Background:Adrenaline autoinjectors (AAIs) are prescribed to facilitate the intramuscular administration of adrenaline in patients diagnosed with life-threatening anaphylaxis. This pilot study investigated the injection and functional properties of two AAIs (deploying different delivery systems) under standard conditions, after dynamic and mechanical stresses, and in the presence of denim.Methods:The differences between a cartridge-based AAI (EpiPen® Junior) and a syringe-based AAI (Anapen® Junior) were assessed using three sets of tests. Test 1: under standard conditions, the injection depth and dose were measured in ballistic gelatine (a validated tissue simulant). Test 2: before the safety cap removal and activation forces were measured, AAIs were subjected to either of two preconditioning tests: 1) free-fall drop test; or 2) static load (ie, 400 N, equivalent to 40 kg weight) test; or 3) no preconditioning. Test 3: under standard conditions, injection properties into ballistic gelatine in the presence and absence of denim were investigated. Statistical analyses were performed using the Student’s t-test or Welch’s test.Results:The maximum depth of delivery was significantly greater with cartridge AAI (n = 4, mean 21.09 ± 2.54 mm) than with syringe AAI (n = 5; mean 11.64 ± 0.80 mm; P = 0.003). After 2.5 seconds, cartridge AAI (n = 4) discharged significantly more dose than syringe AAI (n = 3; 74.3% versus 25.7% of total dose; P = 0.001). Both cartridge and syringe AAI withstood the free-fall drop test, but almost all devices failed to activate following the static load test. Under standard conditions, significantly less force was required to remove the safety cap of cartridge AAI than syringe AAI (both n = 15; mean 9.56 ± 2.36 N versus 20.23 ± 6.61 N, respectively; P < 0.001), but a significantly greater activation force was required for cartridge AAI than syringe AAI (mean 23.01 ± 3.96 N versus 8.06 ± 0.51 N, respectively; P < 0.001). The presence of denim did not alter the activation force or effective needle length of either of the AAIs.Conclusion:Cartridge AAI appears significantly more capable of consistently and rapidly delivering a clinically relevant dose of intramuscular adrenaline than syringe AAI. However, both devices showed shortcomings in their ability to sustain mechanical stress similar to that which is likely over their shelf life, and as such, may not be fit for life-saving purpose.
BackgroundAnaphylaxis is a medical emergency that requires the intramuscular injection of adrenaline using an adrenaline auto-injector (AAI). This study compared the robustness and performance characteristics of three AAIs available in Europe.MethodsThree AAIs (Jext®, EpiPen®, and Anapen®) were tested in terms of the force needed to activate the AAIs, exposed needle length, injection volume, and injection time. Three conditions were used to assess robustness: base conditions, after three successive free-fall drops from 1.5 m, and after a 40 kg static load challenge. The injection depth and estimated volume of solution delivered into ballistic gelatin were also assessed.ResultsLess force was required to remove the safety cap from Jext and EpiPen than from Anapen under base conditions. The required force was unaffected by free-fall drop tests, whereas the static load test significantly increased the force required to remove the safety cap from Jext (difference from base value 7.7 N; P < 0.001) and from EpiPen ( difference from base value 30.3 N; P < 0.001). Two Anapens could not be activated after the free-fall and static load tests. The mean exposed needle length was 15.36 mm (standard error [SE] 0.04) for Jext, 15.02 mm (SE 0.05) for EpiPen, and 7.49 mm (SE 0.15) for Anapen. The mean maximum injection depth in gelatin within 10 seconds was 28.87 mm (standard deviation [SD] 0.73) for Jext, 29.68 mm (SD 2.08) for EpiPen, and 18.74 mm (SD 1.25) for Anapen.ConclusionA comparison of the robustness and performance characteristics of the three AAIs showed that cartridge-based devices (Jext and EpiPen) appeared to be significantly more robust and capable of rapidly and consistently delivering the correct dose of adrenaline to the correct tissue compartment than the syringe-based Anapen. Overall, Jext performed better than EpiPen or Anapen following mechanical stress designed to mimic real-world use.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.