Decontamination of surgical instruments

We welcome this report, which highlights the importance of effective sterile service departments in providing safe care and treatment to patients. We welcome the opportunity to consider what role we can play in providing oversight of the assurance that healthcare providers have of the safety of their sterile services – be those supplied in house or externally. We are currently developing a new regulatory model, underpinned by a new Single Assessment Framework, in order to adapt to changes in health and care. We’re committed to exploring how this recommendation could be incorporated to support improvements in safety for patients. There are clear links with the recommendations made to the Department of Health and Social Care and NHS England, which should lead to a more consistent approach and an agreement as to the most appropriate framework and standards that providers need to meet. We are pleased to have started to map out how we can work with our colleagues across the three organisations to progress this. Actions planned to deliver the safety recommendation: To consider, in developing the evidence requirements for NHS Trusts, whether evidence about assurance of sterile services can be included in the trust level well led assessment. This action is complete. Work with colleagues in DHSC and NHSE to determine what progress can be made on developing a single framework and / or standards against which a healthcare provider can assure themselves of the quality and safety of their sterile services, by March 2023. Resources in place: Agreement to attend working groups in Autumn 2022. Ongoing involvement in a reviewer capacity through to March 2023. Ensure that any outputs from this work are included in supporting guidance in the new Single Assessment Framework, by post March 2023. Resources in place: Existing policy team resources. Response received on 1 August 2022.

Health Technical Memorandum (HTM) 01-01 “Decontamination of surgical instruments” currently provides guidance to the NHS on this area. NHS England has a rolling programme to update Health Technical Memoranda (HTM’s) and Healthcare Building Notes (HBN’s). A formal process has been established to review all guidance in relation to its priority for updating based on relevant factors including the related risks, emergence of new technology, date of last review, available resources and changes by the NHS to clinical procedures. Actions identified in safety recommendations by the HSIB are included in these reviews. HTM 01-01 has been reviewed and the outcome is that it is not currently in our near term (next 4 year) prioritization, though it will be included in future reviews, so its status is subject to change. However, having reviewed your recommendations, NHS England: Have joined the Department of Health and Social Care’s oversight group for decontamination – whilst we appreciate recommendation R/2022/193 was for the Department of Health and Social Care, NHS England wanted to take a pro-active approach to best inform the next iteration of the HTM. Are proposing to undertake two discrete pieces of work to address your recommendations R/2022/194 and R/2022/195. Guidance resulting from this work is expected to be issued to the NHS as Technical Bulletins which will act as intermediate amendments to the HTM before its formal review. Our proposal is that we will start this work in financial year 2022-23 and we will update you once each item has been completed. Action planned to deliver the safety recommendation: NHS organisations will be provided with guidance on the safety recommendation setting out the changes required, by 31 March 2023. Resources in place: A proposal to deliver Technical Bulletins is being developed to issue actions such as these recommendations. Other dependencies identified: The proposed Technical Bulletins system will need approval from NHSE senior management. Response received on 1 November 2022.

Actions planned to deliver safety recommendation: Competency frameworks for major elements of NHS Estates work, and decontamination of surgical instruments is included in the list of areas to be included, by 31 March 2023. Resources in place: resources have not yet been identified for this work, but will be included in the budget requests for 2023-24. Response received on 1 November 2022. NHS England has released a technical bulletin on the competency framework for staff working in sterile services and decontamination departments . The bulletin outlines the knowledge, skills, abilities and behaviours required by staff working in decontamination units to ensure the highest standards of decontamination are achieved. Updated on 13 March 2024.