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

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Patient Implant Cards - A 19th Century Reform

Patient Implant Cards - A 19th Century Reform

1st Feb 18

Summary —

Dental implants look set to be excluded from a requirement of the Therapeutic Goods Administration (TGA) which would require dental implant manufacturers to supply patient information cards thanks to advocacy by the Australian Dental Industry Association (ADIA).

Key Issues For The Dental Industry —

In late 2017 the TGA proposed a regulatory change to require manufacturers of implantable medical devices to produce and provide implant information cards to patients. This change came about due to an intended alignment of Australia’s regulations with those of the European Union (EU), the latter having adopted the requirement in April 2017.

Following consultations with its membership, ADIA opposed the extension of this measure to include manufacturers of dental implants on the basis of the increased compliance burden it would place on both the dental industry and profession.

Under the TGA’s proposed regulatory reform options, dental implant manufacturers would be required to create and ensure the provision of physical cards to patients containing the information:

Information To Be Included On A Patient Information Card —

Identifying the device including the name, serial number, lot number, unique device identifier (UDI) and device model;
Identifying the manufacturer and its address and website;
Warnings, precautions, or measures that should be taken by the patient or healthcare professional;
Information about the expected lifetime of the device and follow up information; and
Any other safety information including the materials and substances that the patients can be exposed to.

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It is assumed that suppliers will also bear some degree of responsibility for ensuring that the cards are transmitted from the manufacturer, to the healthcare professional and then on to patients. While sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors are all excluded from this requirement, the TGA had proposed to include dental implants.  

ADIA is not opposed to the provision of information on implantable medical devices to patients per-se, it the the TGA's proposed medium used to convey this information.  Rather than extend the electronic MyHealth record to dental patients and have the information registered by a healthcare professional there, the TGA is proposing that the information be provided on a physical card – a nineteenth century solution in the digital age. 

The dental industry’s position has been determined by members serving on the ADIA-PRPC Product Regulation Policy Committee and the ADIA-IIG Implant Interest Group.  ADIA has been engaging with the TGA over a number of months with respect to the proposal and has set out the dental industry's position in a detailed submission to the TGA which can be downloaded below:

Industry Position On Implant Cards —

. .ADIA Paper - Patient implant cards and dentistry [PDF] *

As a result of ADIA’s engagement with the TGA on this matter, it has become clear that the TGA has not considered the need for regulation in the Australian context.  There has been no attempt by the TGA to assess the costs if this reform on the dental industry.  Indeed, the Secretary of the Department of Health has advised ADIA that the Department does not intend to prepare Regulatory Impact Statement (RIS) to quantify the cost to industry.

Since the reform was first proposed ADIA has discussed this with the TGA at six separate meetings.  ADIA has also raised this with the Minister for Health, the Hon. Greg Hunt MP, most recently in a discussion held on 31 January 2018.  As a result of this strong and sustained advocacy, it is expected that the TGA will accept ADIA’s advice to excluded dental implants from the requirement.

Member Engagement —

The association's policy advocacy on dental product regulation is undertaken by the team within the ADIA whom receive advice and guidance from employees of member businesses serving on the ADIA-PRPC Product Regulation Policy Committee.  Member updates are provided at the quarterly series of ADIA State Branch Briefings.

Further Information —

For further information on ADIA's dental product regulation policy advocacy send an email to advocacy@adia.org.au or telephone 1300 943 094.  To keep up to date follow ADIA on Facebook at www.facebook.com/dental.industry or subscribe to the Twitter feed @AusDental.

Currency Of Information & Disclaimer —

This update was issued on 1 February 2018 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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* To download these files you'll need ADIA Member Plus access.
 

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