- Published
- Updated
An unexpected procedural step can affect both adherence to the investigation plan and interpretation of safety. Recording every difference as user error may hide contributions from device design, instructions or the study workflow.
Define the assessment
First describe the sequence that occurred, the instructions available and the response produced by the device. Then route the assessments of protocol deviation, device deficiency and possible safety event to their responsible reviewers. Closing one assessment should not automatically close the others.
Worked example
In a hypothetical procedure, an operator reconnects a component twice. The monitoring note records only an additional step. Further review finds that the connection indicator could be interpreted in two ways. The team reviews the delay, extra intervention and device log together, without accepting the initial blame-based explanation as established fact.
Practical checks
- Reconcile the event timeline against the device log and the original clinical record.
- Identify the applicable instruction version, observed behaviour and scope of training received.
- Track participant impact, data impact and technical investigation decisions with separate owners.
Decision and limitations
An adequate record allows another reviewer to reconstruct the reasoning from observation to classification. One event may trigger several processes. The authorised team should separately assess applicable reporting obligations; an operational label should never substitute for that regulatory assessment or a medically qualified safety review.
Frequently asked questions
- Does a deviation make device investigation unnecessary?
- No. Departure from an instruction and a design or technical problem can contribute to the same event.
- When should user error be recorded?
- Use it as a reasoned assessment after examining the observed action and its context, rather than as the initial default label.