Mallinckrodt syringe reduces risk of nuc med needle sticks

Company leverages parent's strengths

Two years ago, Bermuda-based juggernaut Tyco added Mallinckrodt to its stable of healthcare companies. The idea was to gain strength through size. Since then, Tyco strategists have spun in circles, first announcing plans in January 2002 to split up the company, then retreating from that announcement. In the end, Mallinckrodt and nuclear medicine technologists may benefit from Tyco's original idea and decision to stay with it.

Recognizing the need to develop a syringe that would reduce or eliminate the risk of needle sticks for nuc med technologists--a need evident in daily practice, as well as one mandated by Congress in the Needlestick Prevention Act of 1999--Mallinckrodt turned to sister company Kendall, which makes a broad range of healthcare products, including needles and syringes. The trick was to develop a syringe that protects technologists from needlesticks without increasing the risk of radiation exposure. Mallinckrodt exhibited its solution at the annual meeting of the Society of Nuclear Medicine in Los Angeles in mid-June.

"Nuclear medicine had gotten around the mandate for a safer syringe because the use of radiopharmaceuticals was unique and had special requirements," said Mike Taylor, director of marketing for nuclear medicine imaging at Mallinckrodt. "Now the technology has caught up, and we have the ability to give technologists a product that allows them to achieve compliance."

Engineers at the St. Louis company, working with colleagues at Kendall, adapted Kendall's Monoject Safety Syringe for use with radiopharmaceuticals. Initial clinical testing this spring showed that the specially adapted single-use disposable safety syringe fits into a standard injection and syringe shield yet prevents radiation leakage.

The Monoject platform is itself relatively new, having been released commercially in May. It emerged from some two years of collaborative development between Kendall and Specialized Health Products International, which focuses on healthcare safety products.

The basic Monoject syringe was designed to address an overall market valued at about $260 million. Its adaptation for nuclear medicine, however, has a much smaller market, as only about 12 million nuc med procedures are performed annually in the U.S. But Mallinckrodt strategists are not seeking to make money on the sale of these syringes so much as hoping that its appeal to technologists will help solidify the current customer base for its radiopharmacies while attracting new prospects.

Currently technologists use what is known as a "one-handed recapping method," according to Taylor. After use, the technologist fishes the cap back on the needle, careful not to use a hand to steady the cap for fear of being stuck. The alternative is to just put the syringe, point first, into the lead-lined container typically used for its disposal. But that takes the chance that the hand holding the container will be stuck. Such needlesticks do not happen often, but just about everyone knows someone who has gotten stuck.

"In going around to my customers, I run into at least one person at every account who has gotten a needlestick," said Quent Besing, Mallinckrodt manager for pharmacy marketing.

Even so, appreciating the problem is not the same as appreciating the advantages of Mallinckrodt's new safety syringe. Its formal introduction at the SNM meeting was the first step. The company is now going city to city, contacting nuclear medicine departments, getting in touch with the infection control-risk management staff, and conducting demonstrations.

"Our goal is to raise awareness about this product," Taylor said.

Whether the company will try to recoup development costs in some way--by increasing the charges for the radiopharmaceuticals dispensed by its pharmacies, for example--has not yet been decided. The specially adapted Monoject syringe is guaranteed, however, to be a best-seller. The company has decided to phase out all other syringes at its 41 U.S.-based radiopharmacies this fall.