BERLIN — A large-scale pilot project aimed at establishing interoperable electronic health record (EHR) systems across borders was unveiled by a core group of European Union member nations during eHealth Week here in late April. The declaration signed by the core group was officially adopted by health ministers from all 27 EU member states the following day at a meeting held in Aachen, Germany.

With EUR 12 million ($16.2 million) funding from the European Commission (EC), the large-scale pilot will define a working model for interoperability between national records for patient identification, as well as for medical and medication data needed for emergency care. Norway, Iceland and Liechtenstein, which are not members of the EU, also agreed at the Aachen meeting to adopt the declaration.

“We seek to ensure that, in the future, electronic health services for Europe’s citizens do not stop at national borders,” said Klaus Theo Schr der, state secretary at the German Federal Ministry of Health. “We want to give patients access to their medication records and patient summaries from everywhere within the European Union,” he said. “This not only serves the continuity of care, but also affords safety in an emergency.”

The EC’s strategy is to encourage a lead group of member states to form a consortium to respond to the EU call. This core group would receive the EU funding and then issue its own call for proposals to industry to meet the program requirements and create the supporting IT architecture.

“If a company applied for this funding, the result would be some kind of tool just like any of the dozens of health information systems already on display out there on the exhibition floor,” said John Ryan, head of the Health Information Unit of the European Commission.

Ryan told Biomedical Business & Technology, “With member states driving the process, they will already be on board for the solution, so when we roll it out they will be the ones selling the solution to other member states, not salespeople from an international company.”

The core group that will lead the large-scale pilot was reported to made up of as many as eight EU member nations, though executives from two EU commission directorates declined to name the countries. Both Germany and France are certain to be participants. IT directors for the Dutch and Swedish national eHealth programs told BB&T they will join the core group. The Czech Republic was reported to be joining the group, and Slovenia, which will take over the EU presidency for the next six months, is expected to participate.

The parade of presentations at the Berlin conference, part of an annual updating of progress in each country toward eHealth, offered convincing proof of Europe’s claim to be leading the world with the development of electronic medical systems, including an advanced program for cross-border exchanges among Baltic Sea nations.

Yet it became equally clear that Europe may be quickly constructing the world’s tallest Tower of Babel, brick after brick, with systems unable to communicate even basic patient identifiers across national borders, and in many cases an incompatibility for patient records between regions within the same country.

For example, Sweden, the most advanced European nation for eHealth systems, is currently in the process of establishing a national system to integrate data among the 21 autonomous regional authorities. “For the moment we have a program but not the hardware,” said Daniel Forslund, head of the eHealth section for the Swedish Ministry of Health and Social Affairs. He told BB&T, “Our long experience of advanced functions with medical data shows that IT systems are built for storage and not the exchange of data.”

Patient confidentiality, data security and especially patient control of information are protected by laws at the European level, yet many countries have far more restrictive laws that by treaty must be respected, for example, by caregivers for a German tourist injured on the ski slopes of France or a British retiree living in Barcelona.

Addressing the conference, Viviane Reding, the EU commissioner responsible for the information society, said, “The commission is determined to transform the potential of e-health into a reality. We have doubled the budget for eHealth. It is an economic issue, it creates economic opportunities, it can sustain double-digit growth. Europe can deliver, and it will.”

But, she added, “We need joined-up strategies.”

Madagascar selects OraQuick HIV test

OraSure Technologies (Bethlehem, Pennsylvania), a major participant in the oral fluid diagnostics sector, reported being selected by the government of Madagascar and its National AIDS Control Program to be the exclusive first-line provider of rapid HIV screening tests for the country’s outreach program over the next five years.

The government intends to test more than 400,000 individuals in 2007 with the OraQuick Rapid HIV 1/2 Antibody Test. A major component of the AIDS control program is an outreach effort that includes teams of individuals traveling to highly populated areas and offering HIV tests in convenient locations, including individuals’ homes.

“The rate of prevalence for HIV/AIDS [in Madagascar] is low, and we want to keep it that way,” said Fenosoa Ratsimanetrimanana, executive secretariat of the National AIDS Committee. “Last year we saw a significant increase in HIV testing because we launched a rapid oral fluid HIV test during the second half of the year. This year, we anticipate more than tripling the number of HIV tests administered vs. the prior year.”

OraSure said that due to the immediate impact of the OraQuick test when it was introduced in the latter part of last year, the Ministry of Health, Family Planning and Social Protection has elected to use the test on a preferred basis.

EU directive to require DEHP labeling for medical devices

Medical devices using chemicals known as phthalates must be clearly labeled under a revised European Directive passed by the European Parliament that came into effect in April. The European directive stopped short of banning products using di(2-ethylhexyl) phthalate (DEHP), a compound used to soften vinyl plastic found in medical devices such as IV bags and tubing. Instead the labeling requirement is meant to aid hospitals that are seeking to either phase out or eliminate products containing DEHP.

A significant number of research reports indicate that DEHP can leach out of plastic bags and tubing into the human body. Multiple studies have reported a link between DEHP and altered development of the male reproductive system.

The healthcare procurement journal Healthcare Equipment and Supplies (HES; Sidcup, UK) reports that the European Union argued against a total ban, saying the result would be a ban on too many medical devices considered indispensable for the protection of health.

HES quoted European Commission VPt G nter Verheugen as saying that the new regulation “allows for enhanced patient protection and supports medical progress and innovation. It will improve the functioning of the internal market and strengthen the competitiveness of the European industry.”

The boost to European competitiveness is expected to come through the development of alternative products.

A spokesman for the Health and Environment Alliance (Brussels, Belgium) told European Hospital Magazine that while the group was disappointed the Parliament did not ban DEHP outright; “The new law is a progress for those hospitals that have already been trying to avoid plastic softener but are having a hard time doing so because of a lack of information.”

Karolina Ruzickova, safer materials coordinator for Health Care Without Harm Europe (HCWHE), said, “Alternatives are readily available. A number of European hospitals are already using PVC-free devices for neonates and hemodialysis patients.”

In a statement, HCWHE lauded several examples, saying “the Vienna and Styrian hospital associations, accounting for more than one-third of hospital beds in Austria, are phasing out medical devices containing DEHP and PVC. A majority of neonatal departments in Sweden and Denmark use products without DEHP-softened PVC.”

Coalition focuses on long-term care in UK

One in five persons in the UK will develop long-term care needs, but the care system is still not fit for future generations of pensioners, says a new coalition, which late last month launched a public debate on the future of long-term care funding.

The Caring Choices coalition, run by the King’s Fund, Joseph Rowntree Foundation, Help the Aged and Age Concern and supported by 11 other organizations spanning health and care, have joined forces to host seven regional debates across the UK, aimed at addressing the failings of the care system and look at potential solutions. Caring Choices said views of the public, the elderly and their caregivers will be sought, “to determine how to reach a fairer system of paying for care in the future.”

Key themes, based on evidence from a review of social care funding for older people authored by Sir Derek Wanless for the King’s Fund and Joseph Rowntree Foundation’s long-term care funding program, will be explored.

Those invited to each event include older people and their caregivers; care providers, commissioners and staff; and local and national policymakers. Participants will take part in an interactive voting session, the results of which will be used to encourage wider public and political debate, the coalition said.

Each event will focus on three key questions: “Who should pay for personal care?,” “How do we encourage people to contribute to care costs?” and “How do we support the provision of informal care?”

King’s Fund Chief Executive Niall Dickson said, “A proper debate about roles, responsibilities and risks — and the trade-offs we are prepared to make as individuals and as a society — should make a big contribution to policy development in this important area.”

Julia Unwin, director of the Joseph Rowntree Foundation, said, “We need a ‘Plan B’ for social care funding. The current system is neither fair, clear nor sustainable and the time has come to devise a system that is fit for the 21st century.”

Medela eyes German wound-healing market

Medela Healthcare (McHenry, Illinois) said it has filed a claim in the German District Court of Wiesbaden asking the court to modify an agreement with Kinetic Concepts (KCI; San Antonio) concerning the sale of Medela Vario pumps in Germany.

The agreement, reached between Medela and KCI in 2001, settled a competitive issue between the two companies. Medela committed not to sell the Vario aspirator pump for wound-healing use because Medela did not include “wound healing” in the CE certification and the pump’s manual.

Since then, Medela has included wound healing in the CE certification for the product and has updated the Vario aspirator pump manual. The Vario is an electrical- and battery-powered suction pump used for wound healing by applying negative pressure to the wound site. It is used in tandem with wound dressing.

Medela CEO Roman Kupper said, “We are determined to offer greater choice to patients and healthcare providers and providing the Vario aspirator pump for wound healing is a big part of that.” Medela serves customers through 12 subsidiaries and a network of distribution partners in more than 90 countries.

Computational Engineering, University of Freiburg in new partnership

Computational Engineering International (CEI; Apex, North Carolina) and the University of Freiberg’s (Freiburg, Germany) Department of Diagnostic Radiology, Medical Physics reported a partnership they said would bring new visualization techniques to the medical imaging community. The collaboration will allow researchers to use CEI’s EnSight software to conduct advanced blood flow visualization and analysis with conventional DICOM data.

CEI develops software applications for the scientific and engineering community. CEI’s products also are used in the biomedical and bioengineering communities. The University Medical Center Freiburg, one of Germany’s largest medical centers, is a leading medical research facility.

The partnership will use EnSight software to bring flow-sensitive 4-D MRI techniques developed at the medical center by Dr. Michael Markl, director of cardiovascular MRI, to more researchers wishing to use visualization techniques to study blood flow.

Markl and colleagues have used the techniques to measure and study blood flows in various types of common vascular diseases such as aneurysms in order to better understand the formation and progression of these conditions.

Markl’s techniques take advantage of 3D spatial encoding and flow-sensitive MRI capabilities to provide anatomical and 3D velocity information over the entire cardiac cycle for each pixel within a 3D volume.

“Our partnership with CEI provides the opportunity to integrate EnSight into a clinical environment for direct access to real 3-D flow features inside the human body,” said Markl. Markl also will consult directly with other researchers looking to incorporate EnSight visualization technology into their own work.

CEI offers a suite of engineering and scientific visualization tools, from meshing to plotting to animation, on all major operating systems. The company’s products can be run on everything from laptops to workstations, clusters and supercomputers, with animations displayed in stereo and in

DMS reports robust Scanner scale growth

Diagnostic Medical Systems (DMS; Montpellier, France), a manufacturer of medical scanning equipment, reported that it is back in the black and in a recent statement announced that it is ahead of its plan to realize the 20% growth in revenues for 2007.

Caught in a cash squeeze in early 2006, the company was unable to meet production schedules for contracted equipment.

A stock offering in September 2006 raised EUR 8.3 million ($10.3 million) against pledges to reduce fixed costs and increase sales.

In April, DMS reported first-quarter sales of EUR 6.2 million ($8.6 million), an increase of 63%, boosted by contracts in Japan and Europe.

DMS’s cash problems were linked to the development in 2005 of a sophisticated new product, Paladio, a digital sensor composed of a cooled high-resolution charge-coupled device (CCD) camera with a high reading frequency and a chain of high-performance and automatic images processing which allows immediate visualization of the image and facilitates the interpretation.

DMS at the time reported that while sales were not the cause of its cash problems it was nonetheless forced to cut back international commercial activities to meet its obligations to suppliers and banks.

Current sales activity boosting the company’s financial performance are linked to traditional products. The company confirmed in April that it had won a European contract for EUR 4.8 million ($6.7 million) for remote-controlled radiology tables, sales that will be invoiced in the second and third quarters. DMS said it is in discussions with the same customer for a second contract valued at EUR 800,000 ($1.1 million).

Reports of sales in Asia in late March sent the company’s stock price soaring on the Euronext exchange. DMS announced sales in Japan of 10 UBIS 500 units, an ultrasound bone densitometer and said it targets a 10% share of the estimated 1,000 sold in Japan annually. A contract for osteodensometers in South Korea, valued at EUR 1 million ($1.39 million), is expected to be invoiced before the end of this year.

Looking forward, DMS said a new osteodensometer unit, called Stratos, will come onto the market by the end of 2007, adding that in 2008, it will launch a new remote-controlled radiology table called Trixell.

It also said that it will create a new division this June dedicated to women’s health, called S lenyos, focused on digital mammography.

For 2006 DMS reported a loss of EUR 600,000 ($834,000) against sales of EUR 25.7 million ($35.7 million), a significant improvement from a 2005 loss of EUR 8.3 million ($11.5 million).

In its report to stockholders in March, DMS said personnel expenses have been reduced by 2% and it has cut fixed charges by 15%.

Western Australia ramping up life science efforts in research

Medical researchers in Western Australia reported that they have secured more than $200 million in funding to create what they characterized as a “world-class facility” for biomedical and biotechnology research.

Western Australia Industry and Enterprise Minister Francis Logan reported the funding - a combination of money from the federal and state governments of Australia and the University of Western Australia (UWA; Perth) — at last week’s BIO2007 Convention in Boston.

“This funding, the largest to date, will lead to the creation of a world-class facility for biotechnology and biomedical research in Perth,” Logan said. The facility will have three primary areas of focus - adult, pediatric and ophthalmic health.

“With this funding,” he said, “the WA Institutes for Health (WAIH) will foster innovation, advance that innovation to new medical therapies and provide a conduit to research around the world.”

WAIH has more than 700 medical researchers working on projects for the Western Australian Institute for Medical Research, the Lions Eye Institute and the Telethon Institute for Child Health Research.

Professor Peter Klinken, director of WAIH, said the funding would enable the various institutes to “expand dramatically” their research capabilities on disease prevention and the genetic etiology of disease.

WAIH researchers have discovered genes involved in several diseases, including cancer, leukemia, and muscle and nerve disorders. They also have been credited with improving childhood health by developing new treatments and preventive measures for diseases such as spina bifida, asthma and diabetes, and made major contributions to improving ophthalmic conditions such as glaucoma, retinal degeneration and cataracts.

WAIH has collaborations with research institutions in the U.S., including the National Institutes of Health, Harvard University (Cambridge, Masssachusetts) and St. Jude Children’s Research Hospital (Memphis).

AION Diagnostics reports preliminary study results

In more news involving Western Australia, nano-diagnostics company AION Diagnostics (Perth), a developer of imaging agents, reported positive preliminary results of a pilot study showing the high intravascular contrast enhancement of modified porous silicon (mpSi) in reduced dose amounts.

In the in vivo study, a bolus injection of mpSi in saline suspension was administered intravenously. Ultrasonographic imaging of the vasculature and heart indicated that the mpSi showed high echogenicity and produced strong contrast enhancement with no change in vital signs or evidence of acute cardiovascular or respiratory adverse effects. Silicic acid is a natural byproduct of silicon and mpSi metabolism.

The trialed intravascular contrast agent is based on the same formulation as AION’s Marking Agent, a medical device to be registered under the CE mark and the FDA 510(K) route.

The interim results provide “an excellent advancement to consolidate AION’s position in the ultrasound imaging sector,” the company said, calling ultrasound “a powerful imaging technique that can be used in a wide variety of settings, including surgical, outpatient, emergency room and community healthcare environments.”

mpSi also is visible under other key imaging modalities, including MRI, CT, X-ray and optical imaging.

The European contrast media market, inclusive of all imaging modalities, generated revenues of EUR 1.02 billion in 2006 with an expected CAGR of 7.2% for 2006-2013.

AION said current ultrasound contrast agents have a short imaging life due to their inherent fragility and rapid removal from the bloodstream. The physical stability of mpSi particles overcomes this issue, it said, offering advantages with increased length of time available to clinicians in performing examinations.

“The stability of mpSi particles also will allow clinicians to use higher resolution imaging than is possible with conventional contrast media because of their fragility, which translates to better contrast and improved visualization of anatomical detail,” the company said. It noted that the high visibility of mpSi at low dose is of “vital importance in molecular imaging applications due to the necessity to image minute clusters of diseased cells.”

Generic Medical Devices opens European headquarters

Generic Medical Devices (GMD; Gig Harbor, Washington), which calls itself “the first company to design, develop, manufacture and supply quality surgical products marketed at generic prices,” said it has opened for global business with the establishment of European headquarters in Brussels, Belgium.

J.P. Allar has been named GMD’s VP, international sales and managing director, GMD Europe, and Daniel Verstappen, RN, will join the company as senior director, clinical and regulatory, GMD Europe.

Together, Allar and Verstappen have almost 40 years of experience in the life sciences in the European market. Before joining GMD, Allar served for 10 years as managing director and director of sales for Cyberonics Europe. He also held various positions at Guidant, Eli Lilly Benelux and Deckers Medical.

Verstappen has held various sales, marketing, clinical and regulatory positions at Cyberonics Europe over the past nine years. Most recently, he served as senior director for the clinical and regulatory department.

He added: “The opening of our Brussels office will open the door for business in Europe, which will allow us to begin bringing down healthcare costs for EU-based healthcare facilities and systems where physicians and administrators alike have often been the first to embrace new initiatives that help them deliver the best care to as many patients as possible.”

Companies report gaining CE mark approvals

Following is a selection of reports concerning technologies receiving CE-mark approvals.

• Paradigm Spine (New York). a business of Spinal Implant Solutions, said it has received the CE mark for its DSS implantable dynamic spine stabilization system. The DSS system is a pedicle screw-based, implantable dynamic spine stabilization system indicated for degenerative disc disease (DDD) of the lumbar spine. The DSS system incorporates a hybrid philosophy, combining elements of fusion and motion preservation.

The first surgery involving the DSS system was performed late last month in Straubing, Germany by Rudolf Bertagnoli, MD.

The system was developed in ccooperation with Hans-Joachim Wilke, a well-known professor of biomechanics at the University of Ulm (Ulm, Germany), and Bertagnoli, described by Paradigm as “the most experienced spine arthroplasty surgeon worldwide.”

The company said the modularity of the DSS system “enables the combination of DSS dynamic couplers with DSS fusion couplers at adjacent levels. Therefore, one segment may have functionally dynamic stabilization (non-fusion) while an adjacent segment has rigid segmental fixation (fusion) under the same system.”

The dynamic coupler increases the stiffness of the affected motion segment and restricts the range of motion in flexion, extension, lateral bending and rotation while preserving motion. By selecting the appropriate size, the posterior segmental height also can be adjusted. Meanwhile, the DSS fusion coupler provides rigid segmental fixation using the same instrument set. The use of percutaneous screw positioning facilitates a minimally invasive, muscle-sparing approach, the company said.

Wilke said, “We designed the system to focus on controlling ‘active zone’ motions, which are normally associated with pathologic painful arcs of motion. This product reflects what we have learned about the function of the human spine from multiple spine experiments over many years, based on studies conducted with our validated Finite Element model of a lumbar spinal segment.”

The DSS system is Paradigm Spine’s fourth product to receive a CE mark, following the coflex interspinous implant, the DCI dynamic cervical implant and the coflex-F implant system.

• Cardiocom (Minneapolis), a maker of remote patient monitoring equipment and disease management software, said it obtained CE-marking and launched its products in the European market. The company said it has formed several distribution relationships in the UK, where the government is providing “significant funding” for telehealth solutions to meet the needs of an aging population.

The company will provide its partners with the Commander, Commander Cellular and AutoLink monitoring and alert products. The company’s GlucoCom division will supply blood glucose monitoring supplies for diabetic patients.

Cardiocom’s UK partners will provide nurse call center services for daily monitoring of patient biometric data, health status and compliance using the company’s web-based OmniVisor Pro patient management software system.

• Stereotaxis (St. Louis) reported that its partnered magnetic irrigated ablation catheter has received CE-marking and will be available in Europe in the near future. The company called the catheter “an important addition” to its line of magnetic ablation catheters and that it “further expands electrophysiology applications for the Stereotaxis Magnetic Navigation system.”

• St. Jude Medical (St. Paul, Minnesota) reported expanded European CE-mark approval to include the Therapy Cool Path irrigated ablation catheter with bi-directional steering for use in ablation procedures to treat abnormal heart rhythms. The company said the catheter is the first open-irrigated ablation catheter to provide bi-directional steering, a feature designed to help physicians maneuver the catheter in difficult areas of the heart and perform complex ablations more efficiently.

“The main advantage of the bi-directional catheter is its ease of use in reaching difficult anatomical locations,” said Carlo Pappone, MD, PhD, director of the Arrhythmology Department at San Raffaele University Hospital (Milan, Italy). “Because the catheter requires less manipulation and provides for greater simplicity of navigation, my procedural time was improved by about 20%.”

The catheter is produced by Irvine Biomedical (Irvine, California), a business of St. Jude Medical.

• Angiotech Pharmaceuticals (Vancouver, British Columbia) said it has received CE-mark approval for its Quill Self-Retaining System (SRS). Launched early this year in the U.S., Quill SRS is expected to launch commercially in Europe in mid-year.

“With the potential to improve patient outcomes, save time in the operating room and enhance procedural techniques, Quill SRS represents the next generation in wound-closure technology,” said Dr. William Hunter, president/CEO of Angiotech. “In the first three months of launch in the U.S., we have seen strong physician interest in this product and expect similar reception in Europe.”

The company said Quill SRS’s helical barbed design enables surgeons to suture without the use of knots, which achieves potentially significant time savings in the operating room, especially in suture-intensive procedures

• CoreValve (Irvine, California) said it has received the CE mark for its CoreValve Percutaneous ReValving System for treatment of high-risk patients. The ReValving System consists of a porcine pericardial tissue valve mounted in a self-expanding multi-level frame, which is permanently implanted over the diseased aortic heart valve by an 18 Fr-sized catheter.

The ReValving System procedure is intended to avoid open-heart surgery. It can be performed in a cardiac cath lab just like angioplasty and stenting, which, according to the company, may result in less patient trauma and offer “substantial cost savings” to the healthcare system.

CoreValve said the small size of the delivery catheter is a “key element” of the system, “as it greatly improves overall maneuverability and valve placement while also eliminating the need for surgical cut-down of the femoral artery.”

The company said that it will not immediately market the system, proceeding instead with an expanded clinical evaluation . . . .”