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Problems associated with unauthorised repair of rigid scopes

22 September 2011

The TGA's Incident Reporting and Investigation Scheme receives reports about the safety and performance of medical devices as part of its ongoing monitoring of products supplied in Australia. As part of this process the TGA has recently reviewed several reports associated with repaired endoscopes. These reports relate to the quality of the repair and the use of unsuitable parts.

The TGA recognises that medical device repairers provide a useful service in assisting healthcare facilities to maintain good quality medical devices. However, it is important that healthcare facilities who require repairs to be made to medical devices, such as endoscopes, should satisfy themselves that the repairers have an appropriate level of training and experience to be able to competently undertake the repair work.