A Lexington company is on the verge of deploying a product that could set a new standard for medical needle safety.
MedPro Safety Products Inc. is undergoing safety testing for a product known as the Vacuette Premium Safety Needle System, a self-capping needle used for drawing blood.
The goal of the system is to eliminate accidental sticks with a used needle by eliminating any chance of human error.
Walter Weller, president and chief operating officer of MedPro, said he thinks Vacuette Premium Safety needles have several aspects that make them stand out from existing blood collection systems.
The first is what he describes as "passive" technology — that is, the needle cover deploys on its own. "What's unique about it is that we don't require interaction from the phlebotomist. We don't ask them to push buttons or snap clips," Weller said.
Weller estimates that 35 percent of needle-stick injuries occur from the time the needle leaves the arm to transportation to a container or destructive device.
The Premium Safety Needle comes in two forms: skin-activated and tube-activated. The skin-activated safety system deploys as the needle is inserted into the vein. The tube-activated system works, as its name suggests, when the blood collection tube is inserted but before the blood is drawn. Inserting the collection tube releases a safety cover that rests against the patient's skin. As the needle is withdrawn from the arm, the spring extends fully and the plastic sheath completely covers the sharp. The sheath then locks into place so the needle can't be re-exposed without breaking the device.
Most existing blood collection devices require the user to manually cover the needle. Eliminating human action, Weller hopes, will eliminate needle sticks if a nurse or tech forgets to cap or sheathe contaminated sharps.
Dr. Joseph Conigliaro, director of the University of Kentucky Center for Enterprise Quality and Safety within the UK Medical Center, said the concept of automatic safety systems reflects a larger push in the medical field beyond just needles.
"The whole concept here — here we're seeing it in the realm of blood collection — ... draws from an area called human factors, how we interact with the equipment," Conigliaro said. The idea is to ensure as much as possible against errors, such as those caused by a lack of training or distractions.
Conigliaro cited as another example the way oxygen is delivered to patients at UK Medical Center. The tubing and spigots for the oxygen systems are compatible only with one another, so the wrong gas cannot be administered.
"It presupposes that the user will make a mistake, and will prevent the user from making that mistake. Those are the most effective safety measures. It's better than any policy. It's better than any teaching," he said.
Weller feels optimistic that there will be no training involved with the Premium Safety Needle System. The needle uses standard blood collection tubes, which are inserted in the rear of the device. It operates automatically from there.
"We've really set out to design a portfolio of products that introduce no changes in procedure at all," Weller said. Phlebotomists "don't cognitively have to be aware of doing different things while they're busy monitoring a patient, administering a needle ... and then having to deal with safety on the back end of it."
Finally, the device should be cost-effective, though the specific cost of a single unit won't be finalized until manufacturing is up and running. The Federal Needlestick Safety and Prevention Act requires U.S. medical practitioners to evaluate safer technologies as they become available, regardless of cost.
"But in the practical application of your device, you have to deliver cost-effective safety. Especially today," Weller said.
MedPro was founded in 1995 with the invention of a different type of medical safety device called the Needlyzer, a machine about the size of a shoe box that superheats and destroys used needles.
After the Needlestick Safety and Prevention Act — a federal bill introduced into the U.S. House of Representatives in 2000 — was unanimously passed by the U.S. House of Representatives, Sen. Jim Bunning stalled the bill in the Senate on MedPro's behalf. The language of the bill made no provisions for the degree of safety provided by machines such as the Needlyzer.
"Part of the complaint about the Needlyzer is, you're transporting the contaminated needle from the patient over to the device."
The Needlyzer is no longer in production "exactly for that reason," Weller said.
The company purchased the product at a conceptual stage in 2005 from Hooman Asbaghi and his company, Visual Connections Inc., in California. After almost four years of research and development, the product is now covered by four patents, all owned by MedPro.
All of MedPro's efforts are now focused on Vacuette Premium Safety Needles and similar products that aren't as far along in development.
MedPro, which has 13 employees, is working with Greiner Bio-One, an Austria-based company that owns the Vacuette brand name, to do the manufacturing and marketing.
"We have what we call a minimum volume contract," Weller said. "They have guaranteed a minimum volume of these devices. Over five years, it's 275 million pieces. It's a significant number of pieces."
The needles are currently undergoing Food and Drug Administration testing in America and CE safety testing in Europe.
The company hopes Premium Safety Needles will see use in U.S. and worldwide markets by the end of 2009.