Travanty Michael N, Calawa Bryon, Shalaby Waleed S, Jozwiakowski Michael J, Haraldsen Kyle B
Product Development, Antares Pharma, Minneapolis, MN, USA.
Research Department, Design Science, Philadelphia, PA, USA.
Med Devices (Auckl). 2018 Jul 24;11:241-252. doi: 10.2147/MDER.S157114. eCollection 2018.
Current administration of hydroxyprogesterone caproate (HPC) by intramuscular injection is associated with limitations, including the potential for human error and contamination, patient anxiety, and increased risk of needlestick injury.
To describe the design of an auto-injector for subcutaneous (SC) administration of HPC and the results of studies that evaluated the target user's understanding of the proper use of this device.
A single-use, prefilled, fixed-dose, disposable auto-injector intended for the SC administration of HPC was developed, and its usability by health care providers was evaluated in 3 formative (N=32, 64 injections) and 3 validation studies (N=45, 90 injections). These studies consisted of one-on-one testing sessions performed in a simulated home environment. Analyses were based on observed use error or use difficulty during the performance of specific tasks, including those considered critical (associated with high severity harms).
In the formative studies, the majority of participants correctly administered an injection with the auto-injector, but prior training improved performance. Specific errors were noted, including holding the device at the injection site for a period inconsistent with its instructions for use (IFU). The IFU was modified to reduce potential occurrence of these errors. Use errors were subsequently observed on critical tasks in the first and second validation studies, including hold-time errors that were attributed to using visual cues rather than counting seconds. For the third validation study, the IFU was modified to focus on visual cues and all users were able to successfully perform the injection per the IFU.
An auto-injector device for SC administration of HPC for reduction in risk of recurrent preterm birth was successfully developed through iterative design and validation testing. The device design provides high usability and acceptance of this device by health care professionals.
目前己酸羟孕酮（HPC）通过肌肉注射给药存在局限性，包括存在人为错误和污染的可能性、患者焦虑以及针刺伤风险增加。
描述一种用于皮下注射HPC的自动注射器的设计以及评估目标用户对该设备正确使用理解情况的研究结果。
开发了一种用于皮下注射HPC的一次性、预填充、固定剂量、一次性使用的自动注射器，并在3项形成性研究（N = 32，64次注射）和3项验证性研究（N = 45，90次注射）中评估了医护人员对其的可用性。这些研究包括在模拟家庭环境中进行的一对一测试环节。分析基于在执行特定任务期间观察到的使用错误或使用困难，包括那些被认为关键的任务（与高严重程度危害相关）。
在形成性研究中，大多数参与者正确地使用自动注射器进行了注射，但预先培训提高了操作表现。注意到了特定错误，包括在注射部位握持设备的时间与其使用说明书（IFU）不一致。对IFU进行了修改以减少这些错误的潜在发生。随后在第一项和第二项验证性研究的关键任务中观察到使用错误，包括归因于使用视觉提示而非数秒的握持时间错误。对于第三项验证性研究，对IFU进行了修改以侧重于视觉提示，并且所有用户都能够按照IFU成功进行注射。
通过迭代设计和验证测试，成功开发了一种用于皮下注射HPC以降低复发性早产风险的自动注射器设备。该设备设计具有较高的可用性，并得到了医护人员的认可。
