Current uses of transfusion administration sets: a cause for concern?

Abstract

There is potential for inappropriate use of transfusion administration sets when used in combination with modern infusion pumps with consequences for patient safety. The aims of our study were to (i) establish if the design and testing of transfusion sets specified in International Standard ISO 1135-4 are adequate for their current applications, (ii) identify if infusion pumps currently supplied in the UK for blood component administration are suitable for this purpose and (iii) determine the additional control measures needed to be applied by manufacturers and users to ensure patient safety. Keyword literature search was carried out to review and correlate important transfusion parameters with resultant adverse effects. Units for occlusion pressure, flow rate and haemolysis were standardised for ease of comparison. A sample of transfusion set instructions for use was reviewed. Principal suppliers of infusion pumps to the UK market were surveyed to identify those sold for blood transfusion, their recommended operating parameters and compatible transfusion sets. Previous work showed clinically unacceptable haemolysis at pressures above 40 kPa. Modern infusion pumps operate under negative pressures of up to 210 kPa. ISO 1135-4 design and test requirements do not match this performance and in particular omit testing under negative pressure. Transfusion sets surveyed did not indicate flow or pressure restrictions or specify the blood components with which they had been validated. ISO 1135-4 requires updating and has been initiated. Meanwhile, recommendations are made for transfusion set manufacturers concerning pressure limitations and restrictions on blood component type and for users concerning purchase, configuration and validation of infusion pumps and disposables.