Advisory Committee on the Safety of Medical Devices (ACSMD)

16 May 2016

Role of the ACSMD

The Advisory Committee on the Safety of Medical Devices (ACSMD) is established under Part 6 Division 1DA of the Therapeutic Goods Regulations 1990 (the regulations) to advise and make recommendations to the Minister for Health and the Therapeutic Goods Administration (TGA) on the safety, risk assessment, risk management and performance of medical devices supplied in Australia.

The ACSMD replaces the Medical Device Incident Review Committee (MDIRC), which was a subcommittee of the Advisory Committee on Medical Devices.

ACSMD members

Chair

Professor Guy Ludbrook is a Professor of Anaesthesia at the Royal Adelaide Hospital, Head of Acute Care Medicine at the University of Adelaide, and is the Principle of a clinical trials unit, PARC Clinical Research. Professor Ludbrook has recognised and respected expertise in anaesthesia, healthcare delivery and clinical research. A member of several professional societies, Professor Ludbrook has been awarded numerous research grants, scholarships and honours and has published extensively. Professor Ludbrook provides expertise in the field of anaesthetics.

Members

  • Professor Barry Allen was the Director of the Centre for Experimental Radiation Oncology at the St George Hospital. He was the inaugural Chair of the Health Technology Task Group of the International Union of Physics and Engineering in Medicine (IUPESM). He is also the Past-President of IUPESM and the International Organisation for Medical Physics. Professor Allen provides expertise in the field of nuclear science and biomedical physics.
  • Mr Stephen Blamey is a general surgeon. He has been a consultant surgeon at Monash Health and in private practice in Melbourne since 1983. He was a member and then Chair of the Medical Services Advisory Committee between 1998 and 2008. His clinical interests include all aspects of surgical gastroenterology including bariatric surgery, colorectal surgery, endoscopy and advanced laparoscopic surgery. Mr Blamey provides expertise in the field of gastroenterology.
  • Dr Daniel Cehic is a practicing cardiologist/electrophysiologist at Adelaide Cardiology, (a national healthcare provider which is part of GenesisCare). He also holds appointments as a Clinical Senior Lecturer at the University of Adelaide and as a Senior Lecturer in the School of Medicine at Flinders University. Dr Cehic has a keen interest in the quality and safety aspects of healthcare delivery and provides expertise in the field of cardiology.
  • Dr Robyn Clay-Williams is a former military test pilot and an electronics engineer. As a research fellow at Macquarie University, Robyn conducts health services research in the field of human factors in health care. Current projects include usability of medical devices and IT systems, applying engineering resilience to health care to improve patient safety, system dynamics modelling of health care systems and processes, and analysis of behaviours of health care professionals. Dr Clay-Williams provides expertise in the field of human factors analysis.
  • Dr Dilipkumar Gahankari is an Australian qualified specialist Plastic and Reconstructive Surgeon, with a special interest in cosmetic surgery. He is predominantly in private practice on the Gold Coast. He has published extensively in international academic journals. In addition, Dr Gahankari volunteers his surgical skills with his regular annual charity Plastic Surgery Missions in India. Dr Gahankari provides expertise in the field of plastic and reconstructive surgery.
  • Mr Michael Lovett is the Principal Clinical Engineer within the Medical Engineering and Physics Department at the Royal Perth Hospital and provides specialised professional and technical leadership and management support in clinical engineering. He has over thirty-five years of engineering experience in the biomedical engineering field working at both adult and paediatric teaching hospitals. Mr Lovett provides expertise in the field of biomedical engineering.
  • Associate Professor Gopala Rangan is a senior staff specialist in nephrology at Sydney's Westmead Hospital, and a senior lecturer in medicine at the University of Sydney. Dr Rangan has extensive research and teaching experience, and over 20 years clinical medicine experience in public teaching hospitals. Dr Rangan provides expertise in the field of renal disease.
  • Associate Professor Joanna Sutherland is a Conjoint Senior Lecturer at the University of New South Wales Rural Clinical School, and Visiting Anaesthetist at the Coffs Harbour Health Campus. Associate Professor Sutherland is a member of several professional bodies, including the Australian and New Zealand College of Anaesthetists, the NSW Agency for Clinical Innovation, Anaesthesia and Peri-operative Care Network Executive, and the NSW Surgical Services Taskforce. Associate Professor Sutherland is also a member of the NSW Mid North Coast Local Health District Governing Board and provides expertise in the field of anaesthetics.

ACSMD meeting dates

ACSMD planned meeting dates 2016
Meeting no. Meeting date
13 4 March 2016
14 23 September 2016

The ACSMD Orthopaedic Subcommittee (OSC)

The Orthopaedic Subcommittee is a group of independent orthopaedic surgeons who provide expert advice to the ACSMD and the TGA on the safety, quality and performance of orthopaedic devices. In particular, the OSC will provide advice in relation to orthopaedic implants that have been identified through the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) as experiencing higher than expected revision rates.

OSC members

Chair

Dr Andrew Shimmin is a Director of the Melbourne Orthopaedic Group Research Foundation. He is the President of the Australian Arthroplasty Society, sits on the Australian Orthopaedic Association National Joint Replacement Registry Committee, and is one of only two Australian members of the International Hip Society. Dr Shimmin is involved in research on hip and knee replacements, cartilage regeneration for the treatment of arthritis and anterior cruciate ligament injuries of the knee.

Members

  • Professor Warwick Bruce is a Clinical Professor of Orthopaedic Surgery at the University of Sydney, specialising in hip and knee surgery. He is a past president of the Arthroplasty Society of Australia and holds memberships to many National and International Societies dedicated to Orthopaedics and Sports Medicine. Professor Bruce is involved in teaching and offers Fellowship positions to young surgeons. He has published extensively and has been on prosthesis design teams.
  • Dr Sami Farah is an orthopaedic surgeon practicing in Sydney with additional qualifications in biomedical engineering. His interests are in hip/knee arthroplasty and reconstruction. Dr Farah obtained his combined undergraduate degree, MBBS/BSc from Sydney University. After completing his Royal Australasian College of Surgeons fellowship in Sydney and his Masters in Biomedical Engineering at the University of New South Wales, Dr Farah completed a further fellowship in hip and knee surgery.
  • Dr Michael Gillespie is an orthopaedic surgeon who has been in private surgical practice in Canberra since 1989. His subspeciality interest is primary and revision hip and knee replacement and knee reconstructive surgery. He is the current Australian Orthopaedic Association (AOA) Branch representative on the National Board of the AOA, and is also a member of the Arthroplasty Society of Australia.
  • Professor Stephen Graves is an orthopaedic surgeon. He has been the Director of the Australian Orthopaedic Association National Joint Replacement Registry since it was established in 1999. Professor Graves is also Professor of Arthroplasty at Flinders University and has a Doctorate in Philosophy from the University of Oxford in bone biology. He has presented and published extensively on the outcomes of joint replacement surgery and basic musculoskeletal biology.
  • Associate Professor Bruce Love is a Senior Principal Specialist Orthopaedic Surgeon, a Senior Associate at the University of Melbourne's Department of Surgery at St Vincent's Hospital, and Chairman of the Quality Council also at St Vincent's Hospital in Melbourne. He is a member of the Medical Advisory Committee of Bellbird Private Hospital.
  • Dr Peter Myers is an Orthopaedic Surgeon with an interest in sports orthopaedics, knee and shoulder surgery. He is in private practice in Brisbane, is a Consultant at the Mater Misericordiae Public Hospital and an Associate Professor of Surgery at the University of Queensland. He is a past President of the Australian Knee Society, an Examiner for the Royal Australasian College of Surgeons and is involved with other National and International Associations.
  • Professor Richard Page is Professor in Orthopaedics and Head of Orthopaedics and Musculoskeletal Medicine at Deakin University. He is a member of the Academic Advisory Board for the Deakin University School of Medicine, and Director of the Barwon Orthopaedic Research unit and Fellowship Programme at Geelong Hospital. He is the current Secretary of the Shoulder and Elbow Society of Australia, and member of The Australian Hand Surgery Society. He sits on the Australian Orthopaedic Association National Joint Replacement Registry Committee as a representative of the Shoulder and Elbow Society of Australia.
  • Dr Kevin Woods has practiced in Orthopaedic Surgery in Canberra since 1989, specialising in surgery of the shoulder and knee. Dr Woods is a member of both the Shoulder and Elbow Society of Australia and The Australian Knee Society, an examiner in Orthopaedics at The Royal Australasian College of Surgeons, and has completed the Australian Institute of Company Director's Course.

OSC meeting dates

OSC planned meeting dates 2016
Meeting no. Meeting date
10 22 March 2016
11 TBA
12 5 December 2016

Contacting the ACSMD

To contact the ACSMD Secretariat:

ACMSD Secretariat contact details
Email acsmd.secretariat@tga.gov.au
Phone +61 2 6232 8734
Fax +61 2 6203 1250
Postal address Advisory Committee on the Safety of Medical Devices
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia