ADIA calls for more patient info on custom-made devices

Troy Williams, CEO of the ADIA
Troy Williams, CEO of the ADIA

Strengthening patient confidence in the quality of dental crowns, bridges and similar products is a key theme in a submission to a parliamentary inquiry made by the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of quality dental products.

The inquiry being undertaken by the Australian Capital Territory’s Legislative Assembly Standing Committee on Health, Ageing, Community and Social Services is tasked with reviewing matters associated with sourcing custom-made medical devices from overseas.

“Whereas twenty years ago, most custom-made dental appliances were made in Australia, there is strong anecdotal evidence to suggest that a significant percentage is now manufactured overseas,” said Troy Williams, ADIA Chief Executive Officer.

As part of its inquiry, the committee is reviewing whether appropriate standards and regulations governing the sourcing and supply of dental prostheses and appliances from overseas are in force in Australia. Presently, the regulatory standards for custom-made medical devices are set and enforced by the Therapeutic Goods Administration (TGA) pursuant to the provisions of the Therapeutic Goods Act (Cth) 1989.

“It is important to note that all custom-made dental appliances, whether manufactured in Australia or overseas, are required to meet the same regulatory standards in terms of product design, performance and safety. ADIA is working proactively with the TGA to raise awareness of, and compliance with, these regulatory standards,” Mr Williams said.

ADIA believes that there is some scope to improve the current regulatory standards, particularly in the amount of information provided to patients as to who was responsible for ensuring compliance with the regulatory standards. To this end, ADIA has recommended that current regulations be changed to require a statement of manufacture to be offered to patients, and retained by the dental practitioner. This was a key recommendation from a 2011 Australian Senate inquiry into the regulatory standards for the approval of medical devices and one supported by ADIA.

“ADIA is keen to ensure reforms in this area are based on a risk management approach designed to ensure public health and safety, while at the same time freeing dental laboratories and healthcare practitioners from an unnecessary regulatory burden, Mr Williams concluded.

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