In the parenteral industry, Needlestick injuries remain a global concern with over 3 million exposures to blood occurring every year according to the World Health Organization (WHO).
Sharps injuries result in not only health issues but also psychological and costs issues. In order to overcome those problematic, regulation and recommendations have been established in order to improve patients and health workers conditions. Within those texts, safety devices for prefilled syringes (more precisely automated engineered safety devices) have been highlighted as a key route of improvement. Nemera has developed Safe’n’Sound®, a customizable platform of add-on passive safety devices for prefilled, which not only responds to the recommendations of the US Federal Needle stick Prevention Act, 2000 and the Council Directive 2010/32/EU (aiding in the protection from potential Needlestick injuries), but also provide pharmaceuticals with innovative solutions responding to the new problematic of the parenteral segment.
Indeed, the rise of biologic drugs and the increasing trend towards home-care setting are raising new concerns. Even though self-administration is reducing treatment cost and intended to improve patient compliance, Needlestick injuries remain a concern. Biologics are also adding more complexity to the parenteral segment. Unlike typical drugs made from synthetic chemicals, biologics are produced from a living organism making them more complex drugs on size, complexity and value. Combining those two factors, it results in patients suffering mainly from chronic diseases with / without impairment who have to self-inject large volume drugs, highly concentrated, more viscous, sensitive and expensive. As a result, to overcome those problematic, innovative safety devices as Safe’n’Sound are required.
Safe’n’Sound is a customizable platform of add-on passive safety devices for prefilled syringes to aid in the protection from accidental needlestick. Safe’n’Sound is a single use device designed for naïve users and healthcare professionals. Safe’n’Sound is a patented product, 510(k) cleared which can be sold worldwide Safe’n’Sound is an open, adaptable and customizable platform to give flexibility to pharmaceuticals, and respond to user needs. From a user perspective, as a passive safety device, no extra gesture is required by the user with Safe’n’Sound compared to a naked syringe. The safety feature activates automatically at the end of the injection, easing the use. User interface has been integrated since the beginning in the design and development of the device, integrating many ergonomic features: a large thumb pad surface to smooth the injection; large built-in finger flange to facilitate handling; a round shape for easy and comfortable handling; a spring located at the syringe flange position to provide good visibility of the tip of syringe and able inspection of the drug even with low filling volume drugs. An optional add-on ergonomic extended finger flange has also been developed to improve the handling, gripping and comfort for the user.
From a pharmaceutical perspective, Safe’n’Sound has been designed to give flexibility to the laboratories being an open and customizable platform. Indeed, Safe’n’Sound is compatible with syringes of different filling volume (1ml & 2.25ml), flange type and suppliers. Safe’n’Sound is compatible with marketed ISO standard syringes allowing pharmaceuticals to use syringe from multiple suppliers and de-risk their supply. In order to respond to pharmaceuticals needs, Safe’n’Sound has also been designed to accommodate several flange types. To accommodate larger filling volume drugs and responds to biologics problematic, Nemera has also developed a 2.25ml version of Safe’n’Sound®. It provides pharmaceuticals flexibility on their dosage formulation, and an innovative safety device solution to equip their large volume drugs while responding to patients needs in terms of ease of use and safety.
In a more and more competitive environment, customization is critical. Flexibility is part of Nemera’s customer focus culture. Pharmaceuticals can leverage Nemera’s strong experience in manufacturing and development experience in the parenteral device segment to differentiate from competition with the utmost services and lead times. Potential customization of Safe’n’Sound are to color the add-on Extended finger flange and plunger rod, while improving brand imagery or facilitate drug dosage recognition. Many other customizations are possible. Please consult us your specific drug delivery requirements.