Remote control drug infusion devices via data communication interface
Fact sheet no. 31
October 2006
Background
In 1994 as a result of a recommendation by the Therapeutic Device Evaluation Committee, the TGA issued guidance about the external control of electrical drug infusion devices through a data communication interface.
At the time the TGA advised that in cases where the data communication interface was intended to be used to control either the infusion or the infusion parameters via the drug infusion device, the whole system including the software used in controlling the device should be submitted to the TGA for consideration under the Clinical Trial Notification or a Clinical Trial Exemption schemes.
The decision was made on the grounds that under the Therapeutic Goods Regulations 1990 drug infusion systems and accessories which control the flow of infusion were registrable devices evaluated by the TGA, however the monitoring of a drug infusion device did not require notification to, or assessment by the TGA.
Current regulatory requirements
In October 2002, the Therapeutic Goods Act 1989 was amended to bring medical device requirements in line with international best practice. The Therapeutic Goods (Medical Devices) Regulations 2002 requires medical devices that are intended to act with other medical devices to be regulated as a system and the system as a whole must satisfy, the regulatory requirements for safety and performance.
Hence, remotely controlled drug infusion devices introduced to the market after October 2002 should comply with the safety and performance requirements for medical device systems.
Consequently, the guidance issued by the TGA in 1994 on "Drug Infusion Systems - The Use of Remote Control of Flow Rate Via a Data Communications Interface" is no longer relevant for these medical devices systems supplied after October 2002.
Transition arrangements for older devices
All therapeutic devices that were supplied in Australia prior to October 2002 have until the end of the 5 year transition period (October 2007) to meet these regulatory requirements.
Some drug infusion devices currently in the market may not have been assessed against the new requirements. Should this be the case, users intending to use data communication interfaces to control these devices should consult with the manufacturer to determine if the performance of a proposed system has been verified.
Disclaimer
This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.
Further information
The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the Therapeutic Goods Administration (TGA) can be contacted by:
Telephone: 1800 141 144
Facsimile: 02 6232 8299
Email: cab.medical.device.information@tga.gov.au
Website: www.tga.gov.au/devices/devices.htm
Mail: PO Box 100, Woden ACT 2606
© Commonwealth of Australia 2006