RAYSTATION

Description of Event or Problem

A CLINIC REPORTED THAT THEY WERE HAVING TROUBLE IMPORTING DATA FROM RAYSTATION INTO THEIR OIS ARIA. THE REASON WAS FOUND TO BE THAT NON-UNIQUE DICOM UIDS WERE BEING GENERATED FROM RAYSTATION AND THAT ARIA REQUIRES UNIQUENESS. NO PATIENTS WERE AFFECTED. THE REPORTED ISSUE RELATES TO RAYGATEWAY, WHICH IS AN OPTIONAL RAYSTATION FEATURE USED ONLY FOR EXPORT OF DATA TO ACCURAY'S IDMS. DICOM UID:S ARE INTENDED TO BE GLOBALLY UNIQUE. EACH UID IS COMPOSED OF TWO PARTS, AN <ORG ROOT> AND A <SUFFIX>. <ORG ROOT> UNIQUELY IDENTIFIES THE MANUFACTURER AND <SUFFIX> SHALL BE UNIQUE WITHIN THE SCOPE OF THE <ORG ROOT>. WHEN EXPORTING DATA FROM RAYSTATION USING RAYGATEWAY, THE SUFFIX PART IS GENERATED AS TEN-DIGIT RANDOM NUMBERS, RESULTING IN SOMETIMES NON-UNIQUE SOPINSTANCEUID:S OR SERIESINSTANCEUID:S, CONTRARY TO THE DICOM STANDARD REQUIREMENT. THIS WOULD NOT DIRECTLY LEAD TO MISTREATMENT, BUT COULD INCREASE THE RISK OF OTHER ERRORS. RT IMAGE, RT DOSE, RT STRUCT, AND RT PLAN OBJECTS EXPORTED FROM RAYGATEWAY MAY BE AFFECTED.

Additional Manufacturer Narrative

A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. MOST LIKELY, THIS ISSUE WILL AT MOST LEAD TO TREATMENT DELAY. IN THE EVENT OF DATA MIX-UP OR USE ERRORS INDIRECTLY CAUSED BY THE NONUNIQUE UIDS, THERE IS A POTENTIAL FOR INCORRECT DATA BEING USED FOR CLINICAL DECISIONS REGARDING RADIOTHERAPY TREATMENT. POTENTIALLY AFFECTED OBJECTS ARE RT PLAN, RT STRUCT, AND RT IMAGE AND RTDOSE. THE CONSEQUENCES WOULD DEPEND ENTIRELY ON THE CLINIC'S WORKFLOW AND EQUIPMENT. RESIDUAL RISK AFTER CORRECTION: WITH THE CORRECTION IN THE FORM OF UPDATED LABELING, THE RESIDUAL RISK IS ACCEPTABLE. THE RAYSTATION INSTRUCTIONS FOR USE REQUIRES USERS TO STUDY THE RELEASE NOTES CAREFULLY, AS THESE NOTES PROVIDE FINAL INSTRUCTIONS ON HOW TO USE THE RAYSTATION SYSTEM. WHEN FOLLOWING THE INSTRUCTIONS IN THE UPDATED LABELING, DUPLICATE UIDS CAN BE AVOIDED AND THERE IS NO RISK OF HARM. FOR THE ONE CLINIC THAT HAS REPORTED FREQUENT OCCURRENCES OF THE ISSUE, THE WORKAROUND DESCRIBED IN THE FSN MAY NOT BE AN ACCEPTABLE SOLUTION FOR MORE THAN A SHORT TIME. A SUPPORT TOOL OR SERVICE PACK MAY THEREFORE BE CREATED. THE LONG-TERM SOLUTION IS TO RELEASE A NEW VERSION OF THE RAYSTATION SYSTEM ELIMINATING THE PROBLEM. THE RELEASE IS PLANNED FOR (B)(6) 2025.