Contents

Cleaning, Disinfecting, and Sterilising RMDs

Policy

Our practice follows equipment decontamination procedures that meet the requirements of:

• NZS 8134:2021 Ngā paerewa Health and disability services standard
• AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities.

Quality assurance is an essential part of reprocessing reusable medical devices (RMDs) at our facility. Any problems are investigated and reported to the IPC lead so that quality improvement initiatives can be identified. Serious events are reported following our processes for managing and reporting incidents or adverse events, and reported to the clinical governance group.

• There is a process for the calibration and preventative maintenance of all reprocessing equipment.
• We have written policies and procedures for all decontamination procedures.
• All records of maintenance and sterilisation cycles allow for identification and tracking/traceability of critical/semi-critical RMDs. We keep records for a minimum of five years.

  If an instrument is found to be contaminated, there needs to be a system in place for tracing:

  • which sterilisation batch the instrument was included in
  • all other items sterilised in that batch
  • which patients each of the items from that batch were used on, and the date.

    This might be a written record that includes details of the sterilised item(s), alongside the patient information.

Training and team participation

Only staff who are appropriately trained are given responsibility for any/all parts of the decontamination process. Clinical staff are trained on the principles of infection prevention and control and sterilisation during their induction, and again annually.

Staff must demonstrate competency in sterilisation procedures. Competency and training records are documented.

When buying products for reprocessing we:

• involve staff competent in all aspects of the process, to ensure that all items/equipment can be reprocessed effectively
• consider the skills of staff undertaking reprocessing.

Staff involved in any part of the decontamination process:

• have easy access to information about the use, care, and cleaning of RMDs
• exercise standard precautions when handling and cleaning RMDs.

Q40

In our team the following staff are trained to use the autoclave:

• [name and role]
• [name and role]

Decontamination

All RMDs are thoroughly decontaminated to prevent patient-to-patient transmission of infection.

We use a risk-based approach which involves:

1. Identifying and assessing risks through a risk assessment.

   A risk assessment process might follow the following steps:

   1. Assemble a team.
   2. Create a list of all RMDs used, and assess the risk of each using Spaulding's Classification.
   3. Determine the reprocessing required for each RMD.
   4. Develop a process flow for RMDs.
   5. Carry out a risk analysis of contamination for each step in the process using a risk matrix to grade the risks.

      The risk assessment should include handling, transporting, and storing RMDs.

   6. Add risks to the hazard and risks register.
   7. Mitigate the risks (implement any changes needed).
   8. Evaluate and review risks and the risk assessment process at least annually or whenever there is a change.

   The reprocessing requirements for each RMD are determined using Spaulding's Classification. Special consideration is given to any high-risk devices such as surgical instruments.

   Risk	Decontamination process	Storage
   Critical: High risk of infection. Comes into contact with sterile or vascular tissue. Examples: Surgical instruments, scalpels	Clean as soon as possible after use Sterilise by moist heat (if possible) If moist heat sterilisation is not compatible with the RMD, use low temp sterilisation (minimum)	Storage in sterile packaging in a designated area, to prevent environmental contamination
   Semi-critical: Comes into contact with mucous membranes or broken skin. Examples: Tweezers, scissors	Clean as soon as possible after use Sterilisation by moist heat (if possible) If moist heat sterilisation is not compatible with the RMD, use low temp sterilisation, or high level disinfection (minimum)	Store in a designated storage system such as a drying cabinet, to prevent environmental contamination
   Non-critical: Only comes into contact with non-broken skin Examples: BP cuff, stethoscope	Thorough cleaning and low-level disinfection using a compatible, low-level instrument-grade disinfectant or thermal disinfection	Store in a clean dry place where environmental contamination is minimised

   Spaulding Classification System

2. Putting risk control measures in place.
3. Continually monitoring and reviewing risks.

All parts of the decontamination process for RMDs are carried out in a designated reprocessing area using a dirty-to-clean flow of equipment. We take precautions to ensure that RMDs are handled, transported (if necessary), reprocessed, and stored in an environment that minimises the risk of contamination.

RNZCGP have a sample process flow diagram.

Cleaning

Cleaning is the most important step in reprocessing RMDs. It should be done as soon as possible after use, and must always be done before items are disinfected or sterilised.

• Follow the manufacturers' instructions for the use of cleaning products.
• For non-critical items, a combined cleaning and disinfecting wipe may be used.
• Use an enzyme detergent and/or ultrasonic cleaner for surgical instruments.

Single-use items must not be cleaned and reprocessed for use on other patients.

Disinfection

Low-level disinfection using a low-level disinfectant, or a combined cleaning and disinfecting wipe, is suitable for many non-critical items.

Disinfectants should be compatible with the RMD being treated, and should be stored and handled appropriately.

High-level disinfection of semi-critical items is likely to be outside the scope of most primary care settings.

Sterilisation

Sterilisation removes all bacteria or other living organisms from RMDs. To ensure the sterilisation process is effective, the autoclave needs to be installed, calibrated, and maintained correctly.

1. When a new autoclave arrives:
   • check that it's exactly what was described and ordered
   • ensure that it is installed as detailed in the manufacturer’s instructions.

     Installation qualification (IQ): verifies and documents that the equipment or systems are received as designed and specified, that they are properly installed in the selected equipment, and that this installation adheres to the manufacturer's approved specification and recommendations.

     Healthcare services should maintain records of their equipment or systems specifications (such as model numbers, serial numbers, and software version), calibration documentation and operational instructions.

     Source: Transitioning from AS/NZS 4187:2014 to AS 5369:2023 Australian Commission on Safety and Quality in Health Care.

2. Before the autoclave is used for "real-life" reprocessing, verify that it operates as specified by the manufacturer.

   Operational qualification (OQ): verifies and documents that the installed equipment or system operates according to its intended operational range specified by the manufacturer requirements.

   Healthcare services should ensure that OQ is performed after installation, significant maintenance, or modification, or when introducing new RMDs/other devices or loading configurations.

   Source: Transitioning from AS/NZS 4187:2014 to AS 5369:2023 Australian Commission on Safety and Quality in Health Care.

3. When the autoclave is being used regularly, carry out scheduled maintenance to check it is working reliably and meeting the expected standards.

   Performance qualification (PQ): verifies and documents that installed equipment or system performs effectively and consistently in accordance with predetermined criteria and specifications under real-world, operational conditions.

   Healthcare services should ensure that PQ is performed after IQ and OQ, significant maintenance, or modification, or when introducing new RMDs/other devices or loading configurations.

   Source: Transitioning from AS/NZS 4187:2014 to AS 5369:2023 Australian Commission on Safety and Quality in Health Care.

   A check of the autoclave's performance is required annually, after repairs, or significant change to types of instruments, size of packages or loading pattern.

All checks/validation reports should be analysed and approved by a competent person.

Q41

See also Decontaminating Specific Items for information about cleaning and disinfecting non-critical items, and the autoclave.

Sterilisation procedure

1. Preparing the load
   1. Visually check that items are functioning, and look clean and free from debris.
   2. Make sure all forceps and scissors are open – use protective covers for tips if necessary.
   3. Package in the approved pouches and seal according to the manufacturer's instructions. Visually check the integrity of the seal.
   4. Make sure each package has a Class 1 chemical indicator incorporated into its external surface.
   5. Label the exterior of the package with a non-toxic, water-resistant marker.

      Include date, load number and, if required, a description of the contents.

   6. Include a Class 1 chemical indicator inside any unwrapped load.

2. Loading and running the steriliser
   1. Load items onto the autoclave racks according to the manufacturer's instructions.
   2. Separate packages to allow air removal, steam penetration, and drying.
   3. Make sure that no packs touch the chamber wall.
   4. Check and run the correct steriliser cycle.
   5. Enter details into the steriliser log.

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

3. Autoclave log

   All sterilisation cycles are recorded and show the:

   • steriliser identification (if more than one autoclave is used)
   • time and date of each cycle
   • load contents
   • temperature, pressure and duration of the sterilising cycle
   • person loading and starting each cycle
   • person releasing the load at the end of cycle.

   Record the results of daily or weekly performance tests, e.g. Bowie-Dick.

4. Unloading the steriliser
   1. Remove items from the steriliser while hot, and place on a rack in the cooling area. Use protective gloves or the manufacturer's approved grip handle.
   2. Check that sterilisation has been successfully completed. Complete the autoclave log.
   3. Once cool, inspect each item. Ensure it is correctly:
      • packaged
      • labelled
      • sealed (no gaps).

5. Storing sterile items
   • When cool, store sterilised packs in a clean, enclosed storage area.
   • Rotate stock so that items sterilised earlier are used first.

Refer to the manufacturer's instructions for full details of operating the autoclave. These are kept in the nurses' office.

Monitoring successful sterilisation

Successful sterilisation is monitored after each cycle, using different indicators:

Q42

Daily and weekly tests are done to check the steriliser's performance, e.g. Bowie-Dick test.

Physical checks are done at the end of each cycle, e.g. checking displays, gauges, or printouts.

Chemical indicators are included in every cycle to check that the correct temperature has been reached.

If indicators show that sterilisation has not been successful:

First failed test:

Check for errors, repack, and repeat sterilisation.

Second failed test:

1. Advise the practice manager, who may need to arrange servicing.
2. Place DO NOT USE label on front of autoclave, and the date.
3. Report the event, following the process for managing and reporting incidents.

Use disposable items only until autoclave is serviced and validated.

This policy was reviewed with input from Ruth Barratt, Infection Prevention & Control and Quality Advisor (PhD, MAdvPrac (Hons), RN, CICP-E).

Related policies

IPC at Our Practice

Adverse Events

Decontaminating Specific Items

Foundation Training

Hazard and Risk Management

Standard Precautions

Supporting Documents

Sample workflow process map – RNZCGP