BBI

The United Kingdom Department of Health (DoH) in April launched a compulsory hospital-acquired infection (HAI) surveillance system that requires all NHS hospital groups to collect data on blood-stream infections of methicillin-resistant Staphylococcus aureus (MRSA). The DoH is due to submit a report on this information in April 2002. At present, MRSA cases are reported on a voluntary basis.

The HAI surveillance system will include areas such as surgical site infections and the DoH has also announced a $4 million research program into antimicrobial resistance. The increasing prevalence and virulance of antibiotic-resistant pathogens is placing growing pressure on the health care industry to improve device sterilization and to increase the applicability of single-use disposable instrumentation. The genome sequencing of methicillin- and vancomycin-resistant Staphylococcus aureus (MRSA and VRSA) most closely associated with blood-stream nosocomial infections, is expected to produce important developments in the fight against bacteremia.

The Glasgow Royal Infirmary (GRI; Glasgow, Scotland) has reported a 50% decline in new cases of MRSA since November 1999, when a pioneering infection control system was adopted. The system is to be the subject of a nationwide trial to assess its effectiveness in a number of hospitals. Process control charts, best known for quality control in industrial applications, are the basis of the GRI system. It consists of fast-tracking feedback of outcomes to controlling staff who in turn adopt fast remedial action, which is itself subject to the same surveillance process. The GRI intends to soon launch a multicenter, randomized, controlled and blind trial to assess the validity of its results using process-control charting.

In Spain, the incidence of nosocomial infections in hospitals is showing a slow improvement, declining from 8.4% of all patients in 1990 to 6.9% 10 years later in 2000. However the Spanish society of preventive medicine, in its latest figures, said that average intensive care unit infection rates remain high at 23% to 27%, with some hospitals reporting figures up to 30%. A key factor in a continuing high infection incidence is the rise in numbers of urgent and invasive surgical procedures.

Melanoma screening and therapy

The SIApen, which has been developed by Astron Clinica (Cambridge, England), can provide primary care physicians with a simple rapid screening test for detecting melanoma, according to John Wilkinson, marketing director at Astron Clinica. He said the SIApen can reduce the number of patients who are unnecessarily referred to a dermatologist.

The SIApen uses a part of technology used in the SIAscope, launched last year to help dermatologists diagnose melanoma. The pen will assess whether or not melanin is present in the patient's dermis. Wilkinson said the pen will be at least 96% sensitive for the disease. "This means that no more than four in 100 patients will be missed using this criterion combined with one or two simple clinical clinical observations," he said. "This is a massive improvement on the present ability of primary care physicians to identify malignant moles," he added.

The pen, which will be sold on a pay-for-use basis, with each test costing $3 to $4.50, is projected to be available in Europe by the second half of 2003.

Photocure (Oslo, Norway) has reported Phase III trial results demonstrating that treatment of nodal basal cell carcinoma (BCC) using its Metvix photodynamic therapy (PDT) resulted in a significantly better outcome than surgical excision, with a 90% or higher cure rate, statistically equivalent to surgery cure rates. The comparative trial in more than 100 patients showed that cosmetically the Metvix PDT results were a significant improvement over surgical procedures.

MRI reimbursable for some mammographies

Contrast media MRI procedures for mammography will now be reimbursable in Germany in cases where the patient experiences recurrence of an aggressive local tumor after surgery or where identification of a cancerous lymph node is only feasible by MRI.

The German national committee for statutory health insurance physicians and sickness funds sanctioned this limited reimbursement at last month's Berlin meeting, but with the stipulation that reimbursement of MRI procedures in the case of recurring tumors would be subject to quality control. Checks would be made on the examination technique used and the qualifications of the physician concerned.

Orthopedic moves in Europe

Synthes-Stratec (Oberdorf, Switzerland) claims a leading position in both the U.S. and in Europe as a producer of devices for trauma surgery, and as leader in Europe for orthopedic power tools.

Encouraged by a better-than-forecast performance in 2000, when sales grew by 26% to $ 770 million, the company plans to carry its success in the European power tool market across the Atlantic to the U.S.

The company, which operates out of Paoli, Pennsylvania, for the U.S. market, specializes in four orthopedic sectors, with devices for spinal, maxillofacial and trauma applications as well as power tools. It plans to make 2001 the first full year in which its battery-powered power tool line is available in America.

IsoTis (Bilthoven, the Netherlands) has appointed Merck subsidiary ScandiMed (Sjobo, Sweden) as a nonexclusive distributor for its SynPlug cement restrictor device on a worldwide basis. The product was developed from the IsoTis Polyactive co-polymer system and it prevents cement leakage into the distal shaft of the femoral canal during cemented hip implant procedures. Clemens van Blitterwijk, president and CEO at IsoTis, said that other medical device and drug delivery uses of Polyactive are under development. SynPlug has already received CE-marking in Europe and 510(k) clearance in the U.S. Full-scale launch by ScandiMed and other independent distributors in both areas is planned for the second half of this year.

Sulzer Medica (Winterthur, Switzerland) orthopedics sales grew by 4% for 1Q01 to $171 million, although spine care unit sales were down 10% to $ 25 million following a fall in cage interbody fusion device sales. Sulzer expects the launch of the BAK/Proximity and BAK/C cage systems will drive up spine care sales for the rest of the year.

In addition to about 1,900 revision surgeries arising from problems with Sulzer Medica's Inter-Op hip shell, the company has informed the FDA of "potential problems" with its porous-coated tibial baseplate. The company said that the faulty product was manufactured between July and December last year and has been implanted in 1,485 people worldwide, mostly in the U.S.

Sulzer Medica said that no other porous-coated products are affected because of differing production processes. It has stated a commitment to "a fair reimbursement of all medical expenses, lost wages and pain and suffering incurred incurred by the affected patients." Since the company has already admitted it can no longer guarantee that it is sufficiently insured to cover the cost of the Inter-Op revision surgeries, costs for any tibial base plate revision surgeries may well hit the company's profits.

Medical device nomenclature

The Global Medical Device Nomenclature (GMDN) is at last nearing publication. It will provide a much-needed rationalization of an existing situation where a variety of different nomenclatures, none of which are complete in themselves, have been used locally or nationally. Since regulatory data needs to be exchanged on an international basis, the GMDN also will provide a major contribution to safety and to the efficient operation of vigilance systems.

It is expected that when it is officially approved by the International Standards Organization and the European Committee for Standardization, the GMDN will initially be available in a 740-page paper format and subsequently as a CD-ROM from national standards bodies. Maintenance of the GMDN will be provided by a maintenance agency controlled by the FDA, the European Commission, the Japanese Ministry of Health and Labor and major regional industry associations.

German physicians press on payments

Physicians in Germany are constantly under pressure: they are continually obliged to treat more patients, and their reimbursement is inadequate. These are the views of Dr. Manfred Richter-Reichhelm, chairman of the national association of statutory health insurance physicians (KBV). "The time has come to re-evaluate the financing of doctor-patient treatment procedures," he said at the recent Berlin Capital City Congress. He said he felt that a change was needed in the present system, under which the patient contributes to a health insurance fund (krankenkasse), which then reimburses the physician for his services. At no point does money change hands between physician and patient.

The number of physicians working in Germany is still increasing, and, according to the federal chamber of physicians, has now reached 369,000. Of these, 295,000 are actually in practice, with the remainder employed in other parts of the health care industry. About 140,000 are working in hospitals and clinics and 128,500 are in practice outside hospitals.

Ulla Schmidt, the German federal health minister, recently held a meeting in Berlin with delegates from the health industry, health insurance organizations, patients, physicians and hospital associations to institute a constructive dialogue about the future of health care services in Germany.

"I wish to discuss the middle- to long-term problems of the service. Hopefully we can come to a consensus on a solution for modernizing the health system," she said. The meeting is viewed by Schmidt as being the first in a series of quarterly sessions.

Schmidt issued proposals to remove from physicians the so-called "collective responsibility" system whereby local physicians' associations are jointly responsible for excess payments when individual physicians exceed their budgets. She proposes that in these cases physicians should have to refund payments from their own pockets.

The draft proposals have been welcomed by the KBV. Vice Chairman Dr. Leonhard Hansen said, "The minister has kept her promise to the general practitioners. Now the ball is in the court of the sickness funds." The draft requires the krankenkassen to keep regional physicians associations informed of their expenditure programs and Hansen called upon the krankenkassen to ensure speedy availability of the data.

Schmidt also sought to allay the concerns of east German physicians who claim that they are unfairly treated because of a continuing disparity between reimbursements from east-based health insurance funds and those in the west. She said that the solidarity strengthening law would help to redress the balance. "In the last year alone, DM 2.8 billion ($1.3 billion) flowed from west to east Germany. This year the figure is predicted to be DM 4.8 billion ($2.2 billion)," she said. It was clear that the "risikostrukturausgleich," a mechanism introduced to balance east and west krankenkassen contributions, was having the desired effect, she said.

The present reimbursement fee catalog for east German physicians provides an average of 86% of the sum which would be received by their west German counterparts. "This is due to be raised to 90% this year and will contribute to the strengthening of ambulatory health care in east Germany," she said.

Getinge acquires Maquet surgical table line

Getinge Industrier (Stockholm, Sweden), the parent company of Getinge/Castle (Rochester, New York), a worldwide supplier of disinfection, sterilization and surgical equipment, has acquired Maquet (Rastatt, Germany) for an undisclosed sum. Maquet is an important supplier of surgical tables, with an estimated 30% share of the world market. Getinge said that the acquisition will allow Getinge/Castle to expand significantly its range of product offerings for surgical suites.

Gehe continues European expansion

Gehe (Stuttgart, Germany), already Europe's largest pharmaceutical distribution organization, has acquired for an undisclosed price Norway's biggest distributor, Norsk Medisinal Depost (NMD; Oslo, Norway). NMD's sales last year were NOK 6.2 billion ($661 million).

Vital Signs increases Breas Medical holding

Vital Signs (Totowa, New Jersey) produces single-use products for anesthesia and critical care. It has increased its ownership in Breas Medical (Molndal, Sweden) to 94% with a payment of $3.8 million plus an additional amount based on sales and earnings at Breas for the year ending in March 2002. The total amount payable is expected to be between $11 million and $35 million, the company said.

Breas Medical recently launched its LTV 1000 portable ventilator in Europe. This versatile compressorless ventilator, which has been developed in partnership with Pulmonetic Systems (Colton, California), can perform a wide range of functions from CPAP to intensive care requirements. It can be used in critical or long-term acute care, home care and other situations such as patient transport.

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