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

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)

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

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 60601-1 Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV IEC 60601-2-1 Particular requirements for the safety of X-ray-based image-guided radiotherapy equipment IEC 60601-2-68

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 60601-2-11 Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment IEC 60601-2-17 Particular requirements for the safety of light ion beam therapy equipment IEC 60601-2-64

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 60950-1 Safety of radiotherapy treatment planning systems IEC 62083 Safety of radiotherapy record and verify systems IEC 62274

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

MITA / NEMA RT Standards Status DICOM Initially Released in 1985 (ACR and NEMA) Basic RT objects added in 1997 - 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

MITA / NEMA RT Industry Participation

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’

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

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

#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.

#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

#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

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

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

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

Interoperability and Interconnectivity Challenges Addressed (http://www.ihe.net/Radiation_Oncology/index.cfm) 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

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