TGA presentation: Health Consumers Workshop - Medical Devices, 1 March 2018
The Therapeutic Goods Administration (TGA), representatives from public health groups and health consumer members of several medical devices related, Commonwealth advisory committees met on 1 March 2018 to discuss the introduction of patient cards and consumer device information (patient information leaflet) for all permanently implantable medical devices.
The initiative announced on 26 October 2017, is in response to concerns from consumers about the absence or limited information provided to consumers about the medical device implanted during surgery. The initiative will be introduced in Australia in a staged approach, beginning from 1 December 2018 with new urogynaecological mesh devices.
The patient cards and consumer device information are tools to empower consumers with information, useful for prior informed consent discussions and after surgery care.
At the meeting, the TGA emphasized that it wanted to engage with, listen and learn from consumers so as to implement the policy such that the needs of consumers is balanced with the costs of regulatory change that medical device industry will have to bear.
The TGA presented an overview of its medical device regulatory processes, including pre and post-market assessments and adverse events reporting, as well as the policy parameters of the consumer information materials.
Participants discussed the principles underpinning the patient information policy as they related to benefits, risks, harms as well as consumer confidence in the role the TGA performs in the health system, the role of health professionals and the device industry. Participants considered that providing feedback to the TGA on both proposed content and format options would be a valuable contribution to the design and adoption of this new policy initiative.
The consumer health representatives were from the Consumers Health Forum of Australia, Public Health Association of Australia, PainAustralia. Members from the Medical Services Advisory Committee (MSAC), the Prosthesis List Advisory Committee, the Health Technology Assessment Consumer Consultative Committee and the Advisory Committee on Medical Device. The Australian Commission on Safety and Quality in Health Care was also represented.
The TGA will continue to engage with consumer organisations and other relevant stakeholders as part of the policy implementation process.
- Device consumer information workshop
- Patient implant card and patient information leaflet
- Patient implant cards – Options for implementation
- Patient information leaflets: Consumer preferences
- Patient Implant Cards and Information Leaflets – Implementation
- Medical Devices: Pre-market authorisation
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.