non-DEHP Blood Pack Validation

Description

Following a change in EU legislation, DEHP plasticiser will be removed from medical devices, including blood packs. NHSBT wishes to commence a validation process in early 2024 for non-DEHP primary collection and ancillary blood packs. The project will have a duration of 2 calendar years from commencement.<br/><br/>Primary collection systems are for the collection of whole blood in two configurations ('bottom and top' and 'top and top').<br/><br/>Ancillary systems are for secondary manufacturing processes and subsequent storage, such as for pooled platelet concentrates or small volume neonatal components. Lot 1: Please note that this is not the start of a procurement process. A separate contract notice will be published to cover this requirement. The purpose of this Prior Information Notice (PIN) is to inform the market of prospective requirements, as far as the details are known at this time.<br/><br/>This PIN is being published by NHSBT on behalf of itself and potentially in collaboration with other Blood Services.<br/><br/>NHSBT seeks to understand the market’s ability to supply non-DEHP primary and ancillary blood packs and to validate these packs in order to support a potential future tender.<br/><br/>Subject to satisfactory agreements, the validation may be in collaboration with other Blood Services, potentially within the European Blood Alliance (EBA) or the Alliance of Blood Operators (ABO). To support validation of the blood packs and avoid duplication across multiple Blood Services, NHSBT will participate in the European Blood Alliance data sharing agreements, and will adopt the published EBA validation strategy as a framework for its own validation activities.<br/><br/>NHSBT intends to validate all non-DEHP blood pack systems that have received CE marking under EU MDR, or which have a credible application and timeline for receipt of the accreditation within the timeline of this validation project. Validation will consist of phase 0 and phase 1 activities. No components will be issued to patients.<br/><br/>Suppliers should contact Samantha Rix, samantha.rix@nhsbt.nhs.uk by 14 March 2024 to express their interest or for further information, should the Supplier have (or is likely to have) non-DEHP primary and ancillary blood packs which meet the criteria and timescales stated above. Additional information: Validation Project Timeline - April 2024 to March 2026<br/>Phase 0 = Physical examination of pack<br/>Phase 1 = small scale product/pack tests