Calls for better use of international dental systems

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An ACT Legislative Assembly report has warned of the risk to patient safety from poor quality imported dental devices including crowns, bridges and dentures.

Released last month, the report from the Standing Committee on Health, Ageing, Community and Social Services inquiry said that existing Australian regulations provide some safeguards for the safety and quality of imported dental devices but compliance with reporting requirements in Australia is low for some custom-made products.

Chaired by dentist and Ginninderra member Chris Bourke, the inquiry found low levels of reporting to the Commonwealth Therapeutic Goods Administration of device manufacturing and problems from devices after they have been received and used by dental practitioners.

As of June last year, there were 285 dentists and 15 dental prosthetists registered for practice in the ACT as well as at least 16 dental laboratories in the territory. No data could be provided on the size of the local dental device market.

The report’s sole recommendation called on the ACT Government to request that the TGA and Dental Board of Australia “consider amending the relevant regulations, codes and guidelines to require the details about the manufacturer of a custom-made dental device to be provided to the prescribing practitioner and the patient.”

Improved awareness of the country of origin of devices would give better protection to patients and dental practitioners, the committee’s report said. Currently there is “an implied requirement to inform patients but not a regulatory one.”

The ACT Dental Health Program supports patients having the right to be informed if an appliance is made overseas.

The inquiry heard as much as 50 to 60 per cent of all custom-made dental devices came from overseas manufacturers and increasingly the local industry used materials and equipment imported into Australia with approval of the TGA, particularly from laboratories in Asia.

Lower costs was the primary reason for the growth in overseas-sourced devices.

The inquiry heard an Australian made crown was likely to cost about $400 to $450 while a crown imported from an Asian laboratory would cost between $60 and $80. Of this amount, only about $15 would be paid to the device’s original manufacturer.

The TGA does not have authority to conduct audits of overseas dental manufacturers.

“Without better data on the size of the dental devices import market and consistent reporting of problems, it is impossible to know if the reality matches the anecdotal concerns about the safety and quality of imported devices,” Dr Bourke said in a statement.

“It is important that practitioners and patients are fully informed about the origin of the dental devices being used in a course of treatment.”

Although cases of inferior products in Australia were found to be isolated, the report said anecdotal evidence showed a high level of public concern about the safety and quality of imported dental devices.

Media reporting about problems in the industry also contributed to concerns from the isolated cases.

Problems found included aesthetic deterioration of devices, including the discolouration of gold crowns and ceramics as well as problems with the fit, shade, shape and finish.

During its deliberations, the committee was told that more Australian dental schools had decided to close their dental laboratories. These moves have resulted in undergraduate students from some dental schools having minimal exposure to lab work which has led to reduced understanding of production procedures and parameters.

Health Minister Simon Corbell announced a new mobile dental clinic on Tuesday, to provide preventative and restorative dental services in a purpose-built vehicle.

The service will provide dental health check-ups to promote good oral health to some of Canberra’s most vulnerable people and those with restricted mobility.

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1 COMMENT

  1. In my experience the main reason for using overseas laboratories is the consistent high quality of the prosthesis – particularly crown and bridgework and CoCr frameworks. Using a reputable overseas laboratory also avoids the problem of getting ripped off by local laboratories who use non-precious alloys when precious metals are prescribed.

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