Blood pack fault monitoring

Abstract

The National Blood Service (NBS) has recalled blood components as a result of manufacturing faults, or defective blood pack component parts leading to the possibility of an 'open' system. There has been an increase in the complexity of blood packs as a result of leucodepletion, sample diversion and sampling. The NBS implemented a mechanism to collate and analyse blood pack faults as a safety and quality initiative in conjunction with blood pack manufacturers. Standard reporting forms were produced and implemented at all Centres. The forms were collated and analysed using statistical analysis software. Control charts were used to identify trends for specific faults, which were resolved with the relevant manufacturer. The overall defect rate per million for the three main blood pack manufacturers used by the NBS for the respective periods 2001, 2002 and 2003, were as follows: Manufacturer A, 1076, 1396 and 954; Manufacturer B, 1496, 1301 and 2169; and Manufacturer C, 1871, 1253 and 1392. Monitoring and analysis of blood pack faults has resulted in the identification and rectification of specific problems associated with blood pack manufacture and use. Close collaboration with manufacturers has enabled effective remedial action. Wider collation of data would provide an early warning of potential areas of concern.