EMBARGO: 00:01 on Thursday 26 May 2022

Issued by the Healthcare Safety Investigation Branch (HSIB)                                                                                                                

New report focuses on regulation and governance to prevent the contamination of surgical instruments

Gaps in meeting the governance requirements relating to sterile services, more specifically the regulation and assurance frameworks, could create a patient safety risk of comminated surgical instruments, says HSIB’s latest report.

The report underpins a national investigation that was prompted by a referral of an incident involving a 56-year-old female patient who had a procedure to remove a kidney stone. During the procedure, ‘black material’ was seen coming out of the end of a surgical instrument which was later confirmed as dried blood. As a result, the patient had to be tested for blood-borne viruses; the tests showed no evidence that she had contracted any. During the investigation, other cases relating to decontamination of surgical equipment were referred to HSIB including that of Nigel, whose shoulder replacement surgery was cancelled twice due to dirty surgical equipment. He reported that the impact on him was one of “deflation and disappointment”.

The investigation focused on the work of sterile services departments (SSDs) in hospitals where reusable equipment is cleaned, disinfected, and sterilised. In particular, it examined the regulatory framework within which the SSD’s work and how they ensure that they comply with policy and procedures. These mechanisms are designed to keep patients safe and enable NHS trusts to manage risk.

The report sets out findings relating to the known national scale of the problem, the governance requirements relating to sterile services, how decontamination is considered in the design phase of surgical equipment and staff training and competence. (the findings can be found on page 8 and 9 of the full report).

Key findings include.

  • There is no requirement to report issues nationally relating to incorrectly decontaminated surgical instruments. This means that the scale of issues relating to decontamination nationally is not fully understood.
  • The investigation identified several gaps in meeting the governance requirements relating to sterile services – for example how external independent audits are integrated in a wider risk management system or how regulatory bodies check that patient safety issues relating to decontaminated equipment are being managed.
  • There are requirements in place for decontamination to be considered during the design phase of a surgical instrument. However, these requirements sit in a complex system that has input from global stakeholders. The investigation heard that if the UK had different standards to the rest of the world, then the cost of equipment would increase. 
  • There is no national competency framework for SSD staff to ensure consistency and standardisation. If the standard of staff training varies across the country, then the standard of decontamination may also vary.

The report concludes with three safety recommendations and five safety observations aimed at:

  • addressing regulatory and assurance gaps in infection control that prevent risks being identified and managed at an appropriate level,
  • removing confusion caused by the current regulatory structure,
  • addressing the lack of data/reporting of incidents to understand scale of the issue,
  • addressing the lack of a national competency framework for sterile services staff.

Neil Alexander, National Investigator at HSIB says “As we saw in our reference case and Nigel’s case, the impact of ineffective decontamination of surgical instruments can be far-reaching. From the risk of severe infection to the anxiety of waiting for tests and the frustration of multiple operations being cancelled due to dirty equipment.

“In an area where little previous work has been done, our investigation offers a detailed examination of how the risk of contamination is currently managed within NHS trusts. By exploring the safety issue at a national level, we identified gaps in the regulatory and assurance process and highlighted that global input on design of surgical instruments and a variation in the standard of staff training adds further challenges.

“Whilst the scale of the issue is not fully understood and underreported at a national level, our investigation heard of the incidents and near misses that have happened. Our safety recommendations have been designed to address the risks identified and support improvements in clinical support services, ensuring safety and consistency across the NHS.”