Elekta Safety PerspectivepJoel Goldwein, MDSenior Vice President and DirectorMedical AffairsMedical Affairs

AAPM/ASTROSafety in Radiation Therapyy pyJune 24, 2010

Objectives and Agendaj g

1 Hi hli ht l b l ( f t ) i1. Highlight global (safety) impvendor

2 O tli d f t t2. Outline vendor safety contro3. Identify currently available

and potentially underutilizedand potentially underutilizedsafety measures

4 Discuss future safety related4. Discuss future safety-relatedmeasures

a

t f di ti lpact of radiation oncology

lol processes

dd

Global Safety Impact

~ 1M RT courses yearly in US

Event TypeEvent Type

Errors w/ serious clinical conseq

Errors w/ significant clinical conseq

Errors w/ serious clinical conseq

Errors w/ significant clinical conseq

i i j

Lots of caveats (e.g. –Lots of caveats (e.g. –

• Most events ≠ serious injury• RT safe, but could/should alway• No event should be tolerated• No event should be tolerated• Elekta devices treat ~ 100,000 pati

• Part of the solution

* Munro – BJR 2007

S (IMV Report – 2007)

Events per million RT courses*~ 10,000 - 20,000AnyEvents per million RT courses*~ 10,000 - 20,000Any

~ 5 - 10quences

~ 1,000 – 10,000quences

~ 5 - 10quences

~ 1,000 – 10,000quences

– under-dosing, under-reporting)– under-dosing, under-reporting)

ys be safer

ients / day world-wide

Why do errors occur?y

RT is complicated, and it's complex!Complicated Problems

Not straight forwardBreak down into series of simplerwith repeatable stepswith repeatable stepsRequires multiple people, teams expertiseTiming and coordination of effortsTiming and coordination of effortsUnanticipated difficulties commonOnce done, relatively easy to rep(Gawande - sending rocket to moRO Analog – RT safely to a pha

Complex ProblemsRequire application of processes q pp p“perfected”, are not easily repeateto the next problem (Gawande - raising a child well)RO Analog – RT safely to a patRO Analog RT safely to a pat

r problems

and differing

s necessarys necessaryn

peat oon)antom

that, once ed and applied

ientient

How Complicated and Hp

Complicated?• Ford’s Failure Mode and

Effect analysis– 269 course process nodes– 127 high risk failure modes– Getting more complicated ??

Complex?pHuman beings are involved on both sides of the table

EVALUA

– Diseases are varied– Processes are fluid

EVALUAUSING ERIC C. FOENGINEERAND THEOIJROBP,

How Complex?p

ATION OF SAFETY IN A RADIATION ONCOLOGY SETTINGATION OF SAFETY IN A RADIATION ONCOLOGY SETTING FAILURE MODE AND EFFECTS ANALYSIS

ORD, PH.D.,* RAY GAUDETTE, M.S.,* LEE MYERS, PH.D.,* BRUCE VANDERVER, M.D., LILLY R, DR.P.H., M.D., M.H.A., RICHARD ZELLARS, M.D.,* DANNY Y. SONG, M.D.,* JOHN WONG, PH.D.,* ODORE L. DEWEESE, M.D.*

2008

Select Hazards and Pot

Human/Use Error• Errors in beam data measure• Incorrect patient setup p p• Incorrect use of accessories (• Incorrect treatment plan param• Failure to perform necessary• Failure to perform necessary

Equipment failure• Design flaws (h/w, s/w)• Component failures• Manufacturing, service

Can all be addressed with existing hazaterm initiatives

tential Causes

ment and entry

(i.e. wedges)meters, prescriptionQ/AQ/A

ard mitigation processes and / or near-

Hazard Mitigation ProceHazard Mitigation ProceHierarchy of Effectivene

1. Forcing functions & constraints2. Automation / computerization3. Simplification / standardization4. Reminders, checklists, double 5. Rules & Policies6. Education & training

esses:esses: ess

s (interlocks)

nchecks

Elekta – Safety Program P

S f t i i i l idi El• Safety is core principal guiding El– Implicated in all areas of produ

manufacturing, distribution, ang, ,– Extensive safety reviews and c

of product life cycleSafety programs are constantl– Safety programs are constantl

• Accommodate emerging techchanges, new training paradig

• Important safety considerations– ALL members of team empowALL members of team empow– Reviews consider safety of pa– Special attention given to haza

Principles

l kt d t d l tlekta product developmentuct design, engineering, nd traininggchallenges incorporated at all phases

ly re evaluated and iteratedly re-evaluated and iteratednological or industry safety standards gms, field workflow changes…

weredweredatient and operatorards mitigated by labeling and training

Elekta – Safety Program P

Ali ith d t d i “H• Align with product design “H– Minimize unnecessary hu– Facilitate human decisionFacilitate human decision– Reduce reliance on low

improving usability (1,2• Utilize experts

– Employees (physicians, psafety engineers )safety engineers...)

– Vendor-vendor collaboratcycleC t t– Customers - cornerstone development...

Conform to Industry standary

Philosophy

i h f Eff ti ”ierarchy of Effectiveness”uman interventionn makingn makinger yield measures (5,6) by ,3,4)

physicists, therapists, nurses,

tions throughout product life-

f d t d iof product design,

rds

Elekta Safety and QualyRegulatory Requiremen

ity Control:ynts

Exemplary Elekta Safetp y

Existing product features aExisting product features a

e.g. -Dose action points, checkli(barcode)Image guidance (Synergy®g g ( y gyRemote linac diagnostics a

Existing Risk Management PUse of (future) enhanced pFeed back into device imprFeed back into device imprHazard mitigation

March 29, 2010 Audit Safety11

ty Featuresy

available to customer baseavailable to customer base

ists, timeouts, accessory verification

®, Clarity™), y )and monitoring (IntelliMAX™)

Processespost-market reporting system /databaserovements through Risk Analysis androvements through Risk Analysis and

Dose action pointsp

Available in OIS since early prohistory

Interlocked andInterlocked and non-interlocked

Spinal Cord

oduct

Dose Action Point enforced for SBRT

Checklists

P i th h t El ktPervasive throughout Elekta devices and applications

Interlocked and non-Interlocked and noninterlocked

LGK Treatment Console Checklist

Universal Timeout in MOOSAIQ

Taking it to the patient…g p …

MOSAIQ Workflow Man

S t t i dSupports customized checkpoints w/ optional alerts and interlocksCould be implemented at any/all high risk hazard

d i k flnodes in work flow

EVALUAEVALUAUSING ERIC C. FOENGINEERAND THEOIJROBP,

nagerg

ATION OF SAFETY IN A RADIATION ONCOLOGY SETTINGATION OF SAFETY IN A RADIATION ONCOLOGY SETTING FAILURE MODE AND EFFECTS ANALYSIS

ORD, PH.D.,* RAY GAUDETTE, M.S.,* LEE MYERS, PH.D.,* BRUCE VANDERVER, M.D., LILLY R, DR.P.H., M.D., M.H.A., RICHARD ZELLARS, M.D.,* DANNY Y. SONG, M.D.,* JOHN WONG, PH.D.,* ODORE L. DEWEESE, M.D.*

2008

Currently Available Eleky

Existing product features aExisting product features a

e.g. -Checklists, quality checklis(barcode)Image guidance (Synergy®g g ( y gyRemote linac diagnostics a

Existing Risk Management PUse of (future) enhanced pFeed back into device imprFeed back into device imprHazard mitigation

March 29, 2010 Audit Safety17

kta Safety Featuresy

available to customer base;available to customer base;

sts, timeouts, accessory verification

®, Clarity™), y )and monitoring (IntelliMAX™)

Processespost-market reporting system / databaserovements through Risk Analysis androvements through Risk Analysis and

Radiation Therapy Reapy

• Elekta is fully committed to yinitiatives

• Will likely have demonstrable functionality well before the 2-year deadline

• Will retrofit to existing MOSAIQ installed base

diness Check Initiative

Elekta's Commitment to

W ( d h l bWe are (and have always beenimproving the safety of our proWe strongly support external eWe strongly support external eenhance safetyWe will (continue to) work togeWe will (continue to) work toge(industry, profession, regulator

o Safetyy

) itt d t ti lln) committed to continually oducts and their useefforts to measure report andefforts to measure, report and

ether with all stakeholdersether with all stakeholders ry, patient advocacy...) to do so

Elekta Safety PerspectivepJoel Goldwein, MDSenior Vice President and DirectorMedical Affairsed ca a s

AAPM/ASTROSafety in Radiation TherapyJune 24, 2010

ASTRO Si P i t PlASTRO Six-Point Plan

• Error Registry• Error Registry– We look forward to working togeth

International registry fully integrateprogramsp g

• Practice accreditation, educacourses

– We welcome the opportunity to coWe welcome the opportunity to coimplementation of these programs

• ASTRO connectivity complia– We remain fully committed to promWe remain fully committed to prom

RO • Support for new/expanded in

– We fully support the CARE initiativy ppother related activities

• Collaboration with Patient Su– We will work with professional orgp g

her with stakeholders to develop ed into existing products and safety

ational training, safety and QA

ollaborate in development andollaborate in development and sance programs (IHE-RO...)motion and further development of IHE-motion and further development of IHE

nitiatives to help protect patientsve, and remain open to consideration of , p

upport Organizationsanizations in support of these endeavorspp

Checklists and MOSAIQQ Workflow Engineg