elekta safety perspective - american association of ...€¦ · 2010-06-24 · 4 discuss future...
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Elekta Safety PerspectivepJoel Goldwein, MDSenior Vice President and DirectorMedical AffairsMedical Affairs
AAPM/ASTROSafety in Radiation Therapyy pyJune 24, 2010
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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
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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
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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
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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
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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-
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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
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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
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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
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Elekta Safety and QualyRegulatory Requiremen
ity Control:ynts
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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
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Dose action pointsp
Available in OIS since early prohistory
Interlocked andInterlocked and non-interlocked
Spinal Cord
oduct
Dose Action Point enforced for SBRT
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Checklists
P i th h t El ktPervasive throughout Elekta devices and applications
Interlocked and non-Interlocked and noninterlocked
LGK Treatment Console Checklist
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Universal Timeout in MOOSAIQ
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Taking it to the patient…g p …
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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
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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
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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
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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
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Elekta Safety PerspectivepJoel Goldwein, MDSenior Vice President and DirectorMedical Affairsed ca a s
AAPM/ASTROSafety in Radiation TherapyJune 24, 2010
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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
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Checklists and MOSAIQQ Workflow Engineg