The regulatory standards for the approval of medical devices in Australia

142 Pages·2011·1.5 MB·English

The Senate

Community Affairs
References Committee
The regulatory standards for the approval of
medical devices in Australia

November 2011
© Commonwealth of Australia 2011
ISBN 978-1-74229-527-5

Secretariat
Dr Ian Holland (Committee Secretary)
Ms Christine McDonald (Inquiry Secretary)
Mr Stephen Palethorpe (Inquiry Secretary)
Dr Bu Wilson (Principal Research Officer)
Dr Merridee Bailey (Senior Research Officer)
Ms Kyriaki Mechanicos (Senior Research Officer)
Ms Aleshia Bailey (Research Officer)
Ms Jo-Anne Holmes (Administrative Officer)
Mr Tim Hillman (Administrative Officer)
Ms Di Warhurst (Administrative Officer)
Ms Penny Bear (Administrative Officer)

PO Box 6100
Parliament House
Canberra ACT 2600
Ph: 02 6277 3515
Fax: [phone]
E-mail: [email protected]
Internet: http://www.aph.gov.au/Senate/committee/clac_ctte/index.htm

Printed by the Senate Printing Unit, Parliament House, Canberra.
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MEMBERSHIP OF THE COMMITTEE
43rd Parliament

Members
Senator Rachel Siewert, Chair Western Australia, AG
Senator Claire Moore, Deputy Chair Queensland, ALP
Senator Judith Adams Western Australia, LP
Senator Sue Boyce Queensland, LP
Senator Carol Brown Tasmania, ALP
Senator Bridget McKenzie (from 1 July 2011) Victoria, NP
Senator the Hon Helen Coonan (until 30 June 2011) New South Wales, LP

Participating member
Senator Nick Xenophon South Australia, IND

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TABLE OF CONTENTS

MEMBERSHIP OF THE COMMITTEE ...................................................... iii 
ABBREVIATIONS .......................................................................................... vii 
RECOMMENDATIONS ................................................................................... ix 
Chapter 1 
Introduction .............................................................................................................. 1 
Terms of reference .................................................................................................. 1 
Conduct of the inquiry ............................................................................................ 1 
Acknowledgement .................................................................................................. 2 
Note on references .................................................................................................. 2 
Structure of the report ............................................................................................. 2 
Chapter 2 
Regulatory issues ...................................................................................................... 3 
Introduction ............................................................................................................ 3 
The role of the TGA in regulating quality of devices ............................................ 4 
Safety standards and approval processes for devices that are
remanufactured for multiple use ........................................................................... 39 
Other matters ........................................................................................................ 44 
Chapter 3 
High revision rates: the consumer experience ..................................................... 47 
Introduction .......................................................................................................... 47 
The DePuy ASR hip system ................................................................................. 47 
The consumer experience ..................................................................................... 51 
Notifying authorities, patients and the general public about faulty devices ........ 65 
Chapter 4 
Subsidised devices ................................................................................................... 83 
Introduction .......................................................................................................... 83 
Subsidised devices ................................................................................................ 83 
Issues .................................................................................................................... 88 
Chapter 5 
Conclusion and recommendations ........................................................................ 97 
Additional Comments by Independent Senator Nick Xenophon ............... 107 
Appendix 1 
Submissions and Additional Information received by the Committee ............ 115 
Appendix 2 
Public Hearing ...................................................................................................... 117 
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Appendix 3 
Review of Health Technology Assessment in Australia
December 2009–Recommendations .................................................................... 119 
Appendix 4 
Review to improve the transparency of the
Therapeutic Goods Administration–Final Report–June 2011 
Executive Summary & Recommendations ......................................................... 123 
Appendix 5 
ASR timelines ........................................................................................................ 129 

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ABBREVIATIONS
ACL Anterior Cruciate Ligament
ACMD Advisory Committee on Medical Devices
ACSQHC Australian Commission on Safety and Quality in Health Care
ADIA Australian Dental Industry Association
AFSSAPS Agence française de sécurité sanitaire des produits de santé
AHIA Australian Health Insurance Association
AHMAC Australian Health Ministers’ Advisory Council
AHMC Australian Health Ministers Conference
AHPRA Australian Health Practitioner Regulation Agency
AIMD Active Implantable Medical Devices
AMA Australian Medical Association
AMC Code Australian Medical Council Good Medical Practice: A Code of Conduct
for Doctors in Australia
AOA Australian Orthopaedic Association
APHA Australian Private Hospitals Association
ARGMD Australian Regulatory Guidelines for Medical Devices
ARTG Australian Register of Therapeutic Goods
ASR Articular Surface Replacement
AusPARs Australian Public Assessment Reports for prescription medicines
BSC Boston Scientific Australia New Zealand
CAB Conformity Assessment Body
CAG Clinical Advisory Group
CE Conformité Européenne
CHF Consumers Health Forum of Australia
CJD Creutzfeld-Jacob Disease
MBS Medicare Benefits Schedule
CMI Consumer Medicine Information
CREPS Centre of Research Excellence in Patient Safety, Monash University
DIISR Department of Innovation, Industry, Science and Research
DoHA Department of Health and Ageing
EC European Community
EU European Union
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EU NB European Union Notified Body
FDA Food and Drug Administration (United States)
GHTF Global Harmonisation Task Force
GMP Australian code of good manufacturing practice for medicinal products
HCP Healthcare Professionals
HTA Health Technology Assessment
ICOR International Consortium of Orthopaedic Registries
IEC Independent Ethics Committee
IRIS Incident Report and Investigation Scheme
JJM Johnson & Johnson Medical Pty Ltd
MDD Medical Device Directive
MDIRC Medical Devices Incident Review Committee
MRA Mutual Recognition Agreement
MSAC Medical Services Advisory Committee
MTAA Medical Technology Association of Australia
NEHTA National E-Health Transition Authority
NJRR National Joint Replacement Registry
OEM Original Equipment Manufacturers
OEWG Orthopaedic Expert Working Group
PDC Prostheses and Devices Committee
PHI Private Health Insurance
PI Product Information
PLAC Prostheses Listing Advisory Committee
PoCE Panel of Clinical Experts
QMS Quality Management System
RACS Royal Australasian College of Surgeons
RSA Radiostereometric analysis
SAS Special Access Scheme
SUD Single Use Device
TGA Therapeutic Goods Administration
UPI Unique Product Identifiers

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RECOMMENDATIONS
Recommendation 1 
5.16  The committee recommends that the Therapeutic Goods Administration
make a list of the devices on the Australian Register of Therapeutic Goods
publicly available. 
Recommendation 2 
5.17  The committee recommends that the Department of Health and Ageing
fully implement Recommendation 8c of the Health Technology Assessment
Review regarding the need for increased rigour of regulatory assessment of
higher-risk medical devices. 
Recommendation 3 
5.18  The committee recommends that the level of assessment of Class III
medical devices be increased. 
Recommendation 4 
5.19  The committee recommends that the Therapeutic Goods Administration
investigate whether allowing an increasing number of medical devices onto the
Australian market actually improves clinical outcomes; and whether a more
judicious approach could improve pre-market assessment and post-market
surveillance of higher risk medical devices, for the ultimate benefit of patients. 
Recommendation 5 
5.23  The committee recommends that the Therapeutic Goods Administration
continue to consult widely with stakeholders, including consumer health
organisations, on the amended proposals related to third party conformity
assessment; and weigh carefully considerations of the advantages of streamlined
international regulatory frameworks and patient safety. 
Recommendation 6 
5.28  The committee recommends that the Therapeutic Goods Administration
continue its prudent approach to the regulation of reprocessed single-use medical
devices, with due consideration for issues of informed patient consent and the
need for suitable mechanisms to enable tracing of remanufactured medical
devices in the case of adverse events. 
Recommendation 7 
5.39  The committee recommends that the Department of Health and Ageing
implements Recommendations 13, 14, and 15 of the Health Technology
Assessment Review in a timely manner. These recommendations address the
need for improved post-market surveillance by increasing the rate of reporting of
adverse events, including by health service providers and consumers; facilitating
the expansion and use of post-market surveillance data to inform safety,
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effectiveness and reimbursement decisions; and establishing further clinical
registers for high risk implantable devices and procedures. 
Recommendation 8 
5.40  The committee recommends that the Therapeutic Goods Administration
put in place mechanisms to educate and encourage doctors to report adverse
incidents associated with the use of medical devices. The committee further
recommends that the Department of Health and Ageing introduce mandatory
reporting for health practitioners to the Therapeutic Goods Administration on
relevant issues, in certain circumstances including problems with medical
devices. 
Recommendation 9 
5.41  The committee recommends that the Government implements the
Recommendations of the Therapeutic Goods Administration Transparency
Review in a timely manner. 
Recommendation 10 
5.42  The committee recommends that the Therapeutic Goods Administration
consider simultaneously allocating or aligning the great variety of codes used to
identify medical devices, in order to facilitate more efficient regulation and more
rapid identification of devices when problems occur. 
Recommendation 11 
5.43  The committee recommends that the Department of Health and Ageing
consider a mechanism for flagging billing codes in order to identify devices
subject to an alert or recall; as well as a consequent adjustment to benefits paid,
based on industry feedback as to the performance of the device. 
Recommendation 12 
5.46  The committee recommends that the Therapeutic Goods Administration
consider whether custom made dental devices are adequately regulated; and
whether the approach used in the United Kingdom of requiring a statement of
manufacture to be provided to patients, and retained by the dental practitioner,
has merit. 
Recommendation 13 
5.47  The committee recommends that the Therapeutic Good Administration
carry out an investigation to ascertain whether importation of medical devices
via the internet is adequately regulated. 
Recommendation 14 
5.52  The committee recommends that the Therapeutic Goods Administration,
in consultation with the National Joint Replacement Registry, investigate ways in
which information provided by the National Joint Replacement Registry can be
used and responded to in a more timely way for the benefit of patients, and to
inform future evidence based decision making on the listing of prostheses on the
Australian Register of Therapeutic Goods. 
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