The document discusses post-market recalls and non-recall actions for medical devices. It proposes changes to the Uniform Recall Procedure for Therapeutic Goods (URPTG) including establishing four types of recall actions and revising the recall classification system. Manufacturers and sponsors have responsibilities for initiating recalls and working with the Therapeutic Goods Administration (TGA) on the recall process, including risk assessment, distribution tracking, and reporting. The TGA reviews recalls and is responsible for overseeing the recall process.

1. Post-market: recalls and non-recall actions
Speakers ―
Simon Waters
Recalls Unit, Therapeutic Goods Administration
Hugh Cameron
Director Regulatory Affairs ANZ, Becton Dickinson

2. Post-market
Recalls and non-recall actions
Simon Waters
Recalls Unit
Manufacturing Quality Branch
Devices Sponsor Information Day 2015
15 October 2015

3. The URPTG
(current) 2004 edition
Available online at
http://www.tga.gov.au/pu
blication/uniform-recall-
procedure-therapeutic-
goods-urptg
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4. Revised URPTG - proposed changes
• Web based format – easy to navigate
• Step-by-step protocol with supporting information
• New/changes to recall terminologies
• Risk classification – inclusion of probability aspects
• Greater clarification on the requirements for medical
devices (including IVDs)
• Refined information required to assess a recall action
Feedback from the public consultation will be considered
before finalising the changes
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5. Recall actions – proposed changes
The proposal is to have four types of recall actions:
• Recall – the permanent removal of deficient goods from the market
or from use
• Recall for Product Defect Correction – repair, modification,
adjustment, re-labelling, update to instructions or labelling
• Hazard Alert – providing information to health practitioners
regarding the issues to implantable medical devices and advice
on how to manage such patients
• Product Defect Alert (new term) – undertaken for critical
therapeutic goods for which there is no alternative product or for
which a recall action will result in interruption of patient treatment or
a shortage
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6. Recall Classification – proposed changes
• a situation in which there is a reasonable
probability that the use of, or exposure to,
a deficient product will cause serious
adverse health consequences or death
Class
I
• a situation in which use of, or exposure to, a
deficient product may cause temporary or
medically reversible adverse health
consequences or where the probability of
serious adverse health consequences is remote
Class
II
• a situation in which use of, or exposure to, the
deficient product is not likely to cause adverse
health consequences
Class
III
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7. Legislative context
Schedule 3
Conformity assessment procedures
• Even though most recall
actions are initiated by the
manufacturer, such actions are
required under the medical
devices legislative framework
and are not voluntary
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8. Legislative Context (cont’d)
Section 41KA: Public notification
and recovery of medical devices
• The Secretary’s powers and
processes for mandating device
recalls not only for currently
‘included’ devices, but also for
exempt, cancelled or illegally
supplied devices
• Competition and Consumer Act
2010 (consumer goods)
– notification to ACCC for safety
related actions
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9. Responsibilities - manufacturers
• Has established recall procedures in
place to initiate a recall action
• Has established relationship with the
Australian Sponsor, including the ability
to quickly provide information when requested
• Identifies issues requiring recall or non-recall action
• Risk assessment (usually known as HHE/HHA)
• Identifies root cause and implements CAPA
• Have an effective QMS in place in accordance with
conformity assessment procedures (ISO 13485)
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10. Responsibilities – Sponsors
• Takes primary responsibility for implementing the recall action
(but can authorise third parties)
• Submits proposed communication strategy and draft letters to
the TGA
• Submits a risk assessment (HHE/HHA) undertaken by the
manufacturer for the issues identified
• Maintains product distribution details (and provides to the
TGA) to assist in facilitating a recall action
• Has established recall procedures in
place to undertake a recall action
• Reporting on the progress of the recall
action
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11. Responsibilities – TGA
• Undertakes independent review of risk
• Reviews recall strategy and correspondence and provides
agreement to initiation of recall action
• Advises stakeholders (primarily the state and territory health
departments) of recall actions including release of distribution
details to monitor the effectiveness of the recall
• Publication of all recalls in the SARA database
• TGA web statements for Hazard Alerts, consumer level and
sensitive recall actions
• Reviews root cause and CAPA and closes-out the recall action
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12. Follow-up reporting
The reporting requirements are:
• 2 and 6-week progress reports are required after the
commencement of the recall
• Close-out report requirements (usually 3 months or another
agreed timeframe):
• the results of the recall - quantity of stock returned,
outstanding etc.;
• the means of disposal, destruction or correction to the
recalled goods and confirmation that this has been
carried out; and
• details of the root cause analysis and
CAPA to prevent the problem from recurring.
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13. GS1 RecallNet Healthcare
The TGA does not require
sponsors to join GS1 RecallNet
Alternative method for notifying
the TGA of recall actions and
communicating with customers
who have been supplied
defective products
• The TGA provided advice to GS1 Australia on the
requirements and procedures outlined in the URPTG
• Has published a clarifying statement on the TGA website.
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14. What are they?
Recalls and associated actions are our “friends”

15. What are they?
Frequently painful

16. What are they?
• Ensure patients / users are protected / can effectively use
• Demonstrate our Manufacturers’ QMSs are working effectively
• Protect Company / Industry reputation
• Compliance is our responsibility

17. What are they?
Think what may happen if we didn’t
conduct Recalls…

18. What is the process?
Actively discuss with Recalls Unit
Pay close attention to what the
URPTG asks (and doesn’t ask) for

19. URPTG
• Is not legislation
“…an agreement between the therapeutic goods
industry and Commonwealth and State/Territory health
authorities.”
• As a Sponsor, you have to determine how to
comply

20. URPTG
• Information to be provided
• Details of the problem / product
• Risk Assessment and proposed action
• Type of hazard / assessment of risk
• Action / Classification / Level proposed

21. URPTG
• Availability of alternative product
New Product Defect Alert relevant here
• Have a focused approach
• provide the information necessary for
a successful outcome
• Importantly
• Collaborative process
• TGA will liaise with Sponsors and provide
advice and assistance

22. URPTG
• Confidentiality
• “It is recognised that some of the information provided may be of
a commercially sensitive or private nature and such information
will be treated appropriately.”
• Mark it as such if you think this is the case
• Some States / Territories may communicate widely on Recalls
• Issues with multiple communications and Recall returns

23. Types / Ways
• Depends on Classification and Level
• It’s a continuum:
• Class III with single / minimal customers
• Class I at the retail / consumer level
• With everything between

24. Types / Ways
• Hard copy / fax / e-mail – confirm receipt
• Receipt of acknowledgement forms
• GS1 RecallNet
Watch outs
• Liability?
• Coverage?
• Improvements into the future
• Requirement should be to Recall effectively
without specifying the medium

25. Manufacturer Responsibilities
An effective QMS that
• Maintains effective feedback
• Formalises evaluation methods
• Communicates and receives
inputs

26. Sponsor Responsibilities
• Requirement to report to TGA in a
timely fashion
• Established relationship with
manufacturer & TGA
• Best practice = written procedure
• Distribution records
• Quality holds
• Receive and action complaints
• Action the Recall and report
• 48 hours from approval
• 2 and 6 week reports,
with final closeout report

27. Questions
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