The following piece was written by Jon Blastland for the Clinical Services Journal’s December 2022 edition.
Not all instruments can be guaranteed clean, especially those with narrow lumens. Jon Blastland argues that single-use alternatives could help reduce the risk of surgical site infection
During surgery, germs can be transferred into the surgical wound through various forms of contact – including microbial flora on the skin, the surgeon’s hands, the operating theatre environment itself, or contact with a contaminated surgical instrument – leading to increased risk of surgical site infection (SSI).
In England, SSIs are one of the most common healthcare-associated infections (HCAIs), accounting for around 16% of all HCAIs. 
SSIs are a major cause of increased length of hospital stays, morbidity, and mortality. The rate of SSI also varies depending on the type of surgical procedure, with rates of less than 1% for orthopaedic procedures and rates of over 10% for large bowel surgery. 
However, as post-discharge SSI surveillance practices vary significantly between Trusts and SSIs often present after the patient has been discharged from hospital, it is widely acknowledged that reported figures are likely to be an underestimate. For patients, an SSI may mean many months in hospital, as well as additional surgical procedures. In addition, SSIs also present a significant financial cost to the NHS. Each infection is estimated to cost just over £10,000 per person, with deep-incisional SSIs costing an astounding £100,000 per patient. 
With health systems still reeling from the effects of COVID-19 – and budgets under extreme pressures – the vital role of infection prevention in improving patient safety and outcomes has never been more prominent. Despite advances in infection control procedures, SSIs still present a significant challenge for healthcare systems across the world.
This is particularly poignant given research shows that up to 60% of SSIs are preventable.  SSI prevention is made up of several stages, all as important as each other – from the environment in which patients are cared for, to the equipment, medications and devices they are exposed to during surgery. One of the biggest challenges is ensuring that reusable surgical instruments are effectively sterilised to minimise the risk of infection to patients. This involves a highly strict set of standards and processes at all stages of the decontamination life cycle – with any misstep increasing the risk to patients.
An important consideration is the fact that not all instruments can be guaranteed clean. This is especially true for instruments with narrow lumens, sharp bends and rough edges. Narrow channels can be difficult to clean, and instruments can also become blunt from use or damaged – which all impact on their performance ability.
In a bid to combat the high level of HCAI rates in the UK and worldwide, and to comply with Government guidelines to adopt best practices in the healthcare setting, a growing number of healthcare facilities are taking steps to evaluate and improve standards in cleanliness – and assessing the costs and benefits of alternative practices, including introducing single-use instruments to replace those that are difficult to clean for surgery.
Single use solutions
The effective decontamination of surgical instruments is essential for patient safety and to avoid unnecessary delays and inefficiencies in hospital operating theatres. High on the list of items which cause concern to most sterilisation managers and end-users alike, are surgical instruments which are difficult to clean. This is why many hospitals around the world are increasingly recognising the benefits of switching to single-use surgical instruments, which present a safer alternative, helping hospitals reduce the risk of patient-to-patient cross-contamination, reduce time, and cut costs.
The traditional alternative to single-use instruments is reusable instruments, which by their very nature carry a degree of risk for cross-contamination and surgical site infections, if not reprocessed effectively. Common errors vary – from staff not having all the manufacturer’s instructions to hand, to not following all the manufacturer’s written instructions, not thoroughly inspecting instruments prior or post reprocessing, and not storing sterile items in a separate, controlled area.
As such, reusable medical instruments pose inherent concerns regarding their maintenance, storage and repeated use. Single-use devices, on the other hand, are sterilised, individually packaged, disposable instruments that eliminate the risks that reusable instruments pose, as well as saving the time and cost involved in reprocessing procedures.
Cleaning and decontaminating
The preferred method of decontaminating surgical instruments is by mechanical cleaning with a detergent solution, followed by thermal disinfection and then drying. Typically, a washer-disinfector will be utilised to automate the process. This is considered a time-efficient and a cost-effective way of cleaning medical devices, but hard to clean instruments usually require manual cleaning with particular attention to the cleaning of internal surfaces. During manual cleaning, staff must brush, wipe, jet wash or hand spray the item to try to remove debris from the instrument.
Medical devices can pose significant hazards to patients if they are inadequately or inappropriately reprocessed. A key step in the reprocessing cycle of any reusable medical device is inspection after cleaning and many decontamination departments rely on simple visual inspection in order to determine whether an instrument is clean.
If an instrument cannot be cleaned, then it cannot be effectively sterilised or disinfected; therefore, it is critical to check that all biological material has been correctly removed from a medical device before the item is passed for packaging and sterilisation. Where instruments are not cleaned properly, organic debris or biofilm can prevent the disinfectant or sterilant from having contact with the instrument, and may also bind and inactivate the chemical activity of the disinfectant.
A report by the Healthcare Safety Investigation Branch – which aimed to help improve patient safety in relation to the decontamination of surgical instruments – recently shed light on this issue. The report highlighted an incident involving a patient who had a procedure to remove a kidney stone and became exposed to another person’s dried blood during surgery. 
The instrument used during the procedure was removed from its sterile wrappings and looked clean when inspected by the nurses. However, during the procedure foreign material was seen coming out of the end of it, which was later identified as dried blood. The report highlights that the set had been through a decontamination cycle but several of its cleaning brushes were missing, which prevented it from being cleaned in accordance with the manufacturer’s instructions for use, and that the importance of the brushes was not understood by operating theatre staff.
This highlights the utmost importance of getting each step (no matter how big or small) right, including instruments being cleaned exactly as per the manufacturer’s instructions, and ensuring staff are properly trained to do so.
Difficult to clean instruments
While visual inspection is an effective element in the reprocessing of many medical devices, difficulties occur when the device has hidden surfaces and parts which are not easily accessible for thorough cleaning and inspection. Several healthcare organisations and researchers worldwide have examined public health issues associated with reusable medical devices that are difficult to clean and have reported that infectious outbreaks have been linked to unclean medical devices, but the evidence is scant. 
The design of the instrument or medical device is a key determinant of whether the decontamination process will be effective. Design configurations such as matted surfaces, sharp angles, rough surfaces, rough edges and complex jaw assemblies are likely to trap germs and complicate the cleaning process.
Narrow-lumened instruments and endoscopes also present some of the biggest reprocessing challenges and are notoriously difficult to clean, as it is impossible to access or visualise the entire surface that needs cleaning. Many of the difficult to clean medical devices listed are also cannulated, which often have a narrow lumen or channel, and the surface of which cannot be inspected, presenting another problem when it comes to cleaning.
If the lumens and channels of endoscopes are not properly cleaned, instruments cannot be disinfected or sterilised to a high-level and can cause dangerous consequences. When reusable brushes are used to clean the lumens, they themselves have to be effectively cleaned and disinfected or sterilised between each case, and they also need to be in good condition.
This is why single-use items, such as single-use lumen brushes, are now commonly used in Central Sterile Supply Departments (CSSD) to clean instruments, as they eliminate the risks of infection. They can be discarded after each use with the additional benefit that their performance does not degrade over time.
In a guidance document to the Department of Health, the Microbiological Advisory Committee (MAC) recommended that, following cleaning, surgical instruments need to be carefully examined for organic material or damage and that, where possible, consideration should be given to using single-use devices to prevent the risks of cross-contamination. 
However, one of the key considerations in deciding whether to switch from hard to clean reusable instruments to single-use alternative instruments are the associated costs.
Repair and replacement costs
The cost of surgical procedures can be an emotive and politically charged topic and, as a result, healthcare practitioners seek efficiencies to reduce costs across the board – while, at the same time, not compromising surgical efficacy or patient safety. One particular area of debate is the cost of single-use surgical instruments when compared to sterilising reusable surgical instruments for multiple operations. Costs that are often mistakenly ignored are storage, labour, energy, inspection, losses, rejection rates, maintenance, and replacement – all of which contribute to the hospital’s overall management of decontamination.
Firstly, for the instrument to be used repeatedly, it has to be sterilised and cleaned (with single-use brushes, chemicals, power and time) and this comes at a cost to the institution reusing surgical instruments. Associated with this are the logistical aspects and errors that come with using reusable instruments, which are involved in managing the journey of the reusable surgical instrument from surgery to sterilisation unit and then back to surgery.
Secondly, the efficacy of reusable surgical instruments, over a period of time, and other potential pitfalls with using them add substantial hidden costs and identifiable risks with their use. For example, would a reusable surgical instrument perform as effectively on its 30th time as on its first? In addition, how effective are the re-sterilisation processes behind reusable surgical instruments and, if they are ineffective, what are the costs to healthcare institutions and healthcare practitioners in dealing with any cross infection between patients?
Ultimately, Eakin Surgical was established in response to the challenge faced cleaning surgical instruments – hospitals identified that difficulty cleaning surgical fine lumen suctions created a high risk of patient-to-patient cross-infection. In the past, single-use instruments had a negative profile within healthcare, but this perception has now changed. Today, there are now products available of the same quality or better feel and function than reusable items, and the increased safety profile of these items is driving their increased adoption in UK hospitals.
Balancing safety and sustainability
Protecting patients and reducing the risk of cross infection remains a priority, but it is also important to recognise the environmental cost of single-use devices. As such, Eakin Surgical is making every effort to be sustainable in the products it manufactures and has reduced its supply chain route by 26,034 miles per year. This equates to a substantial reduction in carbon emissions. It also sends zero waste to landfill.
Products are packaged in cardboard boxes which can be recycled, while the company is also looking to reduce its carbon footprint by investing in solar panels and green energy, working with suppliers that are FSC certified and providing on-site clean rooms and sterilisation services. The Eakin Healthcare Group has also recently appointed a sustainability manager to ensure that sustainability is at the forefront of the company’s activities.
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- Time to act: A state of the nation report on surgical site infections in the UK (December 2020), https://www.pslhub.org/learn/patient-safety-in-health-and-care/high-risk-areas/surgery/ surgical-site-infections/time-to-act-a-state-of-the-nation-report-on-surgical-site-infections-in-the-uk-december-2020-3895/#:~:text=This%20 report%2C%20Time%20to%20Act,SSI%20 rates%20in%20the%20UK.
- HSIB, Decontamination of surgical instruments, 26/05/2022, https://www.hsib.org.uk/investigations-and-reports/decontamination-of-surgical-nstruments/decontamination-of-surgical-instruments/#:~:text=If%20not%20removed%20correctly%2C%20certain,medical%20attention%20following%20the%20surgery.
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