Requirement to report adverse events involving reportable medical devices
41JM Requirement to report adverse events involving reportable medical devices
Report to be given to the Secretary
The chief executive officer (however described) of a healthcare facility must give a report to the Secretary if subsection (2), (3) or (4) applies to the healthcare facility in relation to a reportable medical device and a person.
This subsection applies to a healthcare facility if:
a reportable medical device is used in the facility; and
the use of the device has resulted in the death, or a serious deterioration in the health, of a person while the device is used in the facility.
This subsection applies to a healthcare facility if:
a reportable medical device is not used in the facility because of the intervention of a person in the facility; and
the use of the device, if the device were used, would result in, or would be likely to result in, the death, or a serious deterioration in the health, of a person.
This subsection applies to a healthcare facility if:
a health practitioner provides treatment to a person in the facility for a serious deterioration in the health of the person; and
the use of a reportable medical device has resulted in the serious deterioration in the health of the person.
Report requirements
The report must include the following information about the reportable medical device and the person:
the name, or a description, of the reportable medical device;
a description of the matters covered in subsection (2), (3) or (4);
any other information prescribed by regulations made for the purposes of this paragraph.
For the release of information included in, or relating to, a report, see section 61.
The report must be given to the Secretary:
within the period prescribed by regulations made for the purposes of this subparagraph or such longer period as the Secretary allows in a particular case; and
in the manner prescribed by regulations made for the purposes of this subparagraph.
Exception
Subsection (1) does not apply if the chief executive officer (however described) of the healthcare facility has reported the matters covered by subsection (2), (3) or (4) to:
the chief executive officer of the Australian Commission on Safety and Quality in Health Care; or
the head (however described) of a Department of State of a State or Territory that has responsibility for matters relating to health; or
any other person prescribed by regulations made for the purposes of this paragraph.
Civil penalty
A person contravenes this subsection if:
the person is required to give a report to the Secretary in accordance with this section; and
the person fails to comply with the requirement.
Maximum civil penalty: 30 penalty units.
This provision refers to the regulations (prescribed by regulations
). Made under this Act:
- Therapeutic Goods (Medical Devices) Regulations 2002 · under s 63
- Therapeutic Goods Regulations 1990 · under s 63
5 more instruments made under this Act are listed on the Act’s overview.
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