BBI

In the United States, 15 states have already enacted legislation requiring the use of safety needles in hospitals and health care facilities, and similar rulings are to be introduced soon in another 13 states. The current U.S. market size for safety needle products is estimated at $630 million and projected to increase to more than $2 billion by 2005, according to David Robinson, president and CEO at Specialized Health Products International (SHPI; Bountiful, Ohio), a market leader in safety needle technology.

There are an estimated 600,000 needlestick injuries in the U.S. each year. Although there are no Europe-wide statistics, Jon Richards of Britain's largest health care workers union, UNISON, estimates there are more than 100,000 needlestick injuries in the U.K. each year, with the majority going unreported.

"Less than half of hospitals take part in voluntary programs to record exposures, and there are thousands of physicians' offices and dental surgeries which go completely uncounted," Richards said. The union is pressing the U.K. government to introduce compulsory recording of needlestick injuries after the recent publication of a report by the Department of Health showing a 73% increase in notified injuries to health care workers in 1999. UNISON also is calling for old-fashioned needles to be phased out and "safer needles" – retractable products or those featuring a safety shield – introduced.

In Europe, of 75 documented cases to date of health care workers acquiring HIV infections, 22 were directly attributed to needlestick incidents. Britain's Public Health Laboratory Service said its records showed 477 reports from July 1997 to June 1999 of exposure to HIV, hepatitis B or hepatitis C viruses, with 74% (353 cases) through needlestick injuries.

Becton Dickinson (BD; Franklin Lakes, New Jersey), together with Johnson & Johnson Medical (JJM; Arlington, Texas) and the Kendall (Mansfield, Massachusetts) division of Tyco International (Bermuda), are major companies in the safety needle sector, all of whom have existing agreements with SHPI for the use of one or more safety-needle technologies. SHPI's Robinson said, "We are looking forward to the launch of the first new SHPI safety needle product by JJM in 2000, with an additional four products to be introduced in 2001. In addition, Tyco is projecting the release of the first SHPI safety syringe needle in multiple sizes in fall 2001, followed by a second in 2002."

Med-Design (Denver, Colorado), which has mainly automatic needle retraction technologies, has an exclusive worldwide marketing deal with Becton Dickinson, while Retractable Technologies (Little Elm, Texas) earlier this year signed a five-year distribution deal with Abbott Laboratories (Abbott Park, Illinois) for its VanishPoint line of automated retraction syringes and blood collection devices.

Britain's main safety needle company, NMT (Livingston, Scotland), which has been plagued by production problems and an incomplete product line, raised $35 million in new financing in July. The company is planning for a complete product line of safety syringes, with various needle gauges available on all products. Next in development are a safety IV catheter and phlebotomy set.

NMT is reducing its sales and marketing efforts in Europe, where acceptance of safety needle technology is at an early stage, to concentrate on the U.S., where safety needles are becoming a standard requirement (see Market Updates, page 259). "We believe our technology continues to provide an excellent platform to meet the needs of our target market," said Roy Smith, CEO at NMT.

Two companies in the UK have developed needle-free injection devices: Weston Medical (Deeside, Scotland) and PowderJect (Oxford, England), neither of which yet has a product through to the market although they both have ongoing development projects under way. Weston Medical, which has patented rights to a prefilled, needle-free liquid injection device called Intraject, has six alliances with companies, including Roche (Basel, Switzerland), GlaxoWellcome (London) and Johnson & Johnson (New Brunswick, New Jersey).

PowderJect, whose technology is based on reformulation of drugs or vaccines in powder form for needle-free injection, has Serono (Geneva, Switzerland) among several other collaborators. PowderJect acquired last month for $80 million the Medeva vaccines business of Celltech (Slough, England) to complement its own vaccine R&D development.

Reusable glass syringes in Third World

The World Health Organization (WHO; Geneva, Switzerland) estimates that there are about 12 billion injections administered worldwide each year. In certain African, Asian and Central and East European countries, the reuse of disposable syringes and needles for injections is commonplace, WHO says.

In a recent report, WHO estimates worldwide 8 million to 16 million hepatitis B, 2.3 million to 4.7 million hepatitis C and 80,000 to 160,000 HIV infections occur each year from the reuse of syringe needles without sterilization. Many of these infections could be avoided if syringes were disposed of safely.

Safety needle technologies which prevent syringe reuse are costly and complex to make. Although they may gain a small part of the market for specialized applications, widespread acceptance will be limited by price considerations.

In a first step, which seems likely to presage a return by prudent health care authorities to sterilizable injection devices, the state government of West Bengal in India has recommended a shift to reusable glass syringes because it found that disposal requirements for disposable syringes could not be enforced. WHO is planning the development of a database on practical options for health care waste management, including sharps and syringes, and mainly targeted at developing country situations (soon on www.healthcarewaste.org).

Tissue-engineered bone regeneration

Among synthetic scaffolds used in reconstructive orthopedic surgery as a replacement for autologous bone grafts, a group of researchers at the Lariboisiere Saint-Louis School of Medicine (Paris), led by Herve Petite, have successfully used natural coral exoskeleton combined with autologous marrow stromal cells (MSC). In their animal trials, gaps of up to 25 mm were bridged in sheep metatarsals. Such defects may typically be created in the resection of neoplasms.

Earlier tissue engineering, using MSC seeded onto porous ceramic scaffolds, have had results limited by a slow resorption rate of hydroxyapatite-based ceramics. Petite's group used coral, which is a natural calcium carbonate-based ceramic, with MSC to increase osteogenesis. They found that after four months, there was almost complete resorption of the coral scaffold together with, in most favorable cases, complete recorticalization and the formation of a medullary canal.

Petite has suggested that using alternatives to natural coral, like new-generation, coral-like hydroxyapatite, tricalcium phosphate-hydroxyapatite ceramics and biodegradeable polymers such as polylactic and polyglycolic acids are the logical next stage.

Hospital responsible for infections

The Andalusian health service (SAS) in southern Spain was acquitted by a regional court of responsibility for risk to a patient of contracting a hospital-acquired infection (HAI) during surgery. The Supreme Court of Spain has now reversed the decision, and has found the SAS negligent in failing to implement adequate prevention and treatment.

The case in question concerned a patient infected by S. aureus from an internal suture. The original acquittal was on the premise that patients entering surgery must accept the inherent risks involved.

Around 6.8% of hospital patients in Spain contract a nosocomial infection during their stay. Some 65% of infections are during surgery or post-surgery, the main sources being urinary catheters, surgical procedures and ventilators.

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