Clinical Alarms Clinical Alarms Improvement InitiativeImprovement Initiative

Tobey Clark, MS, CCE, Tobey Clark, MS, CCE, Director, Director, InstrInstr. & Tech. . & Tech. SrvsSrvs. & . & Faculty, Biomedical Engineering University of VermontFaculty, Biomedical Engineering University of Vermont

&&YadinYadin B. David, Ph.D., B. David, Ph.D., Director, Biomedical Director, Biomedical

Engineering Department, Texas Children’s HospitalEngineering Department, Texas Children’s Hospital

4th Annual Conference for MedSun RepresentativesOctober 7, 2005

What is an alarm?What is an alarm?

Alarm definitionAlarm definitionA method to alert care providers to situations A method to alert care providers to situations that require urgent attention and might have that require urgent attention and might have been missed due to distractions and/or system's been missed due to distractions and/or system's limitation and/or use error. limitation and/or use error. (adopted from Human (adopted from Human Factors and Medical devices by H.J.Factors and Medical devices by H.J.MurffMurff, J.H., J.H.GosbeeGosbee& D.W.Bates).& D.W.Bates).

HistoryHistory

Clinical alarms problematic since the first Clinical alarms problematic since the first medical devices were introducedmedical devices were introducedECRI ECRI -- Health Devices Health Devices

First hazard reports on clinical alarms failures in the First hazard reports on clinical alarms failures in the July 1974 issue related to three hyper/hypothermia July 1974 issue related to three hyper/hypothermia incidents incidents

operators not responding to the high temperature warning lightoperators not responding to the high temperature warning light

ASTM standard includes alarms design ASTM standard includes alarms design -- 19791979

Alarm source and recognitionAlarm source and recognition

Humans have difficulty to reliably recognize Humans have difficulty to reliably recognize more than 6 alarms at one time (Stanton, 1994)more than 6 alarms at one time (Stanton, 1994)Sound specific alarms were correctly identified Sound specific alarms were correctly identified by OR personnel (M.D.s, R.N.s, technicians) in by OR personnel (M.D.s, R.N.s, technicians) in various studies between 33various studies between 33--54% of the time. 54% of the time. ((WestenskowWestenskow, 1993), 1993)Poor alarm design, application or setting Poor alarm design, application or setting contributed to false positive alarms reported in 2 contributed to false positive alarms reported in 2 studies between 72studies between 72--75% of all alarms in routine 75% of all alarms in routine general anesthesia. (general anesthesia. (WestenskowWestenskow, 1993), 1993)

Other alarm issuesOther alarm issues

58% of anesthesia staff surveyed stated their patients 58% of anesthesia staff surveyed stated their patients were placed at risk due to source of alarm not being were placed at risk due to source of alarm not being able to be identified (Griffith, 1992)able to be identified (Griffith, 1992)Alarms contribute to stress in anesthesia practice Alarms contribute to stress in anesthesia practice (Griffith, 1992)(Griffith, 1992)Some devices should not have audible alarms! (Some devices should not have audible alarms! (DellerDeller, , 1992)1992)Past manufacturer’s mantra: “Better safe than sorry” Past manufacturer’s mantra: “Better safe than sorry” led to an increase in number of alarms, volume and led to an increase in number of alarms, volume and degree of irritation (Stanton, 1994)degree of irritation (Stanton, 1994)

Clinical Alarm problemsClinical Alarm problems

System DesignSystem Design

System PerformanceSystem Performance

OperatorOperator

EnvironmentEnvironment

Reported Clinical Alarm problemsReported Clinical Alarm problemsCare managementCare management

No response to alarmsNo response to alarmsAttending other patientsAttending other patientsIgnoredIgnoredConfused as to sourceConfused as to sourceVolume off or set too lowVolume off or set too low

Alarm not set correctlyAlarm not set correctlyPriority of alarm not recognizedPriority of alarm not recognizedTraining inadequateTraining inadequateStaffing inadequateStaffing inadequateOver reliance on alarm systemsOver reliance on alarm systems

Reported Clinical Alarm problemsReported Clinical Alarm problems

EnvironmentalEnvironmentalToo much background Too much background noisenoiseCompeting alarmsCompeting alarmsPoor design of facilityPoor design of facilityPatient conditionPatient condition

MaintenanceMaintenanceAlarm failureAlarm failureInterconnects defectiveInterconnects defective

DesignDesignAlarms can be Alarms can be defeated/turned offdefeated/turned offFalse positive alarmsFalse positive alarms

Patient conditionPatient conditionPoor designPoor design

Alarm tones and displays Alarm tones and displays not recognizednot recognizedPoor human factors Poor human factors designdesignPoor integrationPoor integration

Actions to Improve AlarmsActions to Improve Alarms

DesignDesignSmart alarmsSmart alarmsIntegrationIntegrationStandardsStandardsUsability/human factorsUsability/human factors

Care managementCare managementProcess changeProcess changeTrainingTrainingMonitoring (rounds)Monitoring (rounds)Use best practice guidesUse best practice guides

EnvironmentalEnvironmentalBetter design of facilitiesBetter design of facilitiesMonitoring (rounds)Monitoring (rounds)CommunicationCommunication

Alarm integration to Alarm integration to pager, cell phone, etc.pager, cell phone, etc.

Clinical engineeringClinical engineeringEvaluate purchased Evaluate purchased items for usabilityitems for usabilityTest alarms in their Test alarms in their environmentenvironmentSoftware setup/testingSoftware setup/testing

Efforts to study and Efforts to study and improve clinical alarmsimprove clinical alarms

National organizationsNational organizations

AssociationsAssociations

Standards groupsStandards groups

Accreditation organizationsAccreditation organizations

ECRIECRILong history of investigating clinical alarm Long history of investigating clinical alarm problems and recommending system solutionsproblems and recommending system solutionsProblems still exist: Problems still exist:

breathing circuit disconnects, alarms turned off, breathing circuit disconnects, alarms turned off, inappropriate alarm settings, miscommunication of alarminappropriate alarm settings, miscommunication of alarm--paging systemspaging systemsAACN/ECRI Survey: 29% of nurses not trained in alarm AACN/ECRI Survey: 29% of nurses not trained in alarm managementmanagement

Excellent guidance informationExcellent guidance informationCritical Alarms and Patient Safety Critical Alarms and Patient Safety ECRIECRI’’ss Guide to Guide to Developing Effective Alarm Strategies and Developing Effective Alarm Strategies and Responding to JCAHOResponding to JCAHO’’s Alarms Alarm--Safety GoalSafety Goal, Health , Health Devices, ECRI, Volume 31, Number 11, November 2002, Devices, ECRI, Volume 31, Number 11, November 2002, pg. 397pg. 397--413413

Anesthesia Patient Anesthesia Patient Safety Foundation (Founded 1984)Safety Foundation (Founded 1984)Focus on Patient SafetyFocus on Patient Safety

Much work on technology issuesMuch work on technology issuesClinical Alarms InitiativeClinical Alarms Initiative

The APSF Board of Directors' Workshop, The APSF Board of Directors' Workshop, October 2004October 2004

APSF Recommendation Regarding Audible Alarms

“When the pulse oximeter is utilized, the variable pitch pulse tone and the low threshold alarm must be audible.”

“When capnography is utilized, a capnograph alarm for hypoventilation must give an audible signal.”

National Patient Safety FoundationNational Patient Safety Foundation

NPSF Awards First Patient Safety Research NPSF Awards First Patient Safety Research Grants 1999Grants 1999

"Auditory Warning Signals in Critical Care Settings", "Auditory Warning Signals in Critical Care Settings", YanYan Xiao, PhD of the University of MarylandXiao, PhD of the University of Maryland

http://www.npsf.org/html/research/1998award2.http://www.npsf.org/html/research/1998award2.htmlhtmlListserveListserve activity on clinical alarmsactivity on clinical alarms

VA National Center VA National Center for Patient Safetyfor Patient Safety

Wealth of information Wealth of information Systems approach to problemsSystems approach to problems

Root cause analysis, usability, human factors… Root cause analysis, usability, human factors…

Sample systems solutions to alarms managementSample systems solutions to alarms managementReported problem on alarm integration system Reported problem on alarm integration system wireless alert failure wireless alert failure –– systems approach to systems approach to resolutionresolution

VA National Center for Patient Safety VA National Center for Patient Safety http://www.http://www.patientsafetypatientsafety..govgov//

Association for the Advancement of Association for the Advancement of Medical InstrumentationMedical Instrumentation

Health Technology Horizons Health Technology Horizons Summer 05Summer 05::Five Steps to Integrated Alarm Management:Five Steps to Integrated Alarm Management:

Improving Clinical Decision Making andImproving Clinical Decision Making and

Patient Safety”Patient Safety” , Michael McLean, CEO , Michael McLean, CEO EmerginEmergin

Biomedical Instrumentation & Technology Biomedical Instrumentation & Technology Sept/Oct 05Sept/Oct 05

Is the Warning Effective? Clinical AlarmsIs the Warning Effective? Clinical Alarms

Remain an Area for Patient Safety ImprovementRemain an Area for Patient Safety Improvement, , Tobey Clark, Univ. of VermontTobey Clark, Univ. of Vermont

Hospital Information & Hospital Information & Management Systems Society Management Systems Society

(HIMSS)(HIMSS)Increasing number of medical devices Increasing number of medical devices attached to the networkattached to the network

Hospital networks used for clinical purposesHospital networks used for clinical purposesAlarm integration systems Alarm integration systems

HIMSS 2005 Annual MeetingHIMSS 2005 Annual Meeting

Patient Care Devices Patient Care Devices -- Focus on Alarm Integration Focus on Alarm Integration and Interoperability, and Interoperability, Elliot Sloane, PhD, Assistant Elliot Sloane, PhD, Assistant Professor of Information Systems, Villanova University Professor of Information Systems, Villanova University

American Society for American Society for Testing and MaterialsTesting and Materials

Committee F29.15 on Harmonization of AlarmsCommittee F29.15 on Harmonization of AlarmsStandard Specification for Alarm Signals in Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Medical Equipment Used in Anesthesia and Respiratory Care Respiratory Care

ASTM #FASTM #F--14631463--93 (Re93 (Re--approved 1999)approved 1999)Anesthesia and Respiratory equipment onlyAnesthesia and Respiratory equipment only

International Organization for International Organization for Standardization (ISO)Standardization (ISO)

International International ElectrotechnicalElectrotechnicalCommission (IEC)Commission (IEC)

IEC 60601-1-8, Medical electrical equipment – Part 1-8:

General requirements for safety – Collateral Standard: Alarm systems -- requirements, tests and guidelines – General requirements and guidelines for alarm systems in medical electrical equipment and in medical electrical systems

JCAHO Clinical Alarms EffortsJCAHO Clinical Alarms Efforts

Sentinel Event Alert •Sentinel Event Alert • February 26, 2002February 26, 200223 reports of deaths or injuries related to long term 23 reports of deaths or injuries related to long term ventilationventilation----19 events resulted in death and four in 19 events resulted in death and four in coma. coma. Of the 23 cases, 65 percent were related to the Of the 23 cases, 65 percent were related to the malfunction or misuse of an alarm or an inadequate malfunction or misuse of an alarm or an inadequate alarm alarm

JCAHO Clinical Alarms EffortsJCAHO Clinical Alarms Efforts

Patient Safety Goal 6 Patient Safety Goal 6 -- Improve the Improve the effectiveness of clinical alarm systems.effectiveness of clinical alarm systems.

6A: 6A: Implement regular preventive maintenance and testing of Implement regular preventive maintenance and testing of alarm systems.alarm systems.6B: 6B: Assure that alarms are activated with appropriate Assure that alarms are activated with appropriate settings and are sufficiently audible with respect to distances settings and are sufficiently audible with respect to distances and competing noise within the unit.and competing noise within the unit.

Goal implemented in hospitals July 2002 thru Goal implemented in hospitals July 2002 thru July 2004 July 2004 –– dropped, now part of standarddropped, now part of standard

http://www.jcaho.org/accredited+organizations/patienthttp://www.jcaho.org/accredited+organizations/patient+safety/npsg.htm+safety/npsg.htm (see Implementation Expectations)(see Implementation Expectations)

Are Clinical Alarms Still a Problem?Are Clinical Alarms Still a Problem?FDA Maude Database ReviewFDA Maude Database Review

0

10

20

30

40

50

60

70

80

90

100

2001 2002 2003 2004

Alarm-relateddeaths *

•• Reports of deaths Reports of deaths and injuriesand injuries showed an increase in showed an increase in

reports from 189 in 2001 to 449 in 2004reports from 189 in 2001 to 449 in 2004

* Maude problem description includes the term alarm

ACCE Healthcare ACCE Healthcare Technology FoundationTechnology Foundation

Mission:Mission:Improving healthcare delivery by promoting the Improving healthcare delivery by promoting the development and application of safe and effective development and application of safe and effective healthcare technologies through the global healthcare technologies through the global advancement of clinical engineering research, advancement of clinical engineering research, education, practice and their related activitieseducation, practice and their related activities

AHTF website: AHTF website: http://www.http://www.acceacce--htfhtf.org/.org/

ACCE Healthcare ACCE Healthcare Technology FoundationTechnology Foundation

Major initiatives:Major initiatives:Public Awareness of safety issues associated Public Awareness of safety issues associated with healthcare technologieswith healthcare technologiesClinical Engineering CertificationClinical Engineering Certification

Clinical Engineering Excellence AwardClinical Engineering Excellence Award

Clinical Alarms Management and IntegrationClinical Alarms Management and Integration

Purpose: Clinical Alarms InitiativePurpose: Clinical Alarms Initiative

To improve patient safety by To improve patient safety by identifying issues and opportunities for identifying issues and opportunities for enhancements in clinical alarm design, enhancements in clinical alarm design, operation, response, communication, operation, response, communication, and appropriate actions to reduce and appropriate actions to reduce alarmalarm--related events. related events.

AHTF Task Force AgendaAHTF Task Force AgendaAudio Conferences, Town Meetings and Audio Conferences, Town Meetings and ForumsForums

ACCE Audio Conference in June 2005 ACCE Audio Conference in June 2005 –– 91 lines 91 lines called incalled in

Develop a survey for clinical and support staffDevelop a survey for clinical and support staffGrass roots awareness Grass roots awareness –– local, regional, nationallocal, regional, nationalResearch clinical alarm related incidentsResearch clinical alarm related incidentsDevelop educational materialsDevelop educational materials

Website Website http://www.accehttp://www.acce--htf.org/clinical.htmlhtf.org/clinical.html

White PaperWhite Paper

AHTF Clinical AHTF Clinical Alarms Project Task Force Alarms Project Task Force

Jennifer Jennifer OttOtt, CCE, Director , CCE, Director –– Clinical Clinical Engineering, St. Louis University Engineering, St. Louis University HospitalHospitalThomas Thomas BauldBauld, PhD, Technology , PhD, Technology Manager, Riverside Health Systems, Manager, Riverside Health Systems, ARAMARK/CTSARAMARK/CTSBryanneBryanne M. M. PatailPatail, BS, MLS, FACCE, , BS, MLS, FACCE, Biomedical Engineer, US Department Biomedical Engineer, US Department of Veterans Affairs, National Center of Veterans Affairs, National Center for Patient Safetyfor Patient SafetyIzabellaIzabella A. A. GierasGieras, MS, MBA, Clinical , MS, MBA, Clinical Engineering Manager, Beaumont Engineering Manager, Beaumont Services CompanyServices CompanyMarvin Shepard, PE, DEVTEQMarvin Shepard, PE, DEVTEQPaul Frisch Paul Frisch Director, Biomedical Engineering Director, Biomedical Engineering Memorial SloanMemorial Sloan--Kettering Cancer Kettering Cancer CenterCenter

Frank Painter, Director, Technology Frank Painter, Director, Technology Management Solutions LLC, Assistant Management Solutions LLC, Assistant Professor, University of ConnecticutProfessor, University of ConnecticutWilliam Hyman, PhD, Professor, William Hyman, PhD, Professor, Biomedical Engineering, Texas A&M Biomedical Engineering, Texas A&M UniversityUniversityJames Keller, Director, Health Devices James Keller, Director, Health Devices Group, ECRIGroup, ECRIMatt Matt BaretichBaretich, PE, PhD, President, , PE, PhD, President, BaretichBaretich EngineeringEngineeringWayne Morse, MSBME, President, Wayne Morse, MSBME, President, Morse BiomedicalMorse BiomedicalCoCo--chair: chair: Tobey Clark, Director, Tobey Clark, Director, Instrumentation & Technical Services, Instrumentation & Technical Services, University of VermontUniversity of VermontCoCo--chair: chair: YadinYadin David, PhD, Director David, PhD, Director of the Biomedical Engineering of the Biomedical Engineering Department at Texas Children's Department at Texas Children's HospitalHospital

AAMI Town Meeting on AAMI Town Meeting on Clinical AlarmsClinical Alarms

May 2005 in Tampa May 2005 in Tampa –– 90+ attendees90+ attendeesKey pointsKey points

An alarm management plan should be developed based An alarm management plan should be developed based on recommendations from a multion recommendations from a multi--disciplinary teamdisciplinary teamConsider the IEC standard for alarm sound Consider the IEC standard for alarm sound characteristics and display/colorcharacteristics and display/colorWe can not train our way out of the alarm problemWe can not train our way out of the alarm problemHospital design and environment mattersHospital design and environment mattersWe have to look back at what is the purpose of the We have to look back at what is the purpose of the alarmalarm

Town Meeting on Clinical AlarmsTown Meeting on Clinical AlarmsConsensus Vote: Consensus Vote: What should be the area of focus to What should be the area of focus to

improve clinical alarms management and integration?improve clinical alarms management and integration?Design Design –– 35% of attendees35% of attendeesIntegration Integration –– 50% 50% Care management Care management -- >50%>50%Standards Standards -- >50%>50%

All agreed that the clinical alarms problem is a All agreed that the clinical alarms problem is a system issuesystem issue

AHTF Clinical Alarms Survey ToolAHTF Clinical Alarms Survey ToolDemographicsDemographics

Type of facility and locationType of facility and locationJob type and experienceJob type and experience

Questions Questions –– Strongly AgreeStrongly Agree-- Strongly DisagreeStrongly DisagreeDesign, Standards, Environment, Care management, Design, Standards, Environment, Care management, IntegrationIntegration

Rating as to primary versus secondary issuesRating as to primary versus secondary issuesComment field Comment field Survey results to date:Survey results to date:

337 Surveys completed by 146 RN’s, 8 MD’s, 19 Clinical 337 Surveys completed by 146 RN’s, 8 MD’s, 19 Clinical Managers, 90 CE/Managers, 90 CE/BMETsBMETs and other support staffand other support staffSurvey will run until the end of NovemberSurvey will run until the end of NovemberResults available in 2006Results available in 2006

Collaborative OrganizationsCollaborative OrganizationsMedSunMedSun –– Social & Scientific SystemsSocial & Scientific SystemsAORN AORN -- Assoc. of Assoc. of periOperativeperiOperative Registered NursesRegistered NursesAACN AACN –– Amer. Assoc. of CriticalAmer. Assoc. of Critical--care Nursescare NursesECRI ECRI –– Emergency Care Research InstituteEmergency Care Research InstituteACCE ACCE -- American College of Clinical EngineeringAmerican College of Clinical EngineeringMETA META –– Medical Equipment & Technology Assoc.Medical Equipment & Technology Assoc.AAMI AAMI –– Association for the Advancement for Medical Association for the Advancement for Medical InstrumentationInstrumentationNECES NECES –– New England Clinical Engineering SocietyNew England Clinical Engineering SocietyVirginia Biomedical SocietyVirginia Biomedical SocietySupporting publications: 24x7, J. of Clinical Engineering, Supporting publications: 24x7, J. of Clinical Engineering, Biomedical Safety & Standards, AACN NewsletterBiomedical Safety & Standards, AACN Newsletter

Support the Clinical Support the Clinical Alarms Initiative Alarms Initiative

Be part of the task force or provide inputBe part of the task force or provide inputTobey.clark@uvm.eduTobey.clark@uvm.eduybdavidybdavid@@TexasChildrensHospitalTexasChildrensHospital.org.org

Make staff aware of the survey Make staff aware of the survey Online: Online: http://www.http://www.acceacce--htfhtf.org/.org/

Survey link isSurvey link is http://www.survey monkey.com/s.asp?u=339221233056http://www.survey monkey.com/s.asp?u=339221233056

Fax in paper survey or mailFax in paper survey or mailAHTF AHTF 5200 Butler Pike 5200 Butler Pike Plymouth Meeting, PA 19461Plymouth Meeting, PA 19461--1298 1298

Build awareness and develop solutions in your organizationsBuild awareness and develop solutions in your organizations

THANK YOU!THANK YOU!

QUESTIONS?QUESTIONS?