By Nicholas Borgert
An estimated 800,000 needle-stick injuries occur annually in the United States, and many more injuries go unreported. Needle sticks place clinicians at risk for blood-borne diseases, including hepatitis B virus, hepatitis C virus, and HIV.
The best-designed needles offer built-in safety devices to reduce needle-stick injuries before, during, and after use. The most user-friendly safety devices incorporate a barrier between the hands and the needle after use. They also require that a clinician’s hands are positioned at all times behind the needle. Safety features are integrated on the device itself rather than as accessories.
K-Shield® Winged Blood Collection Set
The K-Shield® winged blood-collection set, designed by Kawasumi Laboratories, integrates the needle safety device as part of the product itself. The protective device is activated as the needle is being pulled out from the venipuncture site. K-Shield’s plastic is less rigid and more pliable than other safety collection sets, resulting in increased comfort for the patient, says Scott Horowitz, marketing manager for Kawasumi Laboratories America (KLA).
“Conventional winged blood-collection safety devices require three hands,” Horowitz says. “One hand to hold the gauze, one hand to hold the wings during needle removal, and still another to activate the safety mechanism. K-Shield permits removal of the needle and covering of the needle point using two hands with a minimal change in technique by the health care professional.”
The K-Shield set has been available in the United States for a little more than a year, says Horowitz. The integrated safety set and its distinctive features—ease of use, needle sharpness, and immediate covering of the needle—have been designed to ensure safe needle use for the clinician and the patient.
Key markets for the collection set are clinical laboratories and hospitals, as well as clinics and physician offices where blood is drawn in-house.
One dilemma in converting to safety: Some phlebotomists who draw blood are prone to be resistant to change. They may require extra encouragement and motivation to use new technology-based safety needles in their daily routine. And they are likely to look for such shortcuts as simply not activating the device properly or at all.
The winged blood-collection set is available in both standard configuration and in the K-Shield safety design, and it is offered with a multiple sample luer adapter. Because it is produced without latex, it is safe to use with patients who may have demonstrated an allergic reaction to latex.
According to its most recent annual report (2004), Kawasumi Laboratories achieved revenues of $287.6 million. KLA sells to North America through its own sales force and through manufacturer’s representatives. It partners with a number of established medical-products distributors who supply the products to end-users. These include McKesson, InfoLab, PSS, and Oncology Supply.
The Market
Major markets for Kawasumi include hemodialysis clinics, blood banks, oncology clinics, and critical/intensive care units. Horowitz says Kawasumi manufactures its gravity IV administration sets free of diethylhexyl phthalate (DEHP)—also called dioctyl phthalate (DOP). DEHP is a plasticizer that makes PVC tubing pliable. In Western Europe, DEHP accounts for 30% of all plasticizer usage and, as such, is generally considered the industry standard.
However, DEHP has been under review as a potential carcinogen. Officials from 15 European Union members have challenged allegations that DEHP is a carcinogen. They claim that exposure of the general population to DEHP is at least 280 times below levels at which health is at risk.
Kawasumi has decided to stay clear of DEHP completely in producing its gravity IV and port access infusion sets. “Instead,” Horowitz says, “the company produces its flexible tubing with a plasticizer called Tri Octyl Trimellitate (TOTM) that we believe is a much safer plasticizer than DEHP.”
“In the specific case of gravity IV administration sets, we believe a part of the solution should not be part of the problem,” says Horowitz. “Imagine a cancer treatment being administered using plastic tubing or a drip chamber containing a carcinogen.”
Kawasumi products for the US market are manufactured to ISO 13485:2003 standards. The company’s factories are audited by TUV Product Service. In the United States, the company supplies gravity IV sets, port access infusion sets, and winged blood-collection and small-vein-infusion sets. The company also sells blood-drawing kits and phlebotomy sets. Because the blood-drawing kits don’t contain unnecessary anticoagulant solutions, they’re a cost-saving choice in therapeutic phlebotomy applications where drawn blood is then discarded, according to Horowitz.
The best-designed needles offer built-in safety devices to reduce needle-stick injuries.
Kawasumi also sells a variety of other products to Latin America, including blood bags (blood banks), blood tubing lines, and arterial venous fistula (AVF) sets for hemodialysis applications. Kawasumi AVF sets come in ultrathin-walled and silicone-coated needles that reduce patient discomfort and keep tissue damage at the puncture site to a minimum.
Canada is heating up as promising market for the full line of Kawasumi products, including the K Shield winged blood-collection set. “We have sold some products to Canada in the past, but they now have very stringent standards that are very similar to those established in the United States by the Food and Drug Administration,” Horowitz says.
In Canada, distributors of Class II medical device products are required to apply for and retain an establishment license from Health Canada. In addition, manufacturers must apply for a medical device license to sell each product line. Kawasumi obtained its licenses in December 2004 and has begun to sell its branded oncology, hematology, and hemodialysis products through its sales force and emerging distributor partners across Canada. Core products destined for the Canadian market include the company’s non-DEHP gravity IV sets and products bearing Kawasumi’s newest K-Shield needle safety technology.
“Patient safety has become a growing concern as much in Canadian health care facilities as in the US market,” Horowitz says. “Clinicians are now looking for safer IV sets and needle-stick-prevention alternatives.”
In recent months, Kawasumi has been busy reviewing prospective distributors it can partner with in the Canadian market. The company has already signed up Medique Medical and Genexa for the Canadian market, according to Horowitz.
Sales of the winged blood-collection set outside the United States in general are lower than in the United States, Horowitz says, but the potential of the combined markets in Canada and the United States is extremely promising. He cites a 2001 forecast by the market research firm Frost & Sullivan that sales of safety needles would approach the $700 million level by the end of calendar year 2006.
The research firm’s projection for sales of nonsafety needles, syringes, and needle devices for the United States alone was nearing $1.2 billion. Horowitz says the goal of his American-based group is to boost its share of the standard and safety needle market in the United States from its current 8%. “We have, in many cases, been locked out of the larger labs and hospitals because of longtime contractual arrangements,” Horowitz says. “Now, we’re pushing beyond the small labs, physician-office laboratories, and oncology labs to reach bigger laboratories and hospitals.”
A Sharper Needle Choice
According to Horowitz, Kawasumi frequently hears customers talk about the superior sharpness of its needles, which translates into reduced discomfort levels for patients. He pointed to a study conducted on needle sharpness by North American Science Associates Inc. (NAMSA, an independent tester and evaluator of medical devices, has been operating for nearly 4 decades.)
Nearly 2 years ago, NAMSA released a report comparing the sharpness of the K-Shield winged blood-collection set’s safety needles with needles from six other producers. The NAMSA study found that the Kawasumi needles provided the sharpest needle point and the lowest drag (insertion force during venipuncture) of all the needles tested—both of which decrease patient discomfort.
The integrated K-Shield needle technology offers a safety device that activates easily and automatically upon needle disengagement so the phlebotomist or clinician does not have to perform an extra safety step.
“Phlebotomists are unaccustomed to extra steps. They’re used to taking the needle out of the patient and throwing it away,” Horowitz says. Therefore, requiring an extra effort to activate a safety device is annoying for veteran phlebotomists. “Also, the traditional tubing tends to become extremely coiled during packaging, and therefore difficult for the clinician to easily manipulate.
“In addition, some users will try to defeat a product innovation just to see if it can be done. Clinicians should follow the vendor’s instructions for use to reduce chances of needle sticks,” he says.
Nicholas Borgert is a contributing writer for Clinical Lab Products.
