PediJect Adjustable Dose Syringe for improving safety in children's medical emergencies

Background The latest UK data show that in 2018, 758 children had a cardiac arrest, of whom 575 (76%) died. 530 occurred out-of-hospital, of whom 466 died (87.9%), and 228 in-hospital, of whom 109 died (47.6%). Significant errors and delays in administering adrenaline during paediatric cardiac arrest contribute to these deaths. Preparation of adrenaline in children is complex and time-consuming, requiring precise calculation and administration under pressured circumstances. Adrenaline should be administered immediately once cardiac arrest is confirmed, and then every 3-5 minutes. However, studies have shown a 15 minute delay from ambulance arrival to adrenaline administration, with survival in children decreasing 9% for every minute delay. In addition, simulation studies reveal that 50-80% of emergency medications in children are given incorrectly. Aims and Objectives In this project, we will complete development of the PediJect, a dose-adjustable pre-filled syringe designed to reduce errors and delays in administering adrenaline to children in cardiac arrest. To operate the PediJect, the user twists the device to set the child's age (or weight if known), connects it to an intravenous cannula, and depresses the plunger to administer the correct dose. The PediJect removes the need for any calculations, prevents overdose, and prevents errors relating to adrenaline dilution or strength. Our proof-of-concept prototype has already demonstrated promising results in simulated emergency scenarios, reducing time preparing the initial adrenaline dose from 94 to 16 seconds, serious dosing errors from 50% to 25%, and near-misses from 50% to 12.5%. Methods During this project, we will develop the PediJect from a proof-of-concept prototype to a finalised production-ready device, working with a specialist engineering company to refine the mechanism for safety and useability, and to optimise for manufacture. We will perform testing in simulated emergency scenarios, with a realistic mannequin in place of the patient, at key points during the design process to collect user feedback and data on errors. This will guide development and facilitate preparation of the regulatory technical file. We will partner with a leading medical device manufacturer with experience manufacturing pre-filled syringes and selling into NHS supply chains to drive adoption. Timelines for delivery Over 24 months, we will conduct initial alpha-prototype design and useability testing (months 1-9), beta-prototype testing and simulation studies (months 9-18), and regulatory file compilation and IP protection (by month 24). Anticipated Impact and Dissemination We expect the PediJect will reduce time to administration and reduce medication errors involving adrenaline in paediatric cardiac arrest. This in turn is predicted to reduce mortality and improve neurological outcomes, reduce long-term NHS care burden and litigation costs, reduce staff worry and stress associated with emergency medication preparation, and reduce parental bereavement. By the end of the project, we will have a fully developed device that is safe and meets user needs, with a corresponding package of intellectual property, testing, and regulatory documentation. Our primary strategy is to license this package to a commercial partner. We will disseminate our results through academic publications, trade magazines, conferences, children s charities, social media channels, and our commercial partner.