Universal SafeTMed Devices LLC approached us to help them design a single-use safety syringe to cost-effectively and safely administer medicine. Through many stages of refinement, we created a state-of-the-art needle stick prevention medical device that ensures safety first for healthcare workers and their patients.
How It Works
After the user fills the syringe and administers the medicine, a spring-loaded mechanism retracts the needle into the barrel and locks it in place so the syringe cannot be reused. This solution eliminates the risk to medical professionals of pricking themselves with a used needle.
The solution needed to satisfy requirements and constraints including usability for the healthcare worker, comfort at point of injection for patients, minimized syringe dead space to reduce wastage of medicine after delivery, and reduction of parts and complexity for manufacturability. We also designed an assembly sequence that encourages safety and shields the person assembling the product from needle pricks. The design is scalable across a full range of syringe sizes and is easily expanded to accommodate pre-filled applications.
Testing and Analysis
We conducted extensive product testing to ensure that the syringe would meet ISO standards and operate consistently. Our design needed to pass ISO 7864 and ISO 7886-4 certifications. We conducted; leak, lubrication, vacuum, force-to-operate, resistance to corrosion, and resistance to breakage tests. When a syringe didn’t pass one of these tests, we would isolate the cause of the failure and devise a solution. We experimented with different viscosities and amounts of lubricant to fine tune the performance of the syringe.
Our team assisted as needed with vendor management support that included coordination and project management of hardware and service firms that provide, quality assurance for FDA 510K, IP legal review, injection molding and contract manufacturing. We provided our client with project advice well-informed by our technical expertise and years of experience.
Universal SafeTMed Devices LLC received numerous world-wide patents on the Universal Safety Syringe®, for example:
US7918821B2 – Universal Safety Syringe®