Amendment to Therapeutic Goods Order 64: Standard for Tampons - Menstrual

A recent amendment to Therapeutic Goods Order 64: Standard for Tampons - Menstrual <http://www.tga.gov.au/docs/html/tgo/tgo64.htm> requires that the following additional Toxic Shock Syndrome warning statement be provided on the tampon information leaflet:

"Please note that tampons are not sterile and neither are your hands or vagina. Tampons, while containing very small amounts of bacteria normally present in the air, have not been shown to carry the bacteria which cause Toxic Shock Syndrome (TSS)."

The Order was gazetted on 5 September 2001 and took effect on 5 September 2002. This means that any menstrual tampons supplied in Australia are now required to be in compliance with the Order.

Development of a new regulatory framework for in vitro diagnostic devices in Australia

The current regulatory requirements for in vitro diagnostic devices (IVDs) in Australia were introduced in 1991, and while they may have been world-leading at the time, they are now significantly out of step with the regulatory requirements of the European Union (EU), Canada and the United States. For example, at present only IVDs for human immunodeficiency virus (HIV) or Hepatitis C Virus (HCV) are considered registrable medical devices on the Australian Register of Therapeutic Goods (ARTG), while IVD tests listed on the Pharmaceutical Benefits Scheme, intended for home use, or those containing materials of human origin are considered listable medical devices. In addition, the rigidly prescribed classification of IVDs in the Therapeutic Goods Regulations does not allow the regulatory system to cope with advances in IVD technology.

Work has therefore been initiated on the development of a new regulatory system for IVDs that is aligned with international best practice, including the principles espoused by the Global Harmonization Task Force (GHTF). The GHTF is an international forum of medical device regulators and industry associations led by founding members from the United States, the European Union, Canada, Japan and Australia, and its goal is to develop harmonised principles relating to medical device regulation.

The IVD project has been endorsed by the Australian Health Ministers' Advisory Committee (AHMAC), and the TGA has been specifically charged with developing a framework that will not only result in an appropriate level of regulation for all IVDs, but one that addresses the following issues:

• the inequity between the level of scrutiny afforded to in-house tests compared with commercial tests
• the burgeoning array of sophisticated genetic tests
• the increasing development and availability of home-use IVDs for serious disease markers.

In January 2002, the TGA established an expert advisory group, the National Coordinating Committee for Therapeutic Goods (NCCTG) Working Group on IVDs, with the purpose of providing assistance in the development of the new framework. The Working Group is composed of representatives from key stakeholder groups including the:

• Medical Industry Association of Australia (MIAA)
• Australian Association of Pathology Practices (AAPP)
• Royal College of Pathologists of Australasia (RCPA)
• Human Genetics Society of Australia (HGSA)
• Public Health Laboratory Network (PHLN)
• National Pathology Accreditation Advisory Council (NPAAC)
• National Serology Reference Laboratory (NRL).

In addition, the Working Group includes representatives from State and Territory governments (New South Wales and Western Australia), and the Population Health Division and Health Access and Financing Division of the Commonwealth Department of Health and Ageing.

Key features of the new regulatory framework will include:

• essential principles for safety and performance
• a rules-based classification system (based on disease marker risk)
• pre-market conformity assessment procedures commensurate with the risk classification of a given IVD
• strengthened quality assurance requirements (particularly for tests used to ensure the quality of Australia's blood supply)
• post-market vigilance and surveillance systems.

A Discussion Paper for consultation will soon be available on the TGA website.

Should you have any questions on the new regulatory framework for IVDs, please contact Ms Jocelyn Kula by phone 02 6232 8665, facsimile 02 6232 8687 or email jocelyn.kula@tga.gov.au.

NCCTG Reusable Surgical Instruments Expert Working Group

The TGA is establishing an Expert Working Group to examine public health risks associated with some reusable, multi-component surgical devices whose design may affect their ability to be effectively cleaned and sterilised. This follows two recalls of orthopaedic instruments which were found to contain residual biological materials that had not been removed by normal infection control procedures. Although both sets of instruments were subsequently modified to allow them to be dismantled for thorough cleaning, the risk of this class of surgical instruments to transmit disease is currently unknown.

The Expert Working Group will operate under the auspices of the National Coordinating Committee on Therapeutic Goods (NCCTG) as the issues impact on both Commonwealth and State and Territory regulatory controls. Dr Graeme Harris (Chief Clinical Adviser in Medical Devices, TGA) will chair the group, which will include persons nominated by the States and Territories with expertise in infection control and epidemiology, the medical devices industry and the surgical specialities.

The proposed terms of reference for the Expert Working Group are to:

• examine the public health risks associated with the design and use of some reusable, multi-component devices that cannot be dismantled prior to cleaning and sterilisation;
• develop criteria for the investigation of patient exposure in the event of a report of possible breaches of infection control for these types of devices; and
• propose any necessary regulatory action in response to the public health risks and product design issues.