Safety recommendation
HSIB recommends that the Department of Health and Social Care assesses the benefits of a single regulatory and assurance framework for sterile services departments and implements the findings as required.
Response:
With thanks to the HSIB for their investigation, the Department of Health and Social Care (DHSC) accepts their recommendation to assess the benefits of a single regulatory and assurance framework for sterile services departments.
Officials in the Medical Technology Directorate at DHSC will form a working group with colleagues at the Medicines and Healthcare Products Regulatory Agency (MHRA), the Care Quality Commission (CQC), NHS England, and other stakeholders as required, to assess the benefits of the proposed regulatory change. The working group will meet in a round table format to discuss the feasibility and potential benefits of introducing a single regulatory and assurance framework. DHSC officials will also engage Government lawyers to establish the legal implications of the proposal.
Following conclusion of this engagement, DHSC will implement the findings of this assessment as required.
Actions planned to deliver the safety recommendation:
- Working group to be established with officials from DHSC, MHRA, CQC, NHSE and others as require, by Mid-September 2022.
- Working group to meet in structured round table format to make assessment of proposed regulatory change, by September – December 2022.
- DHSC officials to discuss proposed change with government legal colleagues to inform assessment, by September – December 2022.
- DHSC to summarise findings, proposed plan of action and implementation timescale, by end-March 2023.
Response received on 4 August 2022.