MDEC meeting 2005/2, 17 June 2005

Medical Device Evaluation Committee

Meeting report

The 2005/2 meeting of the Medical Device Evaluation Committee (MDEC) was held on 17 June 2005. The main points of discussion included -

• The application for provision of a conformity assessment certificate for INFUSE Bone Graft/LT-CAGE from Medtronic Australasia Pty Ltd for the use in spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L₄-S₁;
• The application for a variation to the registration of Cypher Sirolimus-Eluting Stent System from Johnson & Johnson Medical Pty Ltd to include coronary in-stent restenotic lesions;
• The application for provision of a conformity assessment certificate for Matricel Collagen Matrix - ACI-Maix Collagen Membrane from Verigan Australia Pty Ltd for use for matrix-induced autologous chondrocyte implantation (MACI);
• Proposed plan to promote the TGA's Medical Device Incident Report Investigation Scheme (IRIS).
• Proposed consultancy to provide advice to the Implantable Medical Device Tracking Subcommittee, the TGA and the Australian Council for Safety and Quality in Health Care on possible implementation models for a national system that associates people with implanted medical devices.

The 2005/3 MDEC meeting is proposed for 9 September 2005.

Summary of key resolutions

NOTE: This summary has been prepared to provide rapid advice of the Resolutions made by the Medical Device Evaluation Committee (MDEC) at its recent meeting. It should not be assumed that recommendations made to the TGA represent the decisions of the TGA.

Device registrations

MDEC resolved that the following medical device applications should be approved, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the TGA. These recommendations for approval may be subject to specific conditions.

Minutes of the previous meeting

RES NO. 2005/10

Subject to minor amendments, the Minutes of the 2005/1 (6th) meeting of the Medical Device Evaluation Committee are accepted and ratified as a true record.

Report from the Medical Device Incident Review Committee (MDIRC)

RES NO. 2005/16

MDEC is seeking a plan to promote the TGA's Medical Device Incident Report Investigation Scheme (IRIS) and recommends that it is developed as soon as possible.

MDEC requests a comprehensive report of the MDIRC progress at the September meeting.

Report from the Implantable Medical Device Tracking Subcommittee (IMDTS)

RES NO. 2005/17

MDEC notes the Implantable Medical Device Tracking Subcommittee (IMDTS) and the TGA are working with the Australian Council for Safety and Quality in Health Care to develop a tender for a consultancy to assess the cost benefit of a national medical device tracking system and to assess, analyse and recommend implementation methodologies for the tracking of patients with implantable medical devices.

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