Serafin Anna, Ryk Aleksandra, Fendler Wojciech
Regulatory Affairs Department, HTL-STREFA S.A, Ozorkow, Poland.
Department of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, Poland.
Expert Rev Med Devices. 2023 Jul-Dec;20(11):963-971. doi: 10.1080/17434440.2023.2254680. Epub 2023 Sep 11.
Needlestick injuries (NSIs) may potentially expose healthcare professionals (HCPs) to bloodborne pathogens. Safety needles are designed to protect against NSIs. We evaluated whether a new fully passive safety needle could be used safely by HCPs.
The passive safety needle was tested by physicians, nurses, and pharmacists in subcutaneous or intramuscular injection scenarios in simulation studies (1-3). Data collected included successes, close calls, difficulties, use errors, and failures. In study 4, HCPs rated the device safety (21-item questionnaire).
Overall, 104 participants completed 4772 simulated tasks, including 932 injections. 915 injections (98.18%) were performed successfully and no NSIs (0%) were observed in any of the studies. Studies 1 & 2: 84.15% tasks and 96.06% injections were completed successfully, but use errors occurred, mostly arising from the participants' mental model. There were no failures in Study 3. In Study 4, >98% of participants responded positively to every question, while all felt that the passive safety feature could eliminate NSIs and would better protect against bloodborne pathogens than other existing devices with active or semi-passive safety mechanisms.
The passive safety needle was used successfully by HCPs, did not lead to any NSIs, and was rated as the safest compared to similar devices.
针刺伤(NSIs)可能会使医护人员(HCPs)接触血源性病原体。安全针旨在预防针刺伤。我们评估了一种新型全被动安全针是否能被医护人员安全使用。
在模拟研究(1 - 3)中,医生、护士和药剂师在皮下或肌内注射场景下对被动安全针进行了测试。收集的数据包括成功案例、险些发生的事故、困难情况、使用错误和失败案例。在研究4中,医护人员对该设备的安全性进行了评分(21项问卷)。
总体而言,104名参与者完成了4772项模拟任务,包括932次注射。915次注射(98.18%)成功完成,且在任何研究中均未观察到针刺伤(0%)。研究1和2:84.15%的任务和96.06%的注射成功完成,但出现了使用错误,主要源于参与者的思维模式。研究3中没有失败案例。在研究4中,>98%的参与者对每个问题都给出了肯定回答,同时所有人都认为被动安全功能可以消除针刺伤,并且比其他具有主动或半被动安全机制的现有设备能更好地预防血源性病原体。
医护人员成功使用了被动安全针,未导致任何针刺伤,并且与类似设备相比被评为最安全的。