Reprocessing of Reusable Medical Devices

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 two primary reprocessing standards are:

1. AS/NZS 4187:2014: Reprocessing of reusable medical devices in health service organisations
2. AS/NZS 4815:2006 - Office-based health care facilities— Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment.

AS/NZS 4187:2014 is the national standard commonly used by hospitals and day procedure services. AS/NZS 4815:2006 is commonly used in office-based practice.

Sterilizing Services Weighting Identification Tool

A comprehensive weighting identification tool has been developed to assist hospital Sterilizing Departments in the applying of weights consistently for NSW Health hospital Sterilizing Departments.

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

Audit Tools to Support Reprocessing Units

The Preventing and Controlling Healthcare-Associated Infection Standard of the National Safety and Quality Health Service Standards requires that reprocessing of reusable equipment, instruments and devices is consistent with relevant current national standards, and meets current best practice.

Australian Commission on Safety and Quality in Health Care Advisory A18/07:Reprocessing of reusable medical devices in health service organisations requires that health service organisations need to:

1. Have completed a gap analysis to determine its current level of compliance with the relevant national or international standards for reprocessing reusable medical devices in use by the health organisation
2. By 31 December 2023, develop an implementation plan that includes:
   1. A strategy to identify and manage any current and emerging risks associated with the compliance gap(s)
   2. The timeframes and actions required to address the compliance gap(s) for:
      • Segregation of clean and dirty activities
      • Design of storage areas for sterile stock
      • Replacement of AS/NZS 4187:2014 non-compliant cleaning, disinfecting and sterilising equipment
      • Monitoring requirements for water quality
3. Executive endorsement.

To support any unit undertaking reprocessing of reusable medical devices with meeting the requirements of Advisory A18/07, a suite of tools have been developed.

These tools are also available in the CEC's Quality Auditing Reporting System (QARS) and NSW public facilities are encouraged to use this system for their self-assessments, peer audit reviews and staff interviews.

To support facilities with the requirements for meeting AS/NZS4187:2014 compliance and preparing for accreditation, the following voice over presentation is available. The presentation also explains how to use the resources provided below.

Resources

Resources to enhance existing Quality Management Systems within reprocessing units for AS/NZS4187:2014 Reprocessing of reusable medical devices in health service organisations can be found on this spreadsheet.

These resources include:
1. An infographic of why the Clinical Excellence Commission have developed 3 types of audits for AS/NZS 4187:2014
2. A calculation sheet to score your compliance with the self-assessment and peer review audits
3. A sample Action Plan
4. NSW Health Risk Matrix to assist you in determining the risk level for your Action Plan
5. Sample questions you can use to develop a register of all reprocessing units within a hospital, district or state/territory
6. Sample of a one-page summary that helps you develop an overview of your quality management system (QMS). This can be used for accreditation, describing your program to your manager/quality manager or educating your staff on what is included in the unit's QMS
7. Sample organisational/governance structure
8. FAQs

AS/NZS 4187:2014 Audit for CSD and Endoscopy

AS/NZS 4187:2014 Audit for satellite sites

AS/NZS 4187:2014 Audit for Oral/Dental Health Services

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.

• Questionnaire - CEC S3 Register of Reprocessing Units and Departments
• Questionnaire - Register of Reusable Ultrasound Probes-Version 2

Find more resources

1. National Safety and Quality Health Service (NSQHS) Standards (second edition) Advisories
2. NSQHS Standard 3.14 – Reprocessing of reusable devices
3. World Federation for Hospital Sterilisation Sciences Guidelines
4. (UK) Medicines and Healthcare Products Regulatory Agency: Decontamination and infection control
5. (US) Food & Drug Administration: Reprocessing of Medical Devices
6. (US) Centers for Disease Control and Prevention: Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)
7. (US) Centers for Disease Control and Prevention: Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the HICPSAC (2016)
8. World Health Organization: Decontamination and Reprocessing of Medical Devices for Health-care Facilities
9. Gastroenterological Nurses College of Australia / Gastroenterological Society of Australia: Infection Prevention and Control in Endoscopy 2021