Policy and procedure guide for reprocessing reusable medical devices (RMDs) - AS 5369:2023 compliant structure

Sep 1, 2026

Policy and procedure guidance for reprocessing reusable medical devices (RMDs) establishes infection prevention and control principles aligned with AS 5369:2023 for health and non-health facilities. It outlines a recommended policy structure and definitions for cleaning, decontamination, disinfection, sterilisation, and sterile barrier systems, plus general principles for safe reprocessing. It specifies segregation of clean and dirty activities, risk-based ventilation and quality risk management, staff training and PPE requirements, and Spaulding classification criteria to determine expected reprocessing and storage levels.

LanguageEnglish

CategoryLetters

FormatDOCX

Pages10

Reading Time4 min

AccessFree to download

How to use this guide

Recommended policy structure

Purpose

Policy

Definitions

General principles

Spaulding Classification of Devices and Associated Risk

Table 1: General criteria for reprocessing and storage of RMDs/other devices in facilities

Practice principles for the reprocessing of RMDs

Facility Design

Quality assurance using a risk-based approach

Policy and procedure guide for reprocessing reusable medical devices (RMDs) How to use this guide This guide includes content from the new standard AS 5369:2023 for general practices reprocessing RMDs and can be used by the practice to build their own policy and procedure. Practices can use the information provided to construct a policy and procedure which is compliant with AS 5369:2023 yet reflects the type of services delivered. Your practices policy must include content from the recommended policy structure section 1-6. to meet certification requirements. Your practice’s procedure should include relevant content from the section suggested procedure content. The practice should review the content of this section and edit out what is not relevant in relation to the type of services the practice delivers, how they manage RCD reprocessing (in house or contracted out) and the type of equipment used for reprocessing. Recommended policy structure Purpose This policy outlines the principles for the reprocessing of reusable medical devices (RMDs) based on Spaulding’s classification system, in alignment with the requirements of the AS 5369:2023 , reprocessing of reusable medical devices and other devices in health and non-health related facilities, to mandate expected standards for safe and effective reprocessing of RMDs. Policy This policy applies to team members that use or reprocess RMDs Definitions Cleaning: The removal of contamination from an item to the extent necessary for further processing or for intended use. Decontamination: Removing, neutralising, or destroying potentially infectious foreign material from an object. There are three levels of decontamination for patient care equipment: cleaning, disinfection and sterilisation. Disinfectant: Chemical or combination of chemicals used for disinfection. Disinfection: Process to inactivate viable microorganisms to a level previously specified as being appropriate for a defined purpose Moist heat sterilisation: A process that uses high-pressure steam or boiling water to kill microorganisms on objects. Reusable Medical Device (RMD): A medical device that is designated or intended by its manufacturer as suitable for reprocessing and reuse. Standard precautions: Work practices that constitute the first line approach to infection prevention and control in the health care environment. Sterile Barrier System (SBS): Minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of the sterile contents at the point of use. Sterilisation: Validated process that renders a product free from viable microorganisms. General principles RMDs are used for diagnostic and/or treatment purposes for patients and are intended by the manufacturer for reprocessing and reuse. Effective and safe reprocessing of RMDs is critical for safe patient care. When performing cleaning, disinfection, and/or sterilisation procedures for RMDs, the requirements of AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities shall be adhered to as follows: All disinfection and sterilisation of critical and semi-critical RMDs shall be performed in designated reprocessing areas. Standard precautions are the minimum infection prevention and control (IPC) practices to be applied when cleaning and handling used RMDs. Appropriate personal protective equipment (PPE) shall be worn to prevent direct skin and mucous membrane contact with body substances Staff accountable for reprocessing of an RMDs should be involved in the selection process prior to purchase, to ensure effective reprocessing can be undertaken using existing equipment and staff skills. When equipment is purchased, the device’s information must be readily accessible by all staff involved in the use, cleaning, and care of the equipment. Team members must only use equipment and/or participate in reprocessing activities once the relevant training has been completed. Item

FAQs

How should the practice use this guide to build its reprocessing policy and procedure?

Use the provided information to construct an AS 5369:2023 compliant policy and procedure that reflects the services delivered. Ensure the policy includes content from the recommended policy structure section 1–6 and adjust the procedure content to match the practice’s RCD reprocessing arrangement and equipment used.

What are the key infection prevention requirements when cleaning and handling used RMDs?

Apply standard precautions as the minimum IPC approach, wear appropriate PPE to prevent direct skin and mucous membrane contact with body substances, and ensure only trained team members use equipment and participate in reprocessing activities.

How does Spaulding classification determine reprocessing levels for RMDs?

Spaulding classification assigns RMDs to critical, semi-critical, or non-critical categories based on intended use. Each category requires specific reprocessing and storage expectations, with general criteria provided in Table 1.

Sep 1, 2026

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