Medical devices reforms: Consumer Working Group meeting statement, Meeting 6, 25 February 2022

Agenda

The Medical Devices Action Plan Consumer Working Group (MDCWG) met via teleconference on 25 February 2022. The agenda included updates on the:

• the TGA medical device reform projects; and
• the Medical Device Adverse Events reporting processes and reports produced for the public via the Database of Adverse Events (DAEN)

Key points

The MDCWG were informed of the progress of the following medical device reforms projects.

Surgical Mesh Up-Classification

All surgical mesh devices are now up classified from Class IIb (medium-high risk products) to Class III (high risk devices).

The MDCWG were advised Class III medical devices require the highest levels of clinical evidence and data and undergo rigorous assessment during the TGA application process. Some surgical mesh devices were removed from the ARTG as they did not meet Class III requirements. The TGA has published a list of surgical mesh devices available for use in Australia. This information is important to assist hospitals and surgeons manage and continue patient care. Further information can be found at the Urogynaecological (transvaginal) surgical mesh hub.

Patient information materials

Since 1 December 2021, manufacturers of all implantable or active implantable medical devices (other than those excluded) are required to make patient information materials available. Patient information materials consist of both patient information leaflets (PILs) and patient implant cards (PICs), and provide:

• patients with information about the type of medical device they might be receiving;
• information to support informed consent conversations with health professional; and
• advice for patients about who and where to report any adverse events associated with the medical device.

The TGA advised work is continuing with hospitals and device sponsors to improve the format and process for providing the information materials to patients. Further information can be found at:

• Patient information material for implantable medical devices
• Five questions to ask your health professional before you get a medical implant.

Proposed mandatory reporting of medical device adverse events by healthcare facilities

The TGA is working with the Australian Commission on Safety and Quality in Health Care and a range of Australian hospitals, peak bodies, state, and territory governments to improve and increase rapid information sharing about medical device safety and effectiveness.

The TGA Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia was published in October 2021 and responses, where consent was provided, are published on the TGA Consultation hub.

Increased reporting of medical device adverse events by healthcare facilities may enhance the ability of the TGA to detect adverse event 'signals' earlier to potential issues.

Proposed changes to the current adverse event reporting exemptions

The proposed changes to remove a number of the exemptions will likely result in an increase in adverse event reporting to the TGA and contribute additional data to the TGA's post market surveillance of medical devices. The MDCWG were advised of an industry workshop on 3 March 2022, the outcomes of which, together with MDCWG feedback, will inform the implementation of any proposed changes.

Development of the Medical Devices Vigilance Program (MDVP)

MDWG members were advised the Proposed program of the TGA inspection and audit of sponsor activities and premises to validate how they conduct their post market surveillance obligations (the MDVP) will support existing monitoring, review, and audit regimes for adverse event by:

• improving medical devices sponsors awareness of and readiness to meet their regulatory obligations;
• reinforcing sponsor requirements to hold and provide timely and accurate adverse event reports and data; and
• providing robust quality assurance information to the TGA regarding adverse events and related matters.

It is expected that increasing sponsor awareness and compliance of their obligations will improve the quality and timelines of reports received by the TGA and assist to safeguard patient safety.

Establishment of the proposed Women's Health Products Working Group

The TGA informed the working group that the Minister for Health and Aged Care recently approved the establishment of a Women's Health Products Working Group (WHPWG) in line with the Action Plan for Medical Devices and in support of the National Women's Health Strategy 2020–2030.

The WHPWG will offer a forum for regulators, health professionals, academia, and patient groups to discuss research and trials, patient reported outcomes initiatives, gender aggregated data reporting and other issues related to therapeutic goods (medical devices and medicines) that are relevant to women.

The MDCWG discussed the updates and noted:

• The TGA should consider improving how consultations occur, including utilising patient groups
• The importance of using appropriate language to acknowledge varying levels of health literacy in the community in relation to patient information materials.
• The importance of having access to information in different forms (digital/non-communication pathways) and to consider applying readability standards.
• Future opportunities for the MDCWG to review examples of patient information materials to ensure that the language used is suitable and appropriate for consumers.

The TGA provided advice on the Adverse Events Reporting and Database of Adverse Events Notifications (DAEN process), including that:

• medical device consumers can report problems or incidents through the consumer online Medical Device Incident Report form;
• the TGA medical device Incident Reporting and Investigation Scheme (IRIS) is responsible for the management of all reports of adverse events or problems associated with medical devices; and
• information is transferred from IRIS to the publicly accessible and searchable Database of Adverse Event Notifications, after it has been reviewed and analysed by TGA staff.

If a safety concern is identified by the TGA, actions the TGA can take in response include:

• informing health professionals and consumers through alerts and articles in publications such as Medical Devices Safety Update (for medical devices) (see the 'Publications' page for further information);
• requiring changes to product labelling, or adding warnings, precautions, and adverse event information to the Patient Information Materials (for implantable medical devices);
• cancelling the ARTG entry of the device, or limiting the population in which it can be used; and
• requiring the sponsor to undertake post-marketing studies to investigate the safety concern if more information is needed before a judgment can be made about the need for further action.

Anyone can search adverse event reports for medical devices received by the TGA via the Database of Adverse Event Notifications (DAEN) - Medical Devices. These reports can come from a wide range of sources and are de-identified to ensure the privacy of the event reporter is maintained. It should be noted that DAEN does not contain all known safety information about a medical device and cannot be used to evaluate whether a medical device is safe or not. It is not a substitute for professional medical advice. The TGA encourages reporting of adverse events.

The MDCWG discussed possible areas for improvement to increase consumer awareness and use, of the online reporting form and DAEN. Comments included:

• the current online adverse event reporting forms are difficult to navigate and there is a need for more clarity on how to use it;
• there could be better sharing of adverse event reporting between other peak/complaint/government bodies and the TGA to reduce the amount of time consumers spend to report to various organisations; and
• the TGA website should be updated to provide information about how the TGA uses the reports Ie: what happens after a report is submitted.

The next meeting is proposed for the end of April 2022.

Further information

Meeting statements are made publicly available after each meeting.

For further information on the MDCWG, please visit the Medical Devices reforms: Consumer Working Group page or contact dwg.tga@health.gov.au.

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