The EPA has implemented changes to the Test protocol for medical and veterinary fluoroscopy X-ray apparatus.
From 8 February 2024, the following three tests are no longer compliance requirements for medical and veterinary fluoroscopy X-ray apparatus, however the accredited compliance tester is still required to perform the tests and document and submit the results to the EPA.
- Test-32 Exposure limit during image acquisition
- Test-35 Air kerma rate at surface of image receptor during DSA
- Test-36 Air kerma rate at surface of image receptor during cinefluorography
The EPA will assess applications for registration of apparatus without requiring the above tests to demonstrate compliance.
Owners and users of fluoroscopy apparatus will not need to demonstrate compliance with these tests.
The EPA has written to registered SA owners of these apparatus and to SA accredited compliance testers to inform them of the changes.
The EPA will issue an exemption from the requirement for owners of fluoroscopy apparatus to comply with these three tests in the South Australia Code of Compliance for medical, veterinary and chiropractic X-ray apparatus 2022 published by the EPA.
However, accredited compliance testers will be required to continue conducting the three tests and to collect data and submit this data, to inform a future review of the tests as part of compliance requirements. Data gathered will not be used for compliance purposes.
Background to changes
These changes have been implemented in response to industry submissions regarding the three specific tests. Concerns were raised regarding meeting the compliance endpoints and impacts to image quality, and may restrict the access to medical and veterinary fluoroscopy. These tests are new in Australia and were not included in previous compliance standards.
The three compliance tests arose from the forthcoming national Australian Radiation Apparatus Testing Requirements to be published by ARPANSA. South Australia will not adopt any document mandating the three referenced tests, and will work with ARPANSA on nationally consistent compliance standards.
The SA EPA considers that removing these tests from compliance requirements will not impact the safety of patients and medical staff.
The EPA has asked radiation apparatus compliance testers to continue to conduct and gather data on these tests. The data gathering will inform a review of the national Australian Radiation Apparatus Testing Requirements to be completed in 2024.
Ongoing compliance requirements are expected to be agreed after 12 months of data gathering and following consultation with owners and users of apparatus.
Interested parties including apparatus owners, users and compliance testers, and those representing the interests of patients, are invited to contact the EPA with any queries or submissions via the YourEPA portal.
