Medical Device Daily and MDDs

A road map to bring French radiology out of a crisis of confidence set off by the death of five patients undergoing radiotherapy was reported by the Minister of Health, Youth and Sport during the recent congress of the Société Fran aise de Radiothérapie Oncologique. Health Minister Roselyne Bachelot unveiled 32 measures to address problems identified in an investigation she launched in September as the scandal widened to reveal that up to 6,000 patients may have been over-radiated as far back as 1987 (Medical Device Daily, Sept. 21, 2007).

In vivo dosimetry will be required for all of France’s 179 centers performing radiation therapy and the ministry is providing € 3 million ($4.5 million) to purchase the needed equipment and another € 2 million ($3 million) has been allocated for funding training centers for radiotherapy physicians, whose number will be doubled to 300 according to a previous announcement.

The frank-speaking Bachelot said during a press conference that the tragedy at the Jean-Monnet Hospital in Epinal is as much a human disaster as a health crisis.

“It is inconceivable, unbearable that a patient would die following a treatment,” she said.

The road map drawn up in response to the accidents aims to “assure equal access for all citizens to safe care.”

Bachelot also reported a Christmas present for the 500 patients most severely affected by improper treatment at the Epinal hospital: a payment of € 10,000 ($15,100) to be awarded immediately. Those patients received radiation greater than the prescribed dosage.

The payments, which total € 5 million ($7.5 million), “in no way influences nor is a substitute for the legal remedies that will continue,” she said, calling it instead “a gesture of solidarity with these families.”

French news media called it an attempt to head off criticism that the government has not kept any promises to these victims, some tragically mutilated, who face a long and uncertain journey in the French legal system. Some 100 lawsuits have been filed against the center and attorneys estimate compensation could reach more than € 20 million ($30.2 million). France does not recognized class action as a remedy.

André-Claude Lacoste, head of the Autorité de Sûreté Nucléaire (Nuclear Safety Authority) said that almost 90% of the country’s 179 radiation treatment centers had been inspected as part of the investigation, and that the remainder would be visited before the end of this year. Twenty-four centers already have been brought up to the new standards set by the Institut National du Cancer (INCA) and the rest will progressively be brought into conformity by the end of 2008, he said.

Among the 280,000 French citizens diagnosed each year with a cancer, 200,000 undergo a form of radiation therapy, according to INCA.

F&S cites interventional radiology growth

Global consulting firm Frost & Sullivan (F&S; London) says in a new report that interventional radiology markets in Europe are registering “steady growth.” It said the advent of technological innovations that allow for “more sophisticated and rapid imaging is gradually widening the application area for interventional radiology and supporting market expansion.”

The report, “European Interventional Radiology Markets,” says that the interventional radiology market earned revenues of $399.5 million in 2006 and estimates this to reach $683.3 million in 2013.

“Advances in the field of medical instrumentation and in radiological imaging technology have led to the rapid development of interventional procedures,” says F&S Research Analyst Darshana De. “[So] the market in Europe is growing steadily due to the large number of cost-effective interventional procedures being performed in lieu of surgery.”

Cardiac interventional radiology represents the fastest-growing segment in the market. The report says that more than 40% of Europe’s population suffers from cardiac diseases, with such patients preferring minimally invasive imaging procedures for related diagnosis and therapy.

Vascular interventional radiology, dedicated mainly to the detection and treatment of peripheral arterial diseases, is the second-largest segment in the market, according to De’s report. Growth in this segment is “likely to be partially retarded” due to competition from other non-invasive imaging techniques.

The report says the lack of dedicated neuro centers across Europe, high prices for equipment and specific installation requirements have restricted the neuroradiology market to a very small size — it comprises the smallest segment in the market.

“However, with the technological advancements and faster imaging technologies, there will be significant market growth in the overall European interventional radiology markets,” De says.

The major challenge for market participants will be to provide products that can be integrated with PACS, electronic medical records and other hospital IT systems. Another area of concern is the lack of well-trained radiologists.

The financial crisis faced by European healthcare systems presents a threat to sustained market growth, according to the report. To curb expenditures, governments across Europe have slashed healthcare budgets, F&S says, “making it difficult for hospitals and clinics to purchase new medical equipment.”

To overcome this challenge, companies will need to produce cost-effective equipment to required specifications. “Producing a fully functional system and then assembling it according to the needs of the end users would make it easier for industry participants as well as end users,” says De.

bioMérieuxplans to close Netherlands site

bioMérieux (Marcy L’Etoile, France) reported that it will phase out activities at its site in Boxtel, the Netherlands by the end of 2009. The Boxtel facility develops and manufactures reagents for molecular biology and immunoassay microplate product lines.

The in vitro diagnostics company said it remains “committed to develop and support the products currently manufactured at Boxtel, recognizing the important role they play in public health.” It said information on the transfer of current activities from Boxtel to other locations will be communicated at a later date.

bioMérieux said 287 employees work at the Dutch site today. It said this decision will result a non-recurring charge of about € 32 million in 2007 financial results.