In vitro diagnostic devices

The National Coordinating Committee on Therapeutic Goods IVD Working Group prepared a discussion paper outlining the proposal for a new regulatory framework for in vitro diagnostic devices (IVDs) <http://www.tga.gov.au/devices/ivdregfw-bg.htm#discussion>. After consultation with stakeholders, the original deadline for comments was extended from 15 May to 16 June 2003. Consultation sessions were also held in most capital cities during April and May 2003.

Medical devices guidance documents

Since the last issue of TGA News three more medical devices guidance documents have been released and two have been updated. These documents provide information about aspects of the new Australian medical devices regulatory program.

Medical device standards

Three Medical Device Standards Orders and two Conformity Assessment Standards Orders <http://www.tga.gov.au/devices/so.htm> were gazetted in March 2003. The orders and guidance documents about each one are available on this website.

Reusable surgical instuments - Cleaning and infection control problems

In 2002 there were two recalls of two different ranges of orthopaedic instruments that were found to contain residual biological materials that had not been removed by normal cleaning and infection control procedures.

To investigate the broader issues associated with difficult-to-clean reusable surgical instruments, the TGA established an expert working group under the auspices of the National Coordinating Committee on Therapeutic Goods (NCCTG). Membership of the working group includes experts in epidemiology, infection control, clinical and surgical practice, operating room practice, Central Sterilising Supply, microbiology, biomaterials, device industry manufacturing and medical device regulation.

The Expert Working Group is currently developing a guidance document on reusable surgical instruments to cover:

• the potential public health risks
• instrument types and design characteristics that create difficulty for cleaning
• the role of stakeholders in reducing risks
• considerations for purchasing instruments
• guidelines for reporting and investigating incidents.

Reuse of single use devices

The report on comments from stakeholders on the consultation document Consultation on the Regulation of the Re-Manufacture of Single Use Devices for Reuse is available. The report:

• provides background information on the issues relating to reusing single use devices
• summarises the range of views expressed by stakeholders who responded to the consultation paper
• describes the main issues raised by stakeholders
• provides the considered response of the TGA working party to the issues and views raised.