Contract agreement boosts medical device trials

The development of innovative medical devices in the UK has received a boost: a new agreement makes it easier to get approved trials in patients underway.

Launched jointly by the Department of Health and the Association of British Healthcare Industries, the model Clinical Investigation Agreement (mCIA) has been welcomed by the medtech industry.

The mCIA covers all medical technology trials funded by industry with patients in NHS hospitals. It removes much of the bureaucracy that has been a barrier to the efficient start-up of such trials in the UK, while meeting the Government’s requirements for transparency. It is closely aligned with the revised model Clinical Trial Agreement for pharmaceutical industry-sponsored research in NHS hospitals (mCTA) that was published in 2006.

Public Health Minister Dawn Primarolo said: “The model Clinical Investigation Agreement is the fi rst time that all UK Health Departments, the NHS and representatives from industry have agreed standard contract requirements for medical technology industry-funded clinical trials. This has been developed to enhance the UK clinical research environment for the benefit of NHS patients.”

Peter Ellingworth, Chief Executive, Association of British Healthcare Industries (ABHI), commented: “ABHI welcomes the launch of the model Clinical Investigation Agreement, which has been the result of a great deal of work by the Department of Health, the medical devices industry and NHS stakeholders. The new Agreement… should help with the goal of making the UK a world-class environment in which to conduct clinical research on innovative medical technologies.”

UKTI helps medtech SMEs to export

UK Trade & Investment (UKTI) has announced new funding rules that will help small and medium-sized businesses to take part in overseas trade fairs such as Medica.

The number of Tradeshow Access Programme (TAP) grants that an SME can apply for in its lifetime has been increased from three to six, with the proviso that the company takes part in trade shows in more than one market.

TAP grants are aimed at SMEs that are relatively ‘new to export’, and this term is being revised to broaden the availability of support.

Gareth Thomas, Minister for Trade and Investment, said: “Small and medium-sized enterprises are the lifeblood of any economy. In difficult times, businesses need to be flexible and innovative and seek out opportunities where they exist.

“Small businesses can find it hard to break into new markets on their own, but UKTI is there to help as their springboard for global growth. These new rules give SMEs more opportunities to access foreign markets and enable them to attend follow-up trade fairs in markets where they see potential for their business.”

King’s Fund urges NHS to go online

The NHS needs to adopt IT solutions more quickly, according to healthcare thinktank the King’s Fund.

A new report, Technology in the NHS, argues that the NHS is falling behind other sectors in the use of e-mail and the Internet, which offer many benefits to patients and clinicians.

The authors recommend that patients should be able to use online communications to book appointments with their GP, receive routine test results, view their medical records and undergo consultations. It also calls for innovative devices such as RFID tags to be made available.

Alasdair Liddell, co-author of the report, commented: “Many of us now use the Internet to bank, shop, and book holidays. But somehow the NHS has not embraced this technology.”

Despite Lord Darzi’s review of the NHS, the King’s Fund report argues, there are still barriers to NHS adoption of new technologies: lack of resources, lack of incentives for clinicians and lack of leadership from the DH.

The report highlights technologies that could become available to NHS patients and clinicians in the next decade, including the ‘doctor’s e-bag’ (a portable computer with diagnostic testing and decision support facilities); nutritional content scanners for food items; smart pill dispensers; and RFID tags with patient data.

European Commission advances patient safety and e-health

New initiatives have been proposed by the European Commission to increase the provision of technologies for infection control and telemedicine in the EU.

European Health Commissioner Androula Vassiliou presented a new Communication on patient safety at the Health First Europe ‘New Horizons’ Congress. “The Commission’s proposed Council recommendations will help to reduce mortality and morbidity of EU citizens receiving healthcare by sharing member states’ data, experiences, expertise and good practice,” she said.

Prevention of healthcare-associated infections (HCAIs) is a key focus of the initiative. Health First Europe’s two new policy papers outline the roles played by ICT systems, health professionals and medical devices in preventing and controlling HCAIs. Health First Europe (HFE) is an alliance of patients, healthcare workers, healthcare experts and the medtech industry that aims to ensure equitable access to innovative and reliable healthcare across Europe.

The European Commission has also launched a Communication to improve access to telemedicine in the EU. Its proposals aim to encourage the provision and dissemination of evidence for the effectiveness of telemedicine services; to clarify EU legislation on these services; and to solve problems related to broadband infrastructure and device interoperability.

European industry association Eucomed applauded the initiative. “The potential benefits to patients and healthcare systems of telemedicine are huge,” said Markus Siebert, chair of Eucomed’s Working Group on Cardiac Rhythm Management Telemonitoring. “The Commission Communication is refreshingly clear in pointing out those benefits, but also with respect to the current obstacles to implementation.”

Wound care specialists unite

UK wound care and compression therapy specialist Activa Healthcare has joined forces with a leading European supplier of advanced wound care and medical textiles, Lohmann & Rauscher (L&R).

The partnership will provide UK pharmacists with a greatly expanded range of products to treat venous and lymphatic disorders.

Marc Courtney, Activa Healthcare’s Managing Director, said: “We’re delighted to join forces with L&R. This is great news for pharmacists across the country who are looking for the best ways to serve customers and help them to better manage their chronic conditions at home.”

Activa Healthcare has enjoyed 10 years of success as a supplier of wound care and compression therapy products. It will remain as Activa Healthcare, but is now a L&R company. Its contact details and UK staff remain the same, and it will continue to supply all its current products as well as introducing a new product range.

L&R is a well-established wound care specialist in Europe, but has not until now had a major presence in the UK. Dr Helmut Leuprecht, CEO of Lohmann & Rauscher, commented: “Combining Activa’s existing strength as a UK market leader with L&R’s expertise and product development pipeline will provide the UK clinician with world-class treatment options and training back-up that is second to none.”

News in Brief

Early surgery is beneficial for patients with chronic symptoms of gastro-oesophageal refl ux disease (GORD), according to a report from the National Institute for Health Research HTA programme. Refl ux affects 20% of the population, and severe cases are usually treated with drugs. The report recommends the use of relatively early laparoscopic surgery for severe cases.

The DH has signed a contract with Capita Group PLC to deliver and develop its NHS Choices online information service for the next three years. NHS Choices provides patients, carers and the public with information about health problems and the health and social care services available.

Sunquest Information Systems, Inc., a leading global provider of laboratory and diagnostic information systems, has acquired UK company Anglia Healthcare Systems (AHSL), which has nearly 60% market share in communications and reporting systems in NHS Acute Trust Hospitals. The acquisition will strengthen Sunquest’s hospital outreach programme in the international market.

The Government has committed £4.5m funding to an organ donation awareness campaign that aims to see nearly half the population on the organ donor register by 2013. However, in line with the recommendations of the Organ Donation Taskforce Group, it has decided not to introduce a system of ‘presumed consent’ at this time.