Guide · checked October 2026
Significant accidental or unintended exposures (SAUE) in the cath lab
Under IR(ME)R regulation 8, the employer must investigate accidental or unintended exposures and notify the enforcing authority (CQC in England) of significant ones; CQC defines an accidental exposure as one where no exposure was intended and an unintended exposure as one significantly greater than, or different from, what was intended.
The definitions
CQC's guidance, agreed across the four UK nations, says an accidental exposure is one where no exposure was intended, and an unintended exposure is one significantly greater than, or different from, what was intended. Clinically significant is not defined in the regulations; CQC points employers to Royal College of Radiologists guidance to help judge it, and notes that the duty of candour applies.
Repeat exposures without a procedural, human, system or equipment error are not reportable, according to CQC.
What regulation 8 requires
- A system for recording analyses of accidental or unintended exposures.
- An immediate preliminary investigation when an exposure may have happened.
- Notification of the enforcing authority straight away, unless the investigation shows beyond reasonable doubt that no such exposure happened.
- A detailed investigation to follow.
In the cath lab
CQC's guidance sets no cardiology-specific criteria. In practice, cases worth reviewing include exposures to the wrong patient, a procedure performed that was not justified, and doses well above what the procedure would normally need because of an error. Good dose recording makes the investigation possible: you need the dose, the equipment and the sequence of events.
What this does not mean
- A high dose for a clinically justified complex case is not automatically an SAUE.
- Not every repeat is reportable; CQC excludes repeats without an error.
- Notification is the employer's duty under its procedures, not an individual's choice.
Where Cath Copilot fits
Cath Copilot does not decide whether an exposure is reportable and does not notify CQC. What it provides is the record an investigation needs: reconciled dose values with their sources, a validated timeline of the case, a flag for doses above a local notification level, and an append-only audit log of who did what.
Cath Copilot is a prototype on synthetic data only. It is not a medical device and is not for clinical use.
Questions
Who enforces IR(ME)R notifications in England?
The Care Quality Commission.
Is a repeated image a reportable exposure?
CQC says repeat exposures without a procedural, human, system or equipment error are not reportable.
Sources
Official pages, checked October 2026. Guidance changes, so check the current version before you rely on it.
General information for healthcare managers and clinical teams, checked October 2026. It is not legal, regulatory or clinical advice; follow the current official guidance and your organisation's own policies. No patient data is used in these examples. Cath Copilot is a prototype running on synthetic data only. It is not a medical device and is not for clinical use. It recommends, drafts, and routes; it never diagnoses, orders, or decides. A clinical safety and information-governance process precedes any use with real patient data.