BACKGROUND: Most needlestick injuries (NSIs) result from unsafe needle devices. DropSafe safety pen needle (SPN) was designed to help prevent such injuries before, during and after use through a built-in sharps injury prevention feature (SIPF). METHODS: A two-phase study was undertaken. For the pilot study, five non-healthcare users (NHCUs) performed evaluations. For the validation study, 30 evaluators comprising 10 healthcare professionals (HCPs) and 20 NHCUs performed evaluations. The aim of the study was to validate the performance of the SIPF of the SPN and to collect feedback from the evaluators on several aspects of the safety device. Participants performed simulated injections into an orange. RESULTS: The results show that no device failures were observed, and all manipulations were performed without a needlestick or without contact with the needle after injection. The safety feature of the SPN was activated successfully. It was shown that: the label on the seal was legible; the SPNs were easy to attach to the pen injector; injections were easy to perform; it was clear when safety feature was activated; removing the SPN from the injection pen was easy; and the written instructions were easy to understand. CONCLUSION: The performance of the safety feature of SPN was successfully evaluated in terms of the prevention of NSIs. User feedback demonstrate that the device's ease of use, handling and instructions for use ensure safety and effectiveness of the SPN when used as intended.
BACKGROUND: Most needlestick injuries (NSIs) result from unsafe needle devices. DropSafe safety pen needle (SPN) was designed to help prevent such injuries before, during and after use through a built-in sharps injury prevention feature (SIPF). METHODS: A two-phase study was undertaken. For the pilot study, five non-healthcare users (NHCUs) performed evaluations. For the validation study, 30 evaluators comprising 10 healthcare professionals (HCPs) and 20 NHCUs performed evaluations. The aim of the study was to validate the performance of the SIPF of the SPN and to collect feedback from the evaluators on several aspects of the safety device. Participants performed simulated injections into an orange. RESULTS: The results show that no device failures were observed, and all manipulations were performed without a needlestick or without contact with the needle after injection. The safety feature of the SPN was activated successfully. It was shown that: the label on the seal was legible; the SPNs were easy to attach to the pen injector; injections were easy to perform; it was clear when safety feature was activated; removing the SPN from the injection pen was easy; and the written instructions were easy to understand. CONCLUSION: The performance of the safety feature of SPN was successfully evaluated in terms of the prevention of NSIs. User feedback demonstrate that the device's ease of use, handling and instructions for use ensure safety and effectiveness of the SPN when used as intended.