Port access needles, used for accessing implanted ports, play a crucial role in providing reliable and convenient access to the vascular system (1). Despite their significance, issues related to safety and the potential for needlestick injuries remain a concern (2–4). In this context, various safety-engineered protection mechanisms have been introduced in the clinical setting to solve the general problem of needlestick injuries (5). Nevertheless, needlestick injuries still occur, even after education and training with devices containing safety-engineered protection mechanisms (6). Looking at factors affecting the occurrence of needlestick injuries on the level of tool and technology factors, the use of personal protective equipment had the highest relative weight followed by the safety design of devices (7).
For designing safety-engineered protection mechanisms, detailed specifications such as the ability to activate the device with one hand are described by current regulations (8–10). To date, a wide range of devices with safety-engineered protection mechanisms have been introduced, including blood collection needles, winged blood collection needles, peripheral intravenous catheters and port access needles. Several studies have been conducted to evaluate different types of safety-engineered protection mechanisms (2, 11–14). These investigations repeatedly found that most injuries occur before or even during activation of the safety-engineered protection mechanism, highlighting the impact of the mechanism itself on the prevention of needle-stick injuries and the need for ongoing optimization of safety-engineered protection mechanisms (15–19).
In the context of available frameworks for implementation of sharp injury preventing programs (8, 10, 20), we proposed a systematic model-based user evaluation of devices with safety-engineered protection mechanism prior to clinical implementation (21). To date, only few user-acceptability studies prior to introduction of safety-engineered port access needles into the clinical area have been published (22–24). New promising approaches focus on virtual reality and corresponding haptic simulation methods, enabling training, evaluation and design optimizations (25–28); however, virtual reality technology is still challenging to simulate fine motor interactions (29). In a previous study, the Polyperf® Safe (PPS) Huber needle was evaluated in cancer patients (22). Compared to the standard Gripper® needle in this study, most nurses were convinced that the PPS needle was safer than the Gripper® needle. However, this study was solely based on questionnaire evaluations with no further information regarding safety aspects. Hence, a systematic comparison of different safety-engineered port access needles and their underlying fundamental mechanisms has not been conducted. Therefore, we expanded our model-based user evaluation of devices with safety-engineered protection mechanism using a lifelike simulation model for port access needles.
In this randomized lifelike model-based study, we hypothesized that significant differences in product characteristics and inexperienced healthcare personnel would reveal user preferences of safety-engineered protection mechanisms of port access needles.