Update on consumer information leaflets and patient cards for implantable medical devices

1. Patient Implant Cards &
Information Leaflets –
Implementation
Dr Elizabeth McGrath
Director, Devices Conformity Assessment
Therapeutic Goods Administration
TGA - HCP Focus Group – 3 May 2018

2. 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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3. 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.
3

4. EU and
Australian
Regulatory
Requirements
MRA
Global
Harmonization
Taskforce (GHTF)
Principles
Australian
Medical Device
Regulations
EU Medical
Device Directives
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5. 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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6. 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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7. Requirement for
Risk Mitigation-
Lifecycle Approach
During
Design
During
Production
During
Use
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8. 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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9. 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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10. 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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11. New Requirements in Australia

12. 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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13. Additions to Essential Principle 13 – Information to be
Provided with a Medical Device
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14. Two Models for Patient Implant Cards

15. EU Model
Permanent Card
Provided at Discharge
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16. 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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17. Temporary Card
Provided at Discharge
Patient Details
Permanent Card
Provided by
Manufacturer
USA Model
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18. Patient Information Leaflet
(Consumer Device Information)

19. 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. 19

20. 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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21. 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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22. 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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23. 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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24. Reporting Adverse Events

25. 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
Numberofreprots
Year
Doctors
Nurses
Sponsors
Consumers
Allied Health
Total
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26. 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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27. 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
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28. 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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29. QUESTIONS