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

Final rinse water quality guidance – published 8th March 2022

The CSC has worked closely with the healthcare Infection Society to draft and finalise this new guidance on final rinse water which has now been published in the Journal of Hospital Infection and is open access for all to read.  We would like to thank the working party and especially Aggie Bak for her hard work in pulling it all together. We would like to dedicate this guidance to Tina Bradley who started the process a number of years ago.

You can read the published guidelines here

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.

CSC Annual Scientific Meeting

“Gastrointestinal endoscopy has been associated with more healthcare associated outbreaks than any other medical device, so the burden of disease has to be determined.”

Margreet C. Vos, Erasmus MC


“Approximately 75 million endoscopies are performed annually in the US and 51.5 m of those procedures are dedicated to gastrointestinal-related procedures. Failure of cleaning and disinfection is a bug bear in medical device reprocessing.”

Paul Caesar, Tjongerschans Regional Hospital


“Disinfection and sterilisation methods are not intended for – and will not remove – organic soil or biofilm from medical devices. The only way to achieve this is with good cleaning.”

Dr Thomas Vanzieleghem, OneLife


Future sterilisation solutions


The Central Sterilising Club Annual Scientific Meeting provided an excellent learning opportunity for all those involved in decontamination - from hands-on operatives, decontamination managers and infection prevention practitioners to associated professionals. With a focus on extending knowledge and improving practice, this year’s event was yet another success.

The Central Sterilising Club (CSC) holds two educational events every year, both being accredited for continuing professional development (CPD), which is currently organised through the Royal College and Pathologist’s scheme. The programme is submitted for review and an appropriate number of CPD points allocated to the content.

The first of the CSC events is a two-day Annual Scientific Meeting which is held in the Spring and comprises a formal programme of lectures, from invited speakers, and a selected number of corporate presentations, which combine to cover a broad range of hot topics. It also includes The Kelsey Lecture which was established in 1980 through a donation generously made by Dr Jos Kelsey to enable a guest lecturer of international repute to be invited to speak at the conference.

CSC chair, Val O’Brien welcomed delegates to the Worsley Park Marriott Hotel & Country Club in Manchester and announced that, due to the success of the annual meeting, the 2020 event will take place at an even larger venue.

Opening proceedings was Dr Robert Spencer, who recently retired from working full time as a medical microbiologist after 45 years in the discipline. Setting the scene, Dr Spencer looked to the future: “There are many questions that must be asked about the future of the NHS. There are a number of unknowns facing us, such as robotic surgery and the impact of antimicrobial resistance. There will be less operations as the risk will be too high and we know that there are still 1.5 million unknown viruses.

“Social media is also having an effect on the public perception of infection prevention, with the influx of ‘fake news’ and the number of parents refusing to have their children immunised. This has resulted in an increase in mumps and measles. A major concern is global warming. With no water, we have no steam, and no sterilisation.”

One of the highlights of the Annual Scientific Meeting is the Kelsey Lecture, this year presented by Margreet C. Vos, professor in medical microbiology, infection prevention, Erasmus MC, in the Netherlands.

Margreet’s talk covered the failure of cleaning and disinfection of endoscopes; prevalence, impact and future solutions.

“With regard to the impact of infections, we are at the tip of a huge iceberg,” he asserted. “The source of bacteria may be endogenous – inherent to the ERCP procedure, the translocation of a patient’s own flora – or exogenous, contaminated ERCP duodenoscopes with biomaterial from previous patients or contamination by AER, drying or storage. The risks are caused by breaches in reprocessing or the complex design of the equipment.

“The impact of contaminated endoscopes is an unresolved issue. Up until now there is no data on the contamination of endoscopes before a procedure and measurement of infection after a procedure. So is an infection related to a contaminated endoscope, or is it endogenous? The risk on exogenous infection is not known.”

A nationwide study on endoscope contamination was undertaken to determine cross-sectional sampling by local staff and 13% of all endoscopes were contaminated. The study revealed contamination is not related to wear and tear, and Margreet questioned whether reprocessing is too complex. “Human error and inaccurate handling is certainly a pitfall,” he noted. “In terms of storage, the use of a drying/storage cabinet and use of compressed air are recommended, but how long should the storage time be? With biofilms, research shows a correlation between the growth of bacterial biofilm in flexible endoscopes and endoscope reprocessing methods.

“Microbiological surveillance is costly and demanding, and adhering to the guidelines is difficult as the recommended frequency differs. We need a recommended frequency. The solution is sterilisation. Gastrointestinal endoscopy has been associated with more healthcare associated outbreaks than any other medical device, so the burden of disease has to be determined. Recent outbreaks related to duodenoscopes have occurred despite guidelines being followed, and this is just the tip of the iceberg.”

Highlighting the need to work together with manufacturers, Margreet concluded: “People want – and expect – no transmission by any medical instrument, so there is a collective responsibility for manufacturers, health systems and providers to ensure reprocessing is mistake-proof.

“So what are the solutions? Brand new endoscopes for every procedure? Sterilisation? Or a new design which will not become contaminated? I believe we should focus on microbiological surveillance, provide teaching in cleaning, and monitor outcomes.”


Test soils and wraps

Richard Bancroft, science technical director at Steris opened the first of two corporate presentations, discussing the use of test soils and surrogate devices to validate endoscope and surgical instrument decontamination.

Addressing duodenoscopes, Richard noted the importance of cleaning and washing, either by mechanical or chemical means. “Soiling microorganisms cannot be seen by the naked eye,” he said. “The Advisory Committee on Dangerous Pathogens' Transmissible Spongiform Encephalopathy (ACDP TSE) subgroup rules that there should be no more than five micrograms – or less – of protein in situ or on the side of an instrument.

“The revision of EN ISO 15883-44, published in December 2018 is important. Part four addresses the requirements for tests for washer disinfectors employing chemical disinfection for thermolabile endoscopes, and there are changes to type testing of washer disinfectors and processes.

“Cleaning challenges exist with all reusable medical devices, but there are products available that demonstrate appropriate cleaning with all such devices on a regular basis.”


The second corporate presentation was hosted by Joy Markey from Clinipak, who discussed risk factor considerations for single use and reusable wraps. Addressing the need to decontaminate, Joy said the ultimate aim was patient safety by preventing infection.

Providing a packaging systems checklist, Joy warned of the risks when reprocessors are not properly trained, highlighting one situation in which instruments were kept in a brown envelope. Addressing evaluation, she asserted: “Any fundamental change to the practice for reprocessing should be risk evaluated to ensure compliance and ‘sterility assurance’ of the end product.

“If a change to the wrapping material or protection products used to sterilise is required, this should not exceed the limits at which the original commission loan was validated, tested to, and signed off as. The end user should determine the methodology best suited to their process, and wrapping training – and validation – should be agreed, and rolled out across the site.”

Following a debate on the existing arrangements for the external audit of decontamination quality management systems, which will be covered in the next issue of The Clinical Services Journal, Paul Caesar from Tjongerschans Regional Hospital in the Netherlands, discussed the sterilisation of flexible endoscopes.

Since an outbreak of M, chelonei in a hospital, due to inadequate working automated endoscope washers in 1992, Paul has researched reprocessing flexible endoscopes. This resulted in some international publications, the development of a course on the cleaning and disinfection of flexible endoscopes for hospital care workers, as well as some consultancy work.

Paul noted: “Approximately 75 million endoscopies are performed annually in the US and 51.5 m of those procedures are dedicated to gastrointestinal-related procedures. Failure of cleaning and disinfection is a bug bear in medical device reprocessing.

“So what are we learning? There are many news stories relating to contaminated flexible endoscopes, therefore if they are so difficult to clean, why do we buy them?”

According to Paul, 50% of the sources of outbreaks are because of ineffective cleaning and disinfection. “Time consuming procedures aren’t followed,” he continued. “There are simply not enough staff to do it and, for one endoscope there may be 190 pages of guidelines. In my opinion, if you can’t clean it, don’t buy it. However, it’s all economically driven – more safety equals more money, particularly with single use devices, brushes and valves.

“We should be shifting towards sterilisation. From the view of today’s standards on patient and healthcare safety, sterilisation must be integrated in the reprocessing of flexible endoscopes. Thorough cleaning is still essential and guaranteed.”

Phillipe Destrez from Advanced Sterilization Products (ASP) closed the first day with a talk on reprocessing validation and the Medical Device Regulation. Citing innovation as the main driver behind guidelines, he said it was time to improve the Spaulding Classification. Originally proposed in 1957, it’s a widely used system for matching the disinfection and sterilisation of surfaces, particularly those of re-usable medical/surgical devices, with available processes.

“We have moved on technologically,” he asserted. “Medical device evaluation can be complex and device manufacturers must take on the responsibility.

“STERRAD systems uses low-temperature, hydrogen peroxide gas plasma technology to sterilise a wide range of instruments efficiently, effectively and safely, for users, patients and the environment. ASP has an online tool that provides customers with a list of devices that fall within the sterility claims. There is a database of over 23,000 device listings that have been tested to meet STERRAD Systems’ claims for sterility, and it is the most comprehensive resource of instrument validations from the device manufacturers, detailing compatibility with STERRAD system and cycle options for a wide variety of instrument types. The platform is designed to enable users to maintain their own inventory for quick and easy reference.”

The first day concluded with the Central Sterilising Club annual general meeting, and a gala dinner and quiz – hosted by Mike Bowden from LTE Scientific.


Biofilms and how to remove them

Day two of the Annual Scientific Meeting began with a talk on biofilms by Dr Thomas Vanzieleghem, head of research and development at OneLife, a biomedical company specialising in decontamination solutions for medical devices and the hospital environment. A bioengineer, Thomas did his PhD thesis in the field of microbiology, in particular, biofilms. Since 2015, he has focused on the development of tools to detect biofilms on medical devices and enzymatic detergents to dissolve them.

“Biofilms are groups - or communities - of microorganisms that develop on surfaces,” said Dr Vanzieleghem. “A protective matrix composed of polymers is produced by the microorganisms and enables aggregation and adhesion to surfaces. In the hospital environment, biofilms have often been found to protect pathogens such as Staphylococcus aureus, Escherichia coli, or Klebsiella.

“The highly-structured polymicrobial communities embedded in a matrix adherent to surfaces, consist mainly of polysaccharides, proteins, DNA and lipids. Biofilms enable bacteria to survive in a wider range of conditions, and bacteria in biofilms are up to 1000 times more tolerant of biocides and disinfectants.

“Antibiotics-resistance is favoured inside biofilms through cell-to-cell signalling mechanism, and, over time, progressive accumulation leads to a build up of resistant biofilm over time. If the detergent action is not efficient against a biofilm matrix, bacterial biofilm can resist high level disinfection.”

Dr Vanzieleghem explained that biofilms form a protective barrier around infectious microorganisms and enhance the survival of exposure to antimicrobials.

He continued: “Prevention starts with good cleaning practices. It’s important to identify which factors prevail and which are not easy to apply – such as non-brushable channels. Effective disinfection can only be achieved when all the soil is removed during cleaning, but we must remember that disinfectants do not clean, they kill what is accessible. Germs in a biofilm are not accessible to biocides, and killing is not cleaning.

He concluded: “Monitor your endoscopes. Currently, there is no standard way to do this, but I suggest proceeding with endoscope sampling, analysing the results, and comparing these to existing guidelines. The surface of a medical device can become contaminated with a biofilm if adequate reprocessing is not performed after every cycle – a threat to patient safety.

“Disinfection and sterilisation methods are not intended for – and will not remove – organic soil or biofilm from medical devices. The only way to achieve this is with good cleaning.”


Surface disinfection and the role of a principal engineer

Bill Keevil is a professor of environmental healthcare and head of the microbiology group at the University of Southampton. A member of the Department of Health Decontamination Group, Prof Keevil researches microbiology and biofilms, as well as decontamination of vCJD prion from surgical instruments and endoscopes. Prof Keevil defined contamination sources and highlighted how a duodenoscope under the microscope revealed how many biofilms were present.

Two talks followed - firstly, Mike Ralph, from NHS Improvement, who discussed the role of a principal engineer. Mike was employed by the NHS for 27 years after a military apprenticeship serving with the army and MoD. His last post in the NHS was as director of estates/redevelopment at Ipswich Hospital, and he has recently become the principal engineer for NHSI England. Secondly, John Campbell from Nottingham University Hospitals Trust, presented his talk, “Cardio-pulmonary bypass and mycobacterium chimaera endocarditis: a perfusionist’s perspective.” John’s cardiac surgery career commenced at Harefield Hospital in 1992, working in the cardiac transplant team. He then worked at King’s College Hospital in both the cardiac surgery and hepatic transplant programmes. In 1996 he joined the cardiac team in Nottingham where he is currently in the post of chief perfusion scientist and governance lead for cardiac surgery. Looking to the future, John warned: “It’s an ongoing battle to protect patients – a battle between machine and microbes. Unfortunately, at present, the microbe is winning.”


Sustainability and the NHS

Rose Gallagher MBE is the professional lead for infection prevention and control at the Royal College of Nursing. Based in the nursing department, she provides strategic leadership and specialist professional advice to the Royal College, its members and key stakeholders across the UK on infection prevention and antimicrobial resistance – as well as the implications for nurses and nursing.

Addressing sustainability, Rose revealed a worrying statistic: “The environment is key. Socio-economic growth has an impact on the earth and in the UK we estimate that we have little more than 100 harvests left until the soil is no longer healthy.

“Exponential health and standard of living improvements of the great acceleration have come at a huge cost to the stability of the natural systems that sustain us. The healthcare system is committed to reducing its carbon emissions in line with the UK Climate Change Act of 2008. Issues include road travel, the use of anaesthetic gases – which represent 5% of acute hospitals’ CO2e emissions – and respiratory inhalers – which represent 4.3% of the healthcare sector’s carbon footprint.”

An additional consideration Rose cited was pharmaceutical and medical instruments, which are the two largest CO2 producers. She continued: “In terms of The Climate Change Act (2008), the UK is required to cut its carbon emissions by 80% by 2050. This target is set against a 1990 baseline and will create a low carbon economy.

“The NHS is the largest public emitter of carbon emissions. It will be required to achieve 34% reduction in CO2e emissions by 2020 and 50% by 2025.”

Rose encouraged a discussion about glove use, in particular improving understanding of, recognition of and management of dermatitis. “We need to engage with other health professionals around these issues,” she continued. “It’s vital that we highlight the sustainability elements of glove use.”

Approximately 1000 healthcare workers develop work-related contact dermatitis of the hands – a painful, debilitating condition which may require nursing staff to be moved out of clinical areas due to the risk of infection.

Work-related contact dermatitis can be caused by frequent exposure to water, cleaning agents and inappropriate glove use. Over or under use of gloves can put many at risk of work-related contact dermatitis, while inappropriate glove use can also prevent effective hand hygiene and can put patients at risk of infection.

On the back of these statistics, and to coincide with World Hand Hygiene on 5 May 2019, The Royal College of Nursing is hosting a week of action to help raise awareness of when gloves should - and shouldn't - be worn, and how to protect the skin on hands.


Corporate presentations

The first of two corporate presentations began with Damien Barrel and Stuart McGerty from Advanced Sterilization Products, who discussed the STERRAD ALLClear system – a low-temperature system that helps central sterile service departments sterilise and reprocess instruments for operating rooms quickly and consistently. The ALLClear technology uses proprietary algorithms in a bid to minimise interruptions and cycle cancellations, and to increase efficiency.

This talk was followed by James Doherty, capital sales manager at Wassenburg Medical, who shared his insight into TOE probe decontamination and disinfection. The company, which is celebrating its 35th anniversary, is a specialist in endoscope reprocessing products and  its end-to-end solution includes pre-cleaning, washing and disinfection, drying and storage, transport and traceability.

Since its establishment, Wassenburg has grown exponentially. With headquarters in The Netherlands, sales offices in The UK, Ireland, Belgium, France, Germany and an exclusive distributor network in Europe, Middle East, Australia, New Zealand and Africa, Wassenburg Medical is expanding its global footprint rapidly.

Following these talks, Wayne Spencer from Spencer Nickson took to the podium. The company was formed by Wayne in 2005 and has established itself as a leader in the field of decontamination facilities and equipment consultancy. ​With a background as technical advisor to the Department of Health's National Decontamination Project at both a national and regional level, Wayne was technical author of the guidance on healthcare laundry for the National Health Service, HTM 01-04 and advises hospitals and organisations on all aspect of decontamination of medical devices.

Wayne is also a member of the British Standards working group which inputs into decontamination ISO and EN guidance and the convenor of ISO TC198 Working Group 12 which is responsible for revision to ISO17664. He therefore has the opportunity to comment and influence forthcoming International and European standards. As an editor for the German based Central Sterilization magazine and past chairman of the Central Sterilising Club he also has good working relationships with others in the field in both Europe and the UK. Wayne recently authored the decontamination chapter for the Manual of Perioperative Care.


A no deal Brexit?

Concluding the event was Fiona Kennedy from Applied Management Systems. A freelance management consultant, working predominantly in the area of decontamination in the healthcare and medical devices sector, Fiona has conducted audits for a number of notified bodies and has a background in hospital and sterile services management.

Her talk focused not only on the Medical Devices Regulations, but also on the impact of a no deal Brexit. She explained: “If this happens, the MHRA will take on responsibility for the UK market, and this scenario would mean UK based Notified Bodies would no longer be able to assess the conformity of medical devices to receive the CE mark and enter the EU market.

“In the event of a no deal Brexit, the MHRA’s position is that certificates issued by UK Notified Bodies prior to the UK’s departure from the EU will continue to be valid for the UK market for a grace period. The UK notified bodies will continue to oversee those devices and manufacturers to ensure ongoing compliance.

“But what about the issue of new certificates after that date – for UK based manufacturers only seeking to supply to the UK market?”

Central Sterilising Club chair, Val O’Brien closed the event by praising the committee and corporate presentations. With yet another successful event, Val thanked delegates and speakers, and announced that the next study day will take place in Nottingham on 16 September 2017.


The Central Sterilising Club was founded in 1960 by a small group of enthusiastic individuals who were either working in the rapidly evolving central sterile supply departments, or were attempting to solve the many problems associated with developing rapid, safe methods for sterilising items in bulk.

Several successful national groups have emerged from the Club’s membership, including the Institute for Decontamination Sciences (IDSc and formally the ISSM), the Infection Prevention Society (IPS, formally ICNA) and the Healthcare Infection Society (formally Hospital Infection Society). Similar groups based on the CSC have been formed in other countries.

The Club’s annual meeting is the only forum where members of all groups can meet, exchange ideas and solve mutual problems. The design of the meeting allows ample time for discussions in both formal sessions and in the less formal atmosphere for which the Club is noted.

Infection Prevention 2019

Infection Prevention 2019

22 – 24 September
ACC, Liverpool, United Kingdom

This is the premier educational event for all those working and interested in infection prevention and control.

The three-day conference will present the latest scientific evidence from around the globe to enable you to recognise, understand and address current and emerging risks. You will learn from experts about practices which are optimising outcomes and increasing the safety of patients.

Visit the website to view the scientific programme, abstract submission information and details of the second Infection Prevention Show.  IP2019 is also hosting two one-day conferences, DIPC Day 2019 and Infection Prevention in Paediatrics, which can be attended on their own or as part of main conference.

Full details and registration can be found online: www.ips.uk.net/conference

Annual Scientific Program April 1-2, 2019

The Worsley Suite

Worsley Park Marriott Hotel and Country Club,

Manchester, M28 2QT



Monday 1 April 2019


09:00               Registration and refreshments


10:00               Welcome and introduction by Val O’Brien, CSC Chair


10:30               Kelsey Lecture: Failure of cleaning and disinfection of endoscopes;

   prevalence, impact and (future) solutions

Professor Margreet C. Vos, Erasmus MC, Rotterdam, The Netherlands


11:30               Tea and coffee


Chair:              John Prendergast


12:00               Corporate presentation 1: The use of test soils and surrogate devices to validate

                                                                    endoscope & surgical instrument decontamination

                                                                    Gary Wright, Steris


12:30               Corporate presentation 2: Risk factor considerations for reusable wrap

                                                                     Joy Markey, Clinipak


13:00               Lunch


14:00               Debate: This house believes that existing arrangements for external audit of decontamination quality management systems delivers critical assurance and value for money


Moderator:       Alison Gee

For:                  David Pickard

Against:           Paul Jenkins


15:15               Tea and coffee


Chair:              Gillian Hill


15:45               Sterilisation of flexible endoscopes: take it or leave it?

Paul J Caesar, Tjongerschans Regional Hospital, Heerenveen, Netherlands


16:15              The medical device manufacturing program - low temperature hydrogen peroxide validation process

Damien Barrel, Advanced Sterilization Products


16:45               Final questions and close


17:00               Annual General Meeting


19:30               Mike Emmerson Drinks Reception


20:00               Annual Scientific Meeting Dinner, followed by Quiz hosted by Mike Bowden




Tuesday 2 April 2019


08:30               Registration and refreshments


Chair:            David Jenkins


09:30               Biofilms and how to remove them              

Dr Thomas Vanzieleghem, OneLife


10:00               Surfaces and surface disinfection: how clean is clean, how dead is dead?

Professor Bill Keevil, Southampton University


10:30               Tea and coffee


Chair:              Karen Tweed


11:00               Role of the Principal Engineer and plans to update the HTMs

Mike Ralph, NHS Improvement


11:30               Cardio-pulmonary bypass and mycobacterium chimaera endocarditis:

a perfusionist’s perspective 2003-2019

John Campbell, Nottingham University Hospitals


12:00               Sustaining the NHS

Rose Gallagher MBE, Royal College of Nursing


12:30               Lunch


Chair:              John Prendergast


13:30               Corporate presentation 3: ASP Sterrad ALLClear - the new rhythm of reprocessing

Damien Barrel and Stuart McGerty, Advanced Sterilization Products



14:00               Corporate presentation 4: TOE probe decontamination and disinfection

                                                                      Speaker to be confirmed, Wassenburg


14:30               Tea and coffee


Chair:              Gill Ellis-Pow


15:00              Evaluation of a new PCD - performance versus protein removal

Wayne Spencer, Authorised Engineer Decontamination


15:45               Registration for decontamination units – onwards and upwards

Fiona Kennedy, Applied Management Systems Limited


16:15               Close of meeting

Val O’Brien, CSC Chair


Corporate Presentations. Annual Scientific Meeting 2019

The Annual Scientific Meeting has been arranged at the Worsley Marriott Hotel, near Manchester from the 1st to 2nd April 2019.

Worsley Park Marriott and Country Park Hotel
Walkden Road
Worsley, M28 2QT
Tel No’ 0161 975 2011

The CSC committee have put together a programme which we hope will be of considerable interest to all
members and this can be viewed on the CSC website: https://centralsterilisingclub.org/ As in previous
years, the meeting gives our Corporate Members an opportunity to make a presentation to the audience.
Four such presentations are allocated in the programme.

Whilst not wishing to prescribe content it is our advice that these presentations work best when
introducing innovations in techniques, research or development work. Straightforward commercial
presentations tend not to work so well.

Where we have more than four possible presentations the committee reserves the right to select those
they think most appropriate. If your company is interested in presenting, a brief paragraph on the content
would help the committee make this decision.

These should be sent to me by email in the first instance by the 8th January 2019 and we will confirm your place by the 31st January 2019.

The club makes a charge of £750 for the presentation slot. Corporate members presenting have a two day
delegate fee gratis to cover attendance at the event (no accommodation included).
Corporate Members taking advantage of the opportunity must be fully paid up for the 2018/19 year.

Best wishes

John Prendergast
CSC Treasurer

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