MDEC meeting 2003/1, 21-22 August 2003

Medical Device Evaluation Committee

Meeting report

The 2003/1 meeting of the Medical Device Evaluation Committee (MDEC) was held on 21-22 August 2003. The main points of discussion included -

• The application for registration of the Cryolife O'Brien Stentless Porcine Aortic Bioprosthesis, Model 300. The valve is indicated for use as a replacement for damaged or diseased aortic valves;
• The establishment of MDEC Subcommittees;
• The establishment of Committee processes for the expedient ratification of resolutions and for the public release of key meeting outcomes on the TGA website;
• Application audits under the new medical device regulatory system;
• Proposal to harmonise Australia's requirements for in vitro diagnostic devices with international best practice; and
• The discussion paper on the Regulation of Human Tissue and Emerging Biological Therapies.

The 2003/2 MDEC meeting is proposed for 28 November 2003.

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 to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medical device should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. This recommendation for approval may be subject to specific conditions.

Establishment of MDEC Subcommittees

RES NO. 2003/4

MDEC recommended the establishment of the following Subcommittees:

1. Medical Device Incident Review Committee (MDIRC)
2. Implantable Medical Device Tracking Subcommittee (IMDTS)
3. Biomaterials and Bioengineering Committee (BBC).

Publication of Minutes and Resolutions

RES NO. 2003/5

MDEC endorses the introduction of a process to achieve ratification of Minutes out-of-session, based on:

1. Within 20 working days of the meeting, distribution of draft Minutes to all Members;
2. Within 10 working days of distribution, submission to the Secretariat, by Members who attended that meeting, with comments on the draft Minutes;
3. Within 5 working days, circulation to all Members of comments received (other than typographical corrections and changes of editorial nature), details of amendments made (if any) and a copy of the amended Minutes;
4. Within 5 working days, provided that the Secretariat has received confirmation by majority of Members present at the meeting that the Minutes as amended (point 3) are a true record of that meeting the Chair may sign them as a true record;
5. If objections are received to the amended Minutes, the Chair may, at his/her discretion, defer ratification of the Minutes to the next formal meeting of the Committee.

Status of MDEC Resolutions and Minutes

1. MDEC endorsed that with every Resolution made by MDEC, a recommendation is made as to whether the Resolution should be made public or not.
2. MDEC recommends that the Minister is advised of the MDEC ratified Minutes and afforded the opportunity to consider the issues prior to publishing;
3. MDEC recommends that, at the earliest possible time, the TGA make public:
   1. Summaries of key MDEC recommendations; and
   2. Report of MDEC meetings, which is an edited version of the ratified minutes.
4. For the purposes of this Resolution, 'edited' means:
   1. deletion of:
      1. trade secrets and/or commercial-in-confidence information;
      2. reference to whether agreement was unanimous or not;
      3. reference to whether or not a Member was present at the time of a vote, unless it relates to a conflict of interest;
      4. any reference that will personally identify Members, unless it relates to a conflict of interest; and
      5. any other information for which public disclosure is inappropriate.
5. In the case of a conflict of interest, the Member's name and the Committee's handling of the conflict is to be retained.
6. For each Resolution, MDEC may flag those that require immediate publication (preferably within 24 hours).

Note: A Member has the right to request non-disclosure of their name in relation to any item.

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