Beyond Clean UK & Ireland, Manchester (2025)

06/02/2025

🚨 Check out the latest Beyond Clean UK & Ireland Expert Series™ release from our Ultrasound Probe Expert™ Ellie Wishart! This 3-page PDF resource is available for download here: https://educate.beyondclean.net/42KQl7I

"High-level disinfection needs to be successful on every probe, every time, to protect every patient from infection risk. In addition to the validation that occurs when a device is manufactured and then installed, automated disinfection systems often have in-build indicators that verify critical efficacy parameters after every cycle. These parameters include time, temperature, disinfectant dosage and concentration, all of which can affect microbiological efficacy. Chemical or biological indicators provide a secondary independent verification of the disinfection process, above and beyond the validation that occurs during performance qualification.

In some countries, such as Germany, there is a legal requirement for on-site validation of the final reprocessing step of semi-critical devices. The Robert Koch Insitut (RKI) reported that they were unable to identify any standards or guidelines that demonstrated successful validation of manual wipes in this context. RKI identified that sufficient mechanical force and application of disinfectant to all surfaces and geometries of a device could not be guaranteed with wipes, making validation not possible. The Dusseldorf area health authority then released a statement on the RKI clarification, stating that wipe disinfection of semi-critical medical devices is not acceptable.

“It is also not yet apparent to us how this could be validated on site as part of the validation of the reprocessing process. Therefore, we currently do not consider the final wipe disinfection of semi-critical medical devices to be validatable.”

Verification of efficacy parameters helps give staff peace of mind that high-level disinfection is being performed reproducibly, every time. If the parameters are not met, the user will be notified and the probe will not be used. Without this in-built verification of efficacy parameters, how can you be sure that the next patient is protected from infection risk?" - Ellie Wishart

08/01/2025

🚨 Check out the latest Beyond Clean UK & Ireland Expert Series™ release from our Ultrasound Probe Expert™ Ellie Wishart! This 3-page PDF resource is available for download here: https://educate.beyondclean.net/4fNMGc6

"Standards in the United Kingdom and Ireland require that all devices used for reprocessing reusable medical devices, including ultrasound probes, must be validated in-field. The process of in-field validation is essential to document that reprocessing equipment functions as intended and as designed for clinical use.

For automated disinfection devices, in-field validation is used to determine that high-level disinfection is delivered effectively and consistently with every cycle, in actual-use conditions. A full validation program consists of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) followed by routine monitoring, testing, and control.

The specific requirements for validation are outlined in international standards, specifically ISO 15883. Local guidelines, such as HTM 01-06 Part D and Health Service Executive (HSE) guidance, also detail validation requirements based on ISO 15883. While HTM-01-06 provides best practice guidance for flexible endoscopes, this guideline is relevant to the reprocessing of other heat-sensitive, semi-critical medical devices, such as ultrasound probes.

Failure to follow requirements for in-field validation can put patient safety at risk. In 2021, 110 patients were recalled by St. Vincent Hospital in Antwerp following the discovery of an error in the connection of an endoscope disinfection bath. As PQ was not carried out, the hospital could not determine if the equipment was operating correctly, meaning patients were potentially exposed to contamination." - Ellie Wishart

05/12/2024

🚨 Check out the latest Beyond Clean UK & Ireland Expert Series™ release from our Ultrasound Probe Expert™ Ellie Wishart! This 3-page PDF resource is available for download here: https://educate.beyondclean.net/3VnHN1U

"When considering high-level disinfection (HLD) processes for ultrasound probes, there are several critical variables to consider. These are variables that have a significant impact on the ability of the HLD process to deliver its intended results reproducibly.

All HLD agents must be in contact with the surface being disinfected for a set time, in order to achieve the efficacy stated on their label. This is known as the contact time. Some methods of disinfection may have different length contact times for different organisms, meaning that the longest contact time must be used to ensure the full spectrum of disinfection required for HLD. For manual HLD methods, such as wipes or soaks, the use of a timer is necessary to ensure that the contact time is being met.

The coverage of a disinfectant on a surface must also be considered. The entire surface of an ultrasound probe must remain wet with disinfectant for the duration of the contact time, in order for disinfection to be successful. For some HLD methods, this can be challenging. In a study of manual disinfection with chlorine dioxide wipes, gaps in surface wetting were identified (moulds, clip-on areas and some housing seams) after using a coloured cleaning wipe kit, meaning that HLD would not be achieved in these areas.

Other methods, such as UV-C disinfection, experience problems with shadowing that can prevent light from reaching all surfaces of the probe evenly. Cracks and crevices in the probe surface, as well as features of the probe morphology, can create shadowed areas that can harbour microorganisms. These organisms have the potential to survive disinfection, if the intensity of light reaching them is under the threshold required for HLD. " - Ellie Wishart

06/11/2024

🚨 Check out the latest Beyond Clean UK & Ireland Expert Series™ release from our Ultrasound Probe Expert™ Ellie Wishart! This 3-page PDF resource is available for download here: https://educate.beyondclean.net/4fCuoLd

"Many high-level disinfection (HLD) methods rely on potent chemical agents to eliminate microorganisms. While highly effective, the chemicals involved in HLD must be handled, stored, and disposed of carefully to protect staff, patients, and the environment.

Manual reprocessing methods have inherent risks, as they involve direct contact with the disinfection chemistry. Users often must manually prepare the chemistry, reprocess the probe, and dispose of waste once the chemistry expires. Depending on the method used, staff may require extensive personal protective equipment (PPE). For example, manual wipes require users to wear gloves and eye protection or a face shield due to the risk of skin and eye irritation. As manual HLD methods are open systems, it is also recommended that they are performed in a well-ventilated space, which can be difficult to achieve in clinical areas.

The use of automated HLD methods is preferred in many guidelines, due to the risks associated with manual processes. The World Federation for Hospital Sterilisation Sciences (WFHSS) recommends automated processes in preference to manual processes due to the risks associated with chemical exposure from aerosols during handling. The ECRI Institute also notes the advantages of automated systems, citing improved efficacy and better chemical safety.

As automated HLD occurs in a closed system, staff require only minimal PPE. There is no contact with the active chemistry, meaning the risk of chemical exposure is negligible. Residual and vapour testing of automated systems means there is minimal risk of hazardous exposure to chemical vapours or residues after the disinfection cycle. Residual testing also means that ultrasound probes are safe to use on patients without putting them at risk of chemical exposure during an examination." - Ellie Wishart

09/10/2024

🚨 Check out the latest Beyond Clean UK & Ireland Expert Series™ release from our Ultrasound Probe Expert™ Ellie Wishart! This 3-page PDF resource is available for download here: https://educate.beyondclean.net/4dDOYJy

"Ensuring that the reprocessing methods used in a facility are compatible with the ultrasound probes they are used on is critical to protect patients from infection. Untested or incompatible cleaning and disinfecting agents can damage the plastic surfaces of ultrasound probes, increasing the risks of cross-contamination.

The MHRA released a Medical Device Alert in the United Kingdom highlighting that incompatible detergent and disinfectant wipes can damage the plastic surfaces of medical devices. An example is wipes containing greater than 70% alcohol, which can cause damage to the ultrasound transducer footprint, screen, cables, and connectors.

Repeated exposure to UV-C light can also have a damaging effect on plastics. Prolonged UV-C exposure can cause photodegradation – a breakdown of polymers that causes the material to become brittle and crack.

This damage to plastics can impact the efficacy of reprocessing. A study found that quaternary ammonium wipes were less effective on thermally-aged and UV-aged PVC, compared with untreated PVC surfaces. UV-C disinfection methods are also less effective on damaged plastics. Damaged surfaces contain microscopic cracks and crevices that can house bacteria and shadow them from UV-C light. In a study, plastic samples exposed to UV-C light showed significantly increased levels of bacterial adhesion, compared to unexposed samples.

Preventing damage to the plastic surfaces of ultrasound probes is critical to lower the risk of infection transmission. The best way to prevent this damage is to use only cleaning and disinfection methods with demonstrated ultrasound probe compatibility. Consult the probe manufacturer IFU for methods that have tested compatibility with a wide range of probes, including the exact brands and models of probes used in your facility." - Ellie Wishart

04/09/2024

🚨 Check out the latest Beyond Clean UK & Ireland Expert Series™ release from our Ultrasound Probe Expert™ Ellie Wishart! This 3-page PDF resource is available for download here: https://educate.beyondclean.net/3AJLEPi

"Ultrasound probes are complex, expensive medical devices that contain many fragile components. Despite the best efforts of the staff that use and reprocess them, damage to probes in clinical use is common. A multicenter study in the UK found that more than 1 in 3 probes were faulty, and more than 1 in 8 were not fit for clinical use.

Damage can have a range of causes, from dropping or knocking the probe to the use of incompatible reprocessing methods. Aggressive cleaning methods, such as vigorous wiping motions, can cause mechanical damage to probes. Similarly, the use of abrasive cleaning wipes or paper towels is not recommended as it can damage sensitive probe components.

The use of incompatible cleaning and disinfection agents, incorrect solution strengths, or exposure to chemicals for longer than recommended can all cause damage to the plastic surface of probes or probe cables.

When damage affects the probe lens or internal elements, it can have clinical implications by affecting image quality. In a UK study, image dropout caused by damage to internal probe elements was detected in 20% of ultrasound probes surveyed. This compromised image quality can potentially lead to missed or incorrect diagnoses. Physical damage, such as dents or scratches, can also interfere with cleaning or reprocessing and create a higher risk of infection for patients.

Probe damage is a common occurrence in all countries where ultrasound probes are used, often resulting from mishandling or the use of abrasive or incompatible reprocessing methods. All staff involved in reprocessing ultrasound probes should handle them with care, and always consult manufacturer instructions for use before using any new cleaning or disinfecting agents." - Ellie Wishart

07/08/2024

🚨 Check out the latest Beyond Clean UK & Ireland Expert Series release from our Ultrasound Probe Expert Ellie Wishart! This 3-page PDF resource is available for download here: https://educate.beyondclean.net/4dazHQZ

"The automation of ultrasound probe disinfection creates a traceable, easily reproducible process that eliminates many of the variables inherent in manual methods.

High-level disinfection (HLD) of ultrasound probes must be successful every time to reliably protect the next patient from infection. This means that the critical parameters required to achieve the disinfectant’s validated efficacy claims must be met on all surfaces of a probe, every time. These parameters include concentration, contact time, coverage of the medical device for the contact time, dose, temperature, and anything else relevant to the specific method used that could affect efficacy.

Manual HLD methods can be difficult to perform reproducibly. For example, the end user of an HLD wipe must ensure the entire probe surface remains wet with the active chemistry for the duration of the contact time. This contact time can vary based on the organisms targeted for disinfection, meaning that the longest stated contact time must be used to achieve the level of efficacy required for HLD.

A recent preprint article identified gaps in coverage on ultrasound probes disinfected using HLD wipes, using a coloured cleaning wipe kit. The study showed that complete surface wetting was not achieved on all probes even when wiping was performed by experienced users, highlighting a key challenge of using manual methods for HLD.

Automation of decontamination steps ensures that critical parameters, including disinfectant coverage, are being met every time. When these parameters are not met, the operator is notified so that the ultrasound probe is not used on a patient. In contrast, manual disinfection methods rely solely on staff to confirm critical parameters.

As automated disinfection methods are standardised and validated, they are considered best practice across Europe for HLD of semi-critical ultrasound probes. Many European guidelines recommend..." - Ellie Wishart

09/02/2024

🚨 Check out the latest Beyond Clean UK & Ireland Expert Series release from our Instrument Repair Expert Dan Coole! 🇬🇧 This 3-page PDF resource is available for download here: https://educate.beyondclean.net/49ktqQy

"With a wider understanding of the Circular Economy (CE), the repairs and refurbishments of medical devices have become a fashionable topic.

However, should saving the planet be the main driver for repair and who are the key stakeholders?

If we start with Sterile Services/Processing, their ‘customer’ requires complete trays to operate to a high standard of operational proficiency and sterilisation. In situations where instruments require repair, a quick turnaround in the resulting repair work is essential. This ensures less downtime for the tray and a happy operating theatre.

Procurement departments are managing spend, so they have a vested interest in these devices being maintained. However, with surgical instruments, typically this is something not often tied in with a maintenance package. Basic repair cost is often the key variable when assessing repair offers from instrument companies by procurement departments. However, quality and value for money should be the primary drivers.

A lot of trust is granted to the repair companies, based on an assumption that an ISO 13485 certificate, whether through a Notified Body or another UKAS accredited certification body, that instruments will be repaired to the desired quality, regardless of qualifications and training of the technicians performing the repairs. Speed and cost are often key variables for repair companies, to ensure profitability.

The patient should be at the top of the tree, in terms of stakeholders as patient care is the ultimate priority! Given a combination of all pressures on stakeholders, it is easy to see why quality can be potentially forfeited. Many stakeholders are reflecting on the fact that it has taken a driver such as carbon reduction, to draw attention to the need for well-maintained instruments to save energy. Being proactive with repair and maintenance not only improves performance, it is more cost-efficient, and saves lives!" - Dan Coole

14/12/2023

[Brought to you by the Beyond Clean UK&I Vendor Focus™] We specialize in creating satisfying solutions. 🙌 From design to completion, let our InstruSafe® Experts help you create the perfect layout for even your most problematic sets. Whether small or large, delicate or robust, we design and manufacture trays to provide optimal instrument protection while complying with FDA regulations and AAMI standards.

To see our process and learn more about our premium InstruSafe® Custom Trays, please visit: https://educate.beyondclean.net/3RDIgvm

14/12/2023

[Brought to you by the Beyond Clean UK&I Vendor Focus™] Say goodbye to your flimsy, old sterilization trays! 👋 Unmatched in durability and quality, our premium sterilization trays ensure your most expensive instruments stay organized and protected. InstruSafe® trays secure instruments with a large variety of soft and durable silicone holders, fastened to the base and lid, ensuring 360 degrees of protection from the O.R. to the SPD.

To view our innovative Sterile Processing solutions for delicate instruments, please visit: https://educate.beyondclean.net/3TlpGtb

14/12/2023

[Brought to you by the Beyond Clean UK&I Vendor Focus™] You heard it here first! 👏 🦸 💥 Let us be your Sterile Processing Superhero and help you expertly design a tray solution for your most problematic instrument sets. Whether you need a solution for fine, delicate instrumentation or large, durable instrument sets, we can create a custom configuration to suit your specific needs.

To learn more about our premium InstruSafe® Custom OEM Trays, please visit: https://educate.beyondclean.net/4ajN8Nt

14/12/2023

Hey and superstars! We are pumped to have another Beyond Clean UK&I Vendor Focus™ series coming at you today. On select weekdays, we open up our social media channels for , to bring you some of the hottest new products, solutions, and services out there helping you , every instrument, every time. Stay tuned in just a bit for today's series featuring Innovia Medical! We hope you enjoy!

[Let us know if you have a favorite brand or vendor you'd like to see featured by commenting below or by emailing us at info@beyondclean.net]

Beyond Clean UK & Ireland

06/02/2025

08/01/2025

05/12/2024

06/11/2024

09/10/2024

04/09/2024

07/08/2024

09/02/2024

14/12/2023

14/12/2023

14/12/2023

14/12/2023

Address

Website

Alerts

Contact The Practice

Shortcuts

Share

Category