Convergence of Convergence of Clinical Engineering and Information Technology:Clinical Engineering and Information Technology:

Trends, Opportunities & ChallengesTrends, Opportunities & Challenges

Stephen L. Grimes, FACCE FHIMSSStephen L. Grimes, FACCE FHIMSSVice President, Enterprise Resource PlanningVice President, Enterprise Resource Planning

Technology in MedicineTechnology in MedicinePresidentPresident

American College of Clinical Engineering (ACCE)American College of Clinical Engineering (ACCE)Past Chair, Medical Device Security WorkgroupPast Chair, Medical Device Security Workgroup

Health Information and Management Systems Society (HIMSSHealth Information and Management Systems Society (HIMSS))

VII Congreso de la Sociedad Cubana de BioingenierVII Congreso de la Sociedad Cubana de Bioingenieríía a Havana, Cuba Havana, Cuba –– 3 al 6 de mayo 20073 al 6 de mayo 2007

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CE & IT ConvergenceCE & IT Convergence

History of Clinical EngineeringHistory of Clinical EngineeringTrends in technologiesTrends in technologiesWhy convergence is necessaryWhy convergence is necessaryHow to make transitionHow to make transitionChallenges we faceChallenges we face

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HistoryHistoryHospitals began engaging (employing or Hospitals began engaging (employing or contracting) clinical or biomedical engineering in contracting) clinical or biomedical engineering in the 1970s as a consequence ofthe 1970s as a consequence of

proliferation of and reliance on increasing complex proliferation of and reliance on increasing complex medical equipmentmedical equipmentpopular reporting of medical equipment related safety popular reporting of medical equipment related safety issues (issues (““electrical safetyelectrical safety””))advent of JCAH (now advent of JCAH (now ““The Joint CommissionThe Joint Commission””) ) standards regarding need for routine medical standards regarding need for routine medical equipment testing equipment testing …… prospect of federal regulations prospect of federal regulations

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HistoricallyHistoricallyOn the advent of clinical engineering (30On the advent of clinical engineering (30--35 35 years ago), it was primarily thought of as a years ago), it was primarily thought of as a ““maintenancemaintenance”” function function …… i.e., something like i.e., something like 90% of CE activities were: 90% of CE activities were:

inspection & pm (i.e., checking function & safety)inspection & pm (i.e., checking function & safety)repairsrepairs

Consequently, clinical engineering was typically Consequently, clinical engineering was typically associated with:associated with:

Maintenance DeptMaintenance DeptFacilities or Plant engineeringFacilities or Plant engineering

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Today the CE Model has changedToday the CE Model has changedDiscrete Equipment Discrete Equipment

ManagementManagementTechnologyTechnologyManagementManagement

The industry is (slowly) recognizing that The industry is (slowly) recognizing that ““electrical electrical safetysafety”” is not now (nor ever really was) a major patient is not now (nor ever really was) a major patient safety problem safety problem Discrete devices today are have fewer components Discrete devices today are have fewer components subject to subject to ““wear & tearwear & tear”” (i.e., and therefore often don(i.e., and therefore often don’’t t benefit from benefit from ““preventive maintenancepreventive maintenance””) ) …… formally a 40formally a 40--50% of CE50% of CE’’s workloads workloadEffective support of medical devices today requires they Effective support of medical devices today requires they be considered as be considered as ““systemssystems”” ……. . ““systemssystems”” of devices of devices (many (many ““integratedintegrated””), people (patients & staff), ), people (patients & staff), environment, and processes. environment, and processes.

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Today the CE Model has changedToday the CE Model has changed

Management & Consulting ServicesManagement & Consulting ServicesInventory & Asset ManagementInventory & Asset ManagementStrategic PlanningStrategic PlanningQuality & SafetyQuality & SafetyRegulatory & standards complianceRegulatory & standards complianceVendor managementVendor management

Support ServicesSupport ServicesEducation (technology users & CE Education (technology users & CE staff)staff)Help DeskHelp DeskInstallation & IntegrationInstallation & IntegrationUpgradesUpgradesTesting, Inspection, Preventive Testing, Inspection, Preventive MaintenanceMaintenanceRepairRepair

Discrete Equipment Discrete Equipment ManagementManagement

TechnologyTechnologyManagementManagement

Management & Consulting ServicesManagement & Consulting ServicesInventory ManagementInventory ManagementSafetySafetyRegulatory & standards complianceRegulatory & standards compliance

Support ServicesSupport ServicesTesting, Inspection, Preventive Testing, Inspection, Preventive MaintenanceMaintenanceRepairRepair

Broadened ScopeBroadened Scope

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Today Typical Today Typical Clinical Engineering Program Clinical Engineering Program

Organization by Function / RolesOrganization by Function / Roles

Technology Consultation, Project Technology Consultation, Project Management & System PlanningManagement & System PlanningEmerging Technology Review, PreEmerging Technology Review, Pre--Acquisition Evaluation, Total Cost Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle of Ownership (TCO) & Life Cycle Cost AnalysesCost AnalysesEducation & trainingEducation & trainingCompliance (government, Compliance (government, accrediting authorities)accrediting authorities)Device Tracking (Hazards, Recalls)Device Tracking (Hazards, Recalls)Incident InvestigationIncident InvestigationContract/vendor managementContract/vendor management

Installation & configurationInstallation & configurationInspectionInspectionPreventive MaintenancePreventive MaintenanceCalibrationCalibrationRepairRepairInservice training of staff (often Inservice training of staff (often impromptu)impromptu)

Communications (client interface)Communications (client interface)Bookkeeping Bookkeeping

–– Accounts Payable & ReceivableAccounts Payable & Receivable–– Payroll & Benefits ManagementPayroll & Benefits Management

CorrespondenceCorrespondenceFilingFilingData entryData entryReportingReporting

Clinical Engineers Biomedical Equipment Technicians Administrative Staff

SafetyCommittee

Healthcare Technology Management (Clinical Engineering)Program Manager (Dir of Clinical Engineering)

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Growing Trends Growing Trends -- Changes in Medical TechnologyChanges in Medical TechnologyMoving from Discrete Devices to integrated Moving from Discrete Devices to integrated ““SystemsSystems””

Medical devices and systems are being designed Medical devices and systems are being designed and operated as special purpose computers and operated as special purpose computers ……more features are being automated, increasing more features are being automated, increasing amounts of medical data are being collected, amounts of medical data are being collected, analyzed and stored in these devicesanalyzed and stored in these devices

There has been a rapidly growing integration There has been a rapidly growing integration and interconnection of disparate medical (and and interconnection of disparate medical (and information) technology devices and systems information) technology devices and systems where medical data is being where medical data is being increasingly exchangedincreasingly exchanged

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A Consequence of TrendsA Consequence of TrendsLeading to Convergence of Leading to Convergence of

not only Technologies but also Associated Professionsnot only Technologies but also Associated Professions

ClinicalEngineering

InformationTechnology

Telecommunications

HistoricallyHistoricallyBusiness, Business, Finance (Billing),Finance (Billing),ADTADT

HistoricallyHistoricallyPatient Safety,Patient Safety,Compliance,Compliance,Testing,Testing,RepairRepair

HistoricallyHistoricallyTelephone,Telephone,PagingPaging

Convergence Convergence …… or aor a perfect storm?perfect storm?

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“People” Challenges to Overcome in Convergence

Complacency

Turf

Culture

Ignorance

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ChallengesChallengesReconciling Traditional Differences Reconciling Traditional Differences

Between Clinical Information & Information TechnologiesBetween Clinical Information & Information Technologies

Clash of culturesClash of culturesClinical Engineering is patient Clinical Engineering is patient centriccentric

structure is geared toward structure is geared toward response time in minutes/hoursresponse time in minutes/hoursemphasis on patient safetyemphasis on patient safetyinnovationinnovation

IT is systems centricIT is systems centricstructure is geared toward structure is geared toward response time in hours/daysresponse time in hours/daysemphasis on integrity of data & emphasis on integrity of data & processesprocessesrulesrules

Medical Devices & SystemsMedical Devices & SystemsLIFE LIFE

CRITICALCRITICAL

MISSION MISSION CRITICALCRITICAL

IT SystemsIT Systems

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Successful Convergence RequiresRecognizing & Encouraging Key Synergies

As an ever-increasing percentage of biomedical technology integrates or networks with computer components, a synergistic relationship is possible and desirable between healthcare IT and the Biomedical / CE programs.

Synergies come from Biomedical / CE ‘s intuitive understanding of the medical device – patient dynamic and the

IT personnel’s understanding of computer hardware and information processing concepts.

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Convergence of Technologies Inevitable Ultimately Success Depends Cooperation &

Coordination Between Key Stakeholders

In today’s highly “connected” environment, medical technology can only be addressed by bringing the expertise of clinical engineering and information technology professions together in a team effort.

Both professions need to coordinate their efforts and develop strategic solutions at the industry as well as the local (e.g., institution) level.

Increasingly, effective coordination is leading to the formal integration of departments and a crossing over of skill sets

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Moving toward Convergence As long as CE and IT departments remain separate entities

Establish regular lines of communication and cooperation at their management and technical levels. Biomedical and information technologies are inextricably entwined and only grow more so.

Cooperate to ensure that technical issues do not “fall through the cracks,” that new technologies are effectively adopted and supported, and that there is appropriate cross-training between staff

As CE and IT departments merge into a Healthcare Technology Management Service …

Identify overlaps & gaps in skills, resources, technologies

Fill gaps as necessary, realign skill sets, resources & technologies

Cross-pollinate (i.e., learn from each other)

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Considerations for Considerations for SuccessfulSuccessful Convergence Convergence ……

ClinicalEngineering

InformationTechnology

Telecommunications

Convergence of Convergence of Integrated Technologies Integrated Technologies

…… or aor a perfect storm?perfect storm?The Healthcare Technology The Healthcare Technology ““TentTent””

Distinctive Distinctive ……but under one strategic & collaborative Healthcare Technology Dobut under one strategic & collaborative Healthcare Technology Domainmain

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Our Mission

To apply engineering, technical, and To apply engineering, technical, and managerial expertise to the imanagerial expertise to the identification, acquisition and support of safe, effective, and safe, effective, and economical technology as needed by this economical technology as needed by this institution for patient care, teaching, research, institution for patient care, teaching, research, and community serviceand community service

ClinicalEngineering

InformationTechnology

Physicians, Nurses Physicians, Nurses & other Providers& other Providers PatientPatient

OurOurFOCUSFOCUS

Additional Technical Additional Technical ChallengesChallenges

Why we need to Why we need to ““get it rightget it right””and some ideas on and some ideas on ““howhow””

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ChallengesChallengesSignificant Medical Device Industry Trends and ImplicationsSignificant Medical Device Industry Trends and Implications

The number of integrated & The number of integrated & networked medical device networked medical device systems is rapidly proliferating systems is rapidly proliferating

And our dependence on the And our dependence on the clinical information maintained clinical information maintained and transmitted by systems for and transmitted by systems for effective & timely diagnosis effective & timely diagnosis and treatment is likewise and treatment is likewise increasing increasing

This dependence on This dependence on integrated systems can have integrated systems can have major implications on our major implications on our ability to deliver patient care ability to deliver patient care and on our business and on our business operations if those systems operations if those systems should failshould fail

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ChallengesChallengesConvergence & Integration Increases Security VulnerabilitiesConvergence & Integration Increases Security Vulnerabilities

i.e. increased opportunities for compromising i.e. increased opportunities for compromising data integrity, availability & confidentialitydata integrity, availability & confidentiality

Clinician withClinician withAuthorized AccessAuthorized Access

PatientPatient Central Station

Data Integrity

Data Confidentiality

Data Availability

Physiologic Monitor

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ChallengesChallengesIntegrated Systems are particularly vulnerable toIntegrated Systems are particularly vulnerable to

Single Points of Failure (SPOF)Single Points of Failure (SPOF)

Network servers and related infrastructure Network servers and related infrastructure components are a likely SPOF for a variety components are a likely SPOF for a variety of clinical systemsof clinical systems

SPOFSPOF

PatientPatient

StaffStaff

An SPOF is any part of a system (e.g., person, component or An SPOF is any part of a system (e.g., person, component or device) whose individual failure will cause the entire (or a device) whose individual failure will cause the entire (or a

substantial portion of the) clinical system to failsubstantial portion of the) clinical system to fail

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Supporting Changes and Challenges in Supporting Changes and Challenges in AmericaAmerica’’s Healthcare Systems Healthcare System

Clinicians, Clinical Engineering & Information Technology must navigate a vast Sea of Healthcare Technologies

Sea of Healthcare TechnologiesIcebergs of Vulnerability

- associated with growing number individual “critical” integrated clinical systems

TechnicalForces

FinancialForces

RegulatoryForces

SocialForces

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Supporting Changes and Challenges in Supporting Changes and Challenges in AmericaAmerica’’s Healthcare Systems Healthcare System

Critical Integrated Clinical Systems will fail Critical Integrated Clinical Systems will fail …… and some failures will result in and some failures will result in significant economic loss and compromised patient care significant economic loss and compromised patient care The number, frequency and severity of clinical system failures dThe number, frequency and severity of clinical system failures depends on epends on clinical engineeringclinical engineering’’s ability to develop and provide a service that can identify s ability to develop and provide a service that can identify vulnerabilities and put appropriate safeguards in place to minimvulnerabilities and put appropriate safeguards in place to minimize the number ize the number & effects of those failures& effects of those failures

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WhatWhat’’s Happening?s Happening?How Are Gaps Evolving?How Are Gaps Evolving?

The Integration of Medical Devices & Information SystemsThe Integration of Medical Devices & Information SystemsLeading to Evolution of Critical GapsLeading to Evolution of Critical Gaps

Integrated medical device systems often come in Integrated medical device systems often come in ““under the under the radarradar”” as theyas they

grow up from within clinical departments by connecting existing grow up from within clinical departments by connecting existing individual medical devices and networking them to serversindividual medical devices and networking them to serversare acquired as new medical device systems without full are acquired as new medical device systems without full consideration given to their inherent vulnerabilities and the imconsideration given to their inherent vulnerabilities and the implication plication of their failure on continuity of patient careof their failure on continuity of patient care

“A system here … a system there …”Last year a preliminary inventory revealed that my institution had at least 80 medical system servers and I predicted given trends in technologies and the institution’s needs that number will likely double in the next 12 to 24 months … a subsequent inventory 12 months later revealed 140 servers

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ChallengesChallengesAvoiding Pitfalls that represent Avoiding Pitfalls that represent

Probable Difference between Success & FailureProbable Difference between Success & Failure

We treat as a collection ofWe treat as a collection ofisolated systems & incidentsisolated systems & incidents

We treat as a series of related We treat as a series of related systems & events requiring systems & events requiring

a a strategicstrategic approachapproach

OROR

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One Approach toward ConvergenceOne Approach toward ConvergenceCoordinator for Clinical Systems Integration & Infrastructure SuCoordinator for Clinical Systems Integration & Infrastructure Supportpport

A A ““Clinical Systems EngineerClinical Systems Engineer””

Key element of a solution .. Description of new function Key element of a solution .. Description of new function ……Maintains current inventory of networked and integrated Maintains current inventory of networked and integrated medical systems (including catalog of services, features, medical systems (including catalog of services, features, interconnections)interconnections)Coordinates security management process including risk Coordinates security management process including risk (e.g., criticality & probability) and vulnerability analysis and(e.g., criticality & probability) and vulnerability analysis andrelated documentation associated with related documentation associated with interconnected/integrated medical systemsinterconnected/integrated medical systemsCoordinates with stakeholders a process to prioritize, Coordinates with stakeholders a process to prioritize, develop and implement plan to manage/mitigate identified develop and implement plan to manage/mitigate identified risks associated with interconnected/integrated medical risks associated with interconnected/integrated medical systems by applying appropriate administrative, physical & systems by applying appropriate administrative, physical & technical safeguardstechnical safeguards

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One Approach toward Convergence One Approach toward Convergence Coordinator for Clinical Systems Integration & Infrastructure SuCoordinator for Clinical Systems Integration & Infrastructure Supportpport

A A ““Clinical Systems EngineerClinical Systems Engineer””

Description of new function (continued) Description of new function (continued) ……Maintains the integrity of FDA approval for Maintains the integrity of FDA approval for interconnected/integrated medical systemsinterconnected/integrated medical systemsWorks with stakeholders to insure effective deployment, Works with stakeholders to insure effective deployment, integration, and support of new medical systems into integration, and support of new medical systems into legacy systems and nonlegacy systems and non--medical elements of the medical elements of the organizationorganization’’s information infrastructure. s information infrastructure.

Works to assure systems are deployed into an optimum Works to assure systems are deployed into an optimum (i.e., secure & supportive) environment. (i.e., secure & supportive) environment. Continually reviews system components to determine Continually reviews system components to determine which are obsolete or otherwise no longer adequately which are obsolete or otherwise no longer adequately supportable and then supportable and then Plans for and implements component Plans for and implements component upgrades/replacement in a timely manner.upgrades/replacement in a timely manner.

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One Approach toward Convergence One Approach toward Convergence Coordinator for Clinical Systems Integration & Infrastructure SuCoordinator for Clinical Systems Integration & Infrastructure Supportpport

A A ““Clinical Systems EngineerClinical Systems Engineer””Description of new function (continued) Description of new function (continued) ……

Identifies and manages appropriate software upgrades, Identifies and manages appropriate software upgrades, security patches and antisecurity patches and anti--virus installs for virus installs for interconnected/integrated medical systems according to interconnected/integrated medical systems according to industry best practicesindustry best practicesConducts Root Cause Analysis (RCA) and Failure Mode Conducts Root Cause Analysis (RCA) and Failure Mode Effects Analysis (FMEA) on incidents involving integrated Effects Analysis (FMEA) on incidents involving integrated medical systems and reports findings to appropriate medical systems and reports findings to appropriate stakeholders for followstakeholders for follow--up actionup actionMonitors and adopts industry Monitors and adopts industry ““Best PracticesBest Practices”” to insure to insure integrity, availability & confidentiality of data maintained andintegrity, availability & confidentiality of data maintained andtransmitted across interconnected and integrated medical transmitted across interconnected and integrated medical systemssystemsEducates stakeholders on security and other implications Educates stakeholders on security and other implications associated with the proliferation of interconnected and associated with the proliferation of interconnected and integrated medical technologies.integrated medical technologies.

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One Approach toward ConvergenceOne Approach toward ConvergenceCoordinator for Clinical Systems Integration & Infrastructure SuCoordinator for Clinical Systems Integration & Infrastructure Supportpport

A A ““Clinical Systems EngineerClinical Systems Engineer””

Stakeholders the new function / role works with Stakeholders the new function / role works with ……Informatics (including network support, disaster Informatics (including network support, disaster recovery)recovery)Clinicians (system users including physicians, nurses, Clinicians (system users including physicians, nurses, technologists, etc)technologists, etc)Medical system manufacturers/vendorsMedical system manufacturers/vendorsRisk managementRisk managementInformation Security Information Security Medical procurementMedical procurementClinical engineeringClinical engineering

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New!

New! Future Clinical Engineering Programs:Future Clinical Engineering Programs:Organization by Function / RolesOrganization by Function / Roles

Clinical EngineersBiomedical

Equipment Technicians Administrative Staff

SafetyCommittee

Healthcare Technology Management (Clinical Engineering)Program Manager (Dir of Clinical Engineering)

Strategic planning, deployment & testing of integrated systems (new & legacy) and associated configurations & processInventory & tracking of clinical systems (including catalog of services, features & interconnections)

Design & maintain support infrastructures that are secure, scalable, flexible, robust, manageableSecurity management

– criticality & probability assessment

– vulnerability analysis– develop, prioritize and

implement plan to mitigate risks

– upgrade/patch management

Technology Consultation, Project Management & System PlanningEmerging Technology Review, Pre-Acquisition Evaluation, Total Cost of Ownership (TCO) & Life Cycle Cost AnalysesEducation & trainingCompliance (government, accrediting authorities)Device Tracking (Hazards, Recalls)Incident InvestigationContract/vendor management

Installation & configurationInspectionPreventive MaintenanceCalibrationRepair

Communications (client interface)Bookkeeping

– Accounts Payable & Receivable

– Payroll & Benefits Management

CorrespondenceFilingData entryReporting

Clinical Systems Engineers

Technology Strategic Planning Committee

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Gartner ResearchGartner Research

A wellA well--known & respected research group known & respected research group that advises clients on predicted that advises clients on predicted implications of ITimplications of IT--related trends in a variety related trends in a variety of different industries (e.g., financial, of different industries (e.g., financial, manufacturing, healthcare, etc)manufacturing, healthcare, etc)A recent (Nov A recent (Nov ’’05) prediction (05) prediction (controversialcontroversial))““By 2009, 50 percent of healthcare By 2009, 50 percent of healthcare providers will move biomedical device providers will move biomedical device management under the CIOmanagement under the CIO””

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““By 2009, 50 percent of healthcare providers By 2009, 50 percent of healthcare providers will move biomedical device management will move biomedical device management

under the CIOunder the CIO”” …… Gartner Research (Nov Gartner Research (Nov ’’05)05)

Key FindingsKey Findings::Biomedical devices increasingly require network support and Biomedical devices increasingly require network support and interoperability with electronic medical record systems.interoperability with electronic medical record systems.Potential network vulnerabilities and infrastructure demands Potential network vulnerabilities and infrastructure demands of biomedical devices must be anticipated and managedof biomedical devices must be anticipated and managed..Progressive convergence of biomedical device planning and Progressive convergence of biomedical device planning and support within the office of the CIO is inevitable; executive support within the office of the CIO is inevitable; executive management needs to orchestrate a smooth transition.management needs to orchestrate a smooth transition.

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““By 2009, 50 percent of healthcare providers By 2009, 50 percent of healthcare providers will move biomedical device management will move biomedical device management

under the CIOunder the CIO”” …… Gartner Research (Nov Gartner Research (Nov ’’05)05)Market ImplicationsMarket Implications::

Biomedical device management needs to be included within the CIOBiomedical device management needs to be included within the CIO's 's strategic, purchasing and operational oversight. strategic, purchasing and operational oversight. Biomedical devices use Biomedical devices use embedded computer technology and often require network accessembedded computer technology and often require network access. . Too often, IT becomes involved after the fact, when a problem suToo often, IT becomes involved after the fact, when a problem surfaces. rfaces.

The inability to scan or patch a device is a vulnerability, and The inability to scan or patch a device is a vulnerability, and biomedical devices biomedical devices can add to the demand for widespread network accessibility and bcan add to the demand for widespread network accessibility and bandwidth. andwidth. The extensive interoperability of biomedical devices with electrThe extensive interoperability of biomedical devices with electronic medical onic medical record systems is a second trigger for convergencerecord systems is a second trigger for convergence. .

Electronic medical record systems can reduce documentation time Electronic medical record systems can reduce documentation time by by capturing data directly from medical devices. capturing data directly from medical devices. The electronic medical record The electronic medical record system is also an early warning device that can fire critical trsystem is also an early warning device that can fire critical trend alerts end alerts based on ifbased on if--then logic and complex multivariable algorithms with biomedical then logic and complex multivariable algorithms with biomedical devices as key data sources. devices as key data sources. When When biomedical device biomedical device –– electronic medical recordelectronic medical record problems arise, clinical problems arise, clinical users shouldn't have to know whether it's the device, the interfusers shouldn't have to know whether it's the device, the interface, the ace, the network or the electronic medical records system to call technicnetwork or the electronic medical records system to call technical support. al support.

Questions?Questions?

Thank You!

Stephen L. Grimes, FACCE FHIMSS

SLGrimes@ACCEnet.org

Stephen.Grimes@TechMed.LincFS.com