Device Vigilance Local Challenges & Global Trends Pam Carter - - PowerPoint PPT Presentation

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
• n 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

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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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