MDEC meeting 2003/2, 28 November 2003

Medical Device Evaluation Committee

Meeting report

The 2003/2 meeting of the Medical Device Evaluation Committee (MDEC) was held on 28 November 2003. The main points of discussion included -

• The application for registration of Multiload-cu375 Radio Opaque from Organon (Australia) Pty Ltd. Multiload is indicated as an intrauterine contraceptive device;
• The application for registration of DuraGen Dural Graft Matrix from Global Scientific Pty Ltd. Duragen is an onlay dural graft matrix indicated for the repair of dura mater defects in cranial and spinal surgical procedures;
• The application for Medtronic Interstim Model 3023 Neurostimulator from Medtronic Australasia Pty Ltd. The intended use for Interstim is for the treatment of urinary urge incontinence in patients who have failed or cannot tolerate conservative treatments;
• Application audits under the new medical device regulatory system;
• The establishment of the Medical Device Incident Review (Sub) Committee (MDIRC) with the following Terms of Reference:
  1. To advise the MDEC and the TGA about matters concerning the safety of any medical device referred to it or that come to the attention of the MDIRC by any other means. This includes:
     • advice on the investigation and actions taken by the TGA as a result of adverse event and malfunction reports that were received by the TGA Medical Device Incident Report Investigation Scheme;
     • advice about the safety of a medical device, taking into account all available information regarding the balance of risks and benefits;
     • advice on the need for regulatory action by the TGA including recall, hazard alert, safety alert, or conditions of approval of a medical device;
     • recommendations regarding research/investigation that should be undertaken to provide information concerning the safety of a medical device; and
     • advice about guidelines for post-market monitoring of medical device safety.
  2. To oversee the Medical Device Incident Report Investigation Scheme, and make recommendations regarding its maintenance and improvement.
  3. To communicate new or updated information to health professionals and the community about the safety or the balance of risks and benefits of using a medical device.
  4. To promote and encourage the reporting of medical device adverse events and malfunctions to the TGA amongst clinicians and other medical device users.
• The establishment of the Implantable Medical Device Tracking Subcommittee (IMDTS) with the following Terms of Reference:
  1. To advise the MDEC and the TGA on tracking requirements for any devices referred to it, including medical devices, tissues and cellular therapies, that are under assessment for entry onto the Australian Register of Therapeutic Goods.
  2. To advise the MDEC and the TGA on the development of a national device tracking system for Australia.
  3. To promote an awareness of the importance of medical device tracking.
• Terms of Reference for the Bioengineering and Biomaterials Subcommittee:
  1. To advise the MDEC and the TGA about any matters concerning engineering and materials aspects of any medical device referred to it by the MDEC or the TGA.
  2. To provide advice about issues arising at the biomaterial/animal derivative and engineering interfaces as they occur in medical devices.
  3. To advise on appropriate measures to minimise the risk of disease transmission through biological materials used in medical devices.
  4. To advise on conditions that may need to be imposed on the supply of medical devices containing materials with inherent or potential risk.
  5. To consider and provide advice on the level of assessment required and other issues related to the use of new materials or new technology.

The 2004/1 MDEC meeting is proposed for 5 March 2004.

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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 devices should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

Application audits under the new medical device regulatory system

RES NO. 2003/11

MDEC endorsed the TGA's Business Rules for the selection of applications for audit in accordance with Section 41FH(1)(b) of the Therapeutic Goods Act 1989 and requested that the TGA provide an ongoing report to MDEC meetings for consideration.

Establishment of MDEC Subcommittees

RES NO. 2003/12

1. MDEC agrees to the establishment of the Medical Device Incident Review (Sub) Committee (MDIRC) with the following Terms of Reference:
   1. To advise the MDEC and the TGA about matters concerning the safety of any medical device referred to it or that come to the attention of the MDIRC by any other means. This includes:
      • advice on the investigation and actions taken by the TGA as a result of adverse event and malfunction reports that were received by the TGA Medical Device Incident Report Investigation Scheme;
      • advice about the safety of a medical device, taking into account all available information regarding the balance of risks and benefits;
      • advice on the need for regulatory action by the TGA including recall, hazard alert, safety alert, or conditions of approval of a medical device;
      • recommendations regarding research/investigation that should be undertaken to provide information concerning the safety of a medical device; and
      • advice about guidelines for post-market monitoring of medical device safety.
   2. To oversee the Medical Device Incident Report Investigation Scheme, and make recommendations regarding its maintenance and improvement.
   3. To communicate new or updated information to health professionals and the community about the safety or the balance of risks and benefits of using a medical device.
   4. To promote and encourage the reporting of medical device adverse events and malfunctions to the TGA amongst clinicians and other medical device users.
2. MDEC notes the MDEC Chair's appointment of Professor Guy Maddern as Chair of this Subcommittee.

RES NO. 2003/13

1. MDEC agrees to the establishment of the Implantable Medical Device Tracking Subcommittee (IMDTS) with the following Terms of Reference:
   1. To advise the MDEC and the TGA on tracking requirements for any devices referred to it, including medical devices, tissues and cellular therapies, that are under assessment for entry onto the Australian Register of Therapeutic Goods.
   2. To advise the MDEC and the TGA on the development of a national device tracking system for Australia.
   3. To promote an awareness of the importance of medical device tracking.
2. MDEC notes the MDEC Chair's appointment of Associate Professor David Morgan as Chair of this Subcommittee.

RES NO. 2003/14

1. MDEC endorses the following Terms of Reference for the Bioengineering and Biomaterials Subcommittee:
   1. To advise the MDEC and the TGA about any matters concerning engineering and materials aspects of any medical device referred to it by the MDEC or the TGA.
   2. To provide advice about issues arising at the biomaterial/animal derivative and engineering interfaces as they occur in medical devices.
   3. To advise on appropriate measures to minimise the risk of disease transmission through biological materials used in medical devices.
   4. To advise on conditions that may need to be imposed on the supply of medical devices containing materials with inherent or potential risk.
   5. To consider and provide advice on the level of assessment required and other issues related to the use of new materials or new technology.
2. The Chair of the Subcommittee will be advised at the next meeting.

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