ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

News

TGA Proposes Patient Implant Cards

TGA Proposes Patient Implant Cards

24th Jul 17

Summary —

 Dental product manufacturers and suppliers are being asked to consider moves by the Therapeutic Goods Administration (TGA) to increase the red-tape burden as a result of proposals associated with the introduction of patient implant cards.

Key Issues For The Dental Industry —

The TGA has sought advice from the dental industry on measures that would see medical device manufacturers provide patient implants cards and product information directed at consumers for all implantable medical devices.

The proposals stem from an Australian Government to align, wherever possible, Australia’s standards for the approval of medical devices with those of the European Union with respect to:  The classification of medical devices; essential principles / requirements; and the adoption of a risk-based approach to variations to medical devices.

The current regulatory requirements require that certain information be provided by manufacturers with medical devices, including information that identifies the device and its manufacturer.  There are also requirements that this information detail any risks, warnings, restrictions, precautions or side effects in relation to the use of the device.  There is no requirement that this information be provided to the patient.

The new European Regulatory requirements, that the TGA is looking to apply within Australia will require manufacturers of implantable devices shall provide together with the device the following:

 

Information To Be Included On Patient Implant Card —

  Information allowing the identification of the device, including the device name, serial number, lot number, the Unique Device Identifier (UDI), the device model, as well as the name, address and the website of the manufacturer.
  Any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions.
  Any information about the expected lifetime of the device and any necessary follow-up.
  Any other information to ensure safe use of the device by the patient including (the overall qualitative and quantitative information on the materials and substances to which patients can be exposed).

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The proposed change to the TGA’s regulations would parallel the new European requirements, making the requirement for patient cards and information explicit in the regulations, to improve information flow to patients and doctors, and to assist in improving patient-doctor discussions.  Patient implant cards and information are already being provided by some medical device manufacturers, and are required in other jurisdictions including the United States of America. These cards are provided to recipients of certain implantable devices such as orthopaedics devices, and active implantable devices.

This proposal also complements work being progressed by the Australian Commission on Safety and Quality in Health Care to strengthen the informed consent process around procedures that may involve certain mesh products.  Further information can be found on the following document:

 

Consultation Paper —

 

EU Regulatory Alignment - Patient implant cards [PDF]

The issue is being considered by ADIA member businesses serving on the ADIA-IIG Implant Interest Group and the ADIA-LIG Laboratory Interest Group who will help frame the context of the submission that will be prepared by the ADIA-PRPC Product Regulation Policy Committee.  ADIA members interested in this matter are encourage to get involved in the work of these interest Groups.

ADIA has also sought advice from its counterpart, the Federation of the European Dental Industry (FIDE), as to the European dental industry’s views on this matter.

Member Engagement —

ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. With respect to to matters associated with medical device regulation, ADIA staff responsible for negotiating policy outcomes with government receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee and also members participating in special interest groups.  Updates are provided at the quarterly series of ADIA State Branch Briefings.

Further Information —

If you have an interest in ADIA's efforts to reform the regulatory standards for equipment installation, for updates subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the Association via email at advocacy@adia.org.au or by telephone on 1300 943 094.

Currency Of Information & Disclaimer —

This update was issued on 24 July 2017 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here. 

 


This information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.

 

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