1. Impacting Radiotherapy Safety and QA with Device Improvements Benedick A Fraass, PhD, FAAPM, FASTRO, FACR Allen S. Lichter Professor of Radiation Oncology and Director of Radiation Physics, Dept. of Radiation Oncology, University of Michigan Chair: ASTRO Multidisciplinary QA Subcommittee AAPM Science Council, Therapy Physics Committee, TG100, Chair: Research Committee FDA Public Meeting: Device Improvements to Reduce the Number of Under-Doses, Over- Doses, and Misaligned Exposures From Therapeutic Radiation

2. Goal: Describe several issues in which vendor or FDA efforts may help us improve patient safety and QA efficiency and effectiveness Impacting Radiotherapy Safety and QA with Device Improvements

3. Need 1: Process-based Analysis + QA MLC Leaf Sequencing Tx Delivery Planning, Prep AutomatedTx Delivery, Verification e-chart, Billing Patient Setup w/ Imaging Inverse Planning Imaging, Targets, Normal Anatomy, Beams Dose Calcs Plan Evaluation Download to Delivery System Patient- specific IMRT QA RT process is complex: we need process-oriented QA to deal with that complexity The vendor can never “provide” all the QA needed for each potential technique Vendors, regulators and clinicians all must recognize that we need more than just QA tests for machine features

4. Patient-specific IMRT QA Need 2: Flexibility to put together new and more effective QA processes MLC Leaf Sequencing Tx Delivery Planning, Prep AutomatedTx Delivery, Verification e-chart, Billing Patient Setup w/ Imaging Inverse Planning Imaging, Targets, Normal Anatomy, Beams Dose Calcs Plan Evaluation Download to Delivery System Patient-specific IMRT QA IMRT Leaf Sequencing Download to Delivery System Patient-specific IMRT QA

5. Typical Patient-Specific IMRT QA Check: Apply IMRT plan to QA phantom Deliver plan to QA phantom + ion chamber Check each beam’s intensity (+ dose distrib?) vs calc (with film or 2-D electronic system) Result: Total dose at one point + confirmation of beam intensities – after lots of work! Need 2: Flexibility to put together new and more effective QA processes

6. Automating Patient-Specific IMRT QA: Need 2: Flexibility to put together new and more effective QA processes By having the flexibility to combine devices and techniques in novel ways:

7. Litzenberg Automating Patient-Specific IMRT QA: Need 2: Flexibility to put together new and more effective QA processes

8. When we are driven by clinical needs to look for better ways to do things – we need the flexibility to do things that individual vendors will not have the resources or motivation to do Automating Patient-Specific IMRT QA: Need 2: Flexibility to put together new and more effective QA processes 4%

9. The clinical workflow is directly related to the QA needed for modern RT: modifications can make crucial improvements MLC Leaf Sequencing Tx Delivery Planning, Prep Automated Tx Delivery, Verification e-chart, Billing (Automated) Patient Setup w/ Imaging Prescription, Inverse Planning MLC Leaf Sequencing Download to Delivery System Patient- specific IMRT QA Imaging, Targets, Normal Anat Beam Arrangement+ Technique Dose to Points Calcs Plan Evaluation Need 3: Flexibility to rearrange clinical process workflow If we identify a process change that can improve safety/quality, we need to have flexibility to implement that change We need better workflow adjustment tools...

10. Need 4: Vendor-provided QA Tools, Updates Vendors must make new QA-related devices, tools, methods quickly accessible to users Note: QA devices must be used routinely before their value, or best uses can be known or proven FDA: A slow or difficult marketing approval process can make potential products impossible to get, test, develop or implement This is particularly problematic for software enhancements or modifications that can fix important bugs or make a hardware device or technique useful

11. MLC Leaf Sequencing Tx Delivery Planning, Prep Automated Tx Delivery, Verification e-chart, Billing (Automated) Patient Setup w/ Imaging Prescription, Inverse Planning MLC Leaf Sequencing Download to Delivery System Patient- specific IMRT QA Imaging, Targets, Normal Anat Beam Arrangement+ Technique Dose to Points Calcs Plan Evaluation Tx delivery QA and monitoring must involve RTTs and convey both qualitative + quantitative info easily and clearly Monitoring must be integrated for efficiency Monitoring must be independent for safety Need 5: Treatment Delivery QA and Monitoring: Integrated or Independent ?

12. about to move move finished UM CCRS System: IJROBP 95 MLC Leaf Sequencing Tx Delivery Planning, Prep Automated Tx Delivery, Verification e-chart, Billing (Automated) Patient Setup w/ Imaging Prescription, Inverse Planning MLC Leaf Sequencing Download to Delivery System Patient- specific IMRT QA Imaging, Targets, Normal Anat Beam Arrangement+ Technique Dose to Points Calcs Plan Evaluation (Relatively) independent verification is possible: Need 5: Treatment Delivery QA and Monitoring: Integrated or Independent ?

13. Need 6: Collaborative + independent input into vendor design, hazard analyses, usability, and workflow efforts… Detailed checks of software or hardware design at the end of the product development process are too late to fix problems or weaknesses Vendors should incorporate independent input (by clinically knowledgeable experts) into design, hazard analyses, test plan designs, usability The earlier this happens in the development process, the better for everyone !

14. Need 7: Vendor support for user groups for sharing of QA methods, issues Users of a given vendor’s system all have much in common: QA needs and techniques Experience with system-specific issues Knowledge how to solve or avoid problems Improvements to suggest Vendors should support user’s groups which help with sharing of this info!

15. Support process-based analysis and QA Flexibility for new + more effective QA processes Flexibility to rearrange clinical process workflow More vendor-provided QA tools + methods Integrated vs independent monitoring Vendors need collaborative + independent input into design, hazard analysis, usability, workflow Support of user groups for QA: sharing processes, methods, issues Impacting Radiotherapy Safety and QA with Device Improvements