JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

27.1: Introduction

This chapter defines the requirements of the UK Blood Transfusion Services for the labelling by the manufacturer of ‘stand-alone’ consumable medical devices (critical consumables) used in the production of therapeutic blood components and tissues.

These devices are distinct from blood bags (either individual bags or within a blood pack or apheresis set assembly, including those pre-filled with anticoagulant or preservatives) that are described in Chapter 26 and tissue containers which are described in Chapter 24.

This specification applies to:

  • stand-alone intravenous (IV) and other solutions including:
    • preservatives and additives (e.g. platelet additive solution)
    •  saline
    •  dextrose and dextran
    •  anticoagulants
    •  pathogen inactivators
       
  •  filters (e.g. leucodepletion, prion filtration)
     
  •  fluid transfer sets
     
  • injection sites, clamps, one-way valves.