New regulatory system for medical devices ready for implementation in 2002

The Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Charges) Amendment Bill 2002 were introduced into Parliament in February 2002. The Bills provide for the introduction of an internationally harmonised framework for the regulation of medical devices in Australia. The Bills were first introduced into Parliament in March 2001 and passed by the House of Representatives in August 2001. However, these Bills were not debated in the Senate prior to the calling of the Federal election in 2001.

It is hoped that the new internationally harmonised regulatory framework for medical devices will be implemented during the latter half of 2002.

To assist industry in its preparation for the introduction of the new harmonised regulatory framework the TGA, with assistance from the Medical Industry Association of Australia, are planning a series of workshops on the legislative requirements and also application procedures for entry onto the Australian Register of Therapeutic Goods under the new system. To provide a comprehensive coverage of the details of the new system it is proposed that the workshops will be held in Sydney, Melbourne, Adelaide and Perth, possibly in late May/early June 2002.

Given the major changes to the regulatory requirements for medical devices, all sponsors are encouraged to send a participant to the workshops. Finalised times, dates, venues and the program for the workshops will be published on the medical devices webpage <http://www.tga.gov.au/devices/devices.htm>. Additionally all medical device sponsors and industry associations will be advised of the workshop details.

More information on the new regulatory system for medical devices: The Australian medical device regulatory system <http://www.tga.gov.au/devices/meddevreg.htm>

Medical devices and the transmissible spongiform encephalopathies (TSE) risk

In February 2001, the TGA wrote to all sponsors of therapeutic goods containing animal sourced materials included on the Australian Register of Therapeutic Goods (ARTG) in order to estimate the levels of risk of possible Transmissible Spongiform Encephalopathies (TSE) contamination.

Although there has been a good response from all medical device sponsors contacted, it has recently come to the TGA's attention that a number of sponsors have not identified all the products in their range that may contain material of bovine, ovine, caprine or human material.

The products listed in the Survey Table sent to sponsors were those that, according to records held on the ARTG contained material of animal origin. The ARTG records were annotated in accordance with the application forms originally submitted for registration or listing. A review of a number of application forms has revealed that these have been incorrectly completed, in that they did not identify the product as containing material of animal origin. Consequently, this omission has led to incomplete information held on the ARTG.

The TGA has serious concerns with the failure of some sponsors to correctly complete application forms, and the subsequent failure to fully identify the range of products containing material of animal origin. The questionnaires issued contain very important questions related to the risk of TSE contamination and the broader issues of public health and safety.

Sponsors who may not have received the questionnaire and whose products listed or registered on the ARTG contain material of human or animal origin are urged to contact the TGA immediately.

IRIS promotional activities

The Medical Device Incident Report and Investigation Scheme (IRIS) undertook several promotional activities in 2001. The most notable activity was a travelling seminar series in which the Manager and Coordinator of the Scheme visited hospitals and other organisations in several Australian cities to promote reporting of incidents with medical devices.

The IRIS team spent two very busy days in Brisbane in March, with visits to the Royal Brisbane Hospital, The Mater Hospital, Prince Charles Hospital, The Wesley Hospital, Princess Alexandra Hospital, Logan Hospital and the Brisbane Biomedical Engineering Group. This was followed by a visit to Perth in September, where seminars were given to representatives from Mount Private Hospital, Biomedical Engineering Group, Officers from the Department of Health of Western Australia, Royal Perth Hospital, Sir Charles Gairdner Hospital, St John of God Murdoch, Princess Margaret Hospital for Children, and St John of God Subiaco.

The seminars included a discussion on how hospital quality managers may best handle adverse events and problem reports within the hospital and recommendation for hospitals to set up procedures to coordinate the reporting of incidents to outside organisations (eg TGA WorkCover, Manufacturers). The seminars also included a discussion of TGA's risk assessment strategies for problem report investigations, the procedures followed when a complaint is received by the Medical Device Incident Report Investigation Scheme and statistical information about problem reports. The participants had many questions about the regulatory process and many wanted more details about specific problems with medical devices.

Similar presentations were made at the Australasian Association for Quality in HealthCare Annual Conference in Melbourne, St Vincent's Hospital in Sydney and Westmead Hospital in Sydney.

The response from participants has been very positive.

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Therapeutic Device Evaluation Committee (TDEC) 2001/2 meeting report

The 2001/2 meeting of the Therapeutic Device Evaluation Committee (TDEC) was held on 30 November 2001. The main points of discussion included-

• The adoption of new Committee processes for the expedient ratification of resolutions and minutes and the introduction of public release of key meeting outcomes on the TGA website;
• The establishment of the TDEC Advisory Panel on Orthopaedic Devices and outcomes of recent recalls for orthopaedic implants;
• The evaluations of a silicone breast implant and a prosthetic heart valve;
• Problem report investigations regarding -
  • kinking and occlusion associated with an epidural catheter;
  • rupture of filter membranes in epidural filters;
  • compatibility problems with anaesthetic vaporiser connections to backbars.
• Review of the technical requirements for computer control of infusion pumps;
• The new medical devices legislation.

The 2002/1 TDEC meeting will be held on 19 April 2002. The TDEC resolutions and extracted ratified minutes will be available on the TGA website in the near future.

Review of requirements for computer controlled infusion pump systems

Infusion pumps may be supplied in Australia after registration on the Australian Register of Therapeutic Goods (ARTG) or for individual patient use, or under clinical trial.

Infusion pumps capable of being driven from external computer systems have been required to either have an evaluation of the external control system intended for use with the pump, or for the manufacturer to limit the use of the communications interface to remote monitoring and not for external control of the pump.

The requirements for third party external control systems have been unclear in this framework, and previous consultations with the Therapeutic Device Evaluation Committee (TDEC) and industry in this area have stalled over concerns for the specification of a standardised, as opposed to proprietary, communication protocol for these systems.

The TGA has recently received several enquiries from sponsors and hospitals regarding the remote monitoring and possible control of drug infusion systems. TDEC undertook a review of the requirements for electronic data communication utilised by powered medicine infusion systems, in November 2001. Following the recommendations of the review, the requirements have been recently amended.

The amended requirements in relation to the external monitoring, programming or control of drug infusion pumps are:

• All drug infusion pumps, both with and without computer interfaces, will be required to meet the existing generic infusion pump requirements for compliance with the standard AS/NZS 3200.2.24:1999 - Particular requirements for safety - infusion pumps and controllers;
• External control systems for infusion pumps may now be supplied as registered devices after favourable evaluation of the hardware and/or software; and
• Either proprietary or standardised communications protocols will be accepted for these systems.

In summary the outcome is that devices for the external control of infusion pumps are considered to be registrable devices requiring premarket evaluation by the TGA.