A Medical Device Daily

Under a plan to revolutionize stroke services in the UK unveiled this week by Health Secretary Alan Johnson, anyone in a higher-risk group who suffers a minor stroke will receive an MRI scan within 24 hours.

The strategy aims to accelerate the emergency response to stroke by setting out a framework for care for those affected by stroke and raising awareness about symptoms and risk factors.

The government has committed £105 million to provide national support for improving stroke services.

By following the actions set out in the new strategy, National Health Service officials said up to 6,800 deaths and cases of disability could be avoided every year, and another 1,600 strokes could be averted through preventive work.

Key elements of the stroke program include:

MRI scans for higher-risk individuals with transient ischemic attacks (TIA), so-called “minor strokes.” Those scans are to be done within 24 hours of the patient experiencing stroke symptoms, within seven days for low-risk individuals. Officials said this step alone could lead to an 80% reduction in the number of people who go on to have a full stroke. Currently, less than 35% of UK healthcare providers manage to treat TIA within seven days.

Immediate transfer of those with suspected stroke to a specialist center offering immediate clinical assessment, scans and clot-busting drugs. The plan calls for all local areas to have 24/7 coverage by at least one specialist center.

Those with stroke requiring urgent brain imaging are to be scanned within the next scan slot during normal working hours, and within 60 minutes out of hours.

All individuals with stroke must spend the majority of their time in a stroke unit.

People affected by stroke and their caregivers should have immediate access to high-quality rehabilitation and support from stroke-skilled services in hospital, and the specialist care should continue for as long as it is needed.

Johnson described the plan as “a bold vision for the delivery of world-class stroke services, from prevention right through to life-long support.”

He added: “Stroke is the third-biggest killer in England, with 50,000 people dying from it each year. It also has a devastating and lasting impact on the lives of those who do survive, with a third left with long-term disability.”

The UK has “made great strides with stroke, heart disease and cancer in recent years,” Johnson said. “However, despite the considerable gains in developing stroke units and falling mortality rates, there remains much to be done to bring stroke services in line with those for cancer and heart disease.”

Of the £105 million committed to improve stroke services, the development of acute and community demonstration sites to pioneer best practices will receive £77 million in funding.

Another £12 million will fund activities aimed at raising stroke awareness nationally, and £1 million will go to training for stroke consultants, nurses and allied health professionals, includes funding for an additional 30 stroke specialist physician training posts in 2008-2009.

Professor Roger Boyle, national clinical director for stroke and heart disease, said raising awareness of how to prevent stroke through healthy living is at the heart of the strategy. “We also need the public and health and social care professionals to recognize stroke symptoms more effectively. [With] only a three-hour window for the use of clot-busting drugs, this means acting fast.”

Jon Barrick, chief executive of the Stroke Association, said, “No longer will stroke be seen as an inevitable, untreatable consequence of old age. This is a momentous opportunity to transform the outcomes and lives of stroke survivors in this country.”

Two Cepheid MRSA and SA tests released

Cepheid (Sunnyvale, California) reported the release of Xpert MRSA/SA-Blood Cultures (BC) and Xpert MRSA/SA-Skin and Soft Tissue Infection (SSTI) tests under the European Directive on In Vitro Diagnostic Medical Devices.

The company said the tests are designed to enable simultaneous rapid detection of two leading causes of hospital and community acquired infections – methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) — directly from blood cultures and soft tissue infection samples, respectively.

“The incidence of both hospital- and community-acquired MRSA and SA infections [has] been shown to be rapidly increasing,” said CEO John Bishop “We believe that the unique ability of the GeneXpert System to provide test results on an on-demand basis in a short period of time may significantly aid in patient management.”

Both the Xpert MRSA/SA-SSTI and Xpert MRSA/SA-BC products deliver results in about 50 minutes, enabling healthcare professionals to rapidly determine the presence or absence of MRSA and SA with a single test. In addition, both products use a multiplex molecular protocol for potentially avoiding clinical false-positive MRSA results.

Staphylococcus aureus is a major cause of bloodstream infection, associated with substantial mortality and healthcare cost,” said Professor Marc Struelens of Catholic University Hospital (Brussels) and head of the Belgian Staphylococcal Reference Laboratory. “By analyzing positive blood cultures, we found the Xpert MRSA/SA test to be very reliable for rapid DNA-based detection and identification of S. aureus and MRSA bacteremia.”

4 more hospitals begin CardioWest training

In late November, two hospitals from Italy, one from Germany and one from Switzerland received the first phase of certification training for implanting the CardioWest temporary Total Artificial Heart (TAH-t) made by SynCardia Systems (Tucson, Arizona).

The four hospitals spent two days in Paris learning proper patient selection, blood management techniques, surgical procedures and patient recovery protocol. A total of 20 hospital staff members participated in the CardioWest certification training. The hospitals included the Heart Surgery Institute at the University of Padua (Italy), the University of Naples (Italy), Hannover Medical School (Germany), and University Hospital Bern (Switzerland).

To date, there are 22 TAH-t certified centers worldwide, with nine additional hospitals undergoing the certification process.

The company noted that the CardioWest TAH-t is the first and only FDA-, Health Canada- and CE-approved temporary total artificial heart in the world. Originally designed as a permanent replacement heart, it is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure.

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