DropSafe safety pen needle helps to prevent accidental needlesticks after injections: results of a simulated clinical study

Abstract

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.

Patient-Reported Preference and Clinical Efficacy of Insulin Pen Devices With Safety Needles in Adolescents and Young Adults With Type 1 Diabetes: A Prospective Study

“…Likewise, Veronesi et al [24], highlighted that the compatibility and simplicity of SPN contributed to a high satisfaction (85%) among the general hospital nurses in northern Italy. Our findings also run in parallel with a recent report by Malinowski et al, in which the SPN was associated with ease-of-use, user satisfaction, and a low incidence of needlestick injuries [11].…”

“…Safety pen needles (SPN), which were primarily introduced for hospital settings, can reduce accidental puncture risk through a retractable shield that automatically lockouts the needle after injection [10]. Recent reports highlighted that SPN was associated with ease-of-use, users' satisfaction, and a low incidence of needlestick injuries [11]. Moreover, it was shown that the use of SPN needed no additional education for the patients who self-administrated their insulin [12].…”

Clinical Application of a Safe Blood Sampling Device with an Indwelling Needle

“…Studies show that the incidence of needlestick injury among nurses in China was 57.3% [ 2 ]; the incidence among intern nurses is even higher, about 60.8% [ 3 ]. Safety needles can be selected to effectively avoid such accidents [ 4 , 5 ]. Traditional blood sampling devices need to press open the catheter valve inward to facilitate inserting a syringe into the valve in order to draw blood.…”