MMDR reform – Patient Implant Cards and Information Leaflets

Elizabeth McGrath A/g Assistant Secretary, Medical Devices Branch Therapeutic Goods Administration ARCS Annual Conference, Sydney 22 August 2018

• Risk Reduction - Current Requirements • New EU Requirements • New Australian Requirements • Implant Card Models • Consultation for Implementation

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The benefit versus risk approach

• No therapeutic good is risk free

• The work of the TGA is based on applying scientific and clinical expertise to decision making

• We ensure that the benefits outweigh any risks associated with the use of medicines, medical devices and other therapeutic goods

• Risks must also be mitigated

Benefits Risks

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Requirement to reduce risk ESSENTIAL PRINCIPLE 2 - the manufacturer must:

a) first, identify hazards and associated risks arising from the use of the device for its intended purpose, and foreseeable misuse of the device; and

b) second, eliminate, or reduce, these risks as far as possible by adopting a policy of inherently safe design and construction; and

c) third, if appropriate, ensure that adequate protection measures are taken, including alarms if necessary, in relation to any risks that cannot be eliminated; and

d) fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted.

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Requirement for Risk Mitigation - Lifecycle Approach

During Design

During Production

During Use

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Current Australian requirement Essential Principle 13 - Information to be provided with medical devices

13.1 Information to be provided with medical devices – general

1) The following information must be provided with a medical device:

a) information identifying the device; b) information identifying the manufacturer of the

device; c) information explaining how to use the device safely;

having regard to the training and knowledge of potential users of the device.

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New European MDR requirements 1. The manufacturer of an implantable device shall provide

together with the device the following:

a) information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;

…the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.

Member states shall require healthcare facilities to provide the cards to patients.

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New European MDR requirements (cont.)

• The following implants are exempt from the requirement of a patient implant card:

sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

• The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom.

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New Requirements in Australia • Patient Implant Cards

• Patient Information Leaflets

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Patient Implant Cards • From 1 December 2018, patient implant cards will be supplied

with new urogyanecological mesh devices

• 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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Additions to Essential Principle 13 – Information to be Provided with Medical Devices

13A.2 Patient implant cards for implantable devices • (1) A card (a patient implant card) that meets the requirements of

subclause (2) and clause 13A.4 must be provided with the medical device.

• (2) The card must include the information mentioned in the following table.

Patient Information leaflets • Patient information leaflets must be supplied with all:

– New implantable medical devices from 1 December 2018

– Existing implantable medical devices by 1 December 2021

• The same exemptions apply as per patient implant cards: − simple implants (dental fillings, dental braces, tooth

crowns, endosseous dental implants, screws, etc.)

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Requirements for Patient leaflet

13A.3 - ...the leaflet must include the information mentioned in the following table

Item Information to be included in patient information leaflet 1 a) the name of the device; and

b) the model of the device

2 a) the intended purpose of the device; and b) the kind of patient on whom the device is intended to be used

3 Any special operating instructions for the use of the device

4 a) the intended performance of the device; and b) any undesirable side effects that could be caused by use of the device

Requirements for Patient leaflet

Item Information to be included in patient information leaflet 5 Any residual risks that could arise due to any shortcomings of the

protection measures adopted as mentioned in subclause 2(2)

6 a) warnings about risks that could arise from the interaction of the device with other equipment; and

b) precautions and other measures that, because of those risks, should be taken by the patient or a health professional

Example 1: The risk of electrical interference from electro-surgical devices. Example 2: The risk of magnetic field interference from magnetic resonance

imaging devices.

Requirements for Patient leaflet Item Information to be included in patient information leaflet 7 a) the nature and frequency of regular or preventative examination,

monitoring or maintenance of the device that should be undertaken; and b) symptoms that could indicate that the device is malfunctioning; and c) precautions and other measures that should be taken by the patient if

the performance of the device changes or the patient experiences any of the symptoms mentioned in paragraph (b); and

d) the expected device lifetime; and e) anything that could shorten or lengthen the device lifetime; and f) precautions and other measures that should be taken at, or near, the

end of the expected device lifetime; and g) other circumstances in which the patient should contact a health

professional in relation to the operation of the device

Requirements for Patient leaflet

Timeframes

Device info leaflet Patient implant card

Urogynaecological mesh

New devices 1 Dec 2018 1 Dec 2018

Existing devices 1 Dec 2019 1 Dec 2019

Surgical mesh

New devices 1 Dec 2018 1 Dec 2020

Existing devices 1 Dec 2021 1 Dec 2021

Implantable devices (other than those exempted)

New devices 1 Dec 2018 1 Dec 2020

Existing devices 1 Dec 2021 1 Dec 2021

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Two Models for Patient Implant Cards

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EU Model

Permanent Card Provided at Discharge

FDA Device Tracking Requirements • The tracking provision is intended to ensure that manufacturers

can expeditiously remove potentially dangerous or defective devices from the market and/or notify patients of significant device problems.

• The types of devices subject to a tracking order may include any Class II or Class III device:

– the failure of which would be reasonably likely to have serious adverse health consequences;

– which is intended to be implanted in the human body for more than one year; or

– which is intended to be a life sustaining or life supporting device used outside a device user facility.

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USA Model

Temporary Card Provided at Discharge

Permanent Card Provided by

Manufacturer

Patient Details

Consultations on Patient Information

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Consultations – Hospitals, States & Territories Objectives

• Inform hospital sectors and States & Territory Health of the consumer information materials

• Understand current practice when a patient card is available

• Importance of adverse event reporting

Teleconferences or workshops held May through August with:

• Healthcare Practitioners, craft groups

• Day Hospitals Australia

• Australian Private Hospitals Association

• States and Territories health departments

• Australian Healthcare & Hospitals Association

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Outcomes – Hospitals, States & Territories Very supportive • Practices/systems vary between hospitals:

– Some already pass on manufacturer supplied cards and/or develop own cards and patient information material

– Others may not - practitioners’ discretion

• Record keeping practices: – US traceability model preferred by a few – Comment - ‘should be an onus on sponsors to be accountable to patients’

– Some hospitals scan bar codes; patient card/device information provided this way could be useful

– ‘Stickers’ as supplied now can be added to discharge summary – Strong preference for MyHealth Record capability

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Consultations – Consumers Health Forum • Objectives

− Raise consumer awareness of:

patient cards

leaflets and

‘questions’ for your doctor

− Engage consumers for feedback

− Develop dissemination strategies for maximum reach

− Organised and managed by Consumers Health Forum (CHF)

• Workshops held in July (Sydney 16th & Melbourne 17th)

• Webinar and focus groups held prior to workshops 24

Outcomes – Consumers Improving consumer information in future

• Consumers would prefer additional information:

– What should I think about before I have this medical device? e.g. Benefits, risks, changes to my lifestyle, precautions to take, potential

interactions, warnings

– When and where to seek medical help if complications arise

– Where to report problems - doctor, manufacturer, TGA

– Materials, substances, and manufacturing residuals; country of origin

– Where to seek help and get more information

– Who are the Sponsor and Manufacturer

– How to contact Sponsor and Manufacturer

– Patient card to include doctor’s name and date of implant 25

Reporting Adverse Events

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Who reports medical device incidents?

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

5500

6000

2010 2011 2012 2013 2014 2015 2016 2017

Num

ber

of re

prot

s

Year

Doctors

Nurses

Sponsors

Consumers

Allied Health

Total

Health Professionals and Consumers Importance of reporting

• Sponsors have mandatory reporting requirements but the TGA still relies on incident reports from users

• User reports help the TGA identify patterns that help it monitor safety and performance of medical devices

• The TGA encourages users to report issues of concern but cannot enforce user reporting

• Evidence suggests that a substantial number of medical device incidents are NOT reported

• “Insite” – a program developed by TGA to encourage reporting of adverse events by health professionals

Medical Device Adverse Events

How to Report

Go to TGA website www.tga.gov.au and follow links for reporting a problem

or directly to the website page for the reporting form https://apps.tga.gov.au/prod/mdir/udir03.aspx

Enter information into the web based form

Device Incident Report (DIR) number will be available immediately after submitting the report

Save or print your report

Further Information

• Database of Adverse Event Notifications (DAEN) http://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx

• Medical device reporting form https://apps.tga.gov.au/prod/mdir/udir03.aspx

• Medical device adverse event reporting information https://www.tga.gov.au/medical-device-incident-reporting-investigation-scheme-iris

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QUESTIONS