A BBI

The UK's National Health Service (NHS) has launched a 50 million effort aimed at eliminating the long waits experienced by orthopedic patients and boost NHS capacity so an additional 41,000 patients a year can undergo orthopedic procedures. In announcing the program, Health Secretary Alan Milburn said that more than a quarter of a million people mainly elderly patients were waiting for orthopedic surgery as of the latest report. "This extra investment to cut waiting times further will make a big difference in improved quality of life for many people," Milburn said.

The NHS said the additional funding would be invested in a variety of orthopedic services, including those in NHS diagnosis and treatment centers, including upgrading existing facilities and buying new equipment. Citing recent success in reducing waiting times overall, the NHS said the extra resources will result in shorter waiting times for patients, with a goal of ensuring that no orthopedic patient is waiting more than six months for treatment by December 2005.

"The extra resources and reforms we are putting into the NHS are reducing both waiting times and waiting lists," Milburn said. "Patients are beginning to see the results in better, faster services."

Around one of every four patients on the overall NHS waiting list needs orthopedic surgery. The health service said that orthopedics is the specialty with the largest share of longer than six-month waits (35% of the total) and nine-month waits (38%). The NHS said in its announcement that many of these are elderly patients whose quality of life is affected by their condition, which causes immobility, pain and discomfort. NHS figures at the end of March indicated that 254,496 orthopedic patients were waiting for inpatient treatment in the UK, representing an decline of almost 10,000 since last December.

"The figures are going in the right direction but there is still a long way to go," the NHS said. "By the end of next year, no orthopedic patient should ever wait more than nine months, with urgent patients being seen more quickly."

Milburn said the 50 million has been targeted for areas with the greatest orthopedic capacity problems, which have been identified by local strategic health authorities as benefiting the most from the extra investment. Around 25 million will be used to target those NHS trusts that have historically struggled to cut orthopedic waiting times and those who have the ability to deliver extra capacity for the NHS. The remaining 25 million will be used to boost the capacity in diagnosis and treatment centers that are focusing on orthopedics.

As an example, the NHS said the Southampton University Hospitals Trust will receive 1.2 million for ward alterations, which will expand its capacity for major/intermediate surgery and partly contribute to expanding its outpatient unit. Those steps will result in an extra 1,438 orthopedic procedures being performed per year. And Mid-Essex Trust will receive 2.8 million for additional operating theaters and preparation rooms, boosting capacity by an additional 2,700 operations per year.

Milburn also said last month that waiting times for surgery in general, which "had been rising for decades in the NHS," now are coming down. "There is a long way to go," he said, "but the health service is on course to deliver the NHS Plan, so that by 2005 no one should have to wait longer than six months for an operation." He said that sustained investment and reform are "really beginning to bite in the NHS," with the result that in the next year, "the maximum waiting time will fall further. There is a long way to go, but the NHS is now turning the corner."

Department of Health figures published in early June show that the NHS is "continuing to make good progress" in eliminating long waiting times for patients, he said. Total inpatient waiting figures for April show that the number of NHS patients waiting longer than 12 months for an operation had fallen from nearly 22,000 at the end of March 2002, to 134 at the end of April this year. "This represents an important milestone on the way to meeting the NHS Plan target that no one should wait longer than six months for an operation by the end of 2005," the Department of Health statement said.

The number of patients waiting longer than nine months has fallen by 43% since March 2002, while the number waiting longer than six months fell by 18%.

Eucomed asks opinion on reclassification

Questioning a request by two national medical technology regulatory agencies for broad reclassification of certain medical devices, Eucomed (Brussels, Belgium) last month called for the legal service of the European Commission to clarify the conditions under which the reclassification of such devices can be requested. The medical technology industry association said it believes that the requirement set by the Medical Devices Directive 93/42/EEC which calls for any request for reclassification by European Union member states to be "duly substantiated" has not been met.

At issue is a request made last November by the UK's Medical Devices Agency (now the Medicines and Healthcare Products Regulatory Agency) and France's Agence Francaise de Securite Sanitaire des Products de Sante to re-classify total joint replacements and all surgically invasive devices in contact with the central circulatory system and transiently with the central nervous system as Class III medical devices. Class III comprises "high risk" medical devices. Eucomed said in a statement that reclassification of a medical device "should be done on a case-by-case basis, after thorough analysis, consultation with the relevant stakeholders and assessment of other available solutions, as this can have a serious impact on their availability to patients and clinicians as well as on the resources of manufacturers and Notified Bodies."

The association suggested that such reclassification should meet several requirements, including the legal basis for the move; the analysis of the safety factors that substantiate the reclassification request, in particular a statistical analysis of incidents relating to the product concerned should be attached to the request; and an indication of the root cause of the reported problem and why the proposed measure is expected to solve the problem. "There must be careful consideration of all possible causes and solutions," Eucomed said. "The end point of the process should be a proposal with respect to an appropriate solution, which may not necessarily be reclassification."

The organization said the regulatory and cost impact of the proposed solution "should be assessed in all member states with respect to its effect on medical practitioners, patients, healthcare providers, Notified Bodies and manufacturers." If there is evidence that a change is justified, said Eucomed, "sufficient transitional arrangements must be provided to allow a smooth and orderly transition for all concerned parties." Furthermore, it said the decision "should clearly indicate the timeline during which the procedure should be carried out."

Eucomed said that in its view a reclassification into Class III of all surgically invasive devices in contact with any part of the arterial system, including the peripheral and capillary systems peripheral stents, for example would "go beyond what may be required to ensure a high level of safety for the patient." As for reclassification of all devices that are intended to be used transiently in contact with the central nervous system, the organization said many such devices are simple instruments with "proven biocompatibility in terms of their intended transient use (e.g., nerve root retractors). For such devices, as with so many others, the risks arise mainly from their manipulation in situ by the surgeon and other operating room personnel."

And it said there is increasing scientific evidence that the quality of total hip joint replacement devices is increasing under the present regulatory regimen. In particular, it said, "registry studies indicate that while the total number of primary hip joint implants has increased, the number of revisions has decreased. Under these conditions, increasing the administrative burden for the CE marking of these devices will probably not add any real benefit for the patient."

New angle on treating Parkinson's

Neurodegenerative disorders such as Parkinson's disease may be due to an imbalance between the generation of new neurons throughout life and the death of neurons, a team of researchers in Sweden suggests. The scientists, whose experiments in mice have shown that neural stem cells naturally replenish the dopamine-producing nerve cells that are lost in people with Parkinson's disease, said their finding opens up a new field of research to investigate how the brain regulates that process.

Ann Marie Janson, associate professor in the department of neuroscience at the Karolinska Institute (Stockholm, Sweden), said, "Our observations could provide an alternative explanation for very slow neurodegenerative disorders such as Parkinson's disease. We know that these conditions go on for years and years and that people slowly lose their population of nerve cells in the substantia nigra of the brain. Our animal experiments suggest that this could be due to too little production of new neurons rather than just that these cells die off."

An account of the group's studies was published in the June 3 issue of the Proceedings of the National Academy of Sciences. The group is working on establishing what factors and signals control the process by which neural stem cells differentiate into dopamine-producing nerve cells, and migrate to the substantia nigra. "We do not want to raise false hopes, but our discovery that there is an endogenous turnover of cells in this part of the mammalian brain suggests that it may be possible to stimulate this process in people suffering from Parkinson's disease," Janson said. "If we can find out what substances regulate this process, then there would be high hopes of having a new remedy for this disease. But first we need to do many more animal experiments."

Decontamination of surgical instruments

A new partnership has been formed between the National Health Service and the private sector to improve standards of decontamination of surgical instruments throughout the NHS. Under the new program, NHS hospitals will be able to work locally in partnership with private contractors to develop new decontamination facilities, which the NHS said would allow its facilities to benefit from the latest technology available in this field. The UK government announced in January 2001 that it would spend 200 million to improve the standard of decontamination in the NHS. That effort has progressed in two phases the first of which was a series of investments to deal with immediate needs in NHS facilities. The second was the development of what the agency calls "a long-term, sustainable approach" involving the commercial sector, which the National Health Service announced recently at its "National Standards-Local Delivery" conference. The new national standard for decontamination services was developed by NHS Estates, an executive agency of the Department of Health, which said the new arrangements "will work within a regulatory framework to ensure the highest standards." All NHS hospitals will be expected to conform to the new standards by 2007.

Peter Wearmouth, chief executive of NHS Estates, said, "It is vitally important, as part of the battle against hospital acquired infection, that NHS organizations take action to improve their decontamination standards. This initiative represents an excellent opportunity for the NHS to do this by making full use of the private sector's resources and expertise." The first new decontamination facility will involve the Bradford Hospitals NHS Trust and the Leeds Teaching Hospitals NHS Trust and should become operational in 2005, according to a Department of Health announcement. Seven additional groups comprising 32 NHS trusts are expecting to advertise for private-sector partners this fall.

German ministry reports on spin-offs

The German Ministry of Education and Research (BMBF) reported on the results of its pilot project to ease the process of spinning companies off from university research. Since mid-2001, the ministry has invested about EUR 7.5 million to support scientists in their efforts to translate research results into marketable products. To date, 35 companies have been launched through the program's efforts, and 29 more are in preparation. The companies are still small, with an average of 5.5 employees. The ministry did not break down its support by sector, but it did say that biotechnology and medical technology, along with information technology, were the "dominant" recipients of the funds.

French units put into receivership

Ventiv Health (Somerset, New Jersey) said last month that its French subsidiaries have been placed into receivership. The subsidiaries have been designated as held for sale in discontinued operations since June of last year.

Ventiv, a provider of sales and marketing solutions to the pharmaceutical and life sciences industries, said it does not expect to recover the approximately $1 million of net assets it carries for the French operations. The company said that its local management team in France would work jointly with the receiver to "minimize the job losses resulting from this action."