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Both patients and nurses expressed very high levels of confidence in using the device in real clinical scenarios. In some of the scenarios the pen injector displayed a minor malfunction that could have occurred when the pen injector was used. The reactions of the nurses or patients were spontaneous and the inadvertent events were self-reported and did not require additional medical intervention. Patients and nurses reported that they would continue using the device in clinical and home settings.
The main issue patients reported in relation to the pen injector was the difficulty in injecting the medication, which occurred mainly when the target site was superficial, when the pen needle was not inserted properly or when the injection speed was too rapid. The same injection profile was one of the scenario where patients reported that the target site was not “visible”.
Related to patient safety, one of the most common issues reported was the injection-site bruising, which occurred as a result of the patient’s inability to inject the pen in a very tight space in the muscle. To mitigate this issue, the Bemfola pen injector and its related educational tools clearly instruct the user not to inject in areas of sensitive tissue (i.e. vein, tendon, tendon sheath, and nearby joints).
The injection-site bruising as stated by nurse and patient can be prevented by training personnel, providing demonstration by the manufacturer, patients training and proper, detailed instruction regarding the purpose and use of the pen injector.
This study met its primary objective, which was to evaluate the impact of human factors on the use of the Bemfola pen injector with special focus on the convenience, safety, and ease of use (especially the adaptation of the dosage). Results showed that there was no significant risk of any critical/major errors occurring in any of the tests, by either nurses or patients, which could have in turn resulted in an incorrect injection process. Both patients and nurses rated highly the ease of use, ease of teaching, and easiness continuing with the same dose or of changing dose in diverse scenarios, which could occur during standard clinical practice. In addition, both patients and nurses would have felt very confident in using the pen alone at home.
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