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

Abstract

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.

Extract of fetal membrane would inhibit thrombosis and hemolysis

“…These devices could be applied in the body e.g. engineered tissues or out of the body which are in contact with blood such as dialysis apparatuses, artificial cardiovascular machines and blood bags [1][2][3]. There are varieties of biomaterials to apply in medical devices with different pros and cons [4].…”

Eurobloodpack: a common European design for blood bag systems with integral leucodepletion filters

“…Anticoagulant fill was 66.5 ml of citrate phosphate dextrose (CPD) enabling collection of 427AE5-522AE5 ml of whole blood and additive solution (AS), 105 ml of saline adenine glucose-manitol (SAG-M) or an Plasma bags were to allow freezing to )80°C. Ports and transfer tubes complied with processing requirements and recent recommendations to ensure compatibility during use [6][7][8]. Other requirements included: A 500 mm compatibility line with a unique number repeated at 35-45 mm intervals; a collection needle with rigid sheath, bevel indicator and guard (to permanently sleeve the needle after use) and a sampling system with 35 ml pouch (maximum fill 40 ml), pre-fitted coupler for evacuated tubes from 3 to 10 ml and 'colour coded', 'non re-openable' clamp (to prevent the reverse flow of air ⁄ blood after filling).…”

Risk of Blood Bag Lesions Induced by Standard Transfusion Devices

“…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 ].…”