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Errors in Radiotherapy- manufacturers perspective
Chris Amies Ph.DH-IM-OCSG
Manufacturers WorldManufacturers World
Regulations Standards
Safety Quality
The medical market is a regulated market in the USAThe medical market is a regulated market in the USA
The objective for such regulations is driven by mandate:
To provide people with safe and efficient healthcare
Provisions include Market approval for medical devices For safe use and efficacy Medical requirements (education, certified medical procedures, guidelines,
clinical trial, quality control,…) Technical requirements (basic safety, essential performance, quality
k t ill )assurance, market surveillance,…) Technical requirements as prerequisite for reimbursement
Standards play an important role in achieving these goals!
RT Quality and Safety StandardsRT Quality and Safety Standards
GeneralProcess standards control design, development, manufacturing, installation,
servicing
• Quality System Regulation21 CFR 820• Medical devices quality management
systemsISO 13485ISO 14971 • Medical device risk managementISO 14971
• Medical device software lifecycle processesIEC 62304• Medical devices (Usability engineering)IEC 62366
RT Quality and Safety StandardsRT Quality and Safety Standards
AcceleratorDevice-specific safety standards specify and control device safety characteristics
• Medical Electrical Equipment - Part 1: General Requirements for SafetyIEC 60601-1 General Requirements for SafetyIEC 60601 1
• Requirements for the safety of electron accelerators in the range 1 MeV to 50 MeVIEC 60601-2-1
• Requirements for Safety: Electromagnetic CompatibilityIEC 60601-1-2
• Requirements for safety: Programmable electrical medical systemsIEC 60601-1-4
RT Quality and Safety StandardsRT Quality and Safety Standards
Treatment Planning and Record & VerifySafety standards governing medical electrical equipment and its accessories
• Requirements for the safety ofRequirements for the safety of radiotherapy treatment planning systems
IEC 62083
• Safety of radiotherapy record IEC 62274 and verify systemsIEC 62274
A strong link between standards and regulationsin the medical device marketin the medical device market
referencee.g., MDD„essential Standards
Authorities IEC, ISO
reqs.“
Harmonization and Publication
Standards detail the regulatory frameworkStandards detail the regulatory framework
Legal requirements have a long life time (decades); standards help to describe legal goals in shorter cycles (years).
Challenge of standardization for medical devicesChallenge of standardization for medical devices
Clinical Benefits Safety
Find the balance between clinical benefits and safety interests Find the balance between clinical benefits and safety interests
Give a common technological baseline, but allow innovations
Describe a framework that is acceptable for all stakeholdersDescribe a framework that is acceptable for all stakeholders
Ensuring standards compliance in product developmentEnsuring standards compliance in product development
List of applicable/ Proof of
EssentialDeclaration of
C f itHarmonized Standards
Essential Requirements
Conformity
Release for
Shipment
Design OutputTest ReportsIEC/EN Tests
Product Engineering
Process
Product Features &
Requirements
Detailed Unit
Engineering Process
Standard and Regulation Management
Design Verification
IMPLEMENTATION
Standards Evolve: MLC and IEC 60601 – 2- 1Standards Evolve: MLC and IEC 60601 2 1
Multileaf collimators offer the opportunity Multileaf collimators offer the opportunity to adapt the beam to the tumor shape, sparing healthy tissue
However, there is some leakage radiation between the leaves
IEC 60601-2-1 max X-ray leakageIEC 60601 2 1 max. X ray leakage through beam limiting device: 1981: 2% (MLC not considered) 1998: 5% for MLC
2008 (CD) 2 5% (MLC f I t it 2008 (CD): 2.5% (MLC for Intensity-Modulated Radiation Therapy)
201X: 1%???
What is a “Safe” product ?What is a Safe product ?
A product is safe if, during the intended or expected use (including any f bl i ) d ki h l d lif l iforseeable misuse), and taking the usual or expected life cycle into account, no danger to personal health and safety arises that is;
considerable considerable incompatible with the nature of use and not acceptable with the generally acknowledged rules of technology
Siemens AG Guidelines for Product Safety.
What is Quality?What is Quality?
(Qualitas - Plato) ability for / to use
(ISO 9000) D t hi h t f i h t(ISO 9000) Degree to which a set of inherent characteristics fulfils requirements
What is a Quality Management System (21 CFR 820)?What is a Quality Management System (21 CFR 820)?
Quality degree to which a set of inherent characteristics fulfils requirements
Management coordinated activities to direct and control an organization
System set of interrelated or interacting elements
Quality Management Systemy g y management system to direct and control an organization with regard to quality
Key Elements of our QMS -How to handle a nonconforming product?
Customer complaint handling Complaint means any written, electronic, or oral communication that
How to handle a nonconforming product?
alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution Any complaint involving risk to patient safety should be immediately
communicated to Quality Management DepartmentMedical Device Reporting
Risk Management Correction & Removal
Implementation of ISO 14971Implementation of ISO 14971
e.g. OCS –Quality Regulation for Risk ManagementManagement
Low – residual risk acceptable, no active risk controlMedium – two levels of acceptability:
Above acceptability level: risk-analysis to determine how to proceed Above acceptability level: risk-analysis to determine how to proceed Below acceptability level: ALARP (as low as reasonably practicable)
High – risk is intolerable; no risk-benefit analysis is acceptable. Risks must be reduced at least to medium area
Key Elements of our QMS -How to control a nonconforming product?
Corrective and Preventive Action (CAPA)
How to control a nonconforming product?
Corrective/Preventive Actions are assigned to track and resolve known issues
Change request management (Charm) Charms covers defects of any nature – be it an error / wish / y
complaint / insufficiency / optimization or similar.
Safety Management and Reporting in the Installed Base
‘complaint’
Safety Management and Reporting in the Installed Base
Report / observationIn installed Base
Safety Advisory Letterto Installed BaseSafety ReviewResponse to
OriginatorNotification of
Authorities
D l t fS f t U d t f
Suggestion forFuture Development of
SolutionSafety Update of
Installed BaseNotification of Authorities
Future Improvement
Key Elements of our QMS -Audits
Internal audits performed by OCS personnel evaluate continued compliance as required e g by ISO 13485:200
Audits
evaluate continued compliance as required e.g. by ISO 13485:200 internal audits serve also as preparation for external audits
External auditsÜ TÜV, UL, BSIAnnual assessment audits to ensure complianceNon Conformities must be fixed within 30 daysMinor Non Conformities must be fixed before next audit
FDA (inspection) for US
Audits are a powerful tool to detectAudits are a powerful tool to detect opportunities for improvement.
Some Final Thoughts on Safety in RadiotherapySome Final Thoughts on Safety in Radiotherapy
Processes are necessary but not sufficient
Can safety be ensured by design? Modern devices are more complex Computers often trust each other
Perhaps there is a need for an ASARA (As safe as reasonably achievable) policy