MMDR reform Patient Implant Cards and Information Leaflets - - PowerPoint PPT Presentation

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

1

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
• utweigh any risks associated with

the use of medicines, medical devices and other therapeutic goods

• Risks must also be mitigated

Benefits Risks

2

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

• f 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

• f 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)

• ther 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

• ne year; or

– which is intended to be a life sustaining or life supporting device used

• utside 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

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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

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Reporting Adverse Events

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Who reports medical device incidents?

500 1000 1500 2000 2500 3000 3500 4000 4500 5000 5500 6000 2010 2011 2012 2013 2014 2015 2016 2017

Number of reprots 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

• r

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