Diagnostics & Imaging Week International Editor

OXFORD, UK — The accent was on electronic health records (EHR) at Europe's annual Connectathon for health information systems, held in mid-April at St. Catherine's College.

For the first time in the eight-year history of the event, the number of tests for interoperability between vendor products and hospital IT infrastructure challenged the traditional dominance of testing for new radiology and picture archiving and communications systems.

This shift in emphasis among the 83 vendors participating in the event is explained by the growing importance of EHRs programs emerging across Europe, according to Eric Poiseau, technical manager for Integrating the Healthcare Enterprise in Europe (IHE-Europe; Brussels), organizer of the Connectathon.

The North America IHE Connectathon took place at the end of January in Chicago, where 70 vendors tested software onboard new medical device systems.

This year's European event also saw the first tests ever conducted for reliability of data from point-of-care (POC) devices using specifications developed through the open development methods of IHE.

The newly developed POC requirements are part of the larger IHE Laboratory domain pioneered by IHE teams in Europe and Japan and responds to what one Connectathon executive said is "a tremendous frustration building among people who are screaming for lab reports, people who want them right now on their office computer."

Laboratory Point of Care Testing (LPOCT) specifications developed by IHE-Europe cover the workflow related to clinical laboratory tests performed during patient medical visits or at bedside by ward staff and move the lab results locked inside proprietary systems to a specific patient's records.

A new and unexpected participant at the Connectathon in Oxford this year was Roche Diagnostics (Basel, Switzerland), whose engineers were there for the LPOCT validation.

Initially driven by the market demand for compatibility among radiology units, IHE has grown by developing technical frameworks, testing tools and integration profiles defining eight distinct areas, or domains, within healthcare including cardiology, patient care coordination and laboratory, for example, as well as the dominant radiology and the growing domain of infrastructure.

Supported by both manufacturers of health systems and IT users, such as regional hospitals, professional medical societies and governmental agencies, IHE uses a collaborative method for integrating different standards for data including Digital Imaging and Communications in Medicine (DICOM), Health Language Seven (HL7).

Compliance with IHE specifications is voluntary and though validation results for specific company products are posted to the IHE website after each Connectathon, there is no official certification of supplier's products.

Yet the broad-based development of IHE specifications has won the formal endorsement of specifications in certain domains by France, Italy, the Netherlands and Finland. In Austria, a national IHE organization was created this year by the health ministry.

Many vendors in Europe selling medical devices within these national systems will increasingly require a proof of compliance with IHE workflows for their hospital departments to satisfy workflows set forth in requests for proposals.

On a larger scale, IHE-Europe will be a partner for the Large-Scale European Pilot for e-health that is to receive funding from the European Union later this year and when developed will see the exchange of shared patient identification, emergency medical summaries and medication histories between eight to 12 nations.

A GE Healthcare (Waukesha, Wisconsin) executive told Diagnostics & Imaging Week the handwriting is on the wall for European medical device manufacturers and indicated the proof can be seen with early adopters at Connectathon testing data exchanges using the upgraded profile for Cross-Enterprise Document Sharing (XDS) that takes advantage of new web service technologies.

Vendors participating in the event ranged from giants like Agfa (Mortsel, Belgium), GE Healthcare and Siemens (Erlangen, Germany) to single-product suppliers of healthcare systems whose sales are exclusive to a single national program.

More informally called a "plug-fest," each supplier at a Connectathon is required to hook up with three competing systems to either push or pull data to demonstrate compatibility. More than 1,850 such tests were conducted over the five days in Oxford.

The cavernous temporary building constructed by St. Catherine's College to house the event looked more like a setting for an Internet gaming tournament than the avant-garde of European healthcare IT.

Only one medical device was physically present and there were several screens for radiology imaging.

Instead the testing is virtual with hundreds of laptops loaded with device software hard-wired to the internet pulling data from remote servers that either simulated hospital IT systems or were actual hospital IT systems participating in the event.

Traffic on the IHE-Europe website that hosts testing software and is used for "speed-dating" among the participating vendors to signal interest and availability for compatibility testing jumped four times its usual weekly volume, according to Poiseau, whose day job is with the Institut National de Recherche en Informatique et Automatique in Rennes, France.

Poiseau said Connectathon presents a unique opportunity for medical device manufacturers to identify and solve problems on the fly during the event.

"The cost of fixing a bug during a Connectathon is about 10 times less than the cost of a bug identified on a customer's site," he said.

TomoTherapy to buy Chinese company

In other China news, TomoTherapy (Madison, Wisconsin), maker of the Hi Art radiation therapy system, said it has entered into an agreement to acquire privately held linear accelerator manufacturer Chengdu Twin Peak Accelerator Technology (Chengdu, China). Financial terms of the deal were not disclosed.

A linear accelerator is a key component in radiation therapy systems, used to create high-energy X-rays for cancer treatments. The linear accelerators designed, developed and manufactured by Twin Peak will be used to supplement TomoTherapy's existing supply source.

TomoTherapy CEO Fred Robertson said, "The acquisition of Twin Peak represents a substantial advance in our ability to control the quality and features of our products. This also is a piece of our longer-term strategy of reducing the cost of the Hi Art treatment system to improve margins."

TomoTherapy said it anticipates that the transaction will close in about 90 days.

TomoTherapy's Hi Art system is an advanced radiation therapy system for the treatment of a wide variety of cancers. The system combines integrated CT imaging with conformal radiation therapy to deliver treatments with speed and precision while reducing radiation exposure to surrounding healthy tissue.

Chinese approval for Calypte test

Calypte Biomedical (Lake Oswego, Oregon), a manufacturer of HIV diagnostic tests, said that its Chinese subsidiary, Beijing Marr Bio-Pharmaceutical, has received registration and marketing approval for the Aware HIV-1/2 OMT (oral fluid) rapid test from the State Food and Drug Administration (SFDA) of China.

The company said the approval makes the Aware OMT test the first SFDA-approved rapid oral fluid HIV test in China.

The Aware product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes, with an accuracy, according to Calypte, comparable to that of FDA-approved, blood-based laboratory HIV EIA tests.

Beijing Marr is a joint venture between Calypte and the Marr Group.

1st VeinViewer^GS units shipped internationally

Luminetx (Memphis, Tennessee) reported it has shipped its first VeinViewer^GS units overseas, marking the company's entrance into the international marketplace. The "GS" unit, standing for "Global Standard," was designed to meet the quality requirements for the international marketplace.

The VeinViewer is an imaging system that allows physicians, nurses and other healthcare professionals to clearly see accessible vasculature, or the lack thereof, in real time.

The device uses a combination of near-infrared light and patented technologies to image vascular structures and projects their location directly on the surface of the skin. This provides clinicians with a safe, non-invasive adjunct technology for clinical treatments and procedures, including, but not limited to, IV insertions, PICC line insertions, routine venipuncture, blood and plasma donations and treatment for varicose and spider veins.

Last December, the VeinViewer technology received EC and ISO 13485:2003 certifications, allowing shipment to European countries and continuing the expansion of the Luminetx global strategy.

The new generation of the VeinViewer meeting these European quality certifications is known as the VeinViewer^GS model, which will be offered to both international and domestic clients as the company's flagship product.