There's more to decontamination than just disinfection…

Disinfection is often the main focus in medical device reprocessing, but is only one step of the decontamination procedure. A successful reprocessing cycle is the sum of its parts — if one stage is compromised, the outcome is compromised. While many providers feel they are responsible for just the disinfection step, their success is dependent on ensuring other factors are completed.

Cleaning

It is commonly accepted that cleaning is the most important step for medical device reprocessing. If a device is improperly cleaned, most disinfectants are unable to perform effectively with the challenge of contamination, and the cycle will be compromised. Under the Australian Standard AS:5369, cleaning agents are regulated by the TGA, and must be included on the ARTG. Standard soaps or detergents mixed with water do not meet the requirement.

It is important that cleaning products are compatible not only with the medical device materials, but also with the method of disinfection. Within Australia, a commonly seen wipe used for cleaning and disinfection of medical devices prior to HLD states on the pack “Not to be used on invasive medical devices” and that it should not be combined with other disinfectants. There have been documented cases of devices being damaged by using a wipe followed by a disinfectant — both were compatible with the materials in isolation, but not combination.

Your medical device manufacturer or disinfection provider should be able to inform you of not only which products are compatible, but also have the appropriate regulatory approvals. Is your cleaning agent on the ARTG for that intended purpose?

Disinfection

Disinfection is only as effective as the user. Machine-based disinfection systems provide a confirmation that a cycle was completed under specific parameters, but often do not recognise basic features that may impact disinfection – such as incorrect device placement. Machines can also be variable in terms of cycle times and delivery. Manual systems rely on the user, but users are trained to recognise and decontaminate, and adjust behaviours to requirements. While machines can feel convenient, nothing replaces the focus of an individual.

Rinsing

The Australian Standard states to rinse medical devices in line with the disinfectant provider’s IFU. Many disinfection technologies do not require rinsing, as they leave no residue, or residue is proven to be negligible. If a device is rinsed, AS:5369 provides guidance on rinse water quality, with detailed feature for compliance.

Traceability

Traceability records for devices that undergo HLD are required to ensure tracking between patients. These records include details of the individual device, the date and time of reprocessing, means of reprocessing and the person who completed it. Other factors required by the disinfectant manufacturer can also be recorded. While traceability has been completed manually in the past, digital traceability is becoming more common, and often contains in-built features such as training or process challenges.

Storage

AS:5369 states that semi-critical devices should be stored to prevent environmental contamination in a designated storage area. Storage systems are designated as an accessory to reusable medical device and must be entered on the ARTG. Many facilities use commercially available plastic bags to store devices, but this does not meet requirements. Additionally, a number of device companies also supply covers for storage, but most have not been validated as suitable for purpose and are not found on the ARTG. Can you claim your cover is compliant?

Tristel provides a stable of products to ensure devices are entirely reprocessed in line with requirements. While many practitioners are familiar with Tristel’s Trio50 for total, validated decontamination of devices, other products are available to fill the gaps left behind in existing practices. Tristel Clean is a dedicated medical device cleaning agent that can be used as a standalone product, or prior to machine-based or manual disinfection. Tristel 3T is a complete digital traceability system that provides guidance to the user and confirms product use. Finally, Tristel Protect is a portable transport and storage system that has been validated to keep devices contamination-free for up to 72 hours.

Images: Supplied.