Critical failure notifications
Critical failure limits have been introduced for certain tests on medical apparatus where non-compliance indicates that the apparatus must not be used clinically.
Critical Failure limits are not applicable for Dental or Veterinary apparatus.
Critical Failure limits are indicated in the Codes of Compliance and Test Protocols for a specific apparatus modality.
Where the non-compliance is a critical failure, the EPA accredited tester must ensure that the owner is made aware of the critical failure by issuing them the form “Notification of compliance Failures” and informing them of their obligation to notify the EPA as soon as practicable.
The owner must ensure no clinical use of the apparatus is undertaken until further instructions are provided by the EPA in accordance with the conditions of authorisation attached to the registered apparatus.
The EPA will endeavour to respond quickly, recognising the importance of safety of patients and workers, and the clinical issues associated with apparatus that is unavailable.
For further information, please refer to our following published guidance documents:
- Owner of medical diagnostic X-ray equipment
- Cyclic compliance testing of diagnostic X-ray apparatus
- Chiropractic Practice
To notify the EPA of a Critical Failure CLICK HERE to fill in the online form
For guidance on how to notify the EPA of a Critical Failure, please click here.
