Gabler Feline, Heiden Pierre, Deibert Peter, Steinmann Daniel
Department of Anesthesiology and Critical Care, Medical Center-University of Freiburg, Freiburg, Germany.
Occupational Medical Service, Medical Center-University of Freiburg, Freiburg, Germany.
Front Med Technol. 2025 Apr 3;7:1505184. doi: 10.3389/fmedt.2025.1505184. eCollection 2025.
Preventing needlestick injuries caused by hypodermic needles is crucial for healthcare personnel. In this context, port access needles play an important role. However, systematic comparisons of different safety-engineered port access needles have not been conducted. Therefore, we evaluated differences in product characteristics and user preferences of safety-engineered protection mechanisms of port access needles.
Port puncture was performed using port access needles with four different safety mechanisms: (a) EZ Huber™ PFM Medical, (b) Gripstick® Safety OMT, (c) Gripper Micro® Smiths Medical and (d) pps ct® Vygon. Each needle type was used in three consecutive tries: an uninstructed first handling, after which instructions were given according to operating manual. Subsequently, a first and second trial were conducted. Study endpoints included successful activation, activation time, way of activation (one hand or two hands), correct activation, possible risk of needlestick injury, possibility of deactivation and preferred safety mechanism.
Overall, successful activation rate during the second trial was equal for all four devices (100%). Median activation time was (a) 6 s, (b) 3 s, (c) 11 s and (d) 6 s. Single-handed activation during the second trial was (a) 0%, (b) 75%, (c) 1% and (d) 1%. Single-handed activation after further preparation with two hands during the second trial was (a) 0%, (b) 0%, (c) 0% and (d) 50%. Correct activation during the second trial was (a) 97%, (b) 66%, (c) 19% and (d) 44%. Possible risk of needlestick injury during the second trial was highest with (b). Possibility of deactivation was (a) 75%, (b) 94%, (c) 97% and (d) 22%. Individual preferences for each system were (a) = 5, (b) = 2, (c) = 1 and (d) = 24. The main written reasons given for preference were the safety protection mechanism and handling of the port needle.
We have shown significant differences regarding product characteristics of safety mechanisms of port access needles. Our evaluation approach provides specific data for both, technical (e.g., single-handed activation) and personal device selection criteria (e.g., preference of the safety mechanism).
预防皮下注射针头导致的针刺伤对医护人员至关重要。在此背景下，端口接入针发挥着重要作用。然而，尚未对不同的安全设计端口接入针进行系统比较。因此，我们评估了端口接入针安全设计保护机制的产品特性和用户偏好差异。
使用具有四种不同安全机制的端口接入针对端口进行穿刺：(a) EZ Huber™ PFM Medical；(b) Gripstick® Safety OMT；(c) Gripper Micro® Smiths Medical；(d) pps ct® Vygon。每种针型连续使用三次：第一次无指导操作，之后根据操作手册给出指导。随后进行第一次和第二次试验。研究终点包括成功激活、激活时间、激活方式（单手或双手）、正确激活、针刺伤的可能风险、停用可能性以及首选安全机制。
总体而言，第二次试验中所有四种装置的成功激活率均为100%。中位激活时间分别为：(a) 6秒；(b) 3秒；(c) 11秒；(d) 6秒。第二次试验中的单手激活率分别为：(a) 0%；(b) 75%；(c) 1%；(d) 1%。第二次试验中双手进一步准备后的单手激活率分别为：(a) 0%；(b) 0%；(c) 0%；(d) 50%。第二次试验中的正确激活率分别为：(a) 97%；(b) 66%；(c) 19%；(d) 44%。第二次试验中针刺伤的可能风险以(b)最高。停用可能性分别为：(a) 75%；(b) 94%；(c) 97%；(d) 22%。对每个系统的个人偏好分别为：(a) = 5；(b) = 2；(c) = 1；(d) = 24。给出偏好的主要书面原因是端口针的安全保护机制和操作。
我们已表明端口接入针安全机制的产品特性存在显著差异。我们的评估方法为技术（如单手激活）和个人设备选择标准（如安全机制偏好）都提供了具体数据。
