should be sent for maintenance or replaced. Be sure to carefully examine restriction points for entrapped moisture and look for physical damage. Scratches and roughened surfaces are difficult to detect, still these can harbour dirt, moisture, and microorganisms, as well as entrapping liquid hydrogen peroxide, aside from their direct impact to patient safety. Trays, containers, and container retainers are also to be inspected. Pack preparation needs to ensure proper configuration and closing of the contained devices, maintenance of set weight restrictions and utilising SBS that are compatible with the sterilising agent and process. Peel pouches, wrapped trays/baskets and rigid containers may be suitable. Examples of configurations are shown in figure 2.

Accessories such as liners, mats, holders, organisers, corner guards, filters and checklists can all still be used provided they are compatible for the sterilisation process. Cellulose (paper) materials are contraindicated in the VH2O2 process because they can absorb the sterilant to such an extent that it reduces the concentration causing the cycle to abort. It also has the ability, when at high concentrations, to spontaneously combust paper. Equally, textiles and other absorbent materials such as swabs and foam can also absorb the vapour and prompt the cycle to fail. Most commonly, pouches and reels made with a clear film face and Tyvek* backing are used. When pouches of different sizes are used, ensure that there is a minimum of 5cm gap between the instrument and pouch seal to reduce the risk of compromising the sterile barrier.

If double pouching, ensure that both pouches are aligned Tyvek to Tyvek, and there is no folding over of the pouch within the larger pouch; this could reduce the area for vaporised hydrogen peroxide penetration and removal. Non-woven polypropylene wraps, often referred to as SMS wraps, due to the combination of spunbond/meltblown/spunbond layers of the composite, are also adequate. A tray should be chosen to suit the dimensions of the instruments to be contained. Densely packed trays will prevent sterilising agent penetration. The wrap is secured with VH2O2-compatible tape, plain or imprinted with an indicator on its surface to indicate exposure to the sterilising agent. Today, there are also trays that have been validated for placement within a pouch. Close attention should be paid especially to the preparation of flexible endoscopes. It is critical to attach the venting cap; this is normally supplied with the endoscope. If the cap is not placed properly, the bending section cover of the endoscope can rupture due to the low pressure in the chamber causing a pressure differential inside the endoscope during the sterilisation cycle1

, as shown on figure 3.

The water-resistant cap also needs to be removed from video endoscopes. As far as packing, best practice dictates that endoscopes are placed on a compatible, correctly sized tray that is lined with a compatible mat and then wrapped either using SMS sheets or Tyvek pouch. It is important for decontamination personnel to understand that there are significant design differences among flexible endoscopes. Surgical flexible endoscopes such as those used in ENT, urology, bronchoscopes and choledochoscopes are within the processing claims of VH2O2 sterilisers.2 However, processing a GI endoscope, e.g., a colonoscope, duodenoscope or sigmoidoscope without a specific indication for use in a VH2O2 steriliser by the endoscope manufacturer may lead to device damage and potential patient injury. GI endoscopes may often contain a chemical lubricant within their internal parts that can react with the sterilising agent to form an acid reaction product. This can damage the endoscope, and, worse, may leak from the endoscope during a procedure, potentially injuring a patient.3

Load configurations and cycle selection

It is crucial that all operators of VH2O2 sterilisers understand the composition of each load they place in the chamber. Cycle selection is then based upon load content and steriliser model.

Device compatibility ranges from model to model, even in systems that may appear similar in design. Some basic variables for each VH2O2-compatible load are addressed in these questions: are the devices labelled for the specific VH2O2 steriliser model and cycle type? What are the lumen and diameter restrictions of the device? Are there weight restrictions? What is the load configuration for maximum throughput?

Understanding the cycle limitations is just

as important as the weight of the total load been processed. For example, non-lumen cycles cannot be used to sterilise a lumened device or a flexible endoscope. Sterilisation cycles may also impose limits on the number of devices that can be processed within a single cycle. While some sterilisers can only process around 9.5 kg of devices in a single cycle, other can process up to 22.7 kg.4

Personnel training and competency Finally, consistent, proper use by trained, competent operators is essential in achieving successful outcomes every time. Some VH2O2 steriliser manufacturers provide frequent operator training programmes in addition to toolkits for daily use, i.e. posters, sample policies, etc. that are consistent with the device instructions for use and can be used to acclimate operators with the new system and


procedures, as well as supplement the facility’s own training and competency programmes, ensuring that all decontamination aspects are understood and followed.

Investment in integrating VH2O2 sterilisation in a facility requires an educated approach about which process works best for the facility, instrumentation, personnel and patients. The fact is that VH2O2 sterilisation will continue to evolve and everyone involved with the process must ensure to keep pace. CSJ

*Tyvek® is a registered trademark of Dupont

References 1 Special Notice to Olympus Users of STERRAD Sterilization Systems: Proper Venting of Olympus Fiberoptic/Video Endoscopes using the ETO or Water- Resistant Cap https://medical.olympusamerica. com/customer-resources/cleaning-disinfection- sterilization/alerts-statements;

2 Technical Data Monograph - V-Pro Max 2 Low Temperature Sterilization System; Document #10382631 Rev. B (M9454EN); https://www.steris. com/healthcare/products/v-pro-sterilizers/v-pro- max-2-low-temperature-sterilization-system

3 Patent US 5716322, Medical Instrument and Method for Lubrication Therof, H Hui, L Feldman, HP Nguyen, D Timm, R Albers. Johnson and Johnson Medical, Inc.

4 Document ID #M9600EN 2018-06.Rev. A; pro-sterilizers/v-pro-max-2-low-temperature- sterilization-system

About the author

Georgia Alevizopoulou MD, CSSD Management, IDSc Cert is the senior clinical and education manager at Steris. Dr. Alevizopoulou has over 15 years of international experience in the field of medical device decontamination and infection prevention control technologies. She leads EMEA Steris University and delivers seminars, clinical lectures, inservices and troubleshooting assessments on a regular basis across EMEA. Previously, she worked as a general physician with the Greek National Health System.


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