Improving compatibility between blood packs and transfusion sets

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.

An evaluation of proposed changes to International Standards for blood bags and transfusion sets to improve their compatibility

“…Spike insertion force tests on this further sample of siliconized spikes gave acceptable, consistently low forces with ports from all suppliers in agreement with the original study (Nightingale, 2006). Findings support the draft revision of ISO 1135‐4 that now refers to the beneficial effect of surface treatment of the spike in improving compatibility with a wider range of port designs.…”

“…Results of all insertion force tests were between 20 and 27·5 N. Forces of less than 35 N are considered acceptable (Nightingale, 2006).…”

“…Proposed changes to international standards for blood bags (BS EN ISO 3826‐1, 2003) and transfusion sets (BS EN ISO 1135‐4, 2004) summarized in Table 1 provide a potential resolution when adopted by manufacturers. Proposals are based on previous investigations to improve compatibility between these medical devices (Nightingale, 2006). However, before embarking on major and costly changes to manufacturing processes, manufacturers and users required evidence that the proposals would not unintentionally worsen the situation.…”

“…A minimum of 26 connections between each combinations of port and spike were tested using pressure and pull tests and three connections for spike insertion force as shown in Table 2. The spike was inserted in the standardized manner previously described (Nightingale, 2006), and an assessment was made of any leakage during insertion of the spike (pre-piercing).…”

“…Difficulties arising from the poor compatibility of some blood bag and transfusion set combinations and their associated safety implications have been described previously (Nightingale, 2006). They remain a significant and ongoing patient safety issue (Clarke, 2007;Clarke et al, 2007).…”