BB&T European Editor and Staff Reports

PARIS – A hospital reform law now in the French Senate that would removes surgeons from decision-making in French hospitals has sparked strong opposition and for the first time sent heads of prestigious medical centers into the streets in protest.

In a city where street demonstrations are as common as traffic jams, the sight of world leading physicians marching and chanting with nurses and unionized caregivers was not just unusual, it was a first.

At stake in the reform law Hospital, Patient, Health and Regions (HPST) is the power to decide which medical equipment to purchase, capital investments in the construction of new surgical centers and annual budgeting that determines the specialties and orientation for hundreds of hospital centers across all regions of France.

The law drafted by the Health Ministry was put on a new legislative fast track and approved by French Assembly in March.

With a majority in both houses, President Nicolas Sarkozy has every chance of pushing through the main points of HPST that would give new decision-making powers to a newly empowered CEO, or super-Boss, for public hospitals that will in turn serve as the hub for re-engineered regional healthcare clusters.

"No human endeavor can function without a leader," said Sarkozy, "I call it a 'boss.' I realize I am taking a risk saying that."

The law also spells out a series of rules and incentives for new Regional Health Authorities (ARS) to encourage general practitioners and specialists to move back into rural regions that are currently underserved.

To defuse opposition, the government separated these measures for restructuring France's healthcare administration from financing measures that are addressed in the Social Security Financing Law (LFSS 2010) and for capital investment in the plan, H pital 2012.

Yet HPST is charged with enough controversial proposals to have provoked widespread opposition from medical professionals who say they are being pushed out of decision-making, from regional authorities who see their powers being undermined, and from unions of nurses and caregivers who are threatened by the spirit of a law calling for a public hospital to be run like a private business.

"Do not fear reform," said Sarkozy, adding, "Who would tell me to keep the status quo for hospitals? No one."

Seizing upon an uproar among medical professionals, the Senate intends to modify the text, saying 'Non' to giving CEO status to hospital directors, and 'Yes' to returning doctors to hospital governance, according to former Prime Minister Jean-Pierre Raffarin, who is a leading member in the party of Sarkozy, the Union for a Presidential Majority.

In a televised interview, Raffarin clearly was enjoying the new powers of the French Senate, in which he played a key role winning in 2008, as he criticized the text approved by the Assembly as "too complex and not quite clear."

"We are not here to lie down to any text sent over from the Assembly," he said. "This is not a revolution, but it is showing something of a rebellious spirit," he said.

Despite its fast-track status, a prolonged stay in the Assembly and a detailed study ahead of debate in the Senate has given physicians an opportunity to gather their strength.

Angry that their counterproposals were not taken into consideration, the heads of the medical committees for France's leading hospitals in a press conference greeted the passage of the Bachelot law by the Assembly with a threat to quit their posts and suspend participation in hospital planning.

"Contrary to what is being said, the law is not going to expand the role of doctors in the operations of the hospital," said Alain Dest e, a neurologist with the Centre Hopitali re Universitaire (CHU) de Lille and president of the Conference of Presidents of the Medical Committees (CME; commission m dicale d' tablissement) for the CHUs.

The CME opposition was followed by another hostile reaction from 25 prominent physicians affiliated with French university hospitals, who jointly published a position papers asking the Senate to completely revise the text approved by the Assembly, and then joined the planned street demonstration on April 28.

At the same moment, the association of French hospital directors wrote to Sarkozy, sending the letter to the French press as well, asking him to resist such changes that would "empty all sense" in the reform law.

The hospital directors said in their letter that any change in the HPST text that limits their ability to be the ultimate decision-maker by forcing co-decisions or the imposition of doctors opinions on any final decision would only lead back to the current state of affairs and thwart the ability of the super-CEO proposed in the Bachelot law to wrestle with budget deficit.

Meanwhile, the French Hospital Federation (FHF) has fallen into line with the government, with Executive Director G rard Vincent saying, "There needs to be an orchestra leader, someone who can take decisions, and that is what is missing today."

Vincent said FHF favors this spirit in the reform law and supports the creation of regional health authorities, saying the challenge today is to "free up the energies in the departments so that a real wind of change will bring change to the current range of healthcare services and respond to the expectations of both medical professionals and patients."

Guillaume Sublet, head of economic intelligence and regulatory affairs with Nextep Consulting & Health Economics (Paris), predicts that despite the rebellious bravado of former Prime Minister Raffarin, the French Senate will ultimately have to vote with Sarkozy's position in mind.

"The president was very clear," said Sublet, who manages an online forum of interviews with leading players in the debate over the hospital reform.

"Medical practitioners may win some points about their importance," he said, "but we can expect that just as in the National Assembly, the core text will pass without significant modification and French hospitals will walk the president's line with a hospital chief executive leading a management inspired by the private enterprise model."

Endoscopic robot wins FDA nod

A robot developed by a French start-up that guides an endoscope during minimally invasive surgeries has been approved by the U.S. FDA and was used for the first time in North America at the Fox Chase Cancer Center (Philadelphia) last month, for ablation of a tumor during a distal pancreatectomy.

In minimally invasive procedures surgeons need both hands to manipulate surgical tools and an assistant typically is required to maneuver the endoscope to provide a view of the surgical field.

The ViKY robotic laparoscope holder, developed by Endocontrol Medical (La Tronche, France), returns endoscope control to the surgeon who directs its movements either through voice recognition or a footswitch.

With a CE mark since May 2007, the ViKY robot has been used in more than 200 surgeries in Paris, at Piti -Salp tri re, the Institut Mutualiste Montsouris, the Centre H pitali re de Nanterre and the Clinique de Turin, at the Grenoble Hospital as well as at reference medical centers in Antwerp, Belgium, and Utrecht, the Netherlands.

Endocontrol reports that 15 ViKY systems have been sold so far to hospitals in Austria, Belgium, France, Holland, Ireland, Italy and Spain.

ViKY is the result of a six-year development effort at the Joseph Fourier University in Grenoble that culminated in a technology transfer from the TIMC-IMAG laboratories (Techniques for biomedical engineering and complexity management – informatics, mathematics and applications) run jointly with the National Center for Scientific Research (CNRS) to the nearby incubator complex Biopolis.

Researchers collaborated with surgeons from the urology and gastroenterology department at Grenoble University Hospital, adapting the technology to the demands of an operating theater by greatly reducing the footprint of the robot arm and controls to the size of an office lamp, and adding ergonomic features, significantly the Bluetooth headset used for voice recognition command of the robot's movements.

ViKY is placed directly on the patient's abdomen and is compatible with all types of endoscopes and trocars. A passive arm holds the motorized scope holder just above the patient abdomen and attaches to the rail of the operating table. The motorized scopeholder and features three degrees of movement, two rotational axes and a mechanical in-and-out zoom.

Another innovation with ViKY is an instrument-tracking system, a challenge for endoscopic procedures in a mass of soft and moveable tissue compared to successes for such systems in orthopedics or neuro surgeries that are performed in close proximity to hard and relatively stable landmarks of the skeletal structure.

Endocontrol was created in 2006 to bring the technology to market and said the FDA approval is vital to the company's growth plans, as the U.S. represents 40% of the global market for endoscopic robots.

Endocontrol, which introduced ViKY to the U.S. market in January at the Society of Thoracic Surgeons meeting in San Francisco, said it already has established a network of distributors for North America and has developed a close working relationship with the department of urology at the Cleveland Clinic.

The company said almost 60% of the 5.4 million laparoscopic surgeries performed annually in the U.S. are target surgeries and that 2.4 million targeted procedures are performed each year in Europe.

The company notes that 2004 estimates of 4.6% annual growth for these procedures have been "overwhelmed" by actual growth estimated now at upwards of 23% annually.

The ViKY robot can be used as an assistant for digestive and bariatric surgeries, complex urological laparoscopic procedures, gynecological surgeries, thoracic surgeries including coronary bypass and pulmonary procedures, as well as abdominal aorta aneurysm surgery.

Diabetes monitoring device delivered

Hardware, software and sensors for a device platform to measure and predict personal blood glucose levels has been delivered by Toumaz Technology (Abingdon, UK) to complete the first phase of a large-scale European Union (EU) project for diabetes patients.

Toumaz is responsible for the device work package that is part of the EU's DIAdvisor project developing a prediction-based tool using historic and current blood glucose measures to optimise the therapy of Type I and developed Type II diabetes with the goal of minimizing the occurrence of diabetic complications and reducing healthcare costs.

DIAdvisor is being developed by a consortium of 13 companies coordinated by Novo Nordisk (Bagsv rd, Denmark), a leader in diabetes care, that includes the European Division of the International Diabetes Federation.

DIAdvisor received €7.1 million ($9.5 million) under the EU's Framework Seven Program in April 2008.

The Toumaz device platform integrates a non-intrusive body-worn wireless vital sign sensor from Sensor Technology and Devices (Belfast, UK) and a noninvasive glucose sensor from Ondaly (Montpellier, France).

Data collected from the sensors is processed onboard the body-worn device with the Toumaz Sensium chip and transmitted using Toumaz ultra-low power Advanced Mixed Signal (AMx) technology that continuously sends and receives data packets using batteries that can be as small as a slip of paper and not larger than a hearing aid battery.

Cardinal Health (Dublin, Ohio) and Texas Instruments (Dallas) have licensed the Toumaz technology to develop intelligent medical devices.

Data sent from an individual monitor in theDIAdvisor project will be processed with software developed by RomSoft (Iasi, Romania) using models developed at Lunds University (Lund, Sweden) and algorithms developed at Johannes Kepler University (Linz, Austria).

The DIAdvisor device will allow patients to actively and accurately predict short-term blood glucose at any moment automating an analysis of glucose measurements, insulin delivery data and specific patient parameters.

Prediction data will be wirelessly transmitted to a designated healthcare provider that in turn will transmit recommended action and treatment advice for display on a patient's handheld mobile device.

Toshiba debuts CT unit for Europe

For European radiology centers on a limited budget, Toshiba Medical Systems Europe BV (Zoetermeer, the Netherlands) has introduced the Aquilion Premium, a 160-detector row CT scanner with software and hardware options allowing an upgrade to research-quality images equivalent to the flagship 320-slice AquilionONE.

Three systems have been sold with two currently being installed in Russia and one in Italy, Toshiba' Europe's senior manager for marketing, Jack Hoogendoorn, told BB&T.

"Aquilion Premium is the only system that can be upgraded from eight centimeter to 16 cm coverage to unlock all the advantages of our AquilionONE CT dynamic volume scanner, which means a safe and sound investment for future for customer needs," he said.

The Aquilion Premium scanner covers 80 mm with a 160-detector row in a single rotation and by using the reconstruction algorithms in the coneXact software, the scanner generates a 320-slice, 3-D volume image.

The good news regarding the narrow coverage of the 160 in-line Quantum detectors is a smaller detector aperture of just 0.5mm, the world's smallest available in CT technology, according to Toshiba, providing fine and fast dynamic volume images for functional CT at low radiation dosages in a single rotation.

The downside is the Aquilion Premium restricts the range of clinical applications to narrow coverage areas, such as the heart or the brain.

The Aquilion Premium can be upgraded with a retrofit to 320-detector rows and 160 mm coverage, generating 640 slices per rotation, the same as the AquilionONE.

Aquilion Premium customers are given a range of software packages on six-month trial basis to experience the advantages of advanced clinical imaging and if convinced of the clinical benefits, and able to come up with the budget, can progressively upgrade capabilities.

"Experience teaches us that the selection of optional software packages can be difficult, and is complicated by budget restrictions," explained Hoogendoorn, adding that as clinical needs emerge a customer may find a need for a different choice of software than originally selected.

For the moment the scalable, upgradable Aquilion Premium platform is only available in Europe, he said.

Eighteen months ago Toshiba made waves at the 2007 Radiological Society of North America meeting in Chicago when it introduced the AquilionONE, a CT scanner featuring a world-first 320-slice architecture, announcing it had pre-sold five units and then winning a purchase from the National Institutes of Health.

The new capabilities of a wide, dynamic volume approach created several clinical advantages by eliminating the stitching of multiple images that create image artifacts, and by lowering radiation doses by as much as 80% according to Toshiba.