array of sophisticated, low-power and small ‘microfilters, microchannels, microarrays, micropumps, microvalves and microelectronics …. integrated onto chips to analyse and control biological objects at the microscale’, that have made decentralized diagnostics possible.

Impact on efficiency, outcomes – and costs
Such time savings can have a dramatic impact on downstream clinical efficiency and patient outcomes. In many cases (although not universally or under all circumstances), they also save costs.
For example, POCT can reduce revenue losses due to workflow delays of test-dependent medical procedures – such as disruptions in magnetic resonance imaging (MRI) or computer tomography (CT) queue. This is not a rare occurrence, and delays in radiology testing have been shown to extend total length of stay in the emergency department (ED).

From lab downscaling to targeted solutions
Early POCTs were based on the simple transfer of traditional methods from a central laboratory, accompanied by their downscaling to smaller platforms. At a later stage, unique, innovative assays were designed specifically for POCT (such as the rapid streptococcal antigen test). This was accompanied by the development of wide arrays of POCT-specific analytic methods, ranging from the simple (such as pH paper for assessing amniotic fluid) to the ultra-sophisticated (for example, thromboelastogram for intra-operative coagulation assessment).
Today, the typical POCT test arsenal includes cardiac biomarkers, hemoglobin concentrations, differential complete blood count (CBC), blood glucose concentrations, coagulation testing, platelet function, pregnancy testing as well as tests for streptococcus, HIV, malaria etc.

Beside and near-bedside POCT
POCT devices are used in a wide range of healthcare settings. They can be divided into two broad groups, depending on size and portability – bedside and near-bedside.
Bedside POCT devices are smaller, usually hand-held, and offer the greatest mobility. Due to their compact nature they are often more specialized and limited in overall functionally. Many are enclosed in test cassettes (such as easy-to-use membrane-based strips) and based on portable, sometimes handheld, instruments. This family of POCT requires only a single drop of whole blood, urine or saliva, and the tests can be performed and interpreted by a general physician in minutes. Nevertheless, some of them can be quite sophisticated.
New POCTs for early detection of rheumatoid arthritis, for example, require only a single drop of whole blood, urine or saliva, and can be performed and interpreted by any general physician within minutes. Two of the earliest efforts in this area were made in Europe. The first, from Sweden’s Euro-Diagnostica detects antibodies to CCP, while Rheuma-Chec from Orgentec in Germany combines two biomarkers – rheumatoid factor and antibodies to MCV. These tests are targeted at primary care.

Near-bedside (or neighbourhood) devices are larger and typically located in a designated testing area. They provide higher calibration sensitivity and quality control and are used for more complex diagnostic tests than their smaller bedside counterparts.
They are themselves also far more complex, with high degrees of automation in comparison to their bedside POCT counterparts. This automation contributes to the increased speed and ease-of-use of the devices. However, it also leads to challenges in training users.

The imperatives of turnaround time
As mentioned, the principal interest in POCT is to reduce turnaround time (TAT) – the duration between a test and the obtaining of results which aid in making clinical decisions. The impact of this has been profound in the emergency department.
Already in 1998, a randomized, controlled trial in the A&E department of a British teaching hospital assessed the impact of POCT on health management decisions. The results, published in British Medical Journal’ in 1998, found that physicians using POCT reached patient management decisions an average of 1 hour and 14 minutes faster than patients evaluated through traditional means.

Use in emergency departments
Though the bulk of POCT is conducted by primary care physicians, one of its fastest growing users has been hospital EDs, which the British Medical Journal’ study hinted at almost 20 years ago.
POCT’s relevance for emergency departments is multi-faceted.
In the ED, prolonged wait times and overcrowding directly correlate to reduced patient satisfaction and adverse clinical outcomes. Several European countries have regulations on length-of-stay time targets in EDs, requiring that patients must transit through four to 8 hours. Though there are several factors at play here, no one would argue that reducing the delay between sample collection and test results can enable healthcare professionals to arrive at quicker decisions and increase patient throughput. POCTs make this possible.
One study in Switzerland evaluated adding POCT to B-type natriuretic peptide levels for ED patients presenting acute dyspnea as their primary symptom. POCT was not only associated with significant decreases in time to treatment initiation, but was also associated with a shorter length of stay and a 26percent reduction in total treatment costs.
Another study on D-dimer POCT in the ED found a 79percent reduction in TAT compared to central laboratory testing and resulted in shorter ED lengths of stay and reduced hospital admissions, while a randomized study in coagulopathic cardiac surgery patients found that POCT-guided hemostatic therapy led to reduction in transfusion and complication rates, and improved survival.

From ACS to pregnancy tests, and overcrowding

Favourable perspectives on POCT in the ED have strengthened over time. One recent study in Critical Care’ found POCT increased the number of patients discharged in a timely manner, expedited triage of urgent but non-emergency patients, and decreased delays to treatment initiation. The study quantitatively assessed several conditions such as acute coronary syndrome (ACS), venous thromboembolic disease, severe sepsis and stroke, and concluded that POCT, when used effectively, ‘may alleviate the negative impacts of overcrowding on the safety, effectiveness, and person-centeredness of care in the ED.’
A great deal of attention has been given to the use of POCT in emergency settings for screening patients who presented with symptoms of acute coronary syndromes (ACS). The rapid identification and treatment of ACS patients is critical.
Due to the time-sensitive nature of ACS, reduced TATs can offer a clear advantage. POCT has been shown to increase the speed at which positive cases of ACS are accurately identified, allowing physicians the ability to admit and initiate treatment at a faster rate than previously possible. Decreased TATs also can result in the earlier identification of negative cases of ACS, thereby increasing the number of successful discharges, and allowing for more efficient use of hospital resources .

The ICU and POCT
Unlike the ED, the use of POCT in intensive care units is still in its infancy. In 2013, researchers at Germany’s Klinikum rechts der Isar in Munich sought to retrospectively investigate whether POCT predicted hospital mortality in over 1,500 ICU admissions. The results were mixed. Lactate and glucose seemed to independently predict mortality. So did some forms of metabolic acidosis, especially lactic acidosis. However, anion gap (AG)-acidosis failed to show any use as a biomarker.
One of the most important areas for POCT focus in the ICU consists of sepsis – which is directly correlated to poor outcomes. ICU patients often have other ongoing disease processes whose biomarkers are shared with sepsis, such as raised white blood cell count and fever. More crucially, many ICU patients are already on antibiotics at admission, making microbiological cultures redundant.

POCT as part of health management strategy
Overall, POCTs have an impact and make most sense when utilized as part of an overall health management strategy which enhances the efficiency if clinical decision-making. Indeed, the rapid TAT provided by POCT allows for accelerated identification and classification of patients into high-risk and low-risk groups, improving quality of care and increasing clinical throughput.
POCT results are often available in minutes. However, decreased TATs on their own mean nothing, until they provide clinical pathways means to impact on workflow. The latter varies widely across healthcare settings.

Differences in practice

Such a scenario is by no means straightforward. In Europe, for example, POCT use is highly irregular and differs greatly between institutions and countries. Though differences in operating procedures are natural by-products of institutional cultures, there are some oversight and quality control issues which healthcare leaders must address to take maximum advantage of POCT.
Answers to the above are not a question of if’ but when’.

Regulation – the future ?

The future of POCT may well be shaped by regulators, and their response to the kind of pressures mentioned above.
In Europe, POCT devices are regulated under the 1998 European Directive 98/79/EC on in vitro diagnostic medical devices, which became operational in 2001. POCT devices are not specifically mentioned or referred to in this directive, and at the European level, coverage of POCT is referred by international standard ISO 22870:2006, used in conjunction with ISO 15189 which covers competence and quality in medical laboratories.
In the US, CLIA88 (Clinical Laboratory Improvement Amendments of 1988) provided a major impetus for growth in POCT. The rules, published in 1992, expanded the definition of laboratory’ to include any site where a clinical laboratory test occurred (including a patient’s bedside or clinic) and specified quality standards for personnel, patient test management and quality.
One of CLIA88’s biggest contributions to POCT growth was to define tests by complexity (waived, moderate complexity and high complexity control), with minimal quality assurance for the waived category.
CLIA88 has been followed by US federal and state regulations, along with accreditation standards developed by the College of American Pathologists and The Joint Commission. These have established POCT performance guidelines and provided strong incentives to ensure the quality of testing.

https://interhospi.com/wp-content/uploads/sites/3/2020/08/IH123_Tosh_POCT_ICU_thematic_crop_2.jpg 182 300 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:18:122021-01-08 12:30:46Point-of-care testing – enhancing throughput in emergency departments

Best practices in patient ventilation

, 26 August 2020/in Featured Articles /by 3wmedia

Accelerating demand from ICUs has been driving the use of mechanical ventilation (MV). This is due to demographic changes triggering growth in elderly patient numbers, as well as advances in the ability to delay or prevent mortality. Nevertheless, there are also significant differences in the management of ventilated patients, and no necessary correlation in outcomes. Given the relatively high costs of mechanical ventilation, experts are seeking ways to develop and share best practices.

Growth in ICU drives demand
The Society for Critical Care Medicine (SCCM) estimates 20-30% of patients admitted to an intensive care unit (ICU) require MV. The scale of the challenge is underlined by the fact that about one-fifth of all acute care admissions in the US and 58% of emergency department admissions are made to an ICU.

The above facts are somewhat ironical. The mechanical ventilator is one of the most powerful symbols of modern medical technology and progress in intensive care technologies has allowed more patients to survive acute critical illness than ever before. However, the very same advances have created what one study describes as ‘a large and growing population of patients with prolonged dependence on mechanical ventilation and other intensive care therapies.’
The roots of such developments go back decades. In 1985, two North American clinicians coined the term chronically critically ill’ in an article about the ICU titled ‘To Save or Let Die’? It is estimated that between 5 and 10% of patients who require mechanical ventilation for acute conditions develop chronic critical illness. Many of these result in death.
Other sources endorse these findings. In 2004, a study on patients with tracheostomy for respiratory failure found that the mortality of ventilator-dependent patients was as high as 57%.

Europe and the US
The situation is challenging in Europe, too, in spite of differences vis-a-vis the US. For instance, although the UK has a seven-fold lower level of ICU beds per capita than the US, 68% of UK patients are mechanically ventilated within 24 hours after ICU admission, well over twice the 20-30% level estimated by the SCCM in the US. In spite of this, there are no differences in mortality for mechanically ventilated patients admitted from the ER.
The impact of these spill over into other areas. Although strictly comparable figures are not available, differences in the ICU environment between one European country and another would clearly have an impact. The per capita density of adult ICU beds varies seven-fold from 3.3/100,000 population in the United Kingdom to 24.0/100,000 in Germany.

Prolonged mechanical ventilation
One of the most pressing challenges, with respect to divergent practices, is the duration of ventilation.
Prolonged mechanical ventilation (PMV) is now generally accepted to be ventilation that lasts for 21 or more days. There are few studies of PMV incidence, and even these are accompanied by variations in definitions.
Nevertheless, a Canadian workshop cites two studies , to estimate that on an international’ basis, patients requiring PMV account for up to 10% of all mechanically ventilated patients, 40% of ICU bed days, and 50% of ICU costs. These figures may be slightly over-estimated. One US study, for example, finds PMV accounting for 7.7% of ventilated ICU admissions.
In Europe, the proportion of PMV is clearly lower than 10% of ventilated patients. In Scotland, for example, the University of Edinburgh’s Old Medical School reports the incidence of PMV to be 4.4% of ICU admissions and 6.3% of ventilated ICU admissions.

The challenges of PMV growth
The rate of PMV has been growing, rapidly, both due to an ageing population and technological advances which allow delaying or preventing mortality in the ICU. In the US, data show patients requiring prolonged mechanical ventilation to be steadily rising. One study covering the period 1993 to 2002 found the incidence of tracheostomy for prolonged mechanical ventilation growing by about 200%, and surpassing changes in the overall incidence of respiratory failure by a factor of three.
The resource load on PMV patients is clearly higher. Up to 40% of ICU resources may be spent on them, even though they represent only 10-15% of the ICU population. The University of Edinburgh study mentioned above found that PMV patients used 29.1% of all ICU bed days. In spite of this, the majority of PMV patients die within six months.

The costs of ventilation
Overall, the sharp growth in demand for mechanical ventilation and the frequent lack of correlation with outcomes is a major strain on financial and human resources, making it necessary to optimize ventilator use by developing best practices.
The cost of mechanical ventilation has been estimated at 1,522 US dollars per day (about 1,345 euros) in the US, and 2,110 euros per day in a recent European evaluation. The US figures are adjusted for patient and hospital characteristics, while the European figures are unadjusted. Nevertheless, it appears that intensive care unit costs are highest during the first two days of admission, stabilizing at a lower level thereafter. Still, the burden of PMV is clearly enormous. In the US, estimated costs per one-year survivor are as high as 423,596 US dollars (371,500 euros).

Costs are also non-financial. These include long-term physical and psychological consequences which impact upon quality of life and often impose substantial symptom burden. One study of 23 hospitals in the US pointed to the risks of ‘prolonged ventilator dependence, reduced mobility, as well as anxiety and depression.’ The study also called for an interdisciplinary, rehabilitative approach in the ICU. This trend correlates with wider lessons acquired over half-a-century of ICU care.
Future innovations in ventilation are likely to be focused ‘on reducing the need for user input, automating multi-element protocols, and carefully monitoring the patient for progress and complications.’

Delivery models: the role of home ventilation
Differences between the US and Europe in delivery models also influence the development of best practices.
The preferred models of care in the US include ‘delivery of protocolized rehabilitation-based care either within the acute ICU or specialized post-ICU venues.’ Patients are generally transferred to respiratory units within an acute hospital or to a long-term acute care hospital, physically located within the former or set up as free-standing institutions.
One crucial factor in the US is the lack of home ventilation, due to current funding models. In Europe, home ventilation is generally present or attaining an increasing profile. Nevertheless, there is still significant variability in practices across countries. The prevalence of home ventilation per 100,000 population averages 6.6 in Europe, but ranges from 17 in France to 0.1 in Poland.

Divergence in care practices and cognitive bias
Heterogeneity of care is probably one of the strongest indicators of the need for best practices. In the context of MV, the need for the latter is underlined by a finding that ICU clinicians are prone to cognitive biases and this may lead to systematic and predictable errors.
The most prominent divergences in practice seem to lie in sedation management and weaning.

Sedation management
Sedation management has been the subject of interest for decades, but is still marked by a lack of consensus.
In 2000, The New England Journal of Medicine’ published results of a study by the University of Chicago study on the benefit of administering sedatives to MV patients by continuous infusion, against daily interruption which allowed patients to wake up’ and be assessed by clinicians. The latter practice was found to reduce the duration of mechanical ventilation as well as the length of stay in the ICU, and sedative dosage.
In 2008, a study in The Lancet’ by the Vanderbilt School of Medicine in the US proposed that a protocol pairing daily interruption of sedatives (spontaneous awakening) with daily spontaneous breathing resulted in better outcomes for MV patients and should become routine practice.
In 2010, a team at the Odense Hospital in Denmark compared interrupted sedation of MV patients versus patients who received no sedation at all. Their findings, also published in The Lancet’, indicated that patients receiving no sedation had significantly more days without ventilation and a shorter ICU stay, with no difference in accidental extubations, need for CT or MRI brain scans or ventilator-associated pneumonia. The researchers called for a study ‘to establish whether this effect can be reproduced in other facilities.’

One ambitious recent effort to study differences in sedation management involved a multicentre study of 40 ICUs in France and Switzerland. The researchers found that a quarter of the participating units did not even have a sedation-management protocol in place. This, they speculated, might be due to a lack of awareness about protocols, or because of limited resources. Another possibility was that physicians tend to resist cookbook recipes’ and limitations to their autonomy. In other words, they observed, the presence of a written procedure ‘does not mean that physicians will follow it.’ Even in ICUs with sedation management protocols, ‘approximately 20% of the physicians were unaware’ about their existence.

Weaning
Another priority for protocols concerns weaning MV patients in the ICU. Studies have shown that 20% of MV patients fail to wean in the ICU and become dependent on mechanical ventilation.
In 2005, as a first step, an international consensus panel proposed classifying weaning into three types, based on difficulty and duration. These consisted of simple’ weaning (successful extubation on a first attempt), difficult’ weaning (patients who require up to three spontaneous breathing trials/SBT, or 7 days) and prolonged’ weaning (patients failing at least three SBT attempts or requiring over 7 days after the first attempt).
The classification was, however, the subject of a major attack in 2011 by Dean Hess, the Assistant Director of Respiratory Care at Massachusetts General Hospital and Neil MacIntyre, a Professor of Pulmonary Medicine at Duke University Medical Center. Writing in The American Journal of Respiratory and Critical Care Medicine’, the two took the international panel to task for using the term weaning’ interchangeably with discontinuation’ of mechanical ventilation. They also attacked the very concept of weaning, suggesting that little evidence supported a gradual reduction of respiratory support. They urged clinicians to focus on treatment of the underlying disease process rather than manipulating the ventilator settings.

Indeed, the linkage between sedation management and weaning, and the lack of hard data and conclusions on either, was highlighted in a 2014 commentary by Italian, French and German ICU clinicians titled Sedation and weaning from mechanical ventilation: time for best practice’ to catch up with new realities?’. The article, published in Multidisciplinary Respiratory Medicine’, argues that ‘delivery of sedation in anticipation of weaning of adult patients from prolonged mechanical ventilation is an arena of critical care medicine where opinion-based practice is currently hard to avoid because robust evidence is lacking.’

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KIMES, 16-19 March 2017, Seoul

, 26 August 2020/in Featured Articles /by 3wmedia
https://interhospi.com/wp-content/uploads/sites/3/2020/08/47098_KIMES-2017_140x210_IHE_arab-health.jpg 1000 667 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:18:122021-01-08 12:30:40KIMES, 16-19 March 2017, Seoul

KIMES 16-19 March 2017

, 26 August 2020/in Featured Articles /by 3wmedia
https://interhospi.com/wp-content/uploads/sites/3/2020/08/47060_KIMES-2017_140x210_IHE-Sep.jpg 1000 667 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:18:122021-01-08 12:30:49KIMES 16-19 March 2017

Imaging centre boosts patient care services in Sicily

, 26 August 2020/in Featured Articles /by 3wmedia

With investments in two new, top-of-the-line DR solutions plus the innovative Portal, the imaging centre owned by Dr. Francesco Fiumara offers a higher level of healthcare service in Sicily, Italy.
Established in 1986, the Centro di Diagnostica per Immagini Dr. Francesco Fiumara is today recognized as the best diagnostic centre in the eastern region of Sicily, and is contributing to enhancing the level of healthcare services in the area. As a private clinic fully dedicated to diagnostic imaging, and accredited by the Italian National Healthcare System, it must offer first-rate services while controlling costs. Agfa HealthCare’s solutions have been key in helping the clinic achieve this goal.

Spread over two floors and 1,200 m2 of a building in Santa Teresa di Riva, some 40 km from Messina, Sicily, the diagnostic imaging clinic carries out diagnostic imaging and medical examinations for about 150 patients every day. The clinic strives to offer patients high-quality services, delivered with competence and compassion. This is reflected in the extended 8 am to 8 pm opening hours, the team of 14 specialists in a total staff of 40, and the use of the most advanced imaging technologies: including digital radiography, mammography, CT, ultrasound and MRI.

The clinic was already a customer of Agfa HealthCare; based on this positive experience, in 2015 it installed the DX-D 800 and DX-D 300 direct radiography (DR) systems. These have supported the clinic to increase and improve its radiology services as well as to reduce patient radiation dose. The clinic also implemented Agfa HealthCare’s Portal solution, giving patients the ability to remotely access and share their own exams.

A broad range of high-quality, dedicated exams
The centre performs a broad range of digital exams. One of the four radiography rooms contains a DR system specifically for mammography, while another is used for dental radiography. The last two rooms house the two new Agfa HealthCare DR systems, used for skeletal imaging, and for digestive and urogenital imaging using contrast media.

The DX-D 300 is installed in the skeletal radiography room; its fully-motorized arm easily accommodates a number of configurations, making it ideal for orthopedic studies. The remote-controlled DX-D 800 can handle general radiography and fluoroscopy, and has a detachable, tethered detector for portable exposures. “We only needed one investment to handle a broad range of applications,” says Dr. Fiumara, owner of the centre. The system is used for functional examinations such as barium enemas and esophagus tests.

Increased efficiency and faster throughput
“Diagnostic radiography has become a strategic service for our clinic to offer. We began working with Agfa HealthCare on this project in 2009, installing the IMPAX RIS/PACS solution, which was continuously updated in the following years. With these tools, we could already increase the efficiency of our imaging workflow and archive all patient exams in our database.”

The centre was one of the first in Sicily to adopt digital radiology. “We installed our first Agfa HealthCare computed radiography (CR) system, the DX-S, in 2012,” says Dr. Fiumara. “Our CR solution was a big innovation in efficiency and quality compared to conventional radiography. The challenge was to keep up a high standard of image quality while simultaneously reducing examination time and – consequently – patient waiting times.”

Once the clinic had experienced the quality of Agfa HealthCare’s technology and support services, Dr. Fiumara was keen to continue this partnership. “Working with Agfa HealthCare makes us feel confident for the future.”

“We considered several aspects when we were looking at the Agfa HealthCare DR solutions,” confides Dr. Fiumara. “Reducing exam time was a significant attraction, but so were the high resolution and the MUSICA image processing software. So we chose both the DX-D 300 and DX-D 800.”

“With these two DR solutions we have increased the number of exams we can perform every day, and at the same time we have enhanced our imaging reputation.”

The agreement with Agfa HealthCare includes full 24-hour service with a local engineer for any hardware problems and remote support for the software. “We have a single point of contact, so if something goes wrong I can directly speak to the technical contact and have an immediate solution,” continues Dr. Fiumara. Expertise in operations and workflow is another advantage; he says: “The specialized knowledge of the local technical and commercial Agfa HealthCare team is very valuable and helps us identify specific needs.”

Reducing patient dose
“As we learned more about dose reduction, we started to look for dose reduction potential in all our radiography systems. This became our strategic objective.”

The clinic’s four digital radiology systems and CT system all feature very low levels of radiation dose. “The I-Dose system in the CT device, for example, reduces dose by 60%. That’s the highest reduction we have reached so far with our devices.”

“Patients today are better informed and ask questions about patient dose. We are proud to offer not only an efficient and high-level radiology service, but also the safest in our area,” continues Dr Fiumara.

A Portal to better patient care and satisfaction

To further expand its patient services, Dr. Fiumara implemented the Agfa HealthCare Portal solution, which gives patients access to information from different sources inside and outside the hospital. This overview of information and actions can help enhance operational efficiency while improving the overall patient experience. “Integrating the Portal with the RIS/PACS solution means patients can access their exams and get an online consultation, instead of needing to return to the clinic just for this. It also speeds up a therapy.”

Patients can look at their own images, results and other aggregated information; and can share them in a secure way with a caregiver or another doctor. By empowering and satisfying patients, the Portal will also support the clinic to increase patient loyalty and to attract new patients.

“With our Agfa HealthCare solutions, we can offer a higher-quality service to patients, with low downtime,” concludes Dr. Fiumara. “We have increased the number of exams we conduct, whilst reducing our costs. Our partnership with Agfa HealthCare puts us in a better position for further growth.”

*DX-D 800 is not available in the US and Canada

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The bidirectional relationship between CVD and cancer

, 26 August 2020/in Featured Articles /by 3wmedia

Cardiovascular disease is the most frequent cause of mortality globally, with cancer the second most frequent cause: CVD accounts for over 30percent, and cancer around 17percent, of deaths worldwide. In the more affluent western countries, because of the enormous improvements in diagnosis and management of CVD, cancer has overtaken CVD as the leading cause of death. However as populations age the two conditions frequently coexist. Of course many of the modifiable risk factors are shared, but CVD is also a known complication of cancer therapy and recent robust population studies have shown that patients with some forms of CVD have an increased risk of cancer.
Most of the modifiable risk factors for both conditions are well known, and include tobacco smoking, physical inactivity, unhealthy dietary habits and obesity. There are also well established risk factors for CVD that recent studies suggest may also be risk factors for cancer, such as Type 2 diabetes, and hypertension and hyperlipidaemia, both prevalent in cancer survivors. Alcohol consumption, a known risk factor for cancers including those of the alimentary tract, liver and breast, is also a risk factor for CVD (unless consumption is light, which is still considered protective against CVD).
As the number of patients surviving cancer continues to increase, more and more data are available demonstrating that the risk of morbidity and mortality from CVD in these individuals is greater than in subjects without a history of cancer. For instance, a robust analysis involving over a million female survivors of breast cancer compared with control women who had not had cancer reported that the risk of CVD mortality was significantly lower in the control group. Cancer itself can cause local and systemic cardiovascular conditions such as effusions and arrhythmias, and in addition many of the drugs and drug combinations used in cancer chemotherapy can be cardiotoxic, such as anthracyclines, trastuzumab and most of the approved tyrosine kinase inhibitors. Radiation therapy can affect the pericardium, valves and myocardium long term.
Recently a Danish group of over 9000 cancer-free chronic heart failure (HF) patients were compared over time with the general Danish population and a significantly increased risk of cancer was demonstrated in the HF group. Over a thousand US cancer-free survivors of myocardial infarction followed by HF were also shown to have a significantly higher risk of developing cancer compared with patients who did not have HF.
It is surely prudent that all healthcare providers as well as CVD and cancer patients are informed about this bidirectional relationship.

https://interhospi.com/wp-content/uploads/sites/3/2020/08/Frances1_c31f06.jpg 300 225 3wmedia https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png 3wmedia2020-08-26 14:18:122021-01-08 12:30:34The bidirectional relationship between CVD and cancer
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