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

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.”

Request for engagement with decontamination specialists re the use of ozone

We have a patented technology which is able to generate ozone within a pre-sealed thermoformed tray or plastic bag with  a proven efficacy of log-6 kills. Ozone has significant benefits over a lot of conventional methods.

We are looking to engage with end users where this technology in either bench-top form or stand alone machine would present applications. We would welcome any feedback or discussion that can help focus final operation and solution requirements. If you are interested in knowing more I can be contacted at [email protected] alternatively by phone on 07491000793.

Many thanks,


Chris Pugh Consulting

Job Vacancies - Validation Engineers

Health Facilities Scotland are currently advertising for two qualified and experienced Validation Engineers to carry out annual testing on a wide range of decontamination equipment throughout Scotland. The job advert is now live on NHS Scotland jobs website:


Closing date for applications is Friday 11th June.

Book of Remembrance in honour of Christina (Tina) Bradley

This Book of Remembrance has been created as a celebration of Tina's life from contributions provided by her many friends and colleagues whose lives she touched.  The book speaks for itself - RIP Tina, always in our memory.

Hard copies of the Book of Remembrance to Tina are available at a cost of £34.00 (delivered). Please order copies of Tina’s remembrance book from [email protected]  by 31st October 2020

Celebrating the Life of Tina Bradley - Remembrance Book - CSC - v3 - 230920 LOW RES

Christina (Tina) Bradley

It is with immense sadness that I have to announce that Tina Bradley died on Tuesday 25th August in the Queen Elizabeth Hospital in Birmingham after her long  illness.   Tina joined the Central Sterilising Club many years ago and was a committee member in various positions throughout culminating in being Chair between 2014-17 and was awarded Honorary Life Membership for her significant contributions to our organisation.

Her work was well known to all of us in CSC but also the wider healthcare community and we are grateful for her enormous contribution to improving overall standards in all areas of decontamination practice. Tina will be very, very sadly missed by all who knew her.

A  Book of Remembrance will be compiled for Tina’s family and friends to highlight Tina’s many accomplishments along with details of her professional career and as an acknowledgement of her dedication and passion for all things decontamination and microbiology.

Could those wishing to add to the Book of Remembrance please send their contributions about how you would like to remember Tina and would wish to celebrate her life to: [email protected]

Sadly, due to COVID-19, there will be limited numbers permitted at Tina’s funeral; however we will provide further details in due course as they become available.

The just-giving page which Tina's sister Janice has established in her memory: https://www.justgiving.com/fundraising/janice-burke. This is for a homeless shelter in Birmingham and full details are on the site.

Val O’Brien

CSC Chair


This Book of Remembrance has been created as a celebration of Tina's life from contributions provided by her many friends and colleagues whose lives she touched.  The book speaks for itself - RIP Tina, always in our memory.

Hard copies of the Book of Remembrance to Tina are available at a cost of £34.00 (delivered). Please order copies of Tina’s remembrance book from [email protected]  by 31st October 2020

Celebrating the Life of Tina Bradley - Remembrance Book - CSC - v3 - 230920 LOW RES

Summer Newsletter

Welcome to the summer newsletter, we are at the halfway point of another busy year in the world of infection prevention and decontamination.

We dedicate the summer newsletter to a review of this year’s annual scientific meeting held in May in the beautiful City of Cardiff. With a record attendance the conference provided a wealth of educational content for the delegates, the event received excellent feedback and commentary, which we will use to shape next years event.

Central Sterilising Club Annual Scientific Meeting, 16-­‐17 April 2018, Cardiff

The Chair of CSC, Val O’Brien, welcomed the audience to Cardiff for this year’s conference, which was formally opened by Dr Marion Lyons of Health Protection Wales and Senior Medical Officer of the Welsh Government. Dr Lyons started her medical career as a paediatrician working in Africa. An outbreak of neonatal tetanus and her involvement in a subsequent campaign to vaccinate pregnant women against tetanus was a pivotal experience and led to her specialising in Public Health on her return to the UK.

The next speaker was Professor Manfred Rotter, an emeritus professor of Microbiology at the Medical University, Vienna, who gave the Kelsey Lecture. This was dedicated to the memory of Professor Graham Ayliffe who passed away last year. Prof Rotter spoke about historical aspects of testing the efficacy of hand antiseptics, beginning with a review of the work and life of Ignaz Semmelweiss, the 19th century Viennese obstetrician who recognised the importance of hand hygiene in the prevention of puerperal sepsis, a frequently fatal infection of newly delivered women now known to be predominantly due to group A beta-­‐ haemolytic streptococci. Professor Rotter gave a comprehensive overview of the development of hand wash and disinfection testing standards which, given the central importance of hand hygiene in clinical care, are fundamental to modern medical practice.

A feature of CSC conferences is the opportunity for industry representatives and  researchers to present on their products, including the science behind innovations. This year, the first industry presentation was given by Jim Baldwin, of Westfield Medical, who talked about Humipaks, moisture retaining pouches for post-­‐operative instrument handling and transport prior to arrival at the CSSD. The aim of Humipaks is to keep surgical instruments moist to facilitate the removal of protein residues as part of re-­‐processing.The second industry presentation was given by Thomas Vanzielegham of OneLife, who reviewed approaches to detection of residual proteins on surgical instruments, highlighting the use of his company’s product , OneLife DETECT, to identify residual protein missed by visual inspection.

This year’s conference debate asked the question, is endoscope decontamination affected by a chemistry cartel? Ean Whalley, managing director of Serve Medical, spoke for the argument that endoscope washer disinfector manufacturers operated a closed shop that unfairly prohibited users from using their own choice of disinfectant chemicals. John Prendergast, Senior Decontamination Engineer for NHS Wales Shared Services Partnership/Specialised Estates Services, countered by arguing that manufacturers, by insisting on defined chemicals, far from running a cartel, were ensuring users could be assured of reliable decontamination. The debate went to the vote and the majority vote fell in favour of the motion of a Cartel.

Wayne Spencer, an independent consultant on sterilisation and healthcare engineering, of Spencer Nickson Limited, continued the theme of endoscope reprocessing, covering issues around; inspection of scopes, especially the problem of internal inspection; a trend towards packaging of reprocessed scopes as an alternative to storage cabinets and the problem of no clear standards for this approach; standards for the storage versus drying of endoscopes, highlighting the requirement for more work on this area of decontamination.

The final presentation of the first day was given by Helen Griffiths, a gastroenterology nurse consultant and lead assessor for the Joint Advisory Group for Gastroenterology and decontamination advisor for the British Society of Gastroenterology, who spoke about direct observation of practice; from training to competence in endoscope decontamination. Drawing on educational theory, Helen discussed issues around training, highlighting the disparate nature of people with varying backgrounds and educational levels involved in decontamination and pointing out that experience does not automatically equate to competence. She also commented on the variable environments of endoscopy units in which decontamination takes place.

The next day’s programme began with a presentation by Andrew Bent from the MHRA, who looked at medical device and equipment compatibility. Andrew described the work of the MHRA in safeguarding patient safety and public health and the regulatory challenges of dealing with a wide range of medical devices, all of which must be acceptably safe when used for their intended purpose and in line with manufacturers’ instructions.

Karen Tweed, Deputy Operations Director for decontamination at Sheffield Teaching Hospital, then talked about her experiences of responding to the 2013 MHRA alert on appropriate decontamination of re-­‐usable medical devices in line with manufacturers’ instructions in order to avoid structural and functional damage of devices, a challenge that is made difficult by the lack of standardisation of decontamination processes approved by manufacturers and the multiplicity of cleaning methods found in large healthcare organisations. Karen’s approach included setting up a multi-­‐disciplinary committee including a decontamination manager, infection prevention, estates, domestic services, supplies, clinical governance and finance. She described the difficulties and successes of this group including the development of a chemical review group.

The next three speakers took as their theme the problem of ensuring safe re-­‐processing of surgical instruments, focusing on the detection and removal of protein residues. Mark Campbell, decontamination manager of Cardiff and Vale University Health Board, covered the operational management of assuring a safe surgical instrument decontamination cycle, including the decontamination of neurosurgery instruments. He described his approach to minimising protein residues, emphasising his view that decontamination is a science, not a process.

The next speaker, Andrew Smith, currently the newly appointed director of the Scottish Respiratory Bacteria Reference Laboratory, developed the scientific approach to decontamination but previously
a lead consultant for medical device decontamination for NHS Greater Glasgow and Clyde. Andrew described his work for the Scottish Infection Research Network aimed at reducing the risk of iatrogenic variant CJD through neurosurgical instruments. His research on the five most commonly used neurosurgical instruments revealed that periosteal elevators, flat instruments that should have been easy to clean, retained very high protein levels after re-­‐processing because of the way they were stacked on top of each other during decontamination. This observation led to Andrew’s view that protein testing at performance qualification was vital but that subsequent downstream protein testing was not necessary if quality controlled loading conditions and washing parameters were met.

The third speaker, Mark Furmage, decontamination engineer of NHS Wales Shared Services Partnership, covered washer disinfectors and ultrasonic cleaning and the role of these devices in protein removal at the pre-­‐cleaning stages of re-­‐processing.

The theme of ultrasonics as an aid to cleaning, especially of lumened instruments, was developed further by an industry speaker, Pawel de Sternberg of Aseptium. He gave a presentation that included the basics of the dynamics of fluid flow through instrument lumens and how ultrasonic cleaners work through the generation of cavitation bubbles that subsequently explode and produce shock waves that remove contaminants. His company produce process challenge devices that aim to verify internal cleaning of lumened instruments.

David Jones from Alphasonics (Ultrasonic Cleaning Systems) gave the next corporate presentation, describing a range of instruments that his company has developed that use ultrasound to clean a range of medical devices including surgical instruments and endoscopes.

David Jenkins, Consultant Medical Microbiologist at University Hospitals of Leicester NHS Trust, described the role of directors of infection prevention and control (DIPCs) in English hospitals and their leadership responsibilities for decontamination. He described the results of a survey of DIPCs that showed many had no professional background in infection prevention or decontamination, highlighting a potential weakness in decontamination governanceThe final presentation of the meeting was from Paul Jenkins, of Southmead Hospital, Bristol, where he is responsible for a number of departments including Decontamination Facilities and Material Management. Paul spoke about the Scan4Safety project that aims to use GS1 barcoding standards to track the use of medical devices in healthcare. It has been claimed that Scan4Safey has the potential to save lives and up to £1 billion for the NHS over the next seven years. Paul described the project and how demonstrator sites across England are using it. Val O’Brien closed the meeting with thanks to all speakers, the audience and industry supporters.

Autumn Study Day 17th September 2018

Central Sterilising Club

2018 CSC Website

For some time the CSC committee
have acknowledged the need to refresh its website, so we have gone one better and have completely rebuilt it! It is very different from the old design and now has all the features and benefits that our members have been asking us for over the last few months.

It features all of the basics, a section ‘about us’ with a little of the history of the club, how and why it was founded, including a timeline with the dates of key events over the years since the CSC was established in 1960. We have added more detail about the current committee and their backgrounds and how to contact each of us if you have a query relating to a specific issue, for example, finance or membership. We have added information on all past chairman and even a list of our international renown Kelsey Lecturers.

Central Sterilising Club
Homepage of the new Central Sterilising Club website.

We have incorporated a member’s section which will be password protected. It will contain information only available to members including copies of presentations delivered at our Study Day and Annual Scientific Meeting, minutes of CSC meetings, and updates from other meetings attended by CSC representatives relevant to the membership. Members will be able to create their own personal profile with contact information which will support a single database and allow us to more easily maintain contact information. Members will have the opportunity to enter into discussions with other members (with their permission) or to ask questions in the member's discussion forum.

A section with frequently asked questions is also incorporated in the member's section as a reference point and a completely new page has been established which will direct you to decontamination related guidance and reference papers. There is also a dedicated list of strategic partners with whom we work closely, or where additional information can be found to support us in our daily work.

We hope you like the new look and content of the website and look forward to regular feedback from our members on how we can improve and add to it.