Device Vigilance Local Challenges & Global Trends

Pam Carter Director, Device Vigilance and Monitoring Section Medical Devices Branch, TGA ARCS Conference 2018

21 August 2018

Topics Local challenges

• Medical Device reforms

– MMDR

– Inquiries and the results

• Relationship between sponsor and manufacturer

• Education and training

• Reporting of AEs

• Relationship with health facilities and professionals

Global hot topics and trends • Women’s health • Post market surveillance

– PSUR/Annual reporting – Life cycle responsibilities – Post market surveillance studies

• Reporting AEs – Electronic – Web forms – Databases – Harmonisation – Communication between regulators

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Local Challenges

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Expert Panel Review (MMDR) • Two reports released during 2015

– Medicines and Devices

– Complementary medicines and Advertising

• Review included discussion papers, submissions and interviews, followed by stakeholder workshops and other meetings

• Department considered feedback and advised Minister, who took preferred position to Cabinet

• Government intent released in May 2016 budget - full response released on 15 September 2016

– Government accepted 56 of the 58 Recommendations

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MMDR medical device projects • Key projects

• Designation of conformity assessment bodies in Australia

• Expedited review process for certain ‘novel’ devices

• Use of approvals from comparable overseas regulators

• Harmonisation with the European Union

• Strengthening of post market monitoring

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European Harmonisation MMDR recommendation:

• Align with new European regulatory framework where possible

• Clear rationale for Australian specific requirements

EU MDR and IVD Regulations came into force on 26 May 2017

Key changes include:

• Definitions

• Classification

• Conformity assessment procedures

• Essential Principles and General Safety & Performance Requirements

• EU regulations also capture in-house IVDs

• Implant cards and patient leaflets

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Medical Devices reforms Patient Implant Cards and Device Information Leaflets

• From 1 December 2018, patient implant cards will begin to be supplied with new implantable medical devices (starting with urogyanecological mesh)

• All permanently implantable devices are affected:

– Phased approach to be fully implemented by 1 December 2021

• Addresses an information gap

• Exempted products:

– simple implants (dental fillings, dental braces, tooth crowns, endosseous dental implants, screws, etc.)

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Medical Devices reforms Patient Implant Cards and Device Information Leaflets Must include the following information about the device:

Cards

– Name

– Model

– Batch code, lot number or serial number

– Unique device identifier (if any)

– Manufacturers name, address and website

Leaflets

– information identifying the device, or the kind of device

– the intended purpose

– information explaining how to use the device safely

– other information that the manufacturer considers would be useful for patients

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Post market monitoring • Better integration and timely analysis of

available datasets

• Electronic reporting of adverse events

• Enhanced information-sharing with overseas regulators

• Deferred: Implementation of registries for all high risk implantable device

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Reforms vs Recommendations from Inquiries • Reforms

– Quicker access to medical device technology through:

Multiple pathways to inclusion

Use of overseas approvals

• Inquiries

– Hips, breast implants, urogynaecological mesh, private health insurance, cosmetic industry, health technology

More oversight of medical devices pre and post market

More information for patients and health professionals

Medical Device Registries

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Relationships • Relationship between sponsor and manufacturer

– Signed agreements

– Flow of information

– Understanding the Australian regulatory system

• Relationship with health facilities and professionals

– inSite

– Who is reporting an adverse event and to whom

– Limitations of the Therapeutic Goods Act

– Expectations on sponsors and manufacturers

Replacement of devices

Reporting 10

Education and Training • Sponsors:

– Staying included

– Sponsor training day

– SME

– consultation

• Health Professionals

– inSite

– Web statements

– MDSU

– Consultation

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Reporting of AEs Still need to work on:

• No ARTG number

• Insufficient information

• Statistics

• Timely response to investigation

Getting better

• Submitting final reports

• Statistics

• Using web portal

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Global hot topics and trends

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Women’s health • Mesh • Breast implants • Contraceptive devices • Morcellators • Dermal fillers

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Post market surveillance • PSUR/Annual reporting

– Align with European guidance

• Life cycle responsibilities

– Post market surveillance studies

– MDSAP

– Post market reviews

Clinical Evidence Report

Risk assessment

Risk mitigations

Post-market vigilance

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Reporting Adverse Events • Electronic reporting • Web forms • Databases • Harmonisation

– Adverse event terminology codes Annex A: Problem terms and codes Annex B: Type of Investigation terms and codes Annex C: Investigation Findings terms and codes Annex D: Investigation Conclusion terms and codes To come: Annex E - Clinical Signs, Symptoms and Conditions,

and Annex F – Health Impacts • Communication between regulators

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