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Presentation: How the TGA uses implant registry data: Experience with the AOANJRR

TGA presentation: ARCS Scientific Congress Sydney, 11-12 May 2016

30 May 2016

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These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Jorge Garcia
  • Presented at: ARCS Scientific Congress Sydney
  • Presentation date: 11-12 May 2016
  • Presentation summary: The recent TGA review of devices has foreshadowed a much greater role for registries in monitoring the long and intermediate term safety of new devices. This presentation provides an example of an established device registry to explore issues such as governance, funding, record linkage, reporting etc.

Transcript

How the TGA uses implant registry data: Experience with the Australian Orthopaedics Association's National Joint Replacement Registry (AOANJRR)

Dr Jorge Enrique Garcia
Principal Scientific Adviser
Medical Devices Branch

ARCS Scientific Congress 11 May 2016

Slide 1 - Outline

  • The AOANJRR:
    • How it works, reporting, benefits, limitations
  • How the TGA uses AOANJRR Data
    • Prostheses with a higher than anticipated rate of revision
    • Adverse Event and Complaint Investigations
    • Premarket Assessment of Submissions
  • Conclusions

Slide 2 - The AOANJRR: How it works

  • A joint replacement procedure triggers data collection
    • Patient identifying details, consulting surgeon, reason for surgery, and the type of implant, including individual implant components
    • If the procedure is a revision: type of revision, reason for revision
  • "Opt Out" System
  • Outcome Measure: Revision
    • Reported as Cumulative Percent Revision from the time of the primary procedure
  • Comparison between different "populations" is possible
    • e.g. primary diagnoses; gender; age; use of cement; type of implant; implant models; etc.
    • Hazard Ratios are used to compare rates of revision

Slide 3 - The AOANJRR: Reporting

  • Annual Reports on Hip, Knee and Shoulder Replacement
    • Published in October each year using data collected to the end of the previous year
    • Collection started in 1999 (2004 for shoulders)
    • Contains information about prostheses with a higher than anticipated rate of revision
  • Supplementary reports on joint replacement:
    • E.g. demographics and mortality of Hip, Knee Arthroplasty; Cement in Hip and Knee Arthroplasty
  • Individual reports on prostheses with higher than anticipated rates of revision (since 2010)
  • Ad-Hoc summary reports from an online web portal

Slide 4 - The AOANJRR: Benefits

  • A wide variety of analyses is possible
    • Cumulative Percent Revision (Kaplan Meier Survivorship)
    • Breakdown of revision rates among particular patient populations, implant types, etc.
  • Completeness of data arising from "opt out" method of enrolment
  • Comprehensive outcome reports
  • Online access to data

Slide 5 - The AOANJRR: Limitations

  • Privacy restrictions
    • The data can be used to track patients only in exceptional circumstances
    • (NB: the TGA can get this information from other sources)
  • Inaccurate coding
    • E.g. some evidence that loosening/lysis, pain, metal sensitivity are being used interchangeably

Slide 6 - How the TGA uses AOANJRR data

  • Prostheses with a Higher than Anticipated Rate of Revision
  • Adverse Event and Complaint Investigations
  • Pre- Market Assessment of Submissions

Slide 7 - Prostheses with a higher than anticipated rate of revision

  • Immediate regulatory action on identified prostheses is not appropriate
    • There are many reasons why the revision rate of a prosthesis is high, only some are related to the prosthesis
    • A prosthesis may also have redeeming features that make the higher revision rate "tolerable"
  • Identification by the AOANJRR initiates an three stage investigation process that determines if the safety and performance of the implant is acceptable

Slide 8 - Prostheses with a higher than anticipated rate of revision

  • Step 1
    • The Sponsor/Manufacturer of the implant is invited to make a submission relating to the safety and performance of the implant
  • Step 2
    • A group of orthopaedic experts considers the information from the AOANJRR and the Manufacturer: Advises the TGA about safety, performance and benefits that may compensate for the high risk of revision
  • Step 3
    • The TGA considers the evidence AND the expert advice and makes a regulatory decision. Can be Recall, Hazard Alert, Safety Alert and/or Cancellation. Can also be do nothing

Slide 9 - Prostheses with a higher than anticipated rate of revision

In 2015 the AOANJRR identified 125 implant combinations (71 hips; 47 knees; 6 shoulders and 1 ankle) placing them into three categories:

  • No Longer Used
    (74 Implants)
    • 32 withdrawn from the market after TGA intervention
    • 42 not supplied at the time they were identified
  • Identified Prior to 2015, Still Used
    (43 Implants)
    • 23 under observation after expert group advice
    • 12 subject of compliance action
    • 8 still under investigation
  • Newly Identified 2015
    (8 Implants)
    • 5 under observation after expert group advice
    • 3 are being investigated

Slide 10 - Adverse event and complaint investigations

  • The TGA will routinely consider information available through the AOANJRR on-line portal during the investigation of implant adverse event reports.
    • EVENT: 2012 Device Incident Report; revision of an acetabular cup; triggers a routine query of the information held about the implant by the AOANJRR
    • FINDINGS: The Cumulative Percent Revision rises sharply 3 years after implantation. This was not yet manifested in a rise in the revisions per 100 observed years used by the AOANJRR to "identify" outliers
    • OUTCOME: Hazard Alert and contra-indication of the use of the device in total conventional hip replacements

Slide 11 - Premarket assessment of submissions

  • In the absence of direct clinical evidence, the TGA has used AOANJRR reports on clinically equivalent implants ....
  • ... and predicates can work both ways
  • Is the clinical study large enough? Is the minimum follow up long enough?
    • AOANJRR data on clinically equivalent implants can provide guidance

Slide 12 - Conclusions

  • Implant registries that can provide comparative analyses on outcomes are an invaluable tool for post-market vigilance and monitoring. Registry information is used for pre-market decisions as well
  • However: The outcome measures must be subjected to thorough clinical/technical assessment to ensure that appropriate regulatory measures are taken.
  • Patient tracking is not particularly useful to Regulatory Agencies
    • The information can be obtained from other sources
    • In case of a problem, it is best for the patient to be contacted by a medical practitioner
  • However: Outcomes registries will still need to track patients to ensure the integrity of the data analysis

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