A Medical Device Daily

IntraOp Medical (Sunnyvale, California) said results of a study at the recent conference of the International Society of Intraoperative Radiation Therapy (ISIORT) in Madrid, Spain, indicate that many women with breast cancer may not need six weeks of daily radiation after surgery.

Noted surgeon Umberto Veronesi, MD, founder of the European Institute of Oncology, shared for the first time the results of an eight-year randomized trial comparing his breast cancer patients' response to two types of radiation therapy.

The results so far show that women who received breast-conserving surgery, followed by a single dose of intraoperative electron-beam radiation therapy (IOERT) at the time of surgery, had an the same chance of survival as did women who underwent the surgery, followed by six weeks of post-operative radiation therapy.

IOERT is the process of delivering a very effective dose of electron-beam radiation to cancer patients during surgery. By pinpointing the exact area that requires radiation, doctors can deliver a direct dose to affected tissue without passing through the surrounding healthy organs and harming them. For breast cancer patients, this often means a single dose of radiation, followed by reconstruction, in a single surgery.

Veronesi's findings demonstrate that the standard radiation regimen for some lumpectomy patients "already expensive, sometimes painful and very time-consuming," according to IntraOp Medical may be unnecessary.

He told the attendees from 21 countries at the conference that IOERT has "obvious advantages in terms of overall treatment time, costs, patient comfort, cosmetic results and quality of life." He added: "In my opinion, this will become the routine procedure for breast conserving therapy."

The only FDA-approved device available in North America that is capable of delivering the IOERT treatment extolled by Veronesi in an unshielded operating room is IntraOp's Mobetron. The company describes the Mobetron as the first fully portable, self-shielded linear accelerator that can be used in an existing operating room.

While more than 20 centers around the world offer IOERT treatments, only one hospital in North America — the Lineberger Comprehensive Cancer Center at the University of North Carolina (Chapel Hill) — currently offers single-dose IOERT treatments for breast cancer:

NHS constitution under consultation

A draft constitution that embodies the principles and values of the National Health Service (NHS) for the future has been published for consultation by UK Secretary of State for Health Alan Johnson.

Said to be the first of its kind in the world, the NHS constitution follows discussions with staff, patients and the public over the last year, Johnson said. It reaffirms the rights to NHS services, free of charge without discrimination of any kind.

The UK government said the document for the first time will bring together in one place and clarify for staff and patients their rights and responsibilities to ensure that the NHS operates fairly and effectively.

The Department of Health said the constitution "also recognizes that the NHS is too important to be left to chance." The government will be obliged by law to renew the NHS constitution every 10 years so that any changes are the result of a full and transparent debate.

"We will place a new legal duty on all NHS organizations to take account of the constitution in decisions that are made," the government said in a statement.

"This is a momentous point in the history of the NHS," Johnson said. "As we approach the 60th anniversary of our health service, it is striking how its founding principles still endure and have resonance for staff, patients and public alike.

He said the content of the document "was not dreamt up by me or civil servants in Whitehall. It is something that has arisen out of discussions with thousands of NHS staff and patients across the country."

Johnson said the document as it exists "is not set in stone but is a good basis for further consultation. I think it strikes the right balance between the need for clarity and avoiding undue litigation, between the need to state what is enduring while ensuring the NHS has the flexibility to change and keep pace with rising expectations and medical advances."

Spanish region taps Tibco

Tibco Software (Palo Alto, California) reported that the health administration service for the Spanish region of Rioja has deployed the company's real-time integration infrastructure. The project, at Servicio Riojano de Salud (SERIS), will link together a range of applications to provide more efficient services for patients and support the opening of the new Hospital San Pedro.

Jose Lorenzo, director of IT programs at SERIS, said, "Tibco provides a good fit for our IT environment. It is extremely flexible and functionally rich. We also had the assurance that using Tibco technology we could meet our rigid deadline for the opening of the San Pedro hospital, something we felt we could not have been so certain of with another supplier."

Tibco ActiveMatrix BusinessWorks and Tibco Enterprise Message Service were chosen for the project because of their ability to work with other applications in a heterogeneous environment. In addition, the company said the range of adaptors offered "outshone those from rival vendors on the SERIS shortlist."

It said the IT administrator is in the final stages of testing BusinessWorks against the HL7 healthcare interoperability standard, which SERIS said would save it significant time and cost in development.

"In the healthcare industry, heterogeneity of IT systems is a given, so platform independence and interoperability is absolutely key," said Fabio Pulidori, senior VP, EMEA for Tibco. "From the simple process of updating patient records to the doctor checking with the pharmacy whether a particular medication is available, it all needs to work seamlessly."