1. FDA-QA-DAS/2010 FDA’s Public Meeting: Device Improvements to Reduce the Number of Under-doses, Over-doses, and Misaligned Exposures from Therapeutic Radiation Indra J. Das, PhD, FIPEM, FAAPM, FACMP, FACR Vice Chair, Professor & Director of Medical Physics Department of Radiation Oncology & Midwest Proton Radiotherapy Institute (MPRI) Indiana University School of Medicine Indianapolis, IN On behalf of American College of Radiology

2. FDA-QA-DAS/2010 Precise and accurate Why QA is Needed? No Precision No accuracy Precise but not accurate

3. FDA-QA-DAS/2010 Institution 1Institution 2Institution 3Institution 4Institution 5 Variations in doses in 803 patients among institutions 63% 46% Das et al. J Natl Cancer Inst 100 (5), 300-3007, 2008

4. FDA-QA-DAS/2010 Q 1. Is there a model QA program that exists which is widely accepted? If so, please describe  There are fragmented QA performed by various agencies such as RTOG, QARC, RPC, etc.  A model QA service is ACR-ASTRO accreditation. (The ACR accreditation program is now collaborative with ASTRO). However, it is on a voluntary basis and unfortunately <10% of the facilities participate in ACR accreditation.  The VA system has mandated that all of their hospital based radiation oncology facilities be accredited by ACR.  Mandatory accreditation could be a solution and should be tied to reimbursement to encourage participation.

5. FDA-QA-DAS/2010 ACR Practice Guidelines and Technical Standards  The Radiation Oncology Accreditation Program is based on the ACR’s Guidelines and Standards.  Recommendations for improvement/corrective action will reference guidelines/standards as well as AAPM Task Group reports, such as, TG 40 (142), TG 51, TG 53, TG 103, TG 106 and other.  Other resources, such as ACR Appropriateness Criteria® are referenced in order to assist facilities as they develop their corrective action plans.

6. FDA-QA-DAS/2010 ACR Guidelines: Staffing  The ACR Practice Guideline recommends proper qualification, training and certification in respective areas  ABR for MD, Physicists  CMD for dosimetrist  ARRT for therapists  Continuing education  Highly recommended that individuals should continue proper CME  ACR maintains a database with recommendations for staffing levels

7. FDA-QA-DAS/2010 ACR: Evaluation  QA traceability of simulators, treatment planning and treatment machine daily, monthly and annual calibration  Measuring equipment redundancy through ADCL & RPC(TLD) for output  External Beam patient dose verification through chart reviews  Small fields and IMRT QA process  Brachytherapy (staff training, machine QA, periodic training, license agreement, violation reporting)  Details: www.ACR.org

8. FDA-QA-DAS/2010 Q2: What types of QA should be the responsibility of the facility, the physicist, the operator, others?  A qualified medical physicist should be responsible for the radiation therapy QA program in terms of radiation/device safety, who will disseminate it to other technical staff.  Trained IT personnel should be responsible for computer related issues.  It should be recognized that there are other types of QA than radiation data; such as efficiency and patient satisfaction that typically must be accounted for in hospital settings in addition to the radiation equipment aspects that FDA is primarily interested in.

9. FDA-QA-DAS/2010 Q3: 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?  It is the medical facility’s responsibility to develop a QA program, including QA procedures.  Manufacturers can participate with facilities by developing equipment-specific test procedures, providing phantoms, data collection/analysis, etc.  There should not be “cookie-cutter” QA procedures. This might encourage facilities without onsite physicists to merely use the manufacturer’s QA procedures without enhancement/customization.  Newer research data should be implemented in every QA process.

10. FDA-QA-DAS/2010 Q4: 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?  We are uncomfortable with manufacturer-run QA training, particularly as an end-all-be-all solution due to their financial interest and probably limited know how in their implementation.  Example: inhomogeneity correction in small fields  Manufacturers can work jointly with facilities on training, but not as the primary driver of the QA training.

11. FDA-QA-DAS/2010 Das et al, Med. Phys. 35(6), 2985, 2008

12. FDA-QA-DAS/2010 Summary  Manufacturers should work with technical staff for defining QA procedure and implementing new research data.  Mandatory reporting of deviation either through electronic (automated) or written should be explored.  QA process for accurate patient dose delivery could be easily mandated by ACR-ASTRO accreditation.  Additional QA process for newer technologies such as CyberKnife, Tomotherapy, Gammaknife, particle beam etc. should be incorporated.

13. FDA-QA-DAS/2010 Thanks