12.1 Infection control

Health and disability services standards

NZS 8134:2021 Ngā paerewa, the Health and Disability Services Standard, section 5; Infection prevention and antimicrobial stewardship, replaces the previous standard (NZS:8134.3:2008).

It fosters continuous quality improvement (CQI) and is considered best practice for primary care. In order for the practice to document how team members are going to manage infection prevention and antimicrobial stewardship, the College recommends all practices comply with NZS/8134:2021.

If a practice is using reusable medical devices (RMD’s) then 4815:2006 also applies (as set out in the indicator).

Antimicrobial stewardship is about avoiding the unnecessary use of antimicrobials, for example, antibiotics, and making sure that whenever they are used, they are used with care to minimise the risk of antimicrobial resistance. Patients, doctors, nurses and pharmacists all play an important part in antimicrobial stewardship.

In the absence of a national antimicrobial stewardship programme, primary care is excluded adhering to 5.3, 5.4 and 5.5.4 and 5.5.5.

New guidance for reprocessing reusable medical devices (RMDs) as per AS:5369:2023

When reprocessing reusable medical devices (RMDs), such as surgical instruments and equipment, it is essential to ensure they are free from infectious organisms.

The Ministry of Health in New Zealand has replaced AS/NZ 4815:2006 with a new Australian standard, AS 5369:2023 for the reprocessing of RMDs within the health sector.

This guidance stipulates that AS 5369:2023 is to be adopted in its place effective from1st February 2026

Because of the wide application of AS 5369:2023 across a variety of health settings, the guidance summarises the requirements and outlines the changes and provides practical steps to achieve compliance .

The key themes of AS 5369:2023 summarised in the guidance and policy guide are:

• expanded scope of the new standard
• emphasis on risk-based approach
• training and education requirements
• contingency planning to ensure compliance
• third party compliance requirements
• designated personnel involvement for quality and control
• Spaulding classification method based on risk assessment
• pre-treatment, cleaning, handling, storage and transport of RMDs
• specific facility requirements.

Key changes of AS 5369:2023 for practices

1. Shift to a risk-based approach to quality management
2. Use the Spaulding classification system for the proper processing and storage of reusable medical devices (RMDs)
3. Develop, and use a process map or a flow diagram to ensure the risks for cross contamination including air flows are effectively managed in accordance with a risk assessment.

A risk-based approach means using a structured process to identify, assess, and reduce risks that could affect quality. It helps ensure that potential problems are spotted early and addressed before they cause issues.

This approach makes practices responsible for the quality management of reprocessing RMDs.

Evidence to provide if a practice is reprocessing RMDs:

• A policy and procedure that covers all six sections as outlined in the College’s Policy and Procedure guide for reprocessing RMDs.
• Demonstrate (onsite) that the reprocessing environment and facility design meets the requirements of AS 5369:2023
• A process map or flow diagram which ensures the risks for cross contamination, including airflows, are effectively managed.
• Evidence of risk assessments and a risk-based approach to reprocessing RMDs.

To support practices with the new areas of compliance, a policy and procedure guide for reprocessing RMDs has been developed by the College which can be adapted to fit the needs of individual practices. This can be accessed in the resources section below.

Team members involved in reprocessing RMDs should update their infection control training to align with the new AS 5369:2023 standard. Training suggestions are provided above the resources section below .

Please note: Reprocessing RMDs can be managed either in house or outsourced to an offsite facility who can demonstrate they meet the requirements of AS 5369:2023.

AS 5369:2023 summarised for general practice settings.

How to reprocess reusable medical devices (RMDs) in general practice

1. To ensure proper reprocessing, practices must follow the manufacturer’s instructions for cleaning, disinfection, packaging, and sterilisation of each RMD and team members must have the appropriate education and training.
2. RMDs should have a designated reprocessing area which must have a clear workflow to prevent cross contamination, moving systematically from ‘dirty’ to ‘clean’ zones. Ideally, this should be a dedicated room separate from treatment and administrative spaces. If the space is shared, physical barriers or methods must be used to separate reprocessing activities.
3. During reprocessing, personal protective equipment (PPE) must be worn.
4. Follow the Spaulding Classification System to determine how reusable medical devices (RMDs) should be reprocessed based on their intended use.
5. Cleaning methods can be manual or by ultrasonic cleaner (optional) followed by manual cleaning
6. When using sealable pouches as the sterile barrier system, they should be:
   1. Labelled for monitoring
   2. On a stock rotation
   3. Identifiable in case issues arise with an item.
7. Steam under pressure is the most reliable sterilisation method and is recommended for general practices. Correctly loading the steriliser is critical to ensure effective air removal and steam penetration.
8. Processing and drying times must be followed according to the load type and proper storage of sterilised packs must be observed
9. Every sterilisation cycle must be documented for quality assurance. Routine monitoring is required to verify that cycle parameters (time, temperature, and pressure) are met, with records kept as evidence. Chemical indicators are used alongside physical monitoring to confirm that the load reached the appropriate temperature.
10. Routine maintenance must be carried out for all reprocessing equipment, including sterilizers and, ultrasonic cleaners. Steriliser cycle validation must be performed annually or after significant changes, such as major repairs or changes in load type.
11. Practices conducting procedures outside of the main facility (e.g., at aged care facilities or during home visits) must establish procedures to ensure the sterility of equipment during transport and the proper handling of used equipment, including correct pre-cleaning immediately after use.

Ensuring proper disinfection and sterilisation of instruments and equipment

The team member/s responsible for infection prevention and control, must ensure that all instruments and equipment used in patient care are properly cleaned, disinfected, or sterilised. The level of processing needed is based on the infection risk associated with their reuse.

Items reprocessed either on-site or by an external sterilisation facility.

• If using an offsite sterilisation provider, such as another general practice with current Foundation Standard certification, or a local hospital, the practice must:
• Keep a copy of the facility's credentials (Foundation Standard certification or other document which qualifies reprocessing of RMDs) and results of annual sterilisation validation/calibration report
• include details of offsite sterilisation in their reprocessing policy and procedure.

Facility Design

• The reprocessing area must be able to provide effective segregation of clean and dirty activities and minimise the risk of cross contamination.
• Hand hygiene basins should not be in clean work areas because they can be a source of contamination. If hand hygiene basin is in a clean work area, the practice can mitigate contamination risk by using a alcohol-based hand rub.
• Ventilation: A risk-based approach is needed to determine the design and operation of ventilation systems.
• Effective segregation of clean and dirty activities must be achieved through a uni-directional workflow, from dirty to clean areas
• A process map or a flow diagram must be developed and followed to ensure the risks for cross contamination including air flows are effectively managed in accordance with a risk assessment.

Example of a process map of workflow

Quality assurance using a risk-based approach

Quality risk management is a systematic, risk-based approach to quality management. The four pillars include risk identification, risk assessment, risk control measures, and continuous monitoring and review.

Some examples of risks could include equipment or machine failure or fault, managing hazardous substances, human error, lack of training.

Suggested steps for establishing a risk-based approach:

1. Identify team members responsible
2. develop a process for team members to follow
3. do a risk analysis – identify safety risks and potentially hazardous situations- use the risk matrix and add these to your practices hazards and risks register
4. mitigate risks
5. evaluate and review at least annually
6. Incidents, process breaches, failures or non-compliance and near misses are to be reported via the practice’s incident management system.
7. undertake improvement activities.