Assessment of breakage resistance of Improvacuter® venous blood collection tubes under standardised drop testing conditions

Abstract

Blood collection tubes are integral to diagnostic workflows but are routinely exposed to mechanical stress during handling, transportation, and routine laboratory processing. Structural failure of these tubes may result in specimen loss and pose potential biohazard risks to healthcare personnel. This standards-based verification study evaluated the breakage resistance of six categories of IMPROVACUTER® venous blood collection tubes. A total of 108 tubes from three independent manufacturing lots were filled to their nominal draw volumes and subjected to a standardised 1 m drop test, with three consecutive drops per tube onto a concrete surface. Following testing, tubes were inspected for visible cracks, leakage, breakage, or cap dislodgement. Evaluation criteria were based on ISO 6710:2017 and ISO 2859-1 (AQL 1.5), with a predefined practical acceptance criterion of at least 90% passing per tube category. The overall pass rate was 94.4% (102/108; 95% CI, 88.3%–97.9%). Citrate tubes achieved a 100% pass rate, while Gel & Clot Activator, EDTA K2, Heparin, and Glucose tubes each demonstrated a 94.4% pass rate. Clot Activator tubes showed a pass rate of 88.9%. These findings indicate high breakage resistance under the standardised drop-test conditions evaluated; other performance characteristics were not assessed.