Hospital Circulars Main Index < Hospital Circulars 2008 Index <

Hospital Circular 01/2008

Date Issued: 3 January 2008

Distribution: Public Hospitals, Community Health Centres, Private Hospitals, General Practitioners, Private Practitioners

Subject: Reprocessing Intracavitary Transducers

Purpose: That all Intracavitary Transducers need to be reprocessed according to Australian Standards 4187:2003

All Victorian health providers will comply with the below Australian standards and guidelines for the reprocessing of intracavitary transducers, including that they must be reprocessed between every patient use.

In Australia, there are two reference documents for the reprocessing of medical equipment:

• Australian/ New Zealand Standard 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities – AS/NZS 4187:2003; and
• Department of Health and Ageing Infection Control Guidelines for the prevention of transmission of infectious diseases in the health care setting, 2004.

The AS/NZS 4187:2003 states that ‘high level instrument grade disinfection shall be a minimum level used for semi-critical items’. It is important to note that Sodium Hypochlorite is not registered as either an instrument grade disinfectant or a sterilant with the Therapeutic Goods Administration (TGA).

At times reprocessing instructions for medical devices does not meet Australian requirements. The TGA advised the department, that if a medical device does not have instructions for reprocessing according to Australian standards and guidelines then this needs to be reported to the TGA’s, Incident Reporting and Investigation Scheme. The TGA will then correspond with the manufacturer and seek clarification as to whether the medical device can be reprocessed to Australian standards and guidelines.

Alison J McMillan
Director, Quality and Safety Branch