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Statement by the TGA on regulations for sterilisation of single use devices

21 July 2003

Single-use devices (SUDs) are those devices that are intended by the manufacturer to be used once and then discarded.

However, a number of States and Territories have facilities that undertake sterilisation of SUDs.

The Therapeutic Goods Administration (TGA), the national regulator for medical devices, does not permit the re-use of single use devices, unless the re-processing of those devices is done to a standard that ensures the devices are safe and perform as originally intended. The TGA's reach does not extend to public hospitals in the States and Territories where most reprocessing of SUDs occurs.

The TGA has taken its concerns up directly with States and Territories through Australian Health Ministers and agreement has been reached on the implementation of a national regulatory framework for any re-manufacture of SUDs.

The TGA's policy is that if there is to be re-use it can only be done in premises licensed by the TGA and any re-manufacturing that takes place must be in accordance with the standards that apply to the original manufacture of the device. In other words, the sterilised SUDs must be of the same quality, performance and safety as if it was a new device.

Health Ministers charged the TGA with the role of developing the regulatory framework which ensures that if a health care facility re-manufactures a SUD, that facility will be regulated as a medical device manufacturer and will need to be licensed by the TGA and comply with rigorous Good manufacturing requirements.

The TGA is now moving to implement the regulatory framework in consultation with the Health Departments of the States and Territories.

It is proposed to phase in the new regulatory requirements over a two-year period to enable public hospitals to implement the new requirements.

Media contact: Kay McNiece, Media Adviser, TGA, 0412 132 585