Blood-transfusion devices

Description

The TSCD II is used across various processes in Blood Establishments, including: Component pooling Leukoreduction Pathogen reduction Collection set modification Component aliquoting Quality control sampling. The TSCD 11s are currently in use in various Blood Establishments (BEs) in Europe, including the Irish Blood Transfusion Service, Scottish National Blood Transfusion Service, Northern Irish Blood Transfusion Service, Welsh Blood Service and the National Health Service Blood & Transplant. Each BE identified above has a fleet of devices of varying ages, the number of devices used is based on the throughput of processing for each BE. Devices greater than 10 years old will no longer be supported by the manufacturer Terumo. In order to ensure continuity of production and compliance with EU Blood Directive 2005/62/EC (standards of quality safety) and the Red Book, the BEs need to replace these older devices and have fully comprehensive maintenance on the systems.There is a contract in place with Terumo and the above BES for the provision of comprehensive Maintenance for TSCD II (United Kingdom-Bristol: repair and maintenance services of medical and precision equipment — 2019/S 126-309240). Quantities will be in the region of 98 devices over a term of 4 years. The BEs reserve the right to procure extra devices if required from a safety or operational perspective over the term. Terumo is the end manufacturer of the TSCD II, it is not operationally feasible or clinically acceptable to have more than one supplier to provide the device and maintenance support for the same technology (TSCD II) from a risk perspective. BEs need to ensure that the appropriate indemnities are in place in the case of any claims, having more than one supplier of the same technology and maintenance increases exposure of the BEs. Terumo BCT Europe NV are the sole manufacturers and providers of TSCDII devices and the maintenance for these devices in UK and Ireland there are no other authorised distributors, agents or sellers for the UK or Ireland.