Improving compatibility between blood packs and transfusion sets

Clarke, Gwen; Hannon, Judith

doi:10.1111/j.1365-3148.2006.00723.x

Cited by 4 publications

(3 citation statements)

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“…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). 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.…”

Section: Proposed Amendments To the Design Requirements Of Internatiomentioning

confidence: 99%

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

Nightingale

Leimbach

2008

Transfusion Medicine

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Difficulties arising from the poor compatibility of some blood bag and transfusion set combinations remain a significant, ongoing patient safety issue. Proposed changes to international standards based on previously published findings provide a potential resolution when adopted by manufacturers. The aims and objectives of this study were to demonstrate that changes to ISO 3826-1 and 1135-4, especially surface treatment of the transfusion set spike (siliconisation) to reduce insertion force and accidental spiking will not result in: 'Pre-piercing' of the port membrane; difficulty in inserting the spike; leakage from the spike/port connection or unintentional removal of the spike during transfusion. The performance of connections (ports from five and siliconized spikes from two manufacturers) was assessed by a range of physical tests including: pressure tests for leakage at 50 kPa (1.5 bar); static stress (pull) tests at 15 and 20 N. Spike insertion force tests were repeated to challenge original findings. Of the 280 connections tested, there was one dubious pressure tests fail (<10 microL), no pull test failures at 15 N and one at 20 N. Spike insertion forces were acceptable and consistently low with ports from all manufacturers. Findings confirm the benefits of siliconized spikes in improving compatibility between transfusion sets and blood bags. This study does not indicate that the evaluated spikes would be subject to unintentional removal or leakage when used in accordance with manufacturer's instructions. Pressure and pull tests on spike/port connections are a valuable addition to ISO 3826-1 and 1135-4 for manufacturing design validation and quality control purposes.

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Section: Proposed Amendments To the Design Requirements Of Internatiomentioning

confidence: 99%

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

Nightingale

Leimbach

2008

Transfusion Medicine

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“…1b ) and the force required to overcome that barrier is negligible. The issue of poor compatibility of blood bags and transfusion devices has previously been raised, mostly regarding the force that is needed for insertion and the stability of the connection [ 3 , 4 , 5 ].…”

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confidence: 99%