madman
Super Moderator
Conclusion
Authentic needle and drug-containing devices were used in order to provide a realistic assessment of the potential for limitations of usability with the SCTE-AI device. Results of this usability validation study indicate the low potential for physical harm associated with use of the device. Results of the study indicate that there is residual risk of (i) not checking the expiration date and (ii) holding the device in place long enough to ensure a complete dose.
The SCTE-AI is intended for use in the at-home setting by the patient or a non-patient caregiver. It may also be used in hospitals, clinics, long-term care and home care settings on adult patients by health care professionals that includes nurses or home health care professionals who may assist patients to use the device in clinical care or home settings. Compared to trained participants, success rates were lower in untrained users who did not read the IFU (reading the IFU improved success rates). From a clinical perspective, these results suggest that it is ideal for each newly prescribed patient to be provided with a first-use in-office specific training on how to use the SCTE-AI. Subsequent to the first-use training, our results suggest a success rate >80% for patients or caregivers with use of the SCTE-AI with minimal use errors.
Overall, the testing in this study is regarded as successful in demonstrating the objective of minimizing the occurrence of preventable use errors. The SCTE-AI device is safe and intuitive to use; is associated with a high rate of injection success, regardless of prior training or experience; and provides patients with an alternative to IM/topical T formulations.
Authentic needle and drug-containing devices were used in order to provide a realistic assessment of the potential for limitations of usability with the SCTE-AI device. Results of this usability validation study indicate the low potential for physical harm associated with use of the device. Results of the study indicate that there is residual risk of (i) not checking the expiration date and (ii) holding the device in place long enough to ensure a complete dose.
The SCTE-AI is intended for use in the at-home setting by the patient or a non-patient caregiver. It may also be used in hospitals, clinics, long-term care and home care settings on adult patients by health care professionals that includes nurses or home health care professionals who may assist patients to use the device in clinical care or home settings. Compared to trained participants, success rates were lower in untrained users who did not read the IFU (reading the IFU improved success rates). From a clinical perspective, these results suggest that it is ideal for each newly prescribed patient to be provided with a first-use in-office specific training on how to use the SCTE-AI. Subsequent to the first-use training, our results suggest a success rate >80% for patients or caregivers with use of the SCTE-AI with minimal use errors.
Overall, the testing in this study is regarded as successful in demonstrating the objective of minimizing the occurrence of preventable use errors. The SCTE-AI device is safe and intuitive to use; is associated with a high rate of injection success, regardless of prior training or experience; and provides patients with an alternative to IM/topical T formulations.
