Decontamination and Sterilisation of NHSBT Instruments and Equipment

Tissue and Eye Services (TES) is a part of the Organ and Tissue Donation and Transplantation Directorate (OTDT) of NHS Blood and Transplant (NHSBT). TES provide high-quality, cost-effective tissue grafts for the benefit of patients, and every effort is made to ensure the safety and efficiency of our products. NHSBT Tissue and Eye Services are licensed by the Human Tissue Authority (HTA) for the retrieval, storage, processing and distribution of human tissue for transplantation throughout the UK. Wherever possible, single use disposable instruments are used for the retrieval and processing of tissue however there are certain instruments which are required to be reused.<br/><br/>NHSBT Reagents is a specialist function within the Clinical Services Directorate of National Health Service Blood and Transplant (NHSBT). NHSBT Reagents is located in Liverpool and produces a range of in vitro diagnostic products including those manufactured from red cell donations. Tubing and accessories required to be used on dispensing equipment require sterilisation prior to being reused to ensure that bioburden is minimised in the final product. <br/>NHSBT now wishes to commence a formal procurement process and is seeking to engage with suppliers and understand the market. <br/><br/>Business Requirements <br/>

• Wash and disinfect all instruments in accordance with the requirements specified in HTM 2030 Washer disinfectors including the use of softened and reverse osmosis.<br/>
• With an agreed number of NHSBT-TES kits being available, provide a 24 hour turn around service, not including weekends and bank holidays.<br/>
• Provide a shelf life on all kits of no less than 3 months.<br/>
• Decontaminate all instruments as a batch and ensure they are kept together during each stage of the process to ensure that devices are tracked to individual cycles of the washers / disinfectors and sterilisers.<br/>
• Inspect all NHSBT-TES kits for completeness upon receipt and again following washing and disinfection and prior to packaging and sterilisation. Any incomplete or damaged kit will be immediately reported to NHSBT-TES.<br/>
• Sterilise all re-useable instruments in a porous load steam steriliser at between 134ºC - 137 ºC for a minimum holding time of 3 minutes and ensure that they can be tracked to the individual machine and cycle number.<br/>
• Ensure compliance with all relevant Health Service Circulars and extant guidance relating to the decontamination of re-useable surgical instruments, particularly taking in to account guidance issued on Spongiform Encephalopathy Advisory Committee (SEAC), National Institute of Clinical Excellence (NICE) and Engineering and Science Advisory Committee –Pr (ESAC-Pr)<br/>
• Detailed draft specification will be shared while scheduling the premarket engagement call.<br/><br/>It is NHSBT's intention to hold premarket engagement meetings the week of 29th September 2025 to 3rd October 2025. The meetings will be held remotely; the dates are to be confirmed. To enable NHSBT to finalise arrangements (e.g., send meeting details and agree time slots) for the meeting’s, interested organisations are required to send an expression of interest via email to Sahithi Bandi sahithi.bandi@nhsbt.nhs.uk by no later than 25th September 2025. This should include a list of your potential attendees and a brief overview (or a website link) of the Goods / Services which might be offered. Please include options, if available, for a managed service contract.<br/><br/>No business whatsoever is guaranteed under any resulting framework agreement or contract, and there is no guarantee that any framework agreement or contract will be put in place in relation to this notice. No compensation etc. will be paid if a tender or resulting framework agreement is withdrawn for any reason. Bidders should take part in this process only on the basis that they fully understand and accept this position.<br/><br/>It should be noted that this procurement exercise may allow other Health authorities to use any agreements awarded.