A Medical Device Daily

Directors of nursing in UK Strategic Health Authorities each will receive £5 million under a new £50 million program aimed at fighting healthcare-associated infections (HCAIs) by doubling the size of infection improvement teams.

Secretary of State for Health Alan Johnson spotlighted the extra funding to fight HCAIs such as methicillin-resistant Staphylococcus aureus (MRSA) and C. difficile. "Tackling MRSA and other healthcare-associated infections is one of my immediate priorities," he said.

"NHS staff has worked hard to slow the increase in C. difficile reports from 17% to 8%, [while] reducing MRSA bloodstream infections by 20%," he said. "This is a step in the right direction, but clearly more must be done to improve the quality of care and patient safety."

Johnson said he was asking each director of nursing in every Strategic Health Authority to "make sure that frontline clinicians are supported in the work they do to reduce infection and to provide a clean, safe environment. On top of this, I am doubling the size of the Department of Health infection improvement teams so that trusts struggling to reduce infections can have access to experts in prevention and control of infection."

Chief Nursing Officer Christine Beasley said, "I know from my visits that some frontline clinicians have trouble accessing modern equipment. This announcement will help frontline NHS staff make a real difference to infection rates by giving them the power to make the changes they know will help patients."

Since last February, the improvement teams have helped about 70 NHS trusts to identify and implement changes to bring their infection rates down. Most trusts visited have seen significant improvements with reductions in MRSA rates of between 16% and 34%. The teams have recently extended their work to cover C. difficile infections.

The improvement teams are groups of experts such as doctors, nurses, microbiologists, infection control practitioners and service improvement experts who work with NHS organizations to diagnose the issues that need to be tackled if there is to be better prevention and control of infections, develop action plans with realistic implementation timescales, implement plans and put in place management and support arrangements that facilitate sustained improvement, and act as catalysts for other trusts in demonstrating what can be accomplished by adopting best practices.

Octagon gets SME status

Octagon Research Solutions (Wayne, Pennsylvania), a provider of electronic transformation of clinical research and development in the life sciences industry, said that the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA) has granted SME (Small and Medium Sized Enterprise) status to the company.

The EMEA launched an SME office in late-2005, focused on providing financial and administrative support to small- and medium-sized enterprises. The initiative was developed to promote innovation and encourage the development of new products by SMEs.

Jim Walker, CEO and chairman of Octagon, said, "We have had success partnering with small- and mid-size companies to meet their regulatory submission objectives. SME designation in Europe enables us to offer additional benefits to these organizations by facilitating the application procedure and taking advantage of agency support throughout the process."

Mark Turner, managing director, Europe, for the company, said, "SME status enables us to offer value as the regulatory agent for small organizations without a European certificate of establishment or company infrastructure wishing to submit a Marketing Authorization application in the European Union."

He added that the company "can pass on reduced or deferred fees associated with Marketing Authorization applications, scientific advice and inspections, eliminating the need for small companies not established in Europe to postpone product clinical and regulatory development or submission activities until they develop a European infrastructure in their own right."

Octagon, whose European headquarters is in Berkhamsted, UK, offers regulatory, clinical, process, and IT solutions to the life sciences industry. It said it "synchronizes processes and increases automation to reduce … inefficiencies within the clinical research and development process."

EDAP pushes French reimbursement case

EDAP TMS (Lyon, France), a sector leader in high-intensity focused ultrasound (HIFU) treatment of prostate cancer, highlighted the mounting pressure for reimbursement in France from a growing base of Ablatherm-HIFU sites in the public health system, and now in private clinics as well.

Pierre Reboul, the company's director for France, said, "Ablatherm is being reimbursed in key European countries and not in France. Our clinical data demonstrates the clear benefits to the French system, making a strong case for reimbursement approval based on effective treatment and clear demand from health centers seeking the opportunity for greater use of this technology."

EDAP also has continued its media and education campaigns with a recent press conference in Lyon during the training visit of David Crawford, MD, from the University of Colorado Health Sciences Center (Denver).

Crawford was visiting Lyon for training prior to beginning U.S. treatments as part of EDAP's clinical study seeking FDA clearance for its Ablatherm-HIFU device in the treatment of localized prostate cancer.

He said: "I am excited about what Ablatherm-HIFU has to offer. Just as with breast cancer, where today more precise and patient quality of life-preserving treatments have reduced the need for radical intervention through a mastectomy as the initial therapy, men are now demanding an alternative to either radical prostatectomy or radiation as a first course of treatment. I have high expectations [for] this technology."