1. Radiation Therapy Safety Standards
Stan Mansfield, Director of System Safety
Varian Medical Systems

2. Overview Applicable Normative Standards
International Standards Organization (ISO)
International Electrotechnical Commission (IEC)
MITA Consensus Standards Initiatives
NEMA RT-1 Radiotherapy Gating Interface
NEMA RT-2 Radiotherapy Readiness Check
NEMA RT-3 Radiotherapy Machine Characterization
Integrating the Healthcare Enterprise (IHE)
Radiation Oncology (IHE-RO)

3. RT Quality and Safety Standards
Radiation Therapy Manufacturers
RT Quality and Safety Standards
General
Process standards covering design, development, manufacturing, installation, servicing
Medical device quality management systems
ISO 13485
Medical device risk management
ISO 14971
Medical device software lifecycle processes
IEC 62304
Application of usability engineering to medical devices
IEC 62366

4. RT Quality and Safety Standards
Accelerator
Device-specific safety standards specify and control device safety characteristics
Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC
Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
IEC
Particular requirements for the safety of X-ray-based image-guided radiotherapy equipment
IEC

5. RT Quality and Safety Standards
Other Delivery Modalities
Device-specific safety standards specify and control device safety characteristics
Particular requirements for the safety of gamma beam therapy equipment
IEC
Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
IEC
Particular requirements for the safety of light ion beam therapy equipment
IEC

6. RT Quality and Safety Standards
Treatment Planning and Information Systems
Safety standards governing other medical equipment (software medical devices)
Information technology equipment – Safety Part 1: General requirements
IEC
Safety of radiotherapy treatment planning systems
IEC 62083
Safety of radiotherapy record and verify systems
IEC 62274

7. MITA / NEMA RT Standards Efforts
Status & industry participation
DICOM - RT
RT-1 Gating Interface
RT-2 Radiotherapy Readiness Check
RT-3 Radiotherapy Machine Characterization
Other NEMA RT standards to follow
MITA members also support IHE-RO

8. MITA / NEMA RT Standards Status
DICOM
Initially Released in (ACR and NEMA)
Basic RT objects added in DICOM 3.0
Regular updates and active industry participation
RT-1 Released 2014
RT-2 Draft (Stakeholder Comment)
RT-3 Working Draft in process
Others to follow

9. MITA / NEMA RT Industry Participation

10. NEMA RT-1:2014 Gating Interface
Standardized Real-time Interface
Treatment Delivery Device (TDD) – i.e. Linac
Patient Position Monitoring System (PPMS)
Detailed Signal and Timing Specifications
Safety and Essential Performance
Specific Safety Checks
Pre-Beam Check
Signal Cross Checks
Beam Hold Verification
Plan Verification
Hard Interlock and Beam Hold - ‘Fail Safe’

11. NEMA RT-2 Radiotherapy Readiness Check
Origin: FDA public meeting June 9-10, 2010
Three safety initiatives introduced by Industry
Radiation Therapy Pre-Treatment Quality Assurance Verification and Approval
Verification of Beam Modifying Devices
Patient Positioning Confirmation
Based on collective experience of RT vendors
Includes MDR assessments and published articles on safety
Addresses needed standardization
Essential Performance and Basic Safety
Specific requirements for each of the three sections
Compliance statement to communicate implementation details

12. Diverse Technology Drives Implementation
Diverse variety of technology by product and by manufacturer
Each vendor to publish a detailed Compliance Statement describing their implementation and rationale
Allows for wide variety of implementations of safety initiatives
Builds on existing Standards

13. #1 Pre-Treatment QA Verification & Approval “Right plan with the right dose for the right patient”
Goal:
Assure treatment cannot be performed without explicit QA approval of the patient’s treatment plan
Solution:
Treatment delivery requires plan QA approval by authorized physicist (via login & password).
QA authorization becomes part of the patient record.
Treatment cannot be delivered without approval – It is Interlocked!
Plan changes require re-approval
Explicit requirements by system:
Treatment Planning System (TPS)
Treatment Management System (TMS)
Treatment Delivery System (TDS)
Quality Assurance System (QAS)
Figure: Plan QA Approval Check – Authorized user must approve plan QA prior to patient treatment delivery.

14. #2: Verification of Beam Modifying Devices “Prevent beam modifier errors”
Goal:
Detect the correct state (presence/absence, identity, attachment and preconditions) of all removable beam modifiers.
SRS Cones, Wedges, Blocks, Applicators, Boli etc.
Solution:
Display and Independent Verification
Description & Identification
Machine settings (jaw settings, beam type, energy)
Interlock if inconsistent with treatment plan
Interlock Sensor Technologies:
Electro-mechanical
Bar-code
RFID

15. #3 Patient ID & Positioning Confirmation “Right patient, right procedure, right site”
Goal:
Verify correct patient identification, set-up, orientation, and position prior to treatment
Solution:
Display at least 2 forms of Patient Identifying Information (PII)
Patient Name, Photo, Date of Birth etc.
User acknowledgement and sign-off
Transmit and verify 3 forms of PII
Patient Name, ID and Date of Birth
Biometrics or other automated systems
Image Guided Radiation Therapy
Unambiguous references and display
Position and Orientation
IGRT is proven to enhance accuracy and consistency of patient set-up

16. NEMA RT-3 Machine Characterization
Goal:
Provide information to develop or compare a software model that captures the characteristics of a Treatment Delivery Device (TDD)
Challenge:
Errors in machine modeling are ‘systematic’
DICOM and IHE-RO don’t handle this
Solution:
Standardized (HTML) template
Automatically generated by TDD
Allows for automated cross-checking
Explicitly includes FDA’s Unique Device Identification (UDI) code
Currently under development

17. IHE-RO
Integrating the Healthcare Enterprise (IHE) is an initiative to improve Interoperability, how computer systems share information in healthcare
Promotes the coordinated use of established standards (such as DICOM & HL-7) to address specific clinical needs in support of optimal patient care
IHE-RO addresses specific needs of the Radiation Oncology (RO) Domain Sponsored by ASTRO Founded in 2004
There are 10 domains under IHE. IHE-RO grew out of meetings at RSNA in 2004 and 2005

18. Facilitating Interoperability
Identify Real-World Interoperability Opportunities
Develop Technical Descriptions of Device Behavior – “Profiles”
Advanced Radiation Therapy Objects Interoperability (ARTI)
Quality Assurance with Plan Veto (QAPV)
Creating Interoperability
Direct Stakeholder Involvement
Manufacturers Create Solutions
Testing Interoperability
Testing to the Profiles
Annual “Connectathon” – Judge the Working Solutions
Users expectations – The market drives support

19. Interoperability and Interconnectivity Challenges Addressed(
Simple/Advanced Treatment Planning use case (NTPL-S / ARTI)
allows seamless connectivity between different treatment planning systems – reducing errors
Multimodality Image Registration use case (MMRO)
Integrates PET and MRI data into the contouring and dose review process – ehancing clinical effectiveness
RT Treatment Workflow use case (TRWF)
Integrates daily imaging with radiation therapy treatments using workflow – reducing errors

20. Conclusions & Summary Safety is embedded in the design of RT products
Standards play a major role in safe design in RT
The CDRH currently recognizes many of these
Standards build on each other
Newer consensus standards fill some key gaps
Interoperability between devices & manufacturers
Fast turnaround and specific situations
RT manufacturers are committed to safety