Patient Implant Cards & Information Leaflets –Implementation

Dr Elizabeth McGrath Director, Devices Conformity Assessment Therapeutic Goods Administration

TGA - HCP Focus Group – 3 May 2018

TGA – what we do

Evaluate therapeutic goods before they are supplied

Focus on safety, quality and efficacy/performance Monitor products once they are on the market Take regulatory action if a safety signal is detected We do not make regulatory decisions based on value for money or make decisions about which products receive Government subsidy

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Supply of medical devices in Australia

Majority of devices are supplied in Australia under European Conformity Assessment certification.

Some high risk devices must hold TGA issued conformity assessment certification in order to be supplied in Australia.

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EU and Australian Regulatory Requirements

Global Harmonization

Taskforce (GHTF) Principles

EU Medical Device Directives

MRA Australian Medical Device

Regulations 4

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

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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 Regulatory Requirements

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 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 Requirements (2)

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

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.

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Additions to Essential Principle 13 – Information to be Provided with a Medical Device

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Two Models for Patient Implant Cards

EU Model

Permanent Card Provided at Discharge

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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

Patient Details

Permanent Card Provided by

Manufacturer 17

Patient Information Leaflet (Consumer Device Information)

Additions to Essential Principle 13 – Information to be Provided with a Medical Device

13A.3 Patient information leaflets for implantable devices (1) A leaflet (a patient information leaflet) that meets the requirements of

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

(2) The leaflet must include the following information: (a) information identifying the device, or the kind of device; (b) the intended purpose of the device; (c) information explaining how to use the device safely; (d) other information about the device that the manufacture

considers would be useful for patients.

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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

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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.

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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

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Requirements for Patient Leaflet

Item Information to be included in patient information leaflet

8 a) the materials and substances included in the device; and b) any manufacturing residuals that could pose a risk to the patient

9 a) a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the Therapeutic Goods Administration; and

b) the address of the Therapeutic Goods Administration’s website

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Reporting Adverse Events

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

DoctorsNursesSponsorsConsumersAllied HealthTotal

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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

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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 27

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