Managing the area for reprocessing for reusable medical devices

Practices need to:

• have a designated area for reprocessing reusable medical devices that is physically separated from treatment and administration areas
• establish a workflow pattern that prevents contamination of clean (pre-sterile and sterile) areas.

The zones within the reprocessing area include:

• Dirty zone: Area where contaminated reusable medical devices are received and pre-cleaned.
• Clean zone, made up of:
  • Pre-sterile zone: Area where reusable medical devices are cleaned, dried, and packaged, but not yet sterilised.
  • Sterile zone: Area where sterilised devices are stored, protected from contamination, and ready for use.

Ideally, the practice has a dedicated room for reprocessing. Shared spaces are acceptable provided physical methods or barriers are used to separate reprocessing activities. For example, locating patient care areas away from the sterilising area, or not processing equipment when patients are present. The methods used should be documented in the practice’s risk register, along with identified mitigants.

The reprocessing area needs to be in a low-traffic part of the practice and is not to be used for linen or waste processing, or storage of supplies unrelated to reprocessing (other than personal protective equipment and consumables). Benches and floors need to be kept clear of unrelated items, such as cardboard boxes, paperwork, or supplies that could introduce dust or fibres and compromise device hygiene.

The practice needs to establish a workflow pattern that systematically moves from designated ‘dirty’ to designated ‘clean’ (pre-sterile then sterile) zones within the dedicated processing area. This means that dirty reusable medical devices do not come into contact with clean or sterilised items.

Key considerations for workflow planning:

• Clearly mark or physically separate each zone.
• Ensure that all staff are trained to maintain the directional flow from dirty > pre-sterile > sterile.
• Avoid any crossover of instruments, packaging, or supplies between zones.

The equipment processing area should have two sinks: one designated ‘dirty’ (for washing used reusable medical devices) and the other designated ‘clean’ (for rinsing the washed reusable medical devices).As the use of a washer-disinfector for pre-cleaning of reusable medical devices is required for precleaning, manual cleaning is not routinely required. In this context, a second sink is not mandatory if the practice can demonstrate, through a documented risk assessment, that all devices are compatible with the washer-disinfector, and that contingency procedures are in place if the washer-disinfector is temporarily out of service. The number and designation of sinks must be recorded in the practice’s risk register and reviewed regularly.

Reprocessing sinks should be made of stainless steel, as this material is durable, resistant to chemicals, and easy to clean. Porcelain or other materials that may chip, crack, or scratch are not recommended. They need to be of sufficient depth and size to allow a device to be completely immersed.

The reprocessing sinks cannot be used for:

• washing hands
• disposing of leftover beverages
• laundering
• washing dishes.

Reusable medical devices must only be cleaned in designated reprocessing sinks, never in a hand basin. Hand basins are for hand hygiene only and are not suitable for instrument cleaning.

Pre-cleaning of reusable medical devices is not to be performed using plastic tubs or other non-validated containers. All pre-cleaning must be performed in the designated compatible sinks or using equipment validated for use with the washer-disinfector. Plastic tubs or containers cannot be adequately reprocessed and may compromise device hygiene and sterility.

Practices are not expected to have a sink dedicated to wastewater disposal.

Wastewater generated during reprocessing activities (for example, detergent or rinse water) may be safely emptied via the dirty sink, provided no instruments or devices are present in the sink at the time.

The sinks used for reprocessing are not to be used for disposal of unrelated liquid waste, including:

• beverage or food waste
• pharmaceutical or medicinal fluids, such as:
  • expired or unused intravenous (IV) fluids
  • irrigation or infusion solutions (for example, saline, glycine, or glucose solutions)
  • disinfectant or chemical solutions not approved for drain disposal
  • vaccine residues or diluents
  • liquid medicines or compounded preparations
• body fluid waste from procedures (for example, wound irrigation fluids, urine, or other clinical waste requiring biohazard disposal)
• handwashing runoff from non-clinical or staff-use-only activities.

The packaging items to be sterilised needs to be done in the ‘clean’ (pre-sterile) zone, away from the ‘dirty’ zone and drying zone, and with adequate space or a physical barrier to minimise contamination.

Equipment, activities and sub-zones within the designated ‘clean’ (pre-sterile) zone include:

• the holding area for reusable medical devices awaiting sterilisation (before the steriliser)
• reprocessing equipment
• the cooling area for packages that are unloaded from the steriliser.

Separation of pre-sterile and sterile items

Pre-sterile (clean) instruments and sterilised instruments need to be physically separated. The same bench, shelf, or area cannot be used for both, to prevent cross-contamination. Sterile items need to be stored in a dedicated cooling or storage area within the sterile zone, clearly separated from any items awaiting sterilisation.

The bench top needs to be cleaned and dried between uses. Any containers in the area need regular wiping to remove dust. There should be no open shelves with materials that can accumulate dust.

Regular cleaning of the reprocessing area ensures a safe, hygienic environment and reduces the risk of contamination of reusable medical devices.

Cleaning frequency and procedure

• The reprocessing area needs to be cleaned according to the practice’s documented cleaning schedule and procedures.
• After each reprocessing session, clean and dry:
  • all equipment
  • sinks and fixtures
  • immediate surrounding areas, including splashbacks and benches.
• The choice of cleaning method (detergent only vs. detergent followed by disinfectant) depends on:
  • local epidemiology
  • a local risk assessment. See Cleaning agents and methods for further considerations.

The practice needs to use separate, dedicated cleaning equipment for the dirty work area and clean work areas.

The use of benches within the reprocessing area for other purposes should be avoided. If this does occur, the benches need to be cleaned immediately after that activity in accordance with the practice’s documented cleaning procedure.

Within the reprocessing area, hand hygiene needs to be performed:

• before putting gloves on
• when moving from ‘dirty’ to ‘clean’ areas
• after handling soiled equipment
• after removing gloves
• before opening the steriliser
• before handling or packaging clean items
• before handling sterilised packs.

Appropriate gloves need to be worn at all times when handling contaminated reusable medical devices. For example, latex-free, puncture resistant, chemical-resistant utility gloves (preferably longer cuffed).

Alcohol-based handrub should be readily available and accessible in all work zones within the reprocessing area.

Hand cream is not to be used when performing reprocessing, because it can contaminate instruments or compromise the integrity of packaging.

As described at Workflow planning, the reprocessing area needs to establish a workflow pattern systematically moving from designated ‘dirty’ to designated ‘clean’ zones within the dedicated area. A one-way workflow prevents dirty reusable medical devices encountering clean reusable medical devices.

Consider the following when setting up the area designated for reprocessing reusable medical devices:

• Surfaces (benches, sinks, splashbacks, walls) need to be smooth, with no rough or textured areas where soiling can accumulate (such as tiles with grouting or silicon sealant) and made of material that does not shed fibres or particles. Ideally there should be no crevices between the walls and floor, or around any fixtures, where dirt can collect. The floor needs to be washable non-slip material.
• A washer-disinfector is required.
• Dedicated sinks, one designated as ‘dirty’ and the other ‘clean’ for pre-treatment, manual cleaning, and rinsing of a reusable medical device need to be provided. Sinks need to be of sufficient depth and size to allow a device to be completely immersed. Cleaning sinks are not to be used for any other purpose, such as washing hands. Similarly, hand basins are not to be used for reprocessing reusable medical devices.
• Provide separate hand hygiene facilities in the reprocessing area, such as a dedicated handwashing sink or hands-free alcohol-based handrub dispenser. Handrub dispensers cannot be placed at sinks or directly over work areas and should be installed adjacent to benches where they will not splash.
• The area needs to be well lit to make it easy for staff to inspect devices for soiling.
• All supplies are to be stored in closed cupboards or drawers; no materials, supplies or equipment is to be left out or stored on benches or floors. Even clean boxes shed fibres that could compromise device asepsis/sterility.
• The area cannot be shared with linen or waste and should be a low-traffic area.
• Clean, dry gloves and aprons, masks and full-face shields should be easily accessible in the reprocessing area. They need to be stored in a closed dry cupboard, well away from possible splashing or contamination.

Sterilised reusable medical device packs need to be stored in enclosed, well-sealed areas to protect them from dust, moisture and other environmental contaminants that could compromise sterility.

Figure 10.3 Example reprocessing area setup demonstrating one-way workflow
 

The workflow is strictly in one direction: the staff member enters the zone with clean hands, dons required PPE and proceeds to work from the ‘dirty’ to ‘clean’ (less contaminated) zones (shown left to right above), washing hands with soap and water if they become visibly contaminated, and reusing alcohol-based handrub after each stage of the process while hands remain visibly clean.

The direction of airflow is from the ‘clean’ zone to the ‘dirty’ zone. The ultrasonic pre-cleaner, if the practice has one, is ideally placed between the two sinks, contingent on plumbing, power and safety considerations.

The diagram is intended as a sample. Alternatives are possible:

• The location of the ultrasonic pre-cleaner (either before Sink 1 or between Sinks 1 and 2) is decided based on a practice's pre-cleaning process.
• The washer-disinfector may be installed under the bench, on the bench, or as a tall unit. Its placement should not disrupt the unidirectional workflow and must allow safe, ergonomic loading and unloading.
• As the use of a washer-disinfector for pre-cleaning of reusable medical devices is required for precleaning, manual cleaning is not routinely required. In this context, a second sink is not mandatory if the practice can demonstrate, through a documented risk assessment, that all devices are compatible with the washer-disinfector, and that contingency procedures are in place if the washer-disinfector is temporarily out of service. The number and designation of sinks must be recorded in the practice’s risk register and reviewed regularly.