OBJECTIVE: Occupational risk of transmission of bloodborne pathogens represents a major challenge in prevention. Even though preventive recommendations to avoid needlestick injuries among healthcare workers include the use of needle protective devices, its use in developing countries is not a standard practice. This study aimed to measure, on experienced nurses, perception of performance characteristics and activation of the safety feature of a safety closed IV catheter system (BD Pegasus*), called catheter P, versus a non-safety device (BD Intima II † ) called catheter I in healthy volunteers. METHOD: Fifty-two nurses and 205 healthy volunteers participated in a prospective, randomized, controlled study in a simulated setting. Each nurse performed two insertions of each catheter (one in each forearm) in four study volunteers; the order of insertions was randomly assigned. Statistical analyses were performed to compare the performance of the two catheters regarding Overall Perception of Clinical Acceptability and Ease of Use. RESULTS:Overall acceptance of the device performance characteristics was 90% or more. In all cases, catheter P performed at least as well as catheter I. There were no differences in the insertion success rate between the two devices (93.7% vs. 96.2%). Activation of the safety feature of catheter P occurred 99.4%. Subjects' perception of pain was similar for both devices. Overall perception of clinical acceptability and ease of use were judged better for catheter P than for catheter I (p = 0.006, and p < 0.001 respectively). All clinicians strongly agreed that catheter P would protect them from needle stick injuries. CONCLUSIONS: Despite the study limitations, mainly its artificial setting and its inability to blind, the results indicate that the Safety Closed IV Catheter System with its safety feature represents a good alternative for IV catheter insertions that can help reduce the incidence of stick injuries in health care workers.
RCT Entities:
OBJECTIVE: Occupational risk of transmission of bloodborne pathogens represents a major challenge in prevention. Even though preventive recommendations to avoid needlestick injuries among healthcare workers include the use of needle protective devices, its use in developing countries is not a standard practice. This study aimed to measure, on experienced nurses, perception of performance characteristics and activation of the safety feature of a safety closed IV catheter system (BD Pegasus*), called catheter P, versus a non-safety device (BD Intima II † ) called catheter I in healthy volunteers. METHOD: Fifty-two nurses and 205 healthy volunteers participated in a prospective, randomized, controlled study in a simulated setting. Each nurse performed two insertions of each catheter (one in each forearm) in four study volunteers; the order of insertions was randomly assigned. Statistical analyses were performed to compare the performance of the two catheters regarding Overall Perception of Clinical Acceptability and Ease of Use. RESULTS: Overall acceptance of the device performance characteristics was 90% or more. In all cases, catheter P performed at least as well as catheter I. There were no differences in the insertion success rate between the two devices (93.7% vs. 96.2%). Activation of the safety feature of catheter P occurred 99.4%. Subjects' perception of pain was similar for both devices. Overall perception of clinical acceptability and ease of use were judged better for catheter P than for catheter I (p = 0.006, and p < 0.001 respectively). All clinicians strongly agreed that catheter P would protect them from needle stick injuries. CONCLUSIONS: Despite the study limitations, mainly its artificial setting and its inability to blind, the results indicate that the Safety Closed IV Catheter System with its safety feature represents a good alternative for IV catheter insertions that can help reduce the incidence of stick injuries in health care workers.