Infection prevention and control guidelines

10. Reprocessing reusable medical devices

Summary of steps in reprocessing medical devices that require sterilisation

      1. Summary of steps in reprocessing medical devices that require sterilisation

Summary of steps in reprocessing medical devices that require sterilisation

For items that require sterilisation, reprocessing involves (Table 10.3. Summary of steps for processing reusable medical devices):

  • initial treatment (wiping or rinsing immediately after use, at the point of use)
  • collection and transportation to the reprocessing area
  • pre-cleaning using an ultrasonic cleaner (if the practice has one)
  • cleaning (manual scrubbing followed by rinsing and drying, or processing in an automatic washer/disinfector with or without an initial ultrasonic cycle)
  • inspection and packaging
  • sterilisation.

Packaging and sterilisation steps include:

  • packaging items for sterilisation in an appropriate covering material (‘sterile barrier system’; pouches, packs, wraps, or rigid containers), using correct materials and technique
  • using appropriate indicators in or on every load to identify packs that have been through the steriliser
  • labelling packs
  • loading the steriliser
  • running the cycle
  • unloading the steriliser
  • before releasing the load for use, checking the printout or data logger to verify that the correct heat, time and pressure parameters were attainted for the cycle
  • recording the name of the person who loaded the steriliser, the load description and load number, results of cycle monitoring, unloading, pack condition (dry, intact seals, chemical indicators show correct colour change), date and signature of staff member authorising release of the load for use or rejection of the load (with details of the issues causing the rejection, where appropriate), and process abnormalities detected (and corrective action, where appropriate)
  • storage, distribution and handling of sterilised packs to the point of use
  • daily, weekly and annual steriliser cleaning and maintenance
  • annual servicing, calibration and validation.

Regular routine maintenance also is required for all other reprocessing equipment, including ultrasonic cleaners, washer-disinfectors with or without ultrasonic capacity, drying cabinets, heat sealers, incubators, and biological indicator readers.

To achieve consistently reliable sterility, the practice must set up a comprehensive sterility assurance program incorporating every aspect of reusable equipment processing, including staff education, to avoid common errors (Table 10.4. Common reprocessing errors).

Table 10.3. Summary of steps for processing reusable medical devices

Initial treatment

Remove visible soiling by damp or dry wiping at point of care (eg in consulting or treatment room).

Transport to reprocessing area.

Pre-cleaning

Run ultrasonic cleaner cycle (optional) followed by rinsing (before manual cleaning).

Items should not be left in detergent solution for later cleaning

Cleaning

Manually clean items

OR

Run a washer–disinfector cycle.

Use personal protective equipment

Rinsing and drying

(required after manual cleaning or ultrasonic cleaning)

Note: Rinsing and drying is not required after cleaning with an instrument washer–disinfector

Rinse in designated ‘clean’ sink.

Drain on clean surface.

Dry manually or in drying cabinet.

Wear clean latex-free gloves (eg utility gloves or nitrile chemically resistant examination gloves) while drying

Preparing the load for sterilising

Check items are clean, intact and functioning.

Select packaging of appropriate size – to match the item or set of items to be sterilised.

Ensure each package has Class 1 chemical indicator incorporated into its surface.

Seal the package – ensure there are no gaps through which air can enter and contaminate the contents.

Label packages (date, load number and, if required, description of contents, and the signature of person responsible for packing).

Loading the steriliser

Place items in steriliser:

  • Items that could collect condensate are placed on their sides
  • Packages are separated to facilitate air removal, steam penetration and drying. Trays are loosely loaded with a single layer of packs per tray, within the boundaries of the loading tray.
  • Ensure that no pack touches the chamber wall.
  • Do not exceed the validated challenge load parameters – check validation record.

Enter description of contents into the logbook.

Running the sterilisation cycle

Check water level – add if necessary (follow manufacturer’s instructions for use).

Choose correct cycle (if steriliser has multiple cycles).

Select correct cycle parameters (if steriliser validated for multiple load types) – check validation record.

Enter required details in steriliser logbook (date, load description and load number, name of the person who prepared the load).

Close door and start steriliser cycle.

Do not attempt to open the steriliser door while the cycle is in operation.

Unloading the steriliser

Do not attempt to open the steriliser door while the cycle is in operation.

When the cycle is completed:

1. Check the physical parameters

2. Remove trays using tray lifter or heat-resistant gloves – do not touch packages while hot

3. Place trays on drying surface – allow to cool for minimum of 30 minutes

4. With clean hands, check cooled packages for class 1 indicator pass and for moisture or damage.

Classify load as PASS or FAIL.

Documenting the cycle

Record details in the steriliser logbook (in addition to previously recorded details):

  • confirmation that Class 1 chemical indicators changed colour
  • results of any other indicators used (eg
  •  chemical or biological)
  • correct time, temperature and pressure was achieved
  • condition of the packs (ie dry and intact)
  • comments (eg action taken for failed cycle)
  • name of the person who released the load.

Storing sterilised equipment

When cool, store sterilised packs in clean enclosed storage area.

Only handle packs with clean hands.

Rotate stock so that items sterilised earlier are used first.

TGA: Therapeutic Goods Administration

Table 10.4. Common reprocessing errors

Inadequate instrument cleaning leaving debris

Incorrect choice of packaging material type

Too many items in package

Excessive wrapping material used on package

Overloading of steriliser

Inadequate maintenance of steriliser

Use of sterilisation equipment not registered by the Therapeutic Goods Administration for the purpose

 

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