FAQs

Transflux™- Myths and Facts

 

MYTH: “The government regulations state that because the syringe manufacturer has labelled the syringe ‘single use’ it cannot be used with more than one patient.”

True:  When the power injector syringe is manufactured and supplied, it is expected to be used with the bundled connecting tubing and is labelled single use by the manufacturer.  Once it has been used this way, with an open fluid path to the patient’s intravenous line, it must be considered contaminated by body fluid and is deemed ‘used’ and unsafe for ‘reuse’ on another patient.  Nor is it considered safe to be reused by way of reprocessing to re-sterilise for resupply.

Medical devices are defined as ‘used’ once they are exposed to body fluids.

False: ...when the syringe becomes part of the Transflux system.  

Syringe/s that are attached to a Transset, and connected by the single patient use Transflux line, are considered part of the Transflux system.  The Transset and syringes operate in a closed system that is never exposed to body fluids and their contents remain sterile throughout the single session of use.

The syringe/s are protected and remain safe for a single session of multiuse when used as part of the Transflux system. In this manner, the role of the syringe has changed to that of a reservoir. This change in role constitutes an ‘off label’ use as it differs from the original manufacturer’s instructions for use.

Off label usage is common. It is not forbidden nor is it penalised by the Therapeutic Goods Administration of Australia (the TGA) where there is scientific proof and evidence that supports the safety of the change in use. The TGA recognises the way in which off label usage can facilitate innovation and progress in medicine.

In accordance with the Therapeutic Goods Act of 1989 [ref section 41BG, current 2015 issue] when a person supplies information for use that differs from the original manufacturer's instructions for use they are assuming the liability arising from that change in use. As the distributor and product sponsor to the TGA, we openly acknowledge this point.  By recommending the multi use of power injector syringes with Transflux, we take responsibility for this ‘off label’ use of the syringe.

The syringe is still ‘single use’, as it is used only once, for one single session of multi use.  Only one single connection is ever made to the syringe.

There is no regulatory basis whatsoever that prevents the end user from utilising any power injector and its syringe/s with the Transflux system.

See below to view the TGA’s response regarding direct comments about this subject.

 

MYTH“The syringe was not made to be reused.  It will break down and risk some kind of mechanical failure.”

Fact:  When power injector syringes are used with Transflux they work less hard, as much less pressure is required to deliver the same injection rates. The resistance of a tubing system is a function of cross sectional area and distance. The low volume tubings often supplied within a syringe pack present a significant resistance to injection. Transflux utilises a larger bore tubing and therefore the injection pressures can be expected to be around ⅓ of those normally seen with the supplied low volume connection tubing. With Transflux, the injection pressure display is more informative as it is telling you what is happening at the IV cannula.

Typical syringes are manufactured to a high standard and a maximum operating pressure of around 400psi, so doing a series of 20-100 psi injections presents no problem. We have vast amounts of post market surveillance that clearly demonstrates the ability of power injector syringes to perform a session of multi use without even the slightest hint of fatigue. 

See below to view the TGA’s response regarding this subject.

 

MYTH:  “We have been told about cross infection risks with systems like this.”

True: …when simplistic and rudimentary arrangements of tubing are used with syringes and reused multiple times, there is a documented risk of cross infection. 

False: However, Transflux is has been specifically designed to eliminate the risk of cross infection and addressing this very risk was the guiding principle and focus in the design process.

Early testing of the concept (using insulin because of its very low level of detectability) demonstrated that one way valves 'off the shelf' were not up to the task and so the valves used in Transflux were especially developed. The valve design and Transflux were awarded international patents in 2006.

It is worth noting that there are multiple valves used in the Transflux system. When valves are linked hydraulically their individual performance goes up exponentially as they support one another by way of a direct pressure interaction. When using Transflux, back flow and diffusion are impossible. Nominal venous pressure ranges from 0.05 - 0.14 psi and the performance of each individual valve is tested at the time of manufacture to several orders of magnitude higher than this. The valve has a burst pressure of 800 psi.

The independently produced and published peer reviewed Study on the Microbial Safety of an Infusion Set for Contrast-Enhanced Imaging [Apr 2012, Investigative Radiology {hyperlink}] utilised an extraordinarily sensitive method to detect any possible contamination of the multi-use section. This radioisotope technique [ref Overview of Translational radiopharmaceutical research, World Journal of Methodology Dec 2013] is sensitive down to the femto-mole, which is effectively the ability to be able to detect a single molecule in one million billion (1 in 1,000,000,000,000,000). This study has been accepted by government authorities and experts as robust scientific proof of 100% safety. Transflux has been in continuous use for over 10 years.

 

Transflux is the only scientifically proven 100% safe multi use contrast delivery system.

 

Click below to view the TGA’s official response regarding the safety of syringe multiuse.

 

Safety study

The safety of Transflux™ products are proven by a safety study of the Catholic University of Leuven, BE. and published in Investigative Radiology’ Volume 47, Number 4.

It concluded that the study proves the convincing advantage of using the Transflux patient-delivery system in terms of microbial safety and cost-benefits.