1. Radiation Therapy Manufacturers FDA Public Meeting June 10, 2010 Device Improvements To Reduce the Number of Under-Doses, Over-Doses and Misaligned Exposures From Therapeutic Radiation Quality Assurance Dominic Siewko, CHP Philips Healthcare on Behalf of MITA and AdvaMed

2. Radiation Therapy Manufacturers C1. Is there a model QA program that exists which is widely accepted? If so, please describe.  Several US and International Programs AAPM Task Group Reports IAEA Tec Doc Series Level of adoption varies  May be difficult to fully implement due to time & resource limitations  Professional organizations could evaluate & prioritize according to effectiveness  Any QA Program should have two aspects: 1. QA of Treatment Device & Accessories 2. QA of Patient-Specific Data & Processes

3. Radiation Therapy Manufacturers C2. What types of QA should be the responsibility of the facility, the physicist, the operator, others?  Clinical QA is Responsibility of the End User: Design & Execution of a QA program Apply scientific/clinical recommendations to establish type & frequency of tests  Users best know their own combination of products, processes, and workflow  AAPM Task group reports say: 1. Ultimate responsibility for the linear accelerator QA program lies with the Qualified Medical Physicist (QMP). 2. MD, dosimetrist, therapist, & administrator, as well as manufacturers, have supporting roles & responsibility

4. Radiation Therapy Manufacturers C3. Should manufacturers provide QA procedures to medical facilities and users of radiation therapy devices? If so, why, and what instructions should be provided? If not, why not? How extensive should they be?  Manufacturers need to provide instructions for safe use  Manufacturers may provide recommendations or references to clinical QA guidance  Manufacturers should provide education & information to assist user in defining QA program: Underlying principles of how the device operates Failure modes and safety mechanisms Recommended maintenance Technical help and expertise available  Robust operator training will allow health care providers to create a solid QA program

5. Radiation Therapy Manufacturers C4. Should manufacturers provide training on QA practices? If so, why, what type of training should be provided, and to which personnel? If not, why not and who should?  Manufacturers train users on the equipment specifications that should be checked to assure proper and safe operation of the equipment  Manufacturers should provide information to users on QA practices and training opportunities Peer to peer training Manufacturer training Professional Society training