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Report a Problem with a Radiotherapy Device

What is Radiotherapy Device Reporting System (RDRS)?
Radiotherapy Device Reporting System (RDRS) is a mechanism for radiotherapy providers to report on issues with the radiotherapy devices that have either compromised or have the potential to impact quality, safety, and/or clinical workflow efficiency in a radiation oncology facility. The RDRS is designed to receive such information in a structured format to facilitate a quick review and analyses of reported issues in a non-punitive and transparent manner. The RDRS does not replace the Food and Drug Administration’s Medical Device Reporting (MDR) that is in place to receive significant medical device adverse events from manufacturers and user facilities. User Facilities are required to report suspected medical device related deaths to both the FDA and the manufacturers. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

Rationale for Radiotherapy Device Reporting
Radiotherapy devices are increasingly getting complex both in scope and functionalities. Furthermore, large amounts of electronic data are shared amongst various radiotherapy devices, which lack seamless connectivity and interoperability. Any observed problem is often a culmination of many issues that require in-depth review by a domain expert. The radiation oncology domain experts at NROP will review each reported issue, communicate with the appropriate device manufacturer representative, report back on the root cause of the problem, and facilitate a timely resolution before it escalates into a potential quality and safety problem.

Follow up
Each reported issue will be critically analyzed by NROP staff and a summary of the reported issues with their resolution will be communicated back to the user community through on line publications and reports.