Device Evaluation Committee
This article was originally published in RAJ Devices
Executive Summary
Resolutions from Australian MDEC's December 2006 meeting
Resolutions from Australian MDEC's December 2006 meeting
The Medical Device Evaluation Committee (MDEC) of the Australian Therapeutic Goods Administration (TGA) held a meeting on 15 December 2006 at which it made a number of resolutions relating to drug-eluting stents, reclassification of joint replacement prostheses and the early revision of certain joint prostheses, implantable medical device tracking and the risks of di (2-ethylhexl) phthalate (DEHP) in devices, among other issues1. They are outlined below.
Drug-eluting stents
The committee noted the TGA's evaluation of the risk of late thrombosis of approved coronary drug-eluting stents and recommended that an expert working group be established to undertake a review of the available clinical and postmarket data and advise the MDEC and the TGA regarding risks associated with drug-eluting stents.
Reclassification of joint replacement prostheses
The MDEC noted the proposal for the reclassification of joint replacement prostheses and in consideration of the Australian Orthopaedic Association National Joint Replacement Registry Annual Report 2006 recommended 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. It also suggested that the TGA indicate its intention to reclassify joint replacement implants to Class III (from Class IIb), unless the review of the evidence does not support this proposal.
Also with respect to joint replacements, the committee endorsed recommendations made by the Medical Device Incident Review Committee (MDIRC) regarding several joint replacement components identified in the National Joint Replacement Registry that have had a higher than anticipated early revision rate. The recommendations included contacting the manufacturers of the prostheses identified to request the following information:
- explanation for the early revision rate of the implant that they supply in comparison to that of other similar devices on the market;
- features of implant design and expected performance that compensate for the apparent additional risk of early revision; and
- explanation as to why the events have not been reported to the TGA, given that early revisions are considered to be reportable adverse events.
The MDIRC had also suggested 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.
Implantable device tracking
The MDEC noted 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.
DEHPs
At the meeting, the MDEC acknowledged that the Bioengineering and Biomaterials Committee had reviewed a draft written report from the National Industrial Chemicals Notification and Assessment Scheme relating to risks of DEHPs in medical devices. A final report is expected to be available in early 2007.
References
1. MDEC Meeting 2006/4 summary of key resolutions, 15 December 2006, www.tga.gov.au/docs/html/mdec/mdec_20064res.htm