Radiation-Emitting Products

For test failures, equipment evaluations and other adjustments, changes, or repairs, are there specific timeframes defining when the verification test(s) must be performed?

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For failures of the tests described in 900.12(e)(8)(ii)(A), 900.12(e)(6), 900.12(e)(7) and/or after adjustments, changes, or repairs that are classified as major, the verification test must be passed prior to using the item clinically. Note: verification testing performed after a major adjustment, change, or repair must be performed on-site by the medical physicist.

For failures of the tests described in 900.12(e)(8)(ii)(B), the facility has a maximum of 30 days from the date of the initial test failure to correct the problem and pass the verification test. Facilities should have the verification test(s) performed (either by the medical physicist or by a qualified individual) as soon as possible after the adjustment, change, or repair is done, so as to allow time to repeat the adjustment, change, or repair if the equipment does not pass the verification test. Note: if the verification test is not passed within the 30 day time period, the item cannot be used clinically until such time as it is truly repaired and passes the test.

For non-major equipment adjustments, changes, or repairs that are performed for any reason other than for failure of a required test, the facility must correct any problems found and perform verification tests to ensure that the equipment remains in compliance with the regulations. This should be accomplished as soon as reasonably possible.

The decision trees included in the Question 6 answer may be used to help in determining the timing and extent of physicist and facility involvement in response to test failures, equipment adjustments/changes/repairs and equipment evaluations.

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Page Last Updated: 07/16/2014
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