PMDA Device XML reporting and Paper Form updates

Summary

PMDA Device XML reporting and Paper Form updates

Description

MHLW published the revised paper format and new XML format for Medical Device reports. PMDA published the regulatory guidance that included various documents like Data element checklist, Check rules and XML reference.

Oracle Argus Safety has been enhanced to support scheduling, generating, tracking, transmitting, and submitting PMDA Device XML reports, according to the PMDA guidance. The PMDA Device XML has been implemented as a new report while the existing PMDA Device Form 8 and Form 10 paper reports have been updated as per the revised template.

Oracle Argus Safety has been enhanced to enable the PMDA Device XML report:

• New fields have been added in Case Form and Console.
• The existing fields length has been increased.
• Codelist values have been updated.
• New standard and flexible codelists have been added.
• New repository has been added to load and maintain the JMDN (Japanese Medical Device Nomenclature) data and the JFMDA (Japan Federation of Medical Devices Associations (JFMDA) codes.

Case Form changes

New fields have been added to capture the additional device-related data to support PMDA device reporting.

The following fields are added in Case Form:

• Case Form > Events section
  • Clinical Sign > Suspicion or Risk
• Case Form > Products > Device section
  • Device Problem code > Listedness, Causality, Suspicion or Risk
  • Health Impact Information > Listedness, Causality, Suspicion or Risk
• Case Form > Products > Device > PMDA Device Information section (these are specific to Japanese users)
  • PMDA Control Number
  • Nullification Reason
  • Nullification Reason Details
  • Completion Status
  • Reason for Incompletion
  • Future Response
  • Corrective Action Category
  • Usage continuing
• Case Form > Products > Device > Device Information section
  • Device Comments
  • Device Outcome
  • Device Outcome details
• JFMDA codes

  PMDA has published the JFMDA codes for device information mapped to IMDRF codes. New field JFMDA code has been added to the following sections in Case Form: Patient Problem, Clinical Sign, Device Problem Information, Device Component, Evaluation / Investigation Code Information for Method/Type, Result/Findings and Conclusion sub sections.

Console Changes

The Existing Device Reporting Category codelist is updated for the revised values.

The Device Classification and the Device Outcome new codelists have been added.

The Device Generic Name, the JMDN code and the Terminology code new fields have been added to Business Configuration > Products and Licenses > Product > J Data Entry screen.

PMDA Medical Device Defect Glossary

The PMDA Device report mandates the use of JMDN codes for Device and of JFMDA Codes for Device Problem, Patient Problem, Device Component and Type of Investigation, Investigation Findings, Investigation Conclusion. New tables have been introduced to the repository to store the JMDN and the JFMDA codes and they are used to code the case. The new repository stores JFMDA codes along with IMDRF codes mapped for all annexures (A to G).

Interchange mapping

The following message profile template for PMDA Device XML has been added:

• PMDA-DEVICE MESSAGE TEMPLATE

Scheduling, generating and transmitting reports

1. XML report

   The new PMDA Device XML report can be manually or automatically scheduled for the agency configured with the PMDA Device message template.

   Based on the Device Reporting category selected for the case, either Form 8 XML or Form 10 XML are generated and transmitted. The PMDA Device XML tracking and submission are similar to E2B reports.

   The EDI gateway can be configured to transmit PMDA Device XML to agency or partners and to import the acknowledgment.

   The existing PMDA device paper forms do not affect the PMDA device XML reporting sequence.

   The PMDA Device Viewer allows you to preview the report using various views:

   • XML view
   • Decode view
   • Paper view
2. Paper report

   When you generate PMDA Device Forms, the report is generated as per the revised Form 8 and Form 10 template published by PMDA. All other reports processing remains the same for Form 8 and Form 10. The Form 10 nullification template is as the Form 10 nullification template published by PMDA.

3. Validation

   During the PMDA Device XML report generation, the application generates a validation report with the validation errors details. The validation report is also available when you click the Draft button from the toolbar and in the ICSR check report.

For changes to the Case Form and the Argus Console fields, refer to Argus_Safety8.4_CaseForm_Console_Updates_Summary.xls.

For Interchange mapping changes, refer to PMDA Device Mapping document for Form 8 and Form 10.xlsx and the PMDA Device Best Practices document.