防针刺伤塑料安瓿开口设计研究

New plastic ampoule opening design for use without needles： an evaluation study

目的本研究重新设计软包装安瓿的开口，使其与注射器的乳头相吻合，以有效避免针刺伤。同时通过实验研究，检测该开口设计的合理性。方法本研究通过3D打印技术制作新型软包装安瓿模型30支，并经环氧乙烷灭菌处理，并用注射器注入2 ml蒸馏水。后应用无针技术抽取出蒸馏水，计算抽取量与注入量的差异（流失量）。并注入1 ml蒸馏水于营养琼脂平板，在（35±1）℃培养48 h，计算菌落数。该实验重复执行2次。对照组采用60支2 m1无菌蒸馏水注射液，采用传统方法抽取液体，同上述方法计算量差（多余量）及菌落数。结果试验组无菌蒸馏水流失量中位数为0．06 m1．95％CI为0．05-0．07 ml；对照组无菌蒸馏水多余量中位数为0．06 ml，95％CI为0．06—0．07ml，2组比较差异无统计学意义（Z=-1．194，P=0．233）。试验组2次实验共培养出8个菌落数（CFU），对照组4个，2组比较差异无统计学意义（P=0．224）。结论该新型软包装开口有助于医护人员有效避免针刺伤。且该开口设计与注射器吻合度好，且不导致液体残留，无针抽药操作也不会增加污染率，提示该设计适用于临床实践。

Objective To produce a plastic ampoule with an opening that fits syringe adapters to allow solutions to be drawn up without needles （to avoid needle stick and sharps injuries） and to test the effectiveness of the new design in terms of residual fluid volume and risk of microorganism contamination. Methods Evaluation study based on laboratory research was adopted. For the experimental group, 30 ampoules based on the new design were produced by 3D printing. The ampoules were sterilized and filled with 2 ml sterile water. The sterile water was drawn up without the use of needles, and the wastage fluid （i.e., 2 ml minus the quantity drawn up） was calculated. A 1 ml aliquot of sterile water from each ampoule was dropped onto a nutrient agar plate, and the number of colony-forming units was assessed after 48 h. For each ampoule, the experiment was performed twice. Sixty 2 ml glass-packaged sterile water injections constituted the control group. The fluid was drawn up with a needle, and the superfluous fluid and number of colony-forming units were assessed, as in the experimental group. Results The mean wastage fluid was 0.06 ml, 95%CI was 0.05-0.07 ml in the experimental group and the superfluous fluid was 0.06 ml, 95%CI was 0.06-0.07 ml in the control group, there was no significant difference between the two groups （Z=-1.194, P=0.233）. The number of colony-forming units was 8 in the experimental group and 4 in the control group, there was no significant difference between the two groups （P=0.224）. Conclusions The newly designed plastic ampoule opening could help health workers to avoid needle stick and sharps injuries when drawing up solution. The wastage fluid and microorganism contamination levels met the required standards, indicating that the new design is suitable for clinical application.