clark safety in hc monday 14 30

7/29/2019 Clark Safety in HC Monday 14 30

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CURSOEOFICIN

ADETRABALHOSOBREGERENCIAMENTODERISCOESEGUR

CURSOEOFICIN

ADETRABALHOSOBREGERENCIAMENTODERISCOESEGURANANAEMSA

AEMSADEDE

Sao

Pau

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5

7,

2007

Safety in HealthcareSafety in Healthcare

Tobey Clark, MSEE, CCETobey Clark, MSEE, CCE

University of VermontUniversity of Vermont

USAUSAAcknowledgement to AHTF Clinical Alarms Task Force and FletcherAcknowledgement to AHTF Clinical Alarms Task Force and FletcherAllen Health CareAllen Health Care


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57

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AgendaAgenda Hour 2Hour 2

Clinical engineeringClinical engineering

Example patient safety improvementExample patient safety improvementprojectproject

ACCE Healthcare Technology FoundationACCE Healthcare Technology Foundation

Clinical Alarms Management and IntegrationClinical Alarms Management and Integration

Hospital safety programsHospital safety programs

GeneralGeneral Environment of Care focusEnvironment of Care focus

Medical Equipment SafetyMedical Equipment Safety

ManagementManagement

Example teaching hospital programExample teaching hospital program


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Impact Of ClinicalImpact Of ClinicalAlarms On PatientAlarms On Patient

SafetySafety

American College of Clinical EngineeringAmerican College of Clinical Engineering

Healthcare Technology FoundationHealthcare Technology Foundation

(AHTF)(AHTF)


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Limitations of clinical alarmLimitations of clinical alarm

systemssystems

Difficulty in learning more thanDifficulty in learning more than 66 different alarmdifferent alarm

signalssignals

Surgery and ICU environment >>Surgery and ICU environment >> 66 different alarmsdifferent alarms

Difficulty in discerning between high and lowDifficulty in discerning between high and lowpriority alarmspriority alarms

Perceived urgency of alarms may not be consistentPerceived urgency of alarms may not be consistent

with criticality of situationwith criticality of situation Better safe than sorryBetter safe than sorrymentality increases the numbermentality increases the number

of alarms included in devicesof alarms included in devices

Some devices do not need alarmsSome devices do not need alarms

more problems than benefitsmore problems than benefits


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Limitations of clinical alarmLimitations of clinical alarm

systemssystems

99.4% of the alarms were determined99.4% of the alarms were determined

to be false with less than 1% of allto be false with less than 1% of allalarms resulting in a change of patientalarms resulting in a change of patient

management.management.

American Journal of Emergency Medicine, 2006American Journal of Emergency Medicine, 2006

False alarms/nuisance alarmsFalse alarms/nuisance alarms

ProceduresProcedures Patient conditionsPatient conditions

DesignDesign High falseHigh false--positive ratespositive rates loss of credibilityloss of credibility disabling of alarms by medical personneldisabling of alarms by medical personnel


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Reported Clinical AlarmReported Clinical Alarm

problemsproblemsEnvironmentalEnvironmental

Too muchToo muchbackground noisebackground noise

Competing alarmsCompeting alarms

Poor design of facilityPoor design of facility

Patient conditionPatient condition

MaintenanceMaintenance Alarm failureAlarm failure

InterconnectsInterconnects

defectivedefective

DesignDesign

Alarms can beAlarms can bedefeated/turned offdefeated/turned off

False positive alarmsFalse positive alarms Patient conditionPatient condition

Poor designPoor design

Alarm tones andAlarm tones anddisplays notdisplays notrecognizedrecognized

Poor human factorsPoor human factorsdesigndesign

Poor inte rationPoor inte ration


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Reported Clinical AlarmReported Clinical Alarm

problemsproblemsCare managementCare management No response to alarmsNo response to alarms

Attending other patientsAttending other patients

IgnoredIgnored

Confused as to sourceConfused as to source Volume off or set too lowVolume off or set too low

Alarm not set correctlyAlarm not set correctly

Priority of alarm notPriority of alarm notrecognizedrecognized

Training inadequateTraining inadequate

Staffing inadequateStaffing inadequate

Over reliance on alarmOver reliance on alarmsystemssystems


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FDA MAUDE Database ReviewFDA MAUDE Database Review

The FDA MAUDE database was queriedThe FDA MAUDE database was queried

(2002(2002--2004) using search terms:2004) using search terms:alarmalarmin the Product Problem fieldin the Product Problem field

deathdeathas the Event Type selectionas the Event Type selection

237237 reports were foundreports were found

Of 139 events that could be analyzed:Of 139 events that could be analyzed: 58 (42%) were related to operator education and58 (42%) were related to operator education and

trainingtraining

67 (48%) were related to work67 (48%) were related to work

conditions or personal problemsconditions or personal problems


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Deaths by YearDeaths by Year


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2007

Joint CommissionJoint Commissions Alarms Alarm--Safety GoalSafety Goal

Sentinel Event AlertSentinel Event Alert February 26, 2002February 26, 2002

Ventilator incidents related to clinical alarmsVentilator incidents related to clinical alarms National Patient Safety Goals for 2003 and 2004National Patient Safety Goals for 2003 and 2004

Maintenance and care managementMaintenance and care management

Focus on alarmFocus on alarm--safety was effective in:safety was effective in: Raising awareness of deaths and injuries that occur due toRaising awareness of deaths and injuries that occur due to

ineffective alarms and inappropriate alarm useineffective alarms and inappropriate alarm use

Promoting a better understanding of the importance ofPromoting a better understanding of the importance ofeffective alarm management strategieseffective alarm management strategies

Despite the two year focus on alarm improvement,Despite the two year focus on alarm improvement,

clinical alarm managementclinical alarm managementstill requires attentionstill requires attention


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2007

Design StandardsDesign Standards IEC 60601IEC 60601--11--88

General requirements for alarm systemsGeneral requirements for alarm systems

Only focused alarm standardOnly focused alarm standard

Defines visual and audible alarm signals that can beDefines visual and audible alarm signals that can beused to prioritize degree of urgencyused to prioritize degree of urgency

Not widely implemented in the U.S.Not widely implemented in the U.S.

Some devices have the option to employ the IECSome devices have the option to employ the IEC--defined alarm tonesdefined alarm tones

Adopted by the FDA as a reference standardAdopted by the FDA as a reference standard

Current AAMI/ANSI standardsCurrent AAMI/ANSI standards Do not address the need for prioritization ofDo not address the need for prioritization of

alarms emitted from different devicesalarms emitted from different devices

Alarms are generally handled on aAlarms are generally handled on adevicedevice--specific basisspecific basis


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2007

Clinical Alarm SurveyClinical Alarm Survey

The survey was completed by 1,327The survey was completed by 1,327individualsindividuals

Nearly all from acute care hospitalsNearly all from acute care hospitals

Over half of respondents wereOver half of respondents were

Registered Nurses (RNRegistered Nurses (RNs)s) OneOne--third from critical care unitsthird from critical care units

2/3rds had more than 11 years of2/3rds had more than 11 years ofexperienceexperience


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Clinical Alarm Survey:Clinical Alarm Survey:

Results SummaryResults Summary

Biggest issue:Biggest issue:False Alarms andFalse Alarms andNuisance AlarmsNuisance Alarms

Reduce attention and responseReduce attention and response

Disrupt care and reduce trust in alarmsDisrupt care and reduce trust in alarms

The majority support:The majority support:

Smart alarmsSmart alarmsand alarm integrationand alarm integrationsystemssystems

Not reported as significant:Not reported as significant:Alarm trainingAlarm training


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ObservationsObservations The number and complexity of alarm systems inThe number and complexity of alarm systems in

critical care environments challenge human limits forcritical care environments challenge human limits forrecognition and actionrecognition and action

Alarms in critical care environments may notAlarms in critical care environments may not

significantly affect care management decisionssignificantly affect care management decisions

Alarms are a tool in assessing patient conditionsAlarms are a tool in assessing patient conditions Should be used inShould be used in conjunctionconjunctionwithwithdirect clinical measurements anddirect clinical measurements and

observationsobservations

Disagreement about the role of user operation ofDisagreement about the role of user operation ofalarm systems in alarm system performancealarm systems in alarm system performance

False alarmsFalse alarms -- consistently reported as a major issueconsistently reported as a major issue

y


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ObservationsObservations

If well designed, remote alarm communicationIf well designed, remote alarm communication

devices can be of valuedevices can be of value Problems occurred when used as primary alert methodProblems occurred when used as primary alert method

The IEC/ISO standards are viewed by many as a wayThe IEC/ISO standards are viewed by many as a wayto improve alarms by:to improve alarms by:

Standardizing audible and visual alarmsStandardizing audible and visual alarms

Priority and parameter differentiationPriority and parameter differentiation

The alarm problem is aThe alarm problem is a systemssystemsissue and actionsissue and actions

toward specific areas must consider their impact ontoward specific areas must consider their impact onthethe systemsystem

y


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Actions to Improve AlarmsActions to Improve AlarmsDesignDesign

Smart alarmsSmart alarms

IntegrationIntegration

StandardsStandards

Usability/human factorsUsability/human factors

Care managementCare management

Process changeProcess change

TrainingTraining

Monitoring (rounds)Monitoring (rounds)

Use best practice guidesUse best practice guides

EnvironmentalEnvironmental Better design of facilitiesBetter design of facilities

Monitoring (rounds)Monitoring (rounds)

CommunicationCommunication

Alarm integration toAlarm integration topager, cell phone, etc.pager, cell phone, etc.

Clinical engineeringClinical engineering Evaluate purchased itemsEvaluate purchased items

for usabilityfor usability

Test alarms in theirTest alarms in their

environmentenvironment Software setup/testingSoftware setup/testing

y


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Healthcare RecommendationsHealthcare Recommendations

Review and revise existing policies related to clinical alarmReview and revise existing policies related to clinical alarmmanagement:management:

Use of defaults, changing of alarm limits, expected clinicalUse of defaults, changing of alarm limits, expected clinicalresponses to alarm conditions, & considerresponses to alarm conditions, & consider

institutional/departmental standardizationinstitutional/departmental standardization

Perform frequent clinical alarm monitoring rounds, to alertPerform frequent clinical alarm monitoring rounds, to alertusers to any variations from unit specific guidelinesusers to any variations from unit specific guidelines

Develop audit tools to measure compliance with establishedDevelop audit tools to measure compliance with establishedpolicies related to clinical alarm managementpolicies related to clinical alarm management

Develop and complete a checklist associated with clinical alarmDevelop and complete a checklist associated with clinical alarmmanagement and document compliance at shift changemanagement and document compliance at shift change

Conduct inConduct in--service and simulation training associatedservice and simulation training associated

with new equipmentwith new equipment

Improve device alarms evaluation prior to purchaseImprove device alarms evaluation prior to purchase

y

Industry/StandardsIndustry/Standards


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Industry/StandardsIndustry/Standards

RecommendationsRecommendations

The medical device industry must focus onThe medical device industry must focus on

reduction of false alarmsreduction of false alarms Accurate parameter recognitionAccurate parameter recognition

Smart alarms employing advanced signalSmart alarms employing advanced signal

processing, event recognition andprocessing, event recognition andparameter/alarm integrationparameter/alarm integration

Usability/human factors designUsability/human factors design

Consider the scientific basis and value of theConsider the scientific basis and value of theIEC 60601IEC 60601--11--8 standards8 standards PrioritizationPrioritization

AnnunciationAnnunciation Audible and VisualAudible and Visual

y

H lth T h lH lth T h l


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Healthcare TechnologyHealthcare Technology

Management and Patient SafetyManagement and Patient Safety

PatientPatient

SafetySafety

Government Maintenanceproviders

EquipmentUsers

Constructors,manufacturers,

Vendors

HealthcareProviders

Public,

Patients

ty


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Healthcare Integrated ProgramHealthcare Integrated Program

Risk ManagementRisk Management

Safety ManagementSafety Management

Employee SafetyEmployee Safety

Environmental SafetyEnvironmental Safety

Patient SafetyPatient Safety

QualityQuality

BenchmarkBenchmark

MeasureMeasure

ImproveImprove

ty


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Healthcare Safety IssuesHealthcare Safety Issues

BloodborneBloodborne

PathogensPathogens

Infection ControlInfection Control

Electrical SafetyElectrical Safety Chemical SafetyChemical Safety

Radiation SafetyRadiation Safety Fire safetyFire safety

Laser SafetyLaser Safety

ty


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Safety Structure in the HospitalSafety Structure in the Hospital


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ety Healthcare TechnologyHealthcare Technology


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Healthcare TechnologyHealthcare Technology

Patient Safety ActivitiesPatient Safety Activities

LIFE CYCLELIFE CYCLE Patient safety monitoring, reporting, and actionsPatient safety monitoring, reporting, and actions

Care managementCare management

EducationEducation MaintenanceMaintenance

FacilitiesFacilities

Adverse event investigationAdverse event investigation

Root cause analysisRoot cause analysis

ActionAction

EducationEducation

ety


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Healthcare Institution/SystemHealthcare Institution/System

Efforts to Improve Patient SafetyEfforts to Improve Patient Safety

Assessment/Acquisition ReviewAssessment/Acquisition ReviewHuman Factors Design/UsabilityHuman Factors Design/UsabilityResearchResearch

RiskRisk--based inspectionsbased inspections

EducationEducation

Recall/alert systemRecall/alert system

RootRoot--cause analysis of incidents &cause analysis of incidents &near missesnear misses

Systems SolutionsSystems Solutions

ety


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Hospital SafetyHospital Safety

CommitteesCommittees

Environment of Care CommitteeEnvironment of Care Committee Focused on seven areas of safetyFocused on seven areas of safety

Safety, Security, Hazardous Materials,Safety, Security, Hazardous Materials,

Emergency, Fire, Utilities, andEmergency, Fire, Utilities, and MedicalMedicalEquipmentEquipment

Work based on continuous qualityWork based on continuous quality

improvement and the need to meetimprovement and the need to meetregulatory, accreditation and standardsregulatory, accreditation and standards

Joint CommissionJoint Commission

ety


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Environment ofEnvironment of

Care CommitteeCare Committee

Meets monthlyMeets monthly

Chair, Vice President for Support ServicesChair, Vice President for Support Services

Leaders from all seven areasLeaders from all seven areas

Also Patient Safety, Infection Control,Also Patient Safety, Infection Control,Nursing, Safety Specialist, EducationNursing, Safety Specialist, Education

Quarterly reports by each areaQuarterly reports by each area

Monthly reports by Clinical EngineeringMonthly reports by Clinical Engineeringon Recalls and Alertson Recalls and Alerts

FAHC = Fletcher Allen Health Care; Burlington VT USAFAHC = Fletcher Allen Health Care; Burlington VT USA

fety


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Medical Equipment ManagementMedical Equipment Management

Joint Commission International Standard

fety


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Medical Equipment ManagementMedical Equipment Management

Joint Commission International Standard

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Medical EquipmentMedical Equipment

ManagementManagement Program Scope:Program Scope:

The Medical Equipment Management PlanThe Medical Equipment Management Planis intended to outline practices,is intended to outline practices,

procedures and systems related to theprocedures and systems related to theuse and support for equipment utilized inuse and support for equipment utilized inpatient care. The plan is intended topatient care. The plan is intended toguide, identify, evaluate and improve theguide, identify, evaluate and improve theprocesses associated with creating a safeprocesses associated with creating a safeand secure environment for all peopleand secure environment for all peopleutilizing the services of Fletcher Allenutilizing the services of Fletcher AllenHealth Care.Health Care.

fety

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ManagementManagement Subcommittee Objectives:Subcommittee Objectives:

Oversee the identification and evaluation of allOversee the identification and evaluation of allmedical equipment at the time of procurement,medical equipment at the time of procurement,prior to utilization at FAHC.prior to utilization at FAHC.

Ensure the maintenance of an equipmentEnsure the maintenance of an equipmentinventory to control, track, maintain, andinventory to control, track, maintain, andmanage all direct patient care equipment.manage all direct patient care equipment.

Review maintenance strategies includingReview maintenance strategies including

inspection intervals to minimize the clinical andinspection intervals to minimize the clinical andphysical risks to patients and staff posed byphysical risks to patients and staff posed bymedical equipment.medical equipment.

Assist/support in the education of staff toAssist/support in the education of staff to

properly operate and use medical equipment.properly operate and use medical equipment.

afety

M di l E iM di l E i t


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ManagementManagement Subcommittee Objectives:Subcommittee Objectives:

Ensure the development and utilization ofEnsure the development and utilization of

methods to identify and report equipmentmethods to identify and report equipment

management problems, failures and user errors.management problems, failures and user errors.

Ensure FAHC complies with Safe Medical DevicesEnsure FAHC complies with Safe Medical Devices

Act (SMDA) requirements.Act (SMDA) requirements.

Meet compliance guidelines related to JointMeet compliance guidelines related to Joint

Commission EC.6.10, 6.20, and HR.2.20.Commission EC.6.10, 6.20, and HR.2.20.

Meet compliance guidelines of patient safetyMeet compliance guidelines of patient safety

goals impacting medical equipmentgoals impacting medical equipment

afety

M di l E i tM di l E i t


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ManagementManagement Basic 2007 Subcommittee Goals:Basic 2007 Subcommittee Goals:

Maintain consolidation of existing medicalMaintain consolidation of existing medicalequipment inventories to include Philips Multiequipment inventories to include Philips Multi--vendor Services, and medical equipmentvendor Services, and medical equipment

supported by contracted/purchased services.supported by contracted/purchased services. Review and propose changes to the MedicalReview and propose changes to the Medical

Equipment Management Plan and maintain anEquipment Management Plan and maintain aninstitution wide Medical Equipment Managementinstitution wide Medical Equipment ManagementPolicy.Policy.

Using the risk assessment process establish anUsing the risk assessment process establish anequipment priority to define/justify preventiveequipment priority to define/justify preventive

maintenance and recurring inspectionmaintenance and recurring inspectionrequirements.requirements.

afety



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ManagementManagement Basic 2007 Subcommittee Goals:Basic 2007 Subcommittee Goals:

Educate equipment users regarding PMEducate equipment users regarding PMrequirements, recurring inspection requirements,requirements, recurring inspection requirements,proper methods for taking equipment out ofproper methods for taking equipment out ofservice when damaged or inoperable, and assistservice when damaged or inoperable, and assist

with rewith re--education of staff/supervisors oneducation of staff/supervisors onequipment when user error appears to be theequipment when user error appears to be thecausative factor of equipment nonperformance.causative factor of equipment nonperformance.

Oversee, coordinate, and provide writtenOversee, coordinate, and provide writtenresponse, to all medical equipment recalls andresponse, to all medical equipment recalls andJCAHO reported or FAHC identified sentinelJCAHO reported or FAHC identified sentinelevents involving medical equipment.events involving medical equipment.

Provide technical consultation and support toProvide technical consultation and support tomedical equipment selection committeesmedical equipment selection committees

afety



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ManagementManagementSpecific 2007 Subcommittee Goals & Targets:Specific 2007 Subcommittee Goals & Targets:

Complete recall notification and closureComplete recall notification and closureimprovement project in conjunction with IS,improvement project in conjunction with IS,Supply Chain, and Medical EquipmentSupply Chain, and Medical Equipment

Subcommittee.Subcommittee. Review device problems classified as DAMAGED.Review device problems classified as DAMAGED.

Develop preventative measures if found to resultDevelop preventative measures if found to resultfrom reasons outside of normal use.from reasons outside of normal use. Target:Target:

90% correct answers on the Staff Knowledgeevaluation questionevaluation question..

afety

M di l E i tMedical Eq ipment


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ManagementManagementSpecific 2007 Subcommittee Goals & Targets:Specific 2007 Subcommittee Goals & Targets:

Actively communicate with departments regardingActively communicate with departments regardinglife support equipment PM/inspections andlife support equipment PM/inspections andimprove device access protocols.improve device access protocols. Target: 100%Target: 100%PM/inspection on Life Support devices.PM/inspection on Life Support devices.

Assist the Safety Education Committee inAssist the Safety Education Committee indeveloping clinical alarms education modules.developing clinical alarms education modules.Target: Module developmentTarget: Module development

Continue to support the Selection and AcquisitionContinue to support the Selection and Acquisitionprocess especially related to the project toprocess especially related to the project toreplace infusion devices.replace infusion devices.

Monitor, review and improve on quality indicatorsMonitor, review and improve on quality indicators

for maintenance, use, education,for maintenance, use, education,regulatory/accreditation compliance, and safety ofregulatory/accreditation compliance, and safety ofmedical devicesmedical devices

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Management SubcommitteeManagement SubcommitteeRECENT AGENDA:RECENT AGENDA:

1.1. Acceptance of previous meeting minutesAcceptance of previous meeting minutes2.2. Recall reviewRecall review

Recall system improvement updateRecall system improvement update

3.3. Performance indicatorsPerformance indicators

4.4. Alarms assessmentAlarms assessment5.5. Clinical equipment incident followClinical equipment incident follow--up and reportingup and reporting

Discussion about Safe Reporting changesDiscussion about Safe Reporting changes

6.6. JCAHO/CMS ReadinessJCAHO/CMS Readiness

7.7. Specific device issuesSpecific device issues Device damage reductionDevice damage reduction Infusion device replacement project updateInfusion device replacement project update

Staff education knowledge improvementStaff education knowledge improvement

ThermometersThermometers variability between techniquesvariability between techniques

8.8. New businessNew business

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Management ReportingManagement Reporting

Corrective Work Order Counts by Work Order Type

(04/01/06 - 6/30/07 by Quarter)

0

100

200

300

400

500

6/30/06 9/30/06 12/31/06 3/31/07 6/30/07

Quarter Ending

Wo

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Maintenance

Random

Use Error

Damaged

No Problem Found

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Corrective Work Order Counts Detail(04/01/06 - 6/30/07 by Quarter)

0

20

40

60

80

100

120

140

6/30/06 9/30/06 12/31/06 3/31/07 6/30/07

Quarter Ending

Wo

rkOrderCounts

Maintenance

Use Error

Damaged

No Problem Found

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User Error and No Problem Found Work Orders By Dev ice Type 4/1/07 -6/30/07

(Excludes Dev ices With Inv entory Count


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Damaged Work Orders By Device Type 4/1/07-6/30/07(Excludes Devices With Inventory Count


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q pq p

Management Reporting:Management Reporting:

RecallsRecallsNew Contact

Date

Description Priority Action Status

Philips

Information

Centers

Letter

dated July

2007

It is possible for a

networked

Information Center to

incorrectly associate

one patients 12-lead

capture with multiplepatients on

Information Centers

connected to the

same database server.

High Contact Philips for software

upgrade. While awaiting

software correction, use

Interim operation

procedures to avoid this

problem.

PENDING: Philips

Medical Systems

contacted. Awaiting

information on software

correction.

Medtronic

LifePak 500Automated

External

Defibrillators

August 10,

2007ECRI

AEDs with software

version 4.4 andbelow may deliver a

shock of 100J when

the AED set to

flexible energy

protocol. The

minimum factorydefault setting is 200J.

High AEDs need to be set to fixed

energy protocol to avoid thisproblem. Contact Medtronic

for possible software fix.

PENDING: Affected

units identified. GregWard contacted. All

LifePak 500 AEDs will

be set to fixed energy

sequence to be consitent

throughout the hospital.

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Management Reporting:Management Reporting:

RecallsRecallsExisting Contact

Date

Description Priority Action Status

Smiths, Level

1 H-1200 Fast

Flow Fluid

Warmers

June 1,

2007

ECRI

Quick reference guide

released including

warnings related to a

February 2007 recall.

Normal Verify the safety alert letter

and guide has been received.

Attach guide to all machines.

COMPLETED: Quick

reference guides attached

to units.

Acknowledgement formfaxed to Smiths Medical.

Smiths, Level

1 H-1200 Fast

Flow Fluid

Warmers

May 25,

2007

ECRI

The plastic clamp slot

door latch may break

or bend. Alarm will

occur. Related to

February 2007 recall.

High

Priority

Verify the safety alert letter

received and discontinue use

of any unit with a bent or

broken door latch.

COMPLETED:

Replacement metal door

latches received from

Smiths. Door latches

installed on units.

Acknowledgement form

faxed to Smiths Medical.

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Adverse Medical EventsAdverse Medical Events
http://seg1.mpeg/http://seg1.mpeg/http://seg1.mpeg/


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Adverse Medical EventsAdverse Medical Events

Investigative ActivitiesInvestigative Activities

DeathsDeaths Serious injuriesSerious injuries

Other injuriesOther injuries

Malfunctions which ifMalfunctions which if

repeated could cause one ofrepeated could cause one of

the abovethe above

Other close callsOther close calls

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Incident Investigation:Incident Investigation:


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Incident Investigation:Incident Investigation:

Arthroscopic IrrigatorArthroscopic Irrigator Incident: Irrigator did not stop infusingIncident: Irrigator did not stop infusing

expanding the patient shoulder joint causingexpanding the patient shoulder joint causingnerve injurynerve injury

Reporting review: Five similar incidents found inReporting review: Five similar incidents found in

FDA Maude database. ECRI reports problem withFDA Maude database. ECRI reports problem withspecific unit.specific unit.

Tool: Digital pressure meter with analog outputTool: Digital pressure meter with analog output

Analysis: Failure not reproduced. Design issueAnalysis: Failure not reproduced. Design issuefoundfound Overpressure relief set to 500mmHg,Overpressure relief set to 500mmHg,recommended is 250mmHgrecommended is 250mmHg

Recommendation: Return to manufacturer forRecommendation: Return to manufacturer for

further evaluation. In future, use irrigator withfurther evaluation. In future, use irrigator withover pressure relief set for lower valueover pressure relief set for lower value

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Test setup for irrigatorTest setup for irrigator


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Test setup for irrigatorTest setup for irrigator

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Safety, Risk and QualitySafety, Risk and Quality


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y, Q yy, Q y

Management SummaryManagement Summary Healthcare safety and reliability is worse thanHealthcare safety and reliability is worse than

many other industriesmany other industries Healthcare technology has brought both benefitsHealthcare technology has brought both benefits

and risksand risks

Specific efforts must take place to improveSpecific efforts must take place to improve

safety and reduce risksafety and reduce risk

Safety and risk are a subset of the overall qualitySafety and risk are a subset of the overall qualityimprovement in healthcareimprovement in healthcare

The Key Requirement for Change is StrongThe Key Requirement for Change is Strong

LeadershipLeadership Quality improvement, reduced risk and better safetyQuality improvement, reduced risk and better safety

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Questions

Comments

Discussion

clark safety in hc monday 14 30

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