1. Quality & Regulatory Services, Inc. | www.qrs-i.com 1 USER TRAINING Presented By Robert J. Morton, M.S. Certified Radiological Physicist President Quality and Regulatory Services, Inc.

2. Quality & Regulatory Services, Inc. | www.qrs-i.com 2 USER TRAINING STATE REGULATIONS Most require education, experience and/or licensing of Radiation Therapy operators Radiation Oncologists Radiation Therapists Medical Physicists

3. Quality & Regulatory Services, Inc. | www.qrs-i.com 3 USER TRAINING PROFESSIONAL BOARDS Require entry level education and experience for Radiation Therapy operator certification. Radiation Oncologists Radiation Therapists Dosimetrists Medical Physicists But, a Certification only demonstrates minimum, entry level competence.

4. Quality & Regulatory Services, Inc. | www.qrs-i.com 4 USER TRAINING MANUFACTURERS Provide free off site training with each new linear accelerator purchase: Two Radiation Therapists Operators) One Medical Physicist Additional students at facilities cost. On site training for all users. Off site training for additional students at facility expense.

5. Quality & Regulatory Services, Inc. | www.qrs-i.com 5 USER TRAINING As Chief of the Radiation Therapy Branch at BRH, I attended the Varian training for operators at BRH/FDA expense. Very thorough training Very thorough User Manual Student expected to share knowledge with peers. It is what occurs after training that governs safe operation.

6. Quality & Regulatory Services, Inc. | www.qrs-i.com 6 USER TRAINING To fill some gaps, BRH funded several projects including symposia and training materials.

7. Quality & Regulatory Services, Inc. | www.qrs-i.com 7 When there was a BRH and a Radiation Therapy Branch Funded contracts and grants: Symposium on Recent Advances and Future Developments of Computed Tomography in Radiotherapy Planning. First International Symposium on Quality Assurance in Radiation Therapy: Clinical and Physical Aspects. Video Cassettes: "Planning Treatment of Cancer in Three Dimensions" with Michael Goitein, Ph.D.

8. Quality & Regulatory Services, Inc. | www.qrs-i.com 8 When there was a BRH and a Radiation Therapy Branch Karzmark, C.J., and Morton, R. J., A Primer on Theory and Operation of Linear Accelerators in Radiation Therapy. HHS Publication (FDA) 82-8181, U.S. Government Printing Office, 1981.

9. Quality & Regulatory Services, Inc. | www.qrs-i.com 9 When there was a BRH and a Radiation Therapy Branch Karzmark, C.J., and Morton, R. J., A Primer on Theory and Operation of Linear Accelerators in Radiation Therapy. HHS Publication (FDA) 82-8181, U.S. Government Printing Office, 1981. Primer on Theory and Operation of Linear Accelerators, 2nd Ed. Authors: C.J. Karzmark & Robert Morton ISBN: 9780944838662 Published: 1998 Medical Physics Publishing

10. Quality & Regulatory Services, Inc. | www.qrs-i.com 10 When there was a BRH and a Radiation Therapy Branch Karzmark, C.J., and Morton, R. J., A Primer on Theory and Operation of Linear Accelerators in Radiation Therapy. HHS Publication (FDA) 82-8181, U.S. Government Printing Office, 1981. Primer on Theory and Operation of Linear Accelerators, 2nd Ed. Authors: C.J. Karzmark & Robert Morton ISBN: 9780944838662 Published: 1998 Medical Physics Publishing 2009 – Sold 174 2010 – Sold 53

11. Quality & Regulatory Services, Inc. | www.qrs-i.com 11 EXPERIENCE AND OBSERVATIONS Facility often has two or more linear accelerators often different models and sometimes different manufacturers. Operators are rotated between linacs for variety and cross-training. Operators leave facility. Operators operate different linacs during lunch, breaks and vacations. The facility does not fund Manufacturer training for additional staff.

12. Quality & Regulatory Services, Inc. | www.qrs-i.com 12 EXPERIENCE AND OBSERVATIONS Linacs and accessories have become more capable, sophisticated and complicated. Rectangular collimators, and even multileaf collimators, that do not move during treatment can be verified as correct by the operator prior to commencing treatment.

13. Quality & Regulatory Services, Inc. | www.qrs-i.com 13 EXPERIENCE AND OBSERVATIONS But, proper location of a collimator jaw or leaf moving during treatment and during gantry rotation cannot be verified as correct by a human. Proper location of a collimator jaw or leaf moving during treatment and during gantry rotation must Be designed with redundant encoders and Be verified as correct prior to the treatment by a human. A good QA program can provide confidence, but not verification of each patient’s treatment.

14. Quality & Regulatory Services, Inc. | www.qrs-i.com 14 MANDATORY TRAINING FACTS CDRH/FDA has authority to regulate the manufacturer. STATES have authority to regulate the user and use. CDRH/FDA could require the manufacturer to provide specific training, but only the STATES could require the users to attend! (States Rights)

15. Quality & Regulatory Services, Inc. | www.qrs-i.com 15 RECOMMENDATIONS Manufacturers should design training for each linac model and each advanced mode, such as IMRT & IGRT. Manufacturers should provide a Certificate specific to the model/mode training. Training to include: Potential errors Recognition of incorrect linac operation Emergency response training and drills.

16. Quality & Regulatory Services, Inc. | www.qrs-i.com 16 RECOMMENDATIONS CDRH/FDA require the manufacturer to provide a training plans with each device 510(K) submission. STATES require operators to possess a Certificate specific to the device and advanced mode being operated and to post the Certificate at the point of operation.