MDEC meeting 2006/4, 15 December 2006

Medical Device Evaluation Committee

Meeting report

The 2006/4 (12th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 15 December 2006. The main points of discussion included:

• an application by Abbott Australia Pty Ltd for the provision of a conformity assessment certificate for the XienceT V Everolimus Eluting Coronary Stent Systems to be used for improving luminal diameter in patients with symptomatic ischaemic heart disease due to discrete de novo native coronary artery lesions.
• an application by St Jude Medical Australia Pty Ltd for the provision of a conformity assessment certificate for the Agilis Steerable Catheter Introducer with Haemostasis Valve for introducing various cardiovascular catheters into the heart, including the left side of the heart through the atrial septum.
• an application by Mondeal Medical Systems Pty Ltd for the provision of a conformity assessment certificate for the Esthelis® range of dermal fillers to be used for facial tissue augmentation.
• an application by Medtronic Australasia Pty Ltd for the provision of a conformity assessment certificate for the DurepairT Dura Regeneration Matrix for use as a soft tissue patch to reinforce soft tissue where weakness exists and for repair of damaged or ruptured soft tissue in dura mater.
• consideration of the risks associated with approved coronary drug-eluting stents.
• consideration of the proposal for the reclassification of joint replacement prostheses
• consideration of the activity reports from the MDEC subcommittees.

The 2007/1 MDEC meeting is proposed for 23 March 2006.

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.

Thrombosis of approved coronary drug-eluting stents

RES NO. 2006/26

MDEC notes the TGA's evaluation of the risk of late thrombosis of approved coronary drug-eluting stents and recommends that an Expert Working Group be established to undertake a review of the available clinical and post-market data and advise MDEC and TGA regarding risks associated with drug-eluting stents.

Reclassification of joint replacement prostheses

RES NO. 2006/27

MDEC notes the proposal for the reclassification of joint replacement prostheses and in consideration of the Australian Orthopaedic Association National Joint Replacement Registry Annual Report 2006 recommends:

1. the establishment of an Expert Working Group to undertake a strategic review of the clinical performance and surveillance of joint replacement prostheses and the regulatory requirements;
2. that the TGA indicates its intention to reclassify joint replacement implants to Class III, unless the review of the evidence does not support this proposal.

Report from the Medical Device Incident Review Committee (MDIRC)

RES NO. 2006/28

MDEC notes the report from the Medical Device Incident Review Committee and endorses its recommendations made at the November 2006 MDIRC teleconference.

RES NO. 2006/6

1. MDIRC notes that the National Joint Replacement Registry has identified several joint replacement components that have a higher than anticipated early revision rate.
2. MDIRC supported the TGA's proposal to contact the manufacturers of prostheses identified in the Australian Orthopaedic Association National Joint Replacement Registry 2006 Annual Report to request the following information:
   1. an explanation for the early revision rate of the implant that they supply in comparison to that of other similar devices on the market;
   2. any features of implant design and expected performance that compensate for the apparent additional risk of early revision; and
   3. an explanation as to why the events have not been reported to the TGA, given that early revisions are considered to be reportable adverse events.
3. MDIRC recommends the establishment of an Expert Working Group to review and assess the clinical data and other relevant information submitted by manufacturers of the identified prostheses of concern. The proposed role of the Expert Working Group is to advise the TGA whether there is sufficient clinical and other relevant information to justify the ongoing availability of the products in Australia, despite the higher early revision rates associated with their use.

RES NO. 2006/7

1. MDIRC notes the adverse event reports in relation to the breakage of tabs on snap connectors for the Fisher and Paykel Continuous Positive Airways Pressure (CPAP) Masks and recommends that TGA initiates a consumer level product correction recall because of the inhalation risks associated with the breakage of the snap connectors tabs.
2. MDIRC considers the risk to be avoidable and that supply of the Fisher and Paykel tabbed snap connectors should cease immediately.
3. MDIRC recommends that Fisher and Paykel contact users to exchange the tabbed snap connectors with the new snap connectors that do not have tabs.

Report from the Implantable Medical Device Tracking Subcommittee (IMDTS)

RES NO. 2006/29

MDEC notes that the Implantable Medical Device Tracking Subcommittee has reviewed a draft written report from the Data Management and Analysis Centre on a consultancy for a national tracking system for medical devices and will provide further comments on the report to the consultant. A final report is expected to be available in early 2007.

Report from the Bioengineering & Biomaterials Committee (BBC)

RES NO. 2006/30

1. MDEC notes the BBC has reviewed a draft written report from NICNAS relating to risks of di (2-ethylhexl) phthalate (DEHP's) in medical devices. A final report is expected to be available in early 2007.
2. MDEC notes that the development of guidelines on minimal requirements for IVF solutions awaits outcome of further consultation on the regulatory framework on reproductive tissues.

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