Ritract Limited is pleased to announce that the clinical evaluation trial of the Company’s safety syringe conducted at St. Vincent’s Hospital (Sydney, Australia) has now successfully completed and the report received.
St. Vincent’s Hospital was chosen as the preferred evaluation site because it is well recognized as being a leading institution for infection control initiatives and evaluation of new medical technologies.
The Ritract® safety syringe trial involved more than 35 nurses on selected wards using over 200 hundred syringes. The aim of the trial was to evaluate the Ritract safety syringe to determine the suitability of the syringe as a safety device. The trial involved the use of the Syringe by Registered Nurses replacing the standard 3 ml syringe.
The participants were asked to comment on safety profile, usability, reliability and suitability of the syringe. The trial period was 3 months and involved the use of the syringe in subcutaneous and intramuscular injections. The performance criteria employed were as follows:
Safe and effective for clinical use – sterility, no leakage during injection, visibility of calibration, no undesirable side effects of abnormal patient reaction, effective in medication delivery.
Safety profile – must be reliable and reduce the risk of needlestick injury.
Usability – must be simple to use, suitable for most injection techniques/procedures, no accidents occur during use.
The Ritract Safety Syringe performed well and no product failures were reported.
Pat Manusu RN, the trial coordinator at St Vincent’s made the following conclusions about the hospital’s experience using the Ritract safety syringe:
- The Ritract Safety Syringe is easy to use and requires minimal staff training
- The syringe was judged by the Hospital to be suitable for intramuscular and subcutaneous injection procedures
- In assessing the safety aspect of the product the Ritract syringe negated the risk of needlestick injury to those involved in the injection procedure.
The trial coordinator further stated that: “there is no other syringe like the Ritract safety syringe available on the market. The Ritract syringe has a significant advantage over other safety syringes because the needle can be changed to suit the patient and the procedure. I believe that when the full range of Ritract syringes is available, it has the potential to replace all other syringes in the hospital, assuming the price is right. I would like to see the syringe made available on the State contract”.
Managing Director of Ritract, Rupert Northcott said "this result is a highly significant event for Ritract. Our world leading syringe design has now been subjected to rigorous clinical testing and has met all the criteria for acceptance and wide use in the demanding hospital environment. We believe that the St.Vincent's trial results are representative of what we expect to be repeated with other hospitals around the world".
Ritract is also pleased to announce the completion of a second trial of the Ritract safety syringe conducted in a General Practice setting at the clinic of the inventor Dr. Bruce Ingram, which also showed excellent results. Eight general practitioners and two practice nurses used the Ritract syringe in over 100 patients to perform a variety of injection procedures in patients ranging from young children to the elderly.
Using much the same assessment criteria as set for the St. Vincent’s trial above, the trial results showed that the Ritract syringe performed well when used in the following procedures:
- Subcutaneous injections on adults, children & infants
- Intramuscular injections on adults, children & infants
- Venepuncture on adults, children & infants
- Intra-articular injections in adults
- Aspiration in one adult
- Infusion of local anaesthetic prior to suturing and ring (nerve) blocks.
The trial coordinator reached the following conclusions:
- The Ritract safety syringe is suitable as a first line safety device for general practice. We believe that used correctly the syringe negates the risk of needle stick injury to those involved in the injection procedure.
- The syringe is likely to be a cost effective device as it can be used for a variety of procedures, and has the advantage of the user being able to select the needle of choice from standard stock.
- When a complete range of syringe sizes is available, the practice would consider a policy to use the Ritract safety syringe exclusively for all injections and in the meantime will continue to use the Ritract 3ml syringe.
Managing Director of Ritract, Rupert Northcott said "the Company’s mission is to help eliminate needlestick injury in the healthcare workplace. These two trials clearly demonstrate that the Ritract safety syringe can provide a safe alternative that will enable us to replace the use of unsafe syringes in hospitals and clinics around the globe. With the successful conclusion of these trials, we will complete the development of a full range of syringe sizes to supply the obvious need for this product. Volume production of the first one million 3ml syringes is already underway and we are now in a position to supply customers with a proven safety syringe.”
For further information please contact Rupert Northcott or John Bell on 02 8923 2512
Ritract Limited listed on the ASX on 18th December 2003 (ASX:RTL). Ritract is a medical devices company with patented products and technologies to meet the growing world demand for safety injection solutions. Ritract’s mission is to develop and market innovative, patented products and technologies that are safe, effective and affordable. To this end, Ritract has aggressively pursued the development of retractable, auto-disable safety syringe technology and has acquired the Needlesleeve safety needle technology to create a range of safety products designed to eliminate needlestick injuries from the healthcare workplace.