A Medical Device Daily

The National Orthopedic Project (NOP), which was established in January 2004 as a special area of attention in helping achieve the UK Department of Health’s December 2005 target that no patient will wait longer than six months for surgery in National Health Service (NHS) facilities, is paying dividends, Health Minister John Hutton said earlier this month.

Hutton’s progress report about the work of the NOP shows that the number of patients waiting longer than six months for orthopedic surgery has fallen by 55%, from 57,000 in January 2004 to 25,700 in February 2005.

The average waiting time for orthopedic patients also has fallen – from more than 19 weeks in 1998 to the current average of just over 12 weeks, a 40% reduction.

Hutton said that early indications of NHS performance data for March made him confident that the NHS would meet the year-end target. He added that the progress of the NOP represented an important step toward the 18 week referral-to-treatment target.

In December 2003, a Priority Review was established between the Department of Health and the Prime Minister’s Delivery Unit to consider the challenges surrounding the overall target that no patient will wait longer than six months for surgery by the end of this year. That review indicated that the NHS could meet the target in all specialties, but that orthopedics would require more support to achieve the target.

Demand for orthopedic treatment such as hip and knee operations has grown over the last 20 years, both in terms of numbers of patients seen per year and the number of treatments. In March 1998, the number of patients waiting longer than six months for orthopedic surgery stood at 95,000.

As part of the push in the orthopedics area, a troubleshooting team worked with the 40 most challenged local health units to implement especially fast progress, with the result that the improvement rate at those sites is 15% quicker than in all other sites.

Citing the UK government priority push for faster access to treatment, Hutton said those on the surgical waiting list have fallen by almost 300,000 from more than a million as of March 1997.

“The National Orthopedic Project was set up to reduce long waits in a challenging area,” he said. “It has delivered real benefits, with the number of people waiting over six months for surgery dramatically reduced. Latest data shows the number stands at 25,694 – a reduction of 73%.” He added that progress has been especially fast within the last year, with a 55% reduction in those waiting, from 57,128 to 25,694.

He said that by working in new ways, the NHS is providing patients with faster access than ever before, adding: “The project will also help drive progress toward the 18 week referral-to-treatment target.”

Michael Benson, president of the British Orthopaedic Association, said, “The National Orthopedic Project has recognized there has been an imbalance between supply and demand which the association has highlighted over many years. A series of initiatives has been undertaken to accelerate treatment.” He added that the Tailored Support Program in particular “has proved very helpful in supporting those health economies with major challenges and intrinsic working difficulties.”

Technical Forum eyes key issues

Eucomed’s (Brussels, Belgium) 10th Technical Forum, scheduled for April 28, will focus on a variety of issues of particular interest to the medical technology industry.

The forum, which will be chaired by Jean-Yves Carentz (regulatory/quality assurance director for Stryker Europe, Middle East & Africa, will include an update on the threats and opportunities of the reorganization of the European Commission.

Richard Moore, Eucomed’s scientific director, will make a presentation on human tissue engineering, and the morning session also will include an update on electronic labeling and the reuse of single-use devices.

With a focus on clinical investigation and post-market surveillance, participants will be provided with an overview of the latest developments of the European Commission’s Clinical Evaluation Task Force and on the revision of MEDDEV 2.12 by the Medical Devices Experts Working Group Vigilance Group.

In the afternoon session, participants will be informed about the status of the revision of the Medical Devices Directive 93/42/EC, including the main amendments, followed by a presentation on the latest developments relating to DEHP-plasticized PVC medical devices.

The other sessions will include an overview of the impact on manufacturers and distributors of Directives 2002/96/EC on Waste Electrical and Electronic Equipment Directive (WEEE) and 2002/95/EC on the Restriction of Hazardous Substances (RoHS).

Among the speakers will be Dr. Joachim Wilke, director of regulatory/quality and clinical affairs, for Medtronic; Peter Schr er, director-Europe, quality systems & regulatory affairs, Johnson & Johnson; Philippe Auclair, director of regulatory affairs and compliance for Guidant Europe and Canada; and Andy Vaughan, group environment manager, KeyMed Ltd.

Oxford researchers cite MassArray QGE

Sequenom (San Diego) said researchers at the Wellcome Trust Center for Human Genetics at the University of Oxford (Oxford, UK) successfully completed testing of the MassArray Quantitative Gene Expression (QGE) application.

The findings were reported in Analytical Biochemistry. The article demonstrated the ability to measure nucleic acid abundance, a process that allows scientists to gain a better understanding of the expression level of genes and how various disease states, treatments and cell stimuli change those levels.

The MassArray QGE procedure is known as real competitive polymerase chain reaction (rcPCR) and consists of competitive PCR in conjunction with MALDI-TOF mass spectrometry to determine nucleic acid levels within a sample.

The Oxford researchers also developed a statistical analysis tool, TITAN, designed for competitive PCR applications.

The study demonstrated that MassArray QGE delivers data with a high level of concordance to real-time PCR (RT-PCR), the current “gold standard” for gene expression analysis. The researchers also said that MassArray QGE provides greater sensitivity and needs less individual assay optimization compared to RT-PCR.