fda-qa-das/2010 fda’s public meeting: device improvements to reduce the number of under-doses,...
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FDA-QA-DAS/2010
FDA’s Public Meeting:FDA’s Public Meeting:Device Improvements to Reduce the Number of Device Improvements to Reduce the Number of Under-doses, Over-doses, and Misaligned Under-doses, Over-doses, and Misaligned Exposures from Therapeutic RadiationExposures from Therapeutic Radiation
Indra J. Das, PhD, FIPEM, FAAPM, FACMP, FACR Indra J. Das, PhD, FIPEM, FAAPM, FACMP, FACR Vice Chair, Professor & Director of Medical PhysicsVice Chair, Professor & Director of Medical PhysicsDepartment of Radiation Oncology &Department of Radiation Oncology &Midwest Proton Radiotherapy Institute (MPRI)Midwest Proton Radiotherapy Institute (MPRI)Indiana University School of MedicineIndiana University School of MedicineIndianapolis, INIndianapolis, IN
On behalf of American College of Radiology
FDA-QA-DAS/2010
Precise and accurate
Why QA is Needed?
No PrecisionNo accuracy
Precise but not accurate
FDA-QA-DAS/2010
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Patient Number
Pres
crip
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Dev
iatio
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Pla
nned
/Pre
scri
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Dos
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MinimumMaximumMedianIsocenter
Institution 1 Institution 2 Institution 3 Institution 4 Institution 5
Variations in doses in 803 patients among institutions
63%
46%
Das et al. J Natl Cancer Inst 100 (5), 300-3007, 2008
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.
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.
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
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
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.
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.
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.
FDA-QA-DAS/2010
CF Difference Between Measurement and TPS at 10.5 cm depth
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Field size (cm x cm)
Dif
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)Oncentra-CCPinnacle-ACEclipse-AAAProwessMonte CarloXiO-SuperpositionRadionicsPlanUNCOncentra-PBBrainLabEclipse-PBXiO-Convolution
Das et al, Med. Phys. 35(6), 2985, 2008
FDA-QA-DAS/2010
SummarySummary 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.
FDA-QA-DAS/2010
Thanks