Medical Device Daily Contributing Writer
And MDDs

French Minister of Health Xavier Bertrand at mid-month reported the launch of Hospital 2012, a five-year plan aimed at bringing the nation's hospitals and care centers up to code and connected through a national information network.

The plan continues the work begun under Hospital 2007, he said, outlining an allocation of 110 billion ($13 billion), half of which will be funded directly by the national health insurance plan.

Hospital 2012 seeks to create the hospital of tomorrow, Bertrand said, citing several centers of excellence built under Hospital 2007. More than 173 scanners and 130 MRI imaging suites were installed under the previous plan, he said.

Yet the priorities the minister outlined speak more to today's problems than tomorrow's vision, with a focus on continuing heavy-lifting construction.

Bertrand unveiled the new plan at the start of a day-long conference on financing for hospital projects that gathered directors from regional centers and clinics. He reported a "special arrangement" valued at 12 billion for low-cost financing negotiated with the minister of finance.

He also promised federal government assistance for regional authorities undertaking priority construction programs, such as asbestos removal.

The business daily newspaper La Tribune reported that in 2005 some 50 urgent care centers in France were not up to required standards and that 13% of medical centers did not meet fire codes.

The Socialist Party immediately criticized the new plan as a "diversionary maneuver meant to mask the magnitude of failure of Hospital 2007." Only 16 billion of the 110 billion allocated under the previous plan were ever "actually allocated," the Socialists said, adding that the government's promises for investment "were only partially met."

After construction, the priorities for Hospital 2012 include building better patient services and an overhaul of healthcare information systems.

The plan calls for increasing by 80% the number of private rooms available to patients and improved patient reception areas.

The introduction of new hospital information systems is critical for the launch of the Personal Medical Dossier (DMP) later this year, which will bring 1 million patient files online. The launch date was recently pushed back from July 1 to "sometime this fall" by the program director.

Another delay involving the bidding process for network service providers was reported recently by the newspaper Les Echos. "Very tense relations" within the government over network specifications are the cause, the newspaper reported, saying those have put in doubt the hoped-for April contract award to prospective bidders France T l com, Atos Origin and Thales.

U.S. firm gets spine system OK

Applied Spine Technologies (AST; New Haven, Connecticut) reported that its new Stabilimax NZ Dynamic spine stabilization system has received CE-mark approval for treatment of degenerative lumbar spine stenosis.

The company's initial product, Stabilimax BAR, which received 510(k) clearance in the U.S. last July, also received CE-mark approval for treatment of degenerative lumbar disease.

Stabilimax NZ is a posterior dynamic-stabilization system designed to support an injured or degenerated spine. The system, which requires no tissue removal or replacement, is intended to be a "substantially less-invasive option for many patients who are currently limited to fusion or artificial disc implants," the company said.

Patients already are being implanted successfully in Europe by Rudolf Bertagnoli, MD, described by ATS as "one of the most experienced motion-preservation spine surgeons in the world."

The company reported last month that it had received permission under an Investigational Device Exemption (IDE) from the FDA to commence a 400-patient, 20-site clinical trial comparing posterior dynamic stabilization using Stabilimax NZ to patients receiving traditional fusion stabilization to treat degenerative lumbar spinal stenosis.

"Stabilimax NZ, our flagship product, is designed to be a considerable improvement in back pain treatment," said president/CEO Thomas Wood, "by stabilizing the spine without eliminating motion, with a treatment that is far less invasive than fusion or disc replacement but uses traditional surgical techniques that are easily adopted by most spine surgeons."

He added that patients can "get the benefits of Stabilimax NZ — which may delay or prevent progression of degenerative spine diseas — while keeping the door open to future treatments, such as fusion, in the event they become necessary."

Stabilimax NZ uses a dual-spring mechanism with a variable dynamic feature that maximizes stiffness and support in the so-called "neutral zone."

Screening program set for MCADD

All babies in England are to be screened for an inherited metabolic disease called Medium Chain Acyl CoA Dehydrogenase Deficiency (MCADD), within two weeks of birth, according to a recent announcement by the UK Department of Health.

There will be a planned rollout of the screening program over the next two years.

Health Minister Ivan Lewis said the check will be carried out as part of the standard "heel-prick" test for babies that screens for other diseases such as sickle cell disorders and congenital hypothyroidism.

MCADD is a rare inherited metabolic disease that reduces the ability to maintain a normal blood sugar during episodes of metabolic stress. It affects between one in 10,000 and one in 20,000 babies born in the UK and screening should identify around 28 cases a year in England, Lewis said.

If the disease is not identified at an early stage, around a quarter of affected children will die from the condition, with one-third of survivors sustaining significant neurological damage. The Department of Health said that once babies are identified and given simple treatment, the risk of acute, life-threatening episodes needing emergency and intensive care and of death is substantially reduced.

Sheila Shribman, national clinical director for children, said, "This is a very important screening program. Evidence shows that screening newborn babies for this condition will not only save lives, but can significantly improve their quality of life. Simple treatment through dietary management will substantially reduce the risk of death and the risk of acute, serious illness."