Raiana Vigilance
Raiana Vigilance helps regulatory and quality professionals assess field incidents involving their products and determine whether an incident may be reportable in the European Union, Switzerland, the United Kingdom, or the United States. The assessment considers the incident details together with the device’s intended purpose and risk classification.
Start a vigilance assessment
Select the jurisdictions
Begin by selecting every jurisdiction in which you want to investigate the incident. The available jurisdictions are the European Union, Switzerland, the United Kingdom, and the United States; the list is expected to expand in the future. In this example, select EU and Switzerland. Raiana will produce a separate reportability result for each selected jurisdiction.
Select the jurisdictions for the assessment. Enter where and when the incident occurred
Specify the country or location where the incident occurred and when you became aware of it. For the example assessment, enter Switzerland as the place of occurrence and indicate that you became aware of the incident last week. These details provide the jurisdictional and timing context for the subsequent assessment.
Record the incident location and awareness timing. Describe the incident
Use the incident description field to provide a clear account of what happened, including the device involved and the event observed in the field. For example, enter that an operator’s finger became trapped as the patient table slid into the bore of a CT scanner. Include the factual details needed for Raiana to understand the event without relying on information that has not been entered. If applicable, complete the available fields about expected side effects and whether you have already decided to take a field safety action. Enter the information when it is known; these details help qualify the incident for the reportability review.
Describe the field incident and the device involved. Use product context from My Raiana
The form also allows you to add product context, but this step is optional. Select the Product context button when you want to associate the assessment with information already stored in My Raiana. Choose the relevant product, such as the Photon Tomo CT scanner in this example. Using this product information helps Raiana obtain details such as the device’s intended purpose and risk class for the assessment.
Optionally select the relevant product from My Raiana. Run the initial assessment
After entering the jurisdictions and the incident information, select Run assessment. Raiana evaluates the incident separately for each selected jurisdiction, taking into account the incident details and, when available, the device’s risk classification and intended purpose. The result opens on a separate preliminary report screen.
Run the first assessment after entering the available information.
Review and complete the preliminary report
Review the jurisdiction-specific verdicts
On the preliminary report screen, review the verdict shown for each jurisdiction you selected. In the example, both the EU and Switzerland results state that the incident could be reportable. This is not yet the final result: Raiana provides additional reportability questions intended to determine whether the incident is reportable or not.
Review the preliminary verdict for each jurisdiction. Review the additional reportability questions
Read the questions Raiana has generated for the incident. These questions identify the additional facts needed to refine the reportability decision for the selected jurisdictions. Review them before returning to the input form so that you can provide the answers that are available from your investigation.
Add the questions to the assessment input
Select Add to input to place the generated reportability questions on the assessment input screen. Raiana returns you to the input screen, where the questions can be answered together with the original incident information. This lets you iteratively improve the assessment rather than starting a new case.
Add the generated questions to the assessment input. Answer the added questions
Enter the additional facts that are known about the incident. Answer as many questions as the available evidence supports; you do not have to complete every question. Answer the questions in the provided answer boxes after each question.
Answer the reportability questions using the known facts. Leave unknown questions unanswered when necessary
If you do not have an answer to a question, leave it unanswered. Raiana will ignore questions with no answer when it performs the next assessment, so you can proceed with the information currently available. This allows you to rerun the assessment without entering unsupported or speculative details.
Run the assessment again
When you have entered the available answers, select Run assessment again. Raiana incorporates the new information into a new jurisdiction-specific assessment and updates the reportability result. You can repeat this process when further relevant information becomes available.
Use the final report
Interpret the updated verdict
Review the updated report screen after reassessment. Check each jurisdiction separately because the report displays an individual conclusion for every jurisdiction selected at the start.
Review deadlines and reporting instructions
Use the Deadlines box to review the reporting deadlines calculated from the information entered in the assessment. The report also indicates where the incident must be reported, to whom it must be reported, and which reporting method to use. Use these jurisdiction-specific instructions when planning the next reporting steps.
Check the applicable deadlines and reporting instructions. Copy, print or send a jurisdiction report
Save the completed assessment for your records using the available report-saving function. You can choose to print the EU report, print the Swiss report, or print all reports. The selected print action produces a PDF containing the assessment data. Use the copy function to copy the report data to the clipboard for pasting into another application, such as Microsoft Word. You can also send the report to ChatMDR using the available send option. Choose the output method that matches your recordkeeping or reporting workflow. When more information is available, you can also go back to input.
Choose the option that matches your workflow.
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