clark safety in hc monday 13 30
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C U R S O E O F I C I N A D E T R A B A L H O S O B R E G E R E N C I A M E N T O D E R I S C O E S E G U R
C U R S O E O F I C I N
A D E T R A B A L H O S O B R E G E R E N C I A M E N T O D E R I S C O E S E G U R A N A N A E M S A
A E M S A D E D E
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Safety in HealthcareSafety in Healthcare
Tobey Clark, MSEE, CCETobey Clark, MSEE, CCE
University of VermontUniversity of VermontUSA USA
Acknowledgment to many ACCE faculty and Andrei Issakov, WHO Acknowledgment to many ACCE faculty and Andrei Issakov, WHO
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Agenda Agenda Hour 1Hour 1
Safety in healthcare overviewSafety in healthcare overview
Patient safetyPatient safetyMedical deviceMedical device
Safety issuesSafety issues International improvement effortsInternational improvement efforts U.S. improvement effortsU.S. improvement efforts
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How hazardous is health care?How hazardous is health care?
1
10
100
1,000
10,000
100,000
1 10 100 1,000 10,000 100,000 1,000,000 10,000,000
Total lives lost per year
N u
m b e r o
f e n c o u n
t e r s
f o r e a c
h f a t a l i t y
DangerousDangerous(>1/1000)(>1/1000)
UltraUltra --safesafe(
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Institute for Medicine Report:Institute for Medicine Report:To err is human: building a safer health system To err is human: building a safer health system
44,00044,000 --98,000 die98,000 dieeach year due toeach year due tomedical errorsmedical errors Failure to perform aFailure to perform a
desired act ordesired act or rightrightaction action
Errors will always occurErrors will always occur-- goal is to reduce thegoal is to reduce thenegative outcomesnegative outcomes
Mostly medicationMostly medicationerrorserrorsMore than 2/3rds dueMore than 2/3rds duetoto human errorhuman error
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Why are errorsWhy are errorsprevalent in healthprevalent in health
care?care?Most complex systemMost complex system
One of most hazardous activitiesOne of most hazardous activitiesLagging behind other highLagging behind other high --riskrisk
industriesindustriesFraught with obstacles to changeFraught with obstacles to change
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Human beings make mistakesHuman beings make mistakesbecause the systems, tasks andbecause the systems, tasks and
processes they work in areprocesses they work in are
poorly designedpoorly designed
Dr LucianDr Lucian Leape Leape , testifying to the Presidents , testifying to the Presidents Commission on Consumer Protection andCommission on Consumer Protection and
Quality in Health Quality in Health
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Adverse Event vs. Adverse Event vs.
Error Error ErrorError definition bears upon concept ofdefinition bears upon concept ofpreventability, and is therefore processpreventability, and is therefore process --focusedfocused
Adverse event Adverse event describes harm to the patient,describes harm to the patient,and is thus outcome focusedand is thus outcome focused
Relationship between errors and adverse events:Relationship between errors and adverse events:
Errors Adverse
Events
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Why Do Adverse EventsWhy Do Adverse Events
Occur?Occur? UseUse errorerror
EquipmentEquipmentfailure/manufacturingfailure/manufacturingdefectdefect
Environmental factorsEnvironmental factors
Poor designPoor design
Patient factorsPatient factors
SystemSystem failurefailure
CombinationsCombinations
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An International An International
ProblemProblem
UK UK around 10% of admissions or at a ratearound 10% of admissions or at a rateof 850,000 adverse events a yearof 850,000 adverse events a year Australia 250,000 adverse events Australia 250,000 adverse events
50,000 permanent disability50,000 permanent disability10,000 deaths10,000 deaths
N.Z. confirmed 10% of admissionsN.Z. confirmed 10% of admissionsDenmark confirmed 9% of admissionsDenmark confirmed 9% of admissionsEUEU every tenth patientevery tenth patient
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Adverse Events in Acute Hospitals Adverse Events in Acute Hospitals
11% of adverse events are due to badmanufacturing of medical devices
11% of adverse events are due to badmanufacturing of medical devices Adverse event rate (percentage)
0
2
4
6
8
10
12
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New York Australia Utah and
Colorado
London New
Zealand
Canada DenmarkNew York Australia Utah and
ColoradoLondon New
ZealandCanada Denmark
National Patient Safety AgencyJuly 2005
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What does it cost?What does it cost?
High toll in financial loss as wellHigh toll in financial loss as well
UK UK 2 billion a year in additional hospital stays;2 billion a year in additional hospital stays;400 million annually in paid litigation claims400 million annually in paid litigation claimsplus potential liability ofplus potential liability of 2.4 billion in existing2.4 billion in existing
and expected claims;and expected claims;
HAIHAI -- 15% of which avoidable15% of which avoidable -- 1 billion1 billioneveryevery yearyearUSA USA
$17$17 --29 billion annually in lost income,29 billion annually in lost income,disability and additional medical expensesdisability and additional medical expenses
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5
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accelerate improvementsaccelerate improvementsFocus on systemsFocus on systemsImprove detection andImprove detection and
understanding of safetyunderstanding of safetyproblemsproblems
Build and spread knowledgeBuild and spread knowledge
base of interventionsbase of interventions Action on topics which address Action on topics which addresssignificant risk significant risk
Support regional and countrySupport regional and countryprogrammesprogrammes
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BUILDING SAFE ENVIRONMENTFOR SAFER CARE
Global Patient Safety ChallengeClean Care is Safer Care, 2005-2006Safe Environment for Safer Care, 2007-2008
Patients for Patient SafetyPatients for Patient Safety
Research for Patient SafetyResearch for Patient Safety
Patient Safety SolutionsPatient Safety Solutions
Reporting and Learning SystemsReporting and Learning Systems
Patient Safety TaxonomyPatient Safety Taxonomy
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Needs analysis &strategic planning Needs analysis &Needs analysis &
strategic planning strategic planning
S a
f
e t y
HTA (macro & micro)
HTA HTA (macro & micro) (macro & micro)
Pre-purchase evaluation
Pre Pre - - purchase purchase evaluation evaluation
Selection & procurement
Selection &Selection & procurement procurement
User & servicetraining
User & serviceUser & servicetraining training
Risk management &quality assurance
Risk management &Risk management &quality assurance quality assurance
CE/HE management& monitoring
CE/HE managementCE/HE management& monitoring & monitoring
Operation, service &maintenance
Operation, service &Operation, service &maintenance maintenance
Acceptance &installation
Acceptance & Acceptance &
installation installation
HealthcareTechnologyManagementSpectrum
HealthcareHealthcareTechnologyTechnologyManagementManagement
SpectrumSpectrum
ty
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WHO Medical DeviceWHO Medical DeviceSafety EffortsSafety Efforts
Development of national policy:Development of national policy: tools to assess and strengthen nationaltools to assess and strengthen national
regulatory authoritiesregulatory authoritiesQuality and safety:Quality and safety: elaboration of new ISO standardselaboration of new ISO standards
Access: Access: WHO Essential Healthcare Technology PackageWHO Essential Healthcare Technology Package
Appropriate use of equipment in order to Appropriate use of equipment in order toreduce risks:reduce risks: diffusion of materialsdiffusion of materials
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U. S. Patient SafetyU. S. Patient SafetyMovement OriginMovement Origin
Meeting of 300 experts held in 1996 in theMeeting of 300 experts held in 1996 in the
Annenberg Conference Center near Palm Annenberg Conference Center near PalmSprings, CA.Springs, CA.
in response to several errorin response to several error --induced sentinelinduced sentinelevents in the midevents in the mid --1990s that captured the1990s that captured theattention of the public media.attention of the public media.
American Medical Association American Medical Association American Association for the Advancement of Science American Association for the Advancement of Science Veterans Administration Veterans AdministrationJoint CommissionJoint Commission
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Joint Commission:Joint Commission:
Accreditation Organization Accreditation Organization Accreditation guidelines sets quality standards for all Accreditation guidelines sets quality standards for allareas including healthcare technologyareas including healthcare technology
Accreditation means hospitals will receive payment for federally Accreditation means hospitals will receive payment for federallycovered patientscovered patients
Use in US hospitals and now internationallyUse in US hospitals and now internationally
Survey processSurvey process Interviews, onInterviews, on --site observation ofsite observation ofpatient care process, policies, procedures and otherpatient care process, policies, procedures and otherdocuments, and results of self documents, and results of self --assessmentassessment
Accreditation Decision Process Accreditation Decision Process-- Each standard is scoredEach standard is scored fully met,fully met, partiallypartially
met,met, oror not met.not met.
ThreeThree -- ear accreditationyear accreditation
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Joint CommissionJoint Commission
Patient Safety StandardsPatient Safety Standards Annual FMEA (Failure Mode Annual FMEA (Failure Mode
and Effect Analysis)and Effect Analysis) Sentinel EventsSentinel Events RCA (RootRCA (Root
Cause Analysis)Cause Analysis) National Patient Safety GoalsNational Patient Safety Goals
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Joint CommissionJoint Commission
International Center for Patient SafetyInternational Center for Patient Safety http://www.jcipatientsafety.org/http://www.jcipatientsafety.org/StandardsStandardsSpeakSpeak UpTMUpTM programsprogramsSystem design and redesign, productSystem design and redesign, productsafety, safety of services, andsafety, safety of services, andenvironment of care,environment of care,
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Medical Device ErrorsMedical Device Errors(from Shepard)(from Shepard)
Estimated at about 1Estimated at about 1 --2% of total in2% of total inIOM report or less than 1000/yearIOM report or less than 1000/year
5050 --70% human error70% human error Devices, external, patient & deliberateDevices, external, patient & deliberate
DevicesDevices Ventilator, transfusion, infusion, defibrillator, Ventilator, transfusion, infusion, defibrillator,utility systems,utility systems, electrosurgeryelectrosurgery ,, trocarstrocars &&
anesthesia unitsanesthesia unitsOperating room & EROperating room & ER -- Home! Home!
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What Medical Devices Are MostWhat Medical Devices Are Most
Commonly Associated with Events? Commonly Associated with Events? Top 10 Medical DevicesTop 10 Medical Devices
1.1. Infusion PumpInfusion Pump wrong dose, infiltration, freewrong dose, infiltration, freeflowflow
2.2. Ventilators and Anesthesia systems Ventilators and Anesthesia systems breathingbreathingcircuit leaks, disconnections, failure to detectcircuit leaks, disconnections, failure to detectalarmalarm
3.3. Patient monitorsPatient monitors improper settings, alarmsimproper settings, alarms
4.4. DefibrillatorsDefibrillators lack of familiarity with deviceslack of familiarity with devices
5.5. Electrosurgical units and lasersElectrosurgical units and lasers fires due tofires due toexcessive oxygen and improper preparationsexcessive oxygen and improper preparationsproceduresprocedures
6.6. HeartHeart --lung bypass unitslung bypass units failure to detect leaksfailure to detect leaks
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What Medical Devices Are MostWhat Medical Devices Are Most
Commonly Associated with Events?Commonly Associated with Events?Top 10 Medical DevicesTop 10 Medical Devices
(continued(continued
):):
7. Catheters and7. Catheters and needlestick needlestick prevention devicesprevention devices shearing duringshearing duringinsertion of catheter, and failure toinsertion of catheter, and failure touseuse needlestick needlestick prevention devicesprevention devices
8.8. TrocarsTrocars and staplersand staplers improperimproperuseuse
9.9. EndoscopyEndoscopy equipmentequipment issues ofissues ofcontamination during endoscopecontamination during endoscopecleaningcleaning
10. MRI10. MRI ferrous metal objectsferrous metal objectsentering MRI suiteentering MRI suite
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U. S. National OrganizationsU. S. National OrganizationsFocused on SafetyFocused on Safety
Food and Drug AdministrationFood and Drug Administration Center for Devices and RadiologicalCenter for Devices and Radiological
HealthHealth http://www.fda.gov/cdrh/http://www.fda.gov/cdrh/
Device approvalDevice approvalRecallsRecalls Example Alert:Example Alert: More Patient DeathsMore Patient Deaths
fromfrom Luer Luer Misconnections Misconnections Design ofDesign of luerluer connectors makes it easyconnectors makes it easyfor unrelated delivery systems to befor unrelated delivery systems to be
connected to each other, sometimes withconnected to each other, sometimes withdisastrous resultsdisastrous results
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FDA FDA Video Video webcastwebcastMisconnectionsMisconnections
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U. S. National OrganizationsU. S. National OrganizationsFocused on SafetyFocused on Safety
MEDSUNMEDSUN Pilot program for FDA Pilot program for FDA Adverse event reporting Adverse event reportinghttp://http:// www.medsun.netwww.medsun.net
Occupational Health and SafetyOccupational Health and Safety Administration Administration
Health Facility WorkersHealth Facility Workershttp://www.osha.gov/SLTC/healthcarefacilities/index.htmlhttp://www.osha.gov/SLTC/healthcarefacilities/index.html
f e t y
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U. S. National OrganizationsU. S. National OrganizationsFocused on SafetyFocused on Safety
ECRI InstituteECRI Institute www.ecri.orgwww.ecri.orgFree Medical Device Safety ResourcesFree Medical Device Safety Resources Safety Precautions in the MR EnvironmentSafety Precautions in the MR Environment Improper Use of Helical Tacks Can HarmImproper Use of Helical Tacks Can Harm
PatientsPatients Sharps Safety andSharps Safety and Needlestick Needlestick PreventionPrevention
Bed Rail SafetyBed Rail Safety White Paper: Event ReportingWhite Paper: Event Reporting Proactive Hazard Analysis and Health Care PolicyProactive Hazard Analysis and Health Care Policy BariatricsBariatrics Risk AssessmentRisk Assessment
http://www.ecri.org/http://www.ecri.org/http://www.ecri.org/Documents/Patient_Safety_Center/hazard_MRI_080601.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/hazard_MRI_080601.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/Hazard_Helical_Tacks_20040801.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/Hazard_Helical_Tacks_20040801.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/Hazard_Helical_Tacks_20040801.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/Hazard_Helical_Tacks_20040801.pdfhttp://www.ecri.org/Products/Pages/Sharps_Safety_Needlestick_Prevention.aspx?sub=Worker%20and%20Environmental%20Safetyhttp://www.ecri.org/Products/Pages/Sharps_Safety_Needlestick_Prevention.aspx?sub=Worker%20and%20Environmental%20Safetyhttp://www.ecri.org/Products/Pages/Sharps_Safety_Needlestick_Prevention.aspx?sub=Worker%20and%20Environmental%20Safetyhttp://www.ecri.org/Products/Pages/Sharps_Safety_Needlestick_Prevention.aspx?sub=Worker%20and%20Environmental%20Safetyhttp://www.ecri.org/Products/Pages/Sharps_Safety_Needlestick_Prevention.aspx?sub=Worker%20and%20Environmental%20Safetyhttp://www.ecri.org/Products/Pages/Sharps_Safety_Needlestick_Prevention.aspx?sub=Worker%20and%20Environmental%20Safetyhttp://www.ecri.org/Documents/Patient_Safety_Center/BedSafetyClinicalGuidance.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/BedSafetyClinicalGuidance.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/Event_Reporting_White_Paper.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/Event_Reporting_White_Paper.pdfhttp://www.milbank.org/reports/Proactive/020925Proactive.htmlhttp://www.milbank.org/reports/Proactive/020925Proactive.htmlhttp://www.ecri.org/Documents/Patient_Safety_Center/RMRep1005.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/RMRep1005.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/RMRep1005.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/RMRep1005.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/RMRep1005.pdfhttp://www.milbank.org/reports/Proactive/020925Proactive.htmlhttp://www.ecri.org/Documents/Patient_Safety_Center/Event_Reporting_White_Paper.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/BedSafetyClinicalGuidance.pdfhttp://www.ecri.org/Products/Pages/Sharps_Safety_Needlestick_Prevention.aspx?sub=Worker%20and%20Environmental%20Safetyhttp://www.ecri.org/Documents/Patient_Safety_Center/Hazard_Helical_Tacks_20040801.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/Hazard_Helical_Tacks_20040801.pdfhttp://www.ecri.org/Documents/Patient_Safety_Center/hazard_MRI_080601.pdfhttp://www.ecri.org/ -
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U. S. National OrganizationsU. S. National OrganizationsFocused on SafetyFocused on Safety
ACCE Healthcare Technology Foundation ACCE Healthcare Technology Foundation http://www.accehttp://www.acce --htf.org/htf.org/
Anesthesia Patient Safety Foundation Anesthesia Patient Safety Foundation
http://www.apsf.org/http://www.apsf.org/Premier Safety InstitutePremier Safety Institute http://www.premierinc.com/safety/http://www.premierinc.com/safety/
University of Chicago CognitiveUniversity of Chicago CognitiveTechnologies LabTechnologies Lab
http://http:// www.ctlab.orgwww.ctlab.org / /
a f e t y
http://www.acce-htf.org/http://www.acce-htf.org/http://www.acce-htf.org/http://www.acce-htf.org/http://www.acce-htf.org/http://www.acce-htf.org/http://www.apsf.org/http://www.apsf.org/http://www.premierinc.com/safety/http://www.premierinc.com/safety/http://www.ctlab.org/http://www.ctlab.org/http://www.ctlab.org/http://www.ctlab.org/http://www.ctlab.org/http://www.premierinc.com/safety/http://www.apsf.org/http://www.acce-htf.org/ -
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U. S. Patient SafetyU. S. Patient SafetyMovement ProgressMovement Progress
The 100,000 Lives CampaignThe 100,000 Lives Campaign3000 participating hospitals3000 participating hospitals6 interventions6 interventions
medication reconciliation to prevent adverse drug events andmedication reconciliation to prevent adverse drug events andreduction of centralreduction of central --lineline--associated bloodstream infectionsassociated bloodstream infections
The 100,000 Lives Campaign had exceeded its 18The 100,000 Lives Campaign had exceeded its 18 --month goal of preventing 100,000 deathsmonth goal of preventing 100,000 deaths Donald Berwick, CEO of the Institute for HealthcareDonald Berwick, CEO of the Institute for Healthcare
ImprovementImprovement
Premier, Inc., an alliance of nonprofit hospitals andPremier, Inc., an alliance of nonprofit hospitals andhealthcare systems, announced that its 3healthcare systems, announced that its 3 --yearyeardemonstration project with the Centers fordemonstration project with the Centers for
Medicare and Medicaid Services is resulting inMedicare and Medicaid Services is resulting inbetter care at lower costs.better care at lower costs.
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The Next Ten Years?The Next Ten Years?From a culture of reporting incidents to oneof learning from incidents;From an accounting approach that tabulatesevents to a synthetic approach thatsearches for patterns;From looking backward at past events tolooking forward in anticipation of future
risks;From a focus on error to a focus oncomplexity.
Authors: David Woods and Richard Cook Authors: David Woods and Richard Cook
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