Abstract
Significant variation between manufacturers exists in the force required to insert transfusion set spikes (closure-piercing device) into blood pack ports. This potential source of difficulty can impact directly on patient and staff safety (delayed transfusion, contamination of blood components, wastage, blood spillage and staff injury) and is not predicted or prevented by conformance of these medical devices to relevant International Organization for Standardization (ISO) standards. A quantitative, objective measurement of insertion force is described together with an assessment of factors affecting compatibility between the port and spike. Several advantageous and disadvantageous design features are identified and are being addressed through ISO Technical Committee 76 Work Group 1.
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