Reprocessing of Reusable Medical Devices

This page is currently under review.

Reusable medical devices (RMDs) are used for diagnostic and/or treatment purposes for multiple patients and are intended by the device manufacturer for reprocessing and reuse.

Reprocessing refers to the activities required to ensure that a RMD is safe for its intended use. Reprocessing is a multistep process that includes cleaning, inspection and assembly, functional testing (if applicable), disinfection (if applicable), packaging and labelling, sterilization (if applicable) and storage.

Further information on reprocessing can be found in the CEC Infection Prevention and Control Practice Handbook.

The primary reprocessing standard is AS 5369:2023, Reprocessing of reusable medical devices and other devices in health and non-health related facilities.

Reprocessing of RMDs on Consignment or Loan (Loan Sets)

The document provides guidance for best practice in reprocessing specialised reusable medical devices on consignment or loan (also known as loan sets) from the medical industry for use in surgical, dental or other invasive procedures undertaken in NSW public health organisations.

• Reprocessing of Reusable Medical Devices (RMDs) on Consignment or Loan for Use in Surgical, Dental or Other Invasive Procedures

Assessment of Reprocessing Competencies

All health workers working in reprocessing areas should understand the principles and practices outlined in Australian standard AS 5369: 2023: Reprocessing of reusable medical devices and other devices in health and non-health related facilities.

The Assessment of Reprocessing Competencies is designed to assess health workers’ knowledge of AS 5369: 2023.

The Assessment of Reprocessing Competencies is divided into an Introduction and 10 sections that correspond with chapters in AS 5369:2023.

• Introduction
• Section 1 Scope and general
• Section 2 Quality assurance
• Section 3 Reprocessing agent characterization
• Section 4 Process characterization and equipment characterization
• Section 5 Product definition
• Section 6 Process definition
• Section 7 Validation
• Section 8 Routine monitoring and control
• Section 9 Release of RMDs-other devices following reprocessing
• Section 10 Maintaining process effectiveness

Complex and difficult to clean RMDs

A difficult to clean RMD is one that has a complex or cannulated structure that provide an ongoing challenge in the cleaning/decontamination steps.

• General rules for reprocessing complex and difficult to clean devices – video laryngoscopes

Resources to register ultrasound probes and reprocessing areas

The CEC have produced two registers to assist with health facilities to register the location of reprocessing areas and ultrasound probes. These registers are located in QARS for NSW public health facilities.

Find more resources

1. Spotlight on: AS 5369:2023, Reprocessing of reusable medical devices and other devices in health and non-health related facilities
2. Australian Commission on Safety and Quality in Health Care: Transitioning from AS/NZS 4187:2014 to AS 5369:2023
3. Australian Commission on Safety and Quality in Health Care: Transitioning from AS/NZS 4815:2006 to AS 5369:2023 Identifying changes and implementation strategies for healthcare services
4. National Safety and Quality Health Service (NSQHS) Standards (second edition) Advisories
5. NSQHS Standard 3.17 – Reprocessing of reusable devices
6. World Federation for Hospital Sterilisation Sciences Guidelines
7. (UK) Medicines and Healthcare Products Regulatory Agency: Decontamination and infection control
8. (US) Food & Drug Administration: Reprocessing of Medical Devices
9. (US) Centers for Disease Control and Prevention: Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)
10. (US) Centers for Disease Control and Prevention: Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the HICPSAC (2016)
11. World Health Organization: Decontamination and Reprocessing of Medical Devices for Health-care Facilities
12. Gastroenterological Nurses College of Australia / Gastroenterological Society of Australia: Infection Prevention and Control in Endoscopy 2021