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MDEC meeting 2004/1, 5 March 2004

Medical Device Evaluation Committee

Meeting report

The 2004/1 meeting of the Medical Device Evaluation Committee (MDEC) was held on 5 March 2004. The main points of discussion included -

  • Training of surgeons in the use of medical devices;
  • Di (2-ethyl hexyl) phthalate (DEHP) in medical devices;
  • Use of symbols in labelling of medical devices;
  • Application audits under the new medical device regulatory framework;
  • Presentation on the Australian Council for Safety and Quality in Health Care; and
  • Progress reports from the Medical Device Incident Review Committee, Implantable Medical Device Tracking Subcommittee and Bioengineering and Biomaterials Committee.

The 2004/2 MDEC meeting is proposed for 25 June 2004.

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.

Training of surgeons in the use of medical devices

RES NO. 2004/16

  1. MDEC notes the TGA's proposal to work with manufacturers and sponsors to recommend the appropriate training that should be available for users of devices.
  2. MDEC endorses the TGA's proposal that, during the evaluation process, the following issues will be taken into consideration for the purposes of assessing the safe use of individual devices:
    • whether a risk analysis was performed
    • whether the risk analysis addresses issues of technology (including surgical techniques required for implantation) of the device, user-error and likelihood for abuse as potential problems associated with the device; and
    • the extent to which user-associated risks have been mitigated by the manufacturer. This will include an assessment of how such risks are addressed, such as through the provision of instructions-for-use and user manuals, restrictions on supply mechanisms, provision of specific training modules. (eg. workshops, videos, seminars). A method for assessment of competence should also be included.

Di (2-ethyl hexyl) phthalate (DEHP) in medical devices

RES NO. 2004/18

  1. MDEC notes the risks associated with di (2-ethyl hexyl) phthalate (DEHP) in medical devices, particularly where those devices are used in susceptible populations and where the exposure is either high or chronic. MDEC agrees that TGA should clarify its position on the use of DEHP in medical devices.
  2. The committee recommends that a risk assessment be conducted and include input from the Office of Chemical Safety. The risk assessment should consider the divergence of views of three international committees about the ability to calculate a Tolerable Intake (TI) for DEHP using the available information.
  3. MDEC recommends that the Bioengineering & Biomaterials Subcommittee (BBC) work with TGA on the review of the risk assessment of DEHP and develop a position statement on the use of DEHP in medical devices.

Use of symbols in labelling of medical devices

RES NO. 2004/19

  1. MDEC supports the recommendation of the former Therapeutic Device Evaluation Committee (TDEC) Resolution No. 2001/3 to reject the use of all-symbol labelling; and
  2. MDEC recommends the TGA accept the use of 'language' and 'symbol' parallel labelling provided that the symbols used are consistent with the harmonised standard (EN980:1997 - Graphical symbols for use in the labelling of medical devices).

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