Amies Errors In Radiotherapy I.ppt€¦ · Errors in Radiotherapy - manufacturers perspective Chris Amies Ph.D H-IM-OCSG . Manufacturers WorldManufacturers World Regulations Standards

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