Managing the area for reprocessing for reusable medical devices

      1. Managing the area for reprocessing for reusable medical devices

Managing the area for reprocessing for reusable medical devices

The reprocessing area must be in a low-traffic area of the practice. It must be set aside for this purpose and  not also used for linen or waste processing, or storage of any supplies except personal protective equipment and consumables required for these tasks.

Within the reprocessing area, no materials or equipment may be left out and nothing should be stored on benches or floors. Any materials in the area can contaminate items for reprocessing (eg cardboard boxes can shed paper fibres).

Ideally, a reprocessing area is fitted with a type B handbasin.

One or more (as required) alcohol-based handrub dispensers could be installed on the wall adjacent to the bench areas where reprocessing is done, but not directly over the work area.

For information on the design requirements of sinks and benches, see 12. Planning a practice: design, fit-out, equipment and consumables.

Workflow planning

It is essential to establish a workflow pattern systematically moving from designated ‘dirty’ to designated ‘clean’ zones within the dedicated processing area. A one-way workflow will ensure that dirty reusable medical devices do not come into contact with clean reusable medical devices.

Designating purposes of sinks

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).

If this is temporarily not possible (eg while refitting the room), a rinsing sink and a separate washing bowl can be used. Avoid routine use of a washing bowl in place of designated sinks.

The reprocessing sinks must never be used for:

  • washing hands
  • disposing of wastewater from cleaning
  • disposing of leftover beverages
  • laundering
  • washing dishes.

After each reprocessing session, all sinks and fixtures (and the immediate area, including splashback and benches) must be cleaned with water and detergent, then dried.

See also 12. Planning a practice: design, fit-out, equipment and consumables.

Work benches

Packaging items for sterilisation must take place in the ‘clean’ zone, away from the ‘dirty’ zone and drying zone, with adequate space or a physical barrier to minimise contamination.

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

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

The bench top must 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.

Hand hygiene

Within the reprocessing area, hand hygiene must 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 must 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 must not be used when performing reprocessing, because it can contaminate instruments or compromise the integrity of packaging.

Cleaning agents and other materials used in reprocessing

Detergents

If cleaning is delayed, pre-treated items can be held in a labelled container for a short, pre-specified The practice must specify and document the maximum period of time permitted between use of a reusable medical device and subsequent processing, as suitable to the practice’s needs, processes and risk assessment. time, covered with a TGA-registered instrument precleaning product that is suitable for metals and plastics.

Items should not be left soaking in detergent solution for later cleaning because bacteria can multiply at room temperature, leading to excessive contamination, and due to splash risk.

Cleaning agents used in reprocessing reusable medical devices must be:

  • listed in the Australian Register of Therapeutic Goods
  • suitable for the reusable medical devices being processed and the selected method of cleaning (for example, non-abrasive and non-corrosive)
  • diluted and used in accordance with the product’s instructions
  • compatible with the available water quality
  • non-toxic at the specified dilution
  • low-foaming
  • free-rinsing.

For example, a mildly alkaline, free-rinsing, low-foaming, biodegradable liquid instrument-grade detergent can be used.

Avoid:

  • abrasive cleaners such as steel wool, domestic cleaning powders and pastes, as these may damage the surfaces of reusable medical devices or leave a residue
  • strongly alkaline detergents for manual cleaning. Although these are more effective, they are caustic and are only safe for use in washer disinfectors
  • chlorine-based products such as bleach, as they can corrode and rust reusable medical devices and sterilisers
  • normal household detergents, as they are generally high foaming and often leave a film that is hard to rinse away and could harbour microorganisms High-foaming detergents increase risk to staff injury because they make items more difficult to see when washing, and can generate aerosols.

Enzymatic detergents are rarely used in general practice and other office-based practices. These are usually used in automated processes and reserved for lumened instruments with internal surfaces that are difficult to access , such as endoscopes.

Brushes

Clean brushes of various sizes, with firm plastic bristles capable of withstanding cleaning agents, should be kept in the cleaning area for use during the cleaning stage.

Reusable brushes must be reprocessed after each use to reduce cross-contamination and biofilm formation. They can be manually cleaned (if the practice does not have a washer-disinfector) and sterilised, or mechanically cleaned and heat disinfected in a washer-disinfector at the end of each working day. Ultrasonic cleaners are generally not suitable for plastics.

Where reusable validated cleaning brushes for instrument cleaning are used, reprocess them in accordance with the manufacturers’ information for users.

Thin disposable brushes (eg cytology brushes) are useful to clean items with lumens, holes or valves. These cannot be reprocessed.

Cloth/paper for drying

Residual lint on instrument surfaces must be avoided because it could cause a foreign body reaction in a patient tissue.

If the practice does not use an automatic washer/disinfector with drying cycle or a drying cabinet, drying must be performed using a reusable lint-free cloth or a disposable low-lint cloth.

If reusable lint-free cloths are used, they must be correctly laundered in accordance with the current relevant standard for laundering of healthcare linen (see 9. Cleaning, laundry and waste management), following a protocol that ensures they are not exposed to dust or contamination while drying.

Disposable kitchen wipes, paper hand towel or tea towels must not be used because they leave a large amount of lint.