HSIB: Decontamination of surgical instruments (26 May 2022)

Summary

This Healthcare Safety Investigation Branch (HSIB) investigation aims to improve patient safety in relation to the decontamination of surgical instruments. It focuses on the work of sterile services departments (SSDs) in hospitals, where reusable medical equipment is cleaned, disinfected and sterilised to make it safe before it is used again. The investigation looked at the regulatory framework which SSDs work within, and their use of assurance models, which provide evidence that a service is running according to the relevant policies and procedures. These mechanisms are designed to keep patients safe and enable NHS trusts to manage risk within their organisations.

For its reference case, the investigation used the case of a 56 year-old woman who underwent surgery to remove a kidney stone in her right kidney. During the procedure, 'black stuff' came out of one of the instruments being used, which was later analysed and found to be dried blood. The surgeon stopped the surgery immediately and proceeded with an alternative procedure to remove the kidney stone, for which the patient had already consented. The patient was tested for blood-borne viruses as she had been exposed to another person's dried blood, but tests did not show any evidence that she had contracted any.

Content

Findings

• There is no requirement to report issues nationally relating to incorrectly decontaminated surgical instruments. This means that the size of the issue is unknown and that the healthcare system does not fully understand the risks and issues it is holding.
• Risks and issues are held within individual SSDs and are not integrated within wider trust management systems.
• Trusts frequently focus on clinical risks and not on the risks that arise from non-clinical supporting departments but which present a patient safety risk.
• There is no national requirement for NHS trusts to have a formalised risk management system.
• All SSDs produce a similar product – decontaminated surgical instruments. The legal status of an SSD determines which national body regulates it (the Care Quality Commission (CQC) or the Medicines and Healthcare products Regulatory Agency (MHRA)).
• The CQC does not inspect SSDs for compliance with regulations and standards.
• The MHRA does not inspect SSDs for compliance with regulations and standards, but relies on external assurance bodies (known as Approved Bodies) to do so. It does undertake a small number of witnessed audits of Approved Bodies while that Approved Body audits an SSD to ensure that standards are being maintained.
• MHRA-regulated SSDs have in place quality management systems, managed at a local departmental level. ‘Top management’ are not involved in this quality management system, therefore risks and issues relating to SSD quality are not formally escalated to a trust organisational level.
• Escalation of SSD quality risks and issues relies on the integrity and professional behaviour of managers rather than being required by policy.
• There is a requirement for manufacturers to design reusable surgical equipment in such a way that it can be decontaminated.
• Surgical equipment can be difficult to decontaminate due to its complexity and size.
• Currently the MHRA regulates under the Medical Device Regulations 2002 which incorporate the European Union’s standards and regulations. The MHRA is restricted in developing its own standards due to market forces.
• To overcome design issues with surgical instruments that relate to decontamination, SSDs rely on decontamination processes to ensure equipment is suitable for use in operating theatres.
• It is difficult to change the design of equipment after it has been approved for use, so the success of the decontamination processes relies on trained and competent staff.
• There is no national competency framework for SSD staff to ensure consistency and standardisation.

Safety observations

• It may be beneficial for sterile services departments and operating theatres to report all incidents of incorrectly decontaminated surgical instruments nationally so that the healthcare system can understand the resulting patient safety risks and issues.
• It may be beneficial to consider the adoption of standardised risk management systems across NHS trusts.
• It may be beneficial to define clear lines of accountability for sterile services departments, to include services provided by NHS trusts and contracted services.
• It may be beneficial to review the process that assures that decontamination of surgical instruments is appropriately considered during the design of surgical instruments.
• It may be beneficial to include a process for cleaning internal surfaces of tubes (lumen) by use of an ultrasonic bath and confirmation clear by high pressure air (where this is not specifically excluded by the device manufacturer) in addition to the requirements set in the manufacturer’s instructions for use.

Safety recommendations

1. HSIB recommends that the Care Quality Commission reviews and ensures that the approach used by healthcare providers to assure themselves that in-house or externally contracted sterile services for decontamination are safe and can identify and respond to patient safety concerns.
2. 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.
3. HSIB recommends that NHS England and NHS Improvement amends Health Technical Memorandum 01-01 to define ‘top management’ and its commitment to quality, and that external independent audits are reported directly to the responsible executive director in a trust who is accountable for the service, not just the certified department.
4. HSIB recommends that NHS England and NHS Improvement develops a competency framework, stating skills, qualifications and professional registration as required, for all sterile services staff and includes it in Health Technical Memorandum 01-01.