Medical Device Daily Contributing Writer

BD Technologies (Little Elm, Texas) reports that clinicians are reacting positively to its release of the BD Integra 1 mL Retracting Tuberculin and Insulin Syringe, featuring a low-waste space volume design.

The syringe also boasts a retracting needle intended to protect healthcare workers against accidental needle sticks. Users activate the syringe by continuing to press down on the plunger following the injection, triggering the retraction of the needle backwards into the syringe.

“More importantly, we've focused on developing devices that could be activated with a single hand rather than two hands,“ BD's senior director of hypodermic technologies, George Goldman, told Medical Device Daily, “because if you're able to activate a syringe holding it in one hand, it's much harder to get stuck by the needle.“

The latest also features wider flanges for greater stability when delivering injections and a clear barrel and bold scale markings for more accurate dosing.

According to Goldman, advances in needles and syringes occurred in three distinct periods: Prior to the 1960s they were made of glass, were re-useable and required rigorous sterilization. By the mid-1960s, glass needles and syringes had given way to plastic and the single-use disposable format, the first area in health where products were thrown away after one-time use.

Modest improvements in product performance followed during the late 1960s and 1970s. However, no major improvements occurred until the 1980s, when accidental needle sticks among healthcare workers became a concern amid the AIDS crisis.

“That's when we launched the very first-safety engineered device of any kind, which also happened to be a safety-engineered hypodermic device, a syringe called Safety-Loc,“ said Goldman.

He added: “This was really the first meaningful change in what the technology was really designed for as we started to pursue safety-engineered designs and concepts.“

The initial Safety-Loc featured a full retractable needle and sliding safety sleeve that locked into a protected position and proved to be very effective in preventing accidental needle sticks. Still, there was room for improvement, said Goldman. The biggest change demanded by clinicians, for example, was improved speed of activation. The original Safety-Loc required two hands to safely activate the device. BD set about to develop not only a one-handed syringe, but one that could be activated without a major shift in hand position.

“The way you activate Integra is much simpler. Once you finish making the injection you just keep pressing and this causes the device to activate. So it's the same motion, you don't move your hand at all, you just keep going. That's obviously as simple an activation process that you can possibly have.“

Another challenge BD took on, says Goldman, was to reduce the amount of medication lost due to waste space volume. When a clinician injects a single dose vial of medication, he explained, “they'll draw once from that vial and that's the end of story.“ Loss of medication is less of concern “as long as you get one dose out of that vial because you're going to throw it away anyway.“ A multi-dose vial is a different story.

“If it's a 10-dose vial and you're wasting a lot — you may only get eight or nine doses. Integra was specifically designed to limit the amount of that space inside the device where medication can get in but can't get back out.“

In conventional needles and syringes, the waste space volume is located in the syringe tip, needle hub and needle cannula. International standards identify the maximum waste space for a 3 ml syringe tip to be 0.07 ml. And while it is recognized that there is additional waste space volume in needle hubs and cannulas — which may increase the overall volume to 0.09 ml — there is no industry standard that controls this volume for needles.

To achieve a low waste space syringe, BD redesigned the needle hub and syringe interface. The result: 72% less waste space than a conventional syringe. Better yet it may eliminate the practice among clinicians of putting 6 or 7 mil of medication in a syringe to compensate for loss when you need 5 mL to get 10.5 doses

“Integra allows you to get 11 or 12 doses out of that vial, for every 10-dose vial. So instead of treating 10 patients, you can treat 11 or 12. So if you have a shortage of vaccine, more patients end up getting treated.“

World fears of a possible flu pandemic have fueled efforts by BD and other companies to reduce the waste of flu vaccine in needles and syringes. Goldman says the BD Integra could play a major role if, as experts predict, such a pandemic becomes a reality.

The Integra was evaluated at the Employee Health Department at Texas Children's Hospital (Houston) and at Test-med (San Francisco), an on-site influenza vaccination provider. In the latter trial, a total of 100 vials were used to evaluate the device during scheduled employee influenza vaccine clinics. The results were encouraging, with clinicians drawing greater than 10 full doses from 52% of the 100 vials.

Protecting healthcare workers from accidental needle sticks is one of the reasons why clinicians are showing increasing interest in the Integra syringe, says Goldman.

Their first concern is for their patients, however. The clinician's ability to read the gradations along the barrel of a syringe or needle, for example, and put in the right amount of medication is an important consideration in their selection of hypodermic products.

“Integra reduces the risk to the patient by having very clear barrels and very readable scales so that, A, the person can accurately read the scale and get the right dose in there for the patient, and B, easily see if there are contaminants floating around that would cause them to throw it away rather than inject it into the patient.“

While the Integra Retracting Tuberculin and Insulin Syringe is available globally, sales to date are confined largely to U.S. hospitals, clinics and doctors' offices. That, says Goldman, is largely due to the fact that “the U.S. is so far ahead of the curve“ in the development of safety engineered hypodermic devices.