Vial-based auto-injector solution enables continued treatment for patients unable to access healthcare facilities
Ilan Shopen | 18.08.2021
The COVID-19 pandemic took the world by surprise and its impact was unprecedented around the globe, no more so than in the healthcare field. Recent months have highlighted the important role of healthcare providers, medical device suppliers and pharmaceutical companies in accelerating the development and introduction of new vaccines and medical treatments, which have mitigated the negative impact of the pandemic on the global economy. In particular, it has become obvious that solutions are required which will enable patients to continue to receive safe and consistent care, without necessarily being able to physically attend a clinic or treatment center.
During the crisis which resulted from the pandemic, many medical staff and their organizations endeavored to find practical solutions for patients who had been deprived of access to medical centers other than in emergency situations, which could create inconsistency in treatment, with potential detrimental effects on patients’ health.
In one enquiry to Elcam E3D, a resident doctor from Mount Sinai Hospital contacted our team and explained the urgent need of his patients, who were unable to visit his clinic in order to receive an injectable drug treatment that must be administered every week over a period of several months. After undertaking internet searches for an effective solution to the problem, he had discovered E3D’s Flexi-Q DV device (Disposable Auto-injector for liquid form Drugs in Vials) which he believed could be used for the benefit of his patients.
The doctor planned to prepare a package for each patient that would contain a ready-to-use vial of drug product, along with a Flexi-Q DV auto-injector device (with its operating instructions) and appropriate ancillary equipment (such as swabs and skin-disinfecting wipes). Such a self-injection package would enable patients to safely and correctly perform the preparation and injection of their drug treatment at home, without having to go to the clinic and without interruption to their treatment schedule.
Flexi-Q DV represents a unique, enclosed and integrated solution for preparation and injection of drugs, filled in vials, in a non-clinical environment. Flexi-Q DV is the only commercially-available device that provides such a user-friendly means for self-administration of vial-filled injectables, simplifying the process of drawing liquid from standard vials. With its fully-automated injection process and needle-safety features (whilst shielding the needle from view at all times), Flexi-Q DV provides a means for a patient to self-inject their required medication in the comfort and convenience of their own home.
The 510(k)-cleared Flexi-Q DV is intended for supply in sterile packaging, allowing a doctor in any clinic to prepare a home injection kit which contains a compatible approved drug. After removing the Flexi-Q DV from its package, the user connects the device to the drug-filled, by means of a Vial Adapter included within the pack, draws the required volume of drug into a syringe incorporated within the device, disconnects the Flexi-Q DV from the Vial Adapter and proceeds to inject. After the injection, the single-use Flexi-Q DV device can be disposed of in an appropriate waste container.
Another configuration of the same auto-injector device platform provides an integrated solution for reconstitution and automated injection of lyophilized drugs in vials – thereby offering a fully-enclosed and simple process for reconstitution of such freeze-dried drugs with diluent, prior to drawing up and injecting the reconstituted medication.
E3D is proud to be able to offer such innovative technologies within its wide portfolio of injection devices. This portfolio is focused on enabling patients to perform their own injections at home – or in other non-clinical environments – with a wide variety of injectable drug products and primary drug containers.