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: 02 6277 5829 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. ii 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 iii 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 v 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 vi 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 vii 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 viii 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