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exposed needles or sharps. As a result, many needle protected safety designs are now available across a wide range of medical products. However, more recently the focus has extended to providing safety products in the home environment where patients, carers and relatives can all be at risk of needlestick injuries. In this setting the design and ease of use of a safety device is integral to the therapy as a whole, especially since it may also have an impact on patient adherence. A crucial element of safe design is simplicity. For patients, a device with a minimum number of components is less intimidating and easier to use, while for manufacturers, a simple product is easier to reliably integrate into manufacturing processes.
UniSafe’s design consists of only four moulded plastic components, and no spring, which can be simply assembled with a prefilled syringe to create the final combination product. A simple design such as this is also advantageous for drug manufacturers as the resulting efficiencies in their production process facilitates scaling up and increasing capacity. A second important safety element is enabling automatic, or passive, deployment of the needle-shielding safety mechanism. During drug administration, once an exposed needle has been removed from the injection site, the user is still at risk of injury. To resolve this issue, UniSafe’s safety shroud fully encases the needle and it is automatically positioned as the user completes the injection procedure. Once injection is complete, the needle retracts into the safety shroud without any additional user steps. Since the procedure is the same as the usual injection technique with a standard syringe, the patient can focus on their injection and still be protected from potential sharps injury. Unique to UniSafe’s design is the mechanism that retracts the needle into the safety shroud. To date, safety syringes on the market have typically been designed with an internal spring, which activates the safety mechanism. However, using a spring comes with challenges. There is a risk that devices can pre-activate during transit; in addition the manufacturing process is complex where the spring is added to the device under high tension. UniSafe does not rely on a spring, which not only eliminates these issues but also adds to the overall simplicity of the device. Furthermore, the absence of
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a spring allows the patient to clearly see the contents of the syringe prior to administration and to confirm that the full dose has been delivered afterwards, a further critical element of safe medication delivery. Finally, safety devices should prevent the syringe plunger at the rear of the device from being completely removed. Removal can lead to drug leakage and wastage and in turn possible missed injections, as well as opening the door to tampering or re-use of devices that are single-use only. THE FUTURE OF SAFETY SYRINGES The design of safety devices is constantly evolving to better meet patient and healthcare professionals’ needs. In particular, there are ongoing efforts to identify opportunities for greater sustainability and increase device connectivity. Syringe-based devices such as autoinjectors are typically single-use only and are used by patients with reduced dexterity who need a larger device than a prefilled syringe to self-administer medication. The UniSafe platform is evolving with sustainability as a key consideration and future developments will include autoinjectors that can be reused rather than requiring disposal in clinical waste after each use. Increasingly in the future, autoinjectors will also include connected devices, allowing the transfer of information between patients, clinicians and payors. There is a growing need for this level of functionality in the pharmaceutical industry; measuring and improving adherence to therapies is of increasing importance to both improve patient outcomes and reduce drug wastage and unnecessary costs.
Author: GEORGE I’ONS - head of Product Strategy and Insights at Owen Mumford Pharmaceutical Services (OMPS)