BD Medical - Pharmaceutical Systems, Becton Dickinson and Company , Le Pont De Claix, France.
Global Clinical Development, Becton Dickinson and Company , Le Pont De Claix, France.
Expert Opin Drug Deliv. 2020 Oct;17(10):1485-1498. doi: 10.1080/17425247.2020.1796630. Epub 2020 Aug 9.
User experience was compared between a new pre-fillable 2.25 mL glass syringe equipped with an ultra-thin-wall (UTW) 8 mm staked needle and a marketed BD Neopak™ syringe equipped with a special-thin-wall (STW) 12.7 mm staked needle.
Participants simulated subcutaneous injections with both syringes alone (formative Human Factors study) and in combination with a needlestick-prevention device (validation Human Factors study).
Usability results of both studies showed higher success rates for delivering the full dose of 2 mL viscous solution (30 cP) with the 8mmUTW syringe than with the 12.7mmSTW one (63% vs. 42% in the formative study). The use of the 8mmUTW syringe demonstrated also better ease of use and acceptance results and 72% of formative study participants preferred this new syringe over the current one when delivering the viscous solution. Using a shorter needle also showed a benefit in decreasing the injection-related anxiety. Besides, in the case of a non-recommended injection technique, the calculated risk of accidental intramuscular injection is reduced by 2 to 13 times with the 8mmUTW syringe.
Altogether, the results obtained demonstrated an improvement of the user experience with this new syringe compared to the current one in the manual delivery of 2 mL viscous solutions.
比较一种新的预填充 2.25 毫升玻璃注射器,该注射器配备有超薄壁(UTW)8 毫米焊接针,和一种市售的 BD Neopak™注射器,该注射器配备有特殊薄壁(STW)12.7 毫米焊接针,两者的用户体验。
参与者单独使用(形成性人因学研究)和与针防护装置联合使用两种注射器进行皮下注射模拟(验证性人因学研究)。
两项研究的可用性结果均表明,在注射 2 毫升粘性溶液(30 cP)时,8mmUTW 注射器的全剂量递送成功率高于 12.7mmSTW 注射器(形成性研究中分别为 63%和 42%)。8mmUTW 注射器的使用还显示出更好的易用性和可接受性结果,在注射粘性溶液时,有 72%的形成性研究参与者更喜欢这种新注射器。使用较短的针也显示出在降低注射相关焦虑方面的益处。此外,在不推荐的注射技术情况下,8mmUTW 注射器将意外肌内注射的计算风险降低了 2 至 13 倍。
总之,与当前的注射器相比,这种新注射器在手动输送 2 毫升粘性溶液时,用户体验得到了改善。