Infection prevention and control guidelines

10. Reprocessing reusable medical devices

Validating reprocessing procedures

      1. Validating reprocessing procedures

Last revised: 17 Jun 2024

Validating reprocessing procedures

Validation is a documented procedure for obtaining, recording and interpreting results, to establish that the practice’s reprocessing procedures, including sterilisation, will consistently yield sterile reusable medical devices and equipment.

Process validation includes:

  • validation of the equipment (steriliser and washer-disinfector) performed by an accredited technician at installation and annually
  • operational qualification (checking the steps are being performed correctly) performed by practice staff or by a technician
  • performance qualification (checking the sterilisation process is effective in killing/inactivating microorganisms) performed by staff or by a technician.

Validation must be performed for each steriliser and for each set of parameters used in cycles. For most practices, validation of the sterilisation cycle will involve only a single steriliser, cycle time, temperature and challenge pack/load. Validation will be more complex for practices that use more than one steriliser or use more than one type of cycle.

Frequency of process validation

Validation of the entire process (all aspects of reprocessing, not just the sterilisation cycle) must be performed at installation (also called commissioning) and then annually.

In addition to technical validation of the steriliser cycle, annual validation should also include reviewing all protocols and procedures for reprocessing of reusable medical devices, from pre-cleaning to storage, and checking staff competency.

Validation of other equipment such as automatic washer/dryers is also required annually.

Validation must be performed again if, between annual validations, any part of the sterilisation process is altered in a way that could affect the sterilisation outcome, for example:

  • The practice installs an ultrasonic cleaner.
  • The steriliser has been returned after offsite repairs.
  • Major repairs to the steriliser have been performed onsite.
  • The practice has started using a different sterile barrier system.
  • The practice has significantly changed the chamber contents and/or loading protocol.

Responsibility for steriliser validation

Validation is managed by the designated staff member with overall responsibility for the practice’s sterilisation process (who may or may not be the infection prevention and control coordinator).

Site of steriliser validation

All aspects of validation should be performed onsite because validation of the sterilisation process outside the practice may not match practice conditions.

Revalidation is required after transporting a steriliser back to the practice after repairs.

When onsite technical servicing is not accessible

Occasionally, in some regional and remote areas, general practices and other office-and community-based practices cannot access onsite technical support.

In cases where annual servicing and calibration occurs offsite, the practice should send a complete ‘challenge pack/load’ with the steriliser to allow checking of penetration time and appropriate selection of sterilisation times and physical checking of ‘time at temperature’ of the steriliser.

Provided that the steriliser has been returned to the practice using appropriate transport and has not been grossly mishandled, the validation process can be completed onsite.

Microbiological qualification using appropriate biological or enzymatic indicators must be performed onsite by the practice. The service technician should send a copy of the printout results of a sterilisation cycle of the challenge pack/load to the practice, so that the practice can confirm the parameters that were tested and achieved, and can compare results obtained from onsite microbiological qualification. The onsite test will help check that no adverse changes occurred during transport.

If neither full onsite validation, nor partial onsite validation (microbiological qualification at both the service centre and practice) is possible, special checking of every cycle must temporarily be performed as an alternative to validation (for example, including use of Class 6 indicators). In such situations, the practice should request advice from the technician on how to perform these checks correctly until the steriliser can be properly validated.

For each type of sterilisation cycle (ie set of parameters) used in the practice, the temperature, time pressure is measured using calibrated equipment with a challenge load in the steriliser, to determine if sterilising parameters are reached. Drying is also checked.

Steriliser validation must include:

  • heat distribution studies conducted on an empty chamber – available from the manufacturer, a previous validation or determined by the service technician
  • a description of the challenge pack and load, and the chamber loading configuration, including a diagram or picture
  • penetration time of the challenge pack The ‘challenge pack’ must be defined for the individual practice. Among all the types of packs and steriliser load configurations that are processed within the practice, the practice needs to identify those that are most difficult for steam to penetrate and required temperature to be reached and maintained. The challenge pack is the most difficult-to-sterilise pack. The contents of the challenge pack and the loading configuration must be recorded so that the same conditions can be replicated at each validation. of the load to be validated, as determined by the service technician at the current validation
  • physical qualification of the sterilisation cycle, including testing time at temperature
  • microbiological qualification.
This involves processing of three identical consecutive cycles, using two biological indicators for each cycle (for each different cycle selected).