New report focuses on regulation to prevent surgical instrument contamination

The report, Decontamination of surgical instruments: Independent report by the Healthcare Safety Investigation Branch NI-003117, underpins a national investigation prompted by a referral of an incident involving a 56-year-old female patient who underwent a kidney stone remove operation, during which ‘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, although these showed no evidence she had contracted any.

During the investigation, other cases relating to surgical equipment decontamination were referred to HSIB, including that of ‘Nigel’, whose shoulder replacement surgery was twice cancelled due to dirty surgical equipment, and who reported that the impact on him was one of ‘deflation and disappointment’.

The investigation focused on the work of hospital Sterile Services Departments (SSDs) where reusable equipment is cleaned, disinfected, and sterilised, focusing in particular on the associated regulatory framework, and how SSDs ensure they comply with policy and procedures designed to keep patients safe, and enable NHS Trusts to manage risk.

Key findings include:

• With no requirement to report issues relating to incorrectly decontaminated surgical instruments nationally, the national scale of such issues is not fully understood.
• Risks and issues are held within individual SSDs, and not integrated within wider Trust management systems.
• Trusts frequently focus on clinical risks, and not on those arising 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 (‘Approved Bodies’) to do so. It does undertake a small number of witnessed audits of Approved Bodies while the latter audit an SSD to ensure standards are being maintained.
• ‘Top management’ is not involved in MHRA-regulated SSDs’ quality management systems at a local departmental level, meaning 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’.

• It is difficult to change the design of equipment after its approval for use, so the decontamination processes’ success relies on trained and competent staff. There is no national competency framework for SSD staff to ensure consistency and standardisation.

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. While there are requirements for decontamination to be considered during surgical instrument  design, the HSIB concluded that these ‘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, the cost of equipment would increase.

The report concludes with four safety recommendations aimed at different bodies, and  five safety observations:

• HSIB recommends the Care Quality Commission review the approach used by healthcare providers to assure themselves that ‘in-house’ or externally contracted sterile services for decontamination are safe, and ensure that they can identify and respond to patient safety concerns.
• It recommends the Department of Health and Social Care assesses the benefits of a single regulatory and assurance framework for SSDs, and implements the findings, ‘as required’.
• NHS England and NHS Improvement should, the HSIB says, amend HTM 01-01 ‘to define top management and its commitment to quality’, while external independent audits should be reported directly to the responsible executive director in a Trust accountable for the service, ‘not just the certified department’.
• HSIB also  recommends that NHSE/I develops a competency framework, stating skills, qualifications, and professional registration as required, for all sterile services staff, and includes it in HTM 01-01.

In its ‘safety observations’, the HSIB suggest SSDs and operating theatres report all incidents of incorrectly decontaminated surgical instruments nationally, ‘so that the healthcare system can understand the resulting patient safety risks and issues’. The Branch adds that ‘it may be  beneficial’ to consider the adoption of standardised risk management systems across NHS Trusts, to ‘define clear lines of accountability’ for SSDS – to include services provided by NHS Trusts and contracted services, and ‘to review the process that assures that decontamination of surgical instruments is appropriately considered during their design’.

The HSIB also suggest including a process for cleaning the internal surfaces of tubes (the lumen) using an ultrasonic bath, and a confirmation clean by high pressure air (where this is not specifically excluded by the device manufacturer), in addition to the requirements set out in the manufacturer’s instructions for use.

Neil Alexander, National Investigator at HSIB, said: “As we saw in our reference case and Nigel’s case, the impact of ineffective decontamination of surgical instruments can be far-reaching. While the scale of the issue is not fully understood, and is under-reported 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 to support improvements in clinical support services, ensuring safety and consistency across the NHS.”