Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential impact on patients and NHS waiting lists of surgical operations being cancelled due to contaminated or defective sterile surgical instrument components; and what steps his Department is taking to ensure inspection protocols are in place to prevent theatre lists being assembled before defects in outsourced surgical parts are identified.
No specific assessment has been made of the impact of cancelled operations due to contaminated or defective sterile surgical instrument components on National Health Service elective waiting lists. Quarterly cancelled elective operation statistics for non-clinical reasons is available online, but this information is not broken down by specialty or reason.
The Care Quality Commission (CQC) is the independent regulator in England with the responsibility to ensure that health and social care providers comply with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Regulation 15: Premises and Equipment require health and social care providers to ensure the equipment used to deliver care and treatment is clean, decontaminated and/or sterilised, and suitable for the intended purpose, maintained, and stored securely in line with current legislation and guidance. Where guidance cannot be met, the provider should have appropriate contingency plans and arrangements to mitigate the risks to people using the service.
Providers retain legal responsibility under this regulation to ensure they are compliant, including when they delegate responsibility through contracts or legal agreements to a third party, independent suppliers, professionals, supply chains, or contractors.