TDEC 10th anniversary

The Therapeutic Device Evaluation Committee (TDEC) was established ten years ago as a statutory committee by amendment of the Regulations to the Therapeutic Goods Act (1966) on 12 November 1987. Its first meeting as a statutory committee was on 10 December 1987, with Clinical Associate Professor Clifford Hughes, AO as chairperson.

TDEC has been central to device regulation in Australia. Some of the notable achievements have been the development of regulatory requirements for high risk medical devices, such as heart valves, implantable cardiac pacing systems and defibrillators, intra ocular lenses, intrauterine contraceptive devices, drug infusion systems, silicone breast implants, and materials of human or animal origin.

TDEC focuses primarily on providing policy advice rather than specific recommendations for individual devices or standards. Advisory Panels provide the indepth information for TDEC's overview.

from left to right, front row: Dr Edith Weisberg, Associate Professor Clifford F Hughes AO (Chairman), Ms Wendy Brown (Guest)
middle row: Ms Anne Vukmanovich, Ms Mary Chiarella, Dr John Russell
back row: Associate Professor Loraine Holley, Mr Martin Van Lith (Executive Secretary), Professor C Rolfe Howlett.

New regulations for sterilisers

Benchtop and portable sterilisers are now required to be listed on the Australian Register of Therapeutic Goods (ARTG). New regulations for benchtop and portable sterilisers came into effect on 24 December 1997 as part of the Department of Health and Family Services' initiative on infection control. The amendment to item 7(e) of Schedule 5 provides that bench top and portable sterilisers (that are not intended by the manufacturer to be permanently plumbed or wired) used for the sterilisation of medical and dental instruments are not exempt from the operation of Part 3 of the Act and are to be listed on the ARTG.

The term "benchtop or portable steriliser" covers any steam sterilisers, dry heat sterilisers, and low temperature sterilisers and liquid sterilants including low temperature plasma sterilisers and peracetic acid sterilising equipment, as described in section 4 of "Australian Standard 4187-1998 Cleaning, Disinfecting and Sterilizing Reusable Medical and Surgical Instruments and Equipment, and Maintenance of Associated Environments in Health Care Facilities".

It is worth noting that the description of sterilisation equipment contained in the Therapeutic Goods Regulations is intended to cover a wider range of equipment than that covered in the description of a portable steam steriliser (benchtop steriliser) contained in the Australian Standard 4187-1998 at paragraph 4.2.4.

Manufacturers and suppliers of benchtop and portable sterilisers must lodge applications for their products to be listed on the ARTG.

7th Global Medical Device Conference

Ian Lindenmayer (former Deputy Secretary, Department of Health and Family Services) and Terry Slater (National Manager, Therapeutic Goods Administration) both delivered presentations at the 7th Global Medical Devices Conference (Sydney 15 - 17 February 1998). It was the first time the conference has been held in the southern hemisphere. The theme was building international cooperation and understanding in the regulation and use of medical devices.

Ian Lindenmayer (right) pictured at the conference with Dann Michols (Director General, Therapeutic Products Directorate, Health Canada) and Beth Pieterson (Director, Medical Devices Bureau, Health Canada).