20 April, 2013The Ritz-Carlton

Doha, Qatar

Enterprise-Wide Medical Device IntegrationFirst CIS Qatar International Conference

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The majority of clinical data originates from biomedical devices. For maximum efficiency, data quality and

timeliness of data, the acquisition of biomedical device data must be automated.

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ConnectivityWorkflow automation through the integration of medical devices and information systems

InteroperabilityThe ability of two or more systems or components to exchange information and to use the information that has been exchanged

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Manual Data AcquisitionData collected or entered late or period missed: 15 min - 8 hoursTypographical or transposition data entry errorsRight data entered into wrong patientFor nurse, entering data read off medical devices into EMRs is extra work for no value

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FunctionalityAutomatically acquires medical device data at specified periodsAcquisition period definable by patientProvides clinician validation of data when required

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BenefitsAcquired data reduces transcription and documentation errors - to zero if barcodes are used

Data immediately available once acquired

Larger volume of consistent data

Increases adoption of EMRs and CPOE

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Productivity Impact

01

23456

78

Hours

Before After

Vitals Capture Time Per Day

Documentation

Vitals Capture

Average vitals capture time = 3.79 minutesApprox. 33% of taking vitals is adminAutomating vitals saves 1.12 minute per vital eventTime saved = 28 to 38 hours per day

Source: Automating the Vitals Capture Process, Michael Phelps, 2005, VA Medical Center, Minneapolis, MN

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Improving patient care with more than $30 billion

in annual health care savings

THE VALUE OF MEDICAL DEVICE

INTEROPERABILITY:

MARCH2013

Impact on Patient OutcomesPolicy white paper evaluating impact on U.S. health care costs

Source: http://www.westhealth.org/institute/interoperability

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Connectivity Impacts

Costs resulting from redundant testing: $3 Billion

Clinician time spent manually entering data: $12.4 Billion

Increased length of stay: $17.8 Billion

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Typical WorkflowsPatient ManagementPatient ContextSchedulingOrder WorkflowData acquisitionData analysis

Clinical documentationSurveillanceMessagingData managementReport generationDevice specific workflows

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Use CasesA methodology used in systems analysis to identify, clarify workflow and organize system requirementsDay-in-the-life story, formal very structured text, flow charts, sequence charts, etc.An agreement between users and product developers regarding how a system will operate

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Use Cases Vary by Medical Device

Vital signs monitors - spot checkContinuous patient monitors - sampling of data stream Infusion pumps - limited EMR supportVentilators - limited EMR supportWorkflows for the same device can vary across clinical areas - e.g., ED, surgery, ICU or Med/Surg units

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Workflow matchesWorkflow gaps

Flexibility - configurabilityEvaluate trade-offs

ProductUse Cases

Physician Writes Medication Order

Rx Order Reviewed

Pharmacy Information

System

Pharmacist on Floor or

In Pharmacy

If paper, RPh enters into PIS and rechecked by second RPHRx Order

Rx Order Validated

Order Items Are Picked from

Inventory

PIS or Workflow

Automation Application

Formulary

Pharmacist or Tech

Using the formulary, the PIS or workflow

app generate a picklist

Nutritional Deficit Diagnosed

Patient Assessment CDSS

Physician on Floor or In

Office

Number of EMR applications vs

manual tasks will vary by site

Patient Hx

Dx Test Results

Clinical Guidelines

Physical Assessment

EMR for:Patient HxDx TestsCPOE

Resulting order can be electronic

or paper worksheet

Previous Therapy

Clinical practiceuse cases

Items Assembled for Compounding

Item's Lot Number,

Expiration Date Checked

PIS or Workflow

Automation Application

Formulary

Inventory

Pharmacist or Tech

Barcode Scanned or Written in Log

Book

Items Ready for Compounding

Medication Compounded

PIS or Workflow

Automation Application

Formulary

Tech

Artifacts Retained for Subsequent

Review

Compounded Medication

Compounded Medication

Review

Workflow Automation Application

Compounding Artifacts

Pharmacist

Inspected manually or may

use workflow application

Medication Compounding

Complete

Medication Prepared for

DeliveryPharmacist

or Tech

Place in delivery bag, affix warning

labels

Medication Delivered

Preprinted Labels

Activity Diagrams: http://en.wikipedia.org/wiki/Activity_diagram

==/13Wednesday, April 17, 13

RecommendationsDocument your workflow with use casesRequire vendors to disclose their uses casesInclude use case requirements in purchase agreements to ensure vendor compliance

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Tim Gee

Medical ConnectivityConsulting

medicalconnectivity.comTim Gee

Medical ConnectivityConsulting

Tim Gee

Medical ConnectivityConsulting

Blog at:

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Patient Management

Database of relevant patient demographicsAdd, edit and delete patients and associated dataSupports flow of patients’ contact with medical device systemData captured prior to, or at the time medical device is applied to patientAnalogs: department marker boards, dashboards

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Patient ContextAssociates medical device data with the patient attached to the deviceCreates and breaks down association with application and removal of deviceMaintains reliable association during use - wireless makes this challengingEssential step requires backup methodsBest managed at point of care

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SchedulingPatient and resource schedulingCan be time-specific or a work listPatient remindersDriven by order setOrder-specific prerequisitesComplex rules-driven scheduling algorithms

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Order WorkflowOrder initiates workflow; can initiate patient managementSpecifies how medical device is to be used Monitoring or therapy orders define device configurationDiagnostic orders define device configuration and procedureCan include establishing patient contextDependent on patient management Includes a formal end step

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Data AcquisitionMedical device data is acquiredCan be continuous, periodic or bothAcquired data can include multiple data setsCan include data annotation - both automatic and manualAcquired data is often edited for reporting or clinical documentation

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Data AnalysisProprietary algorithms extract physiological data and improve data qualityData analysis to render proposed diagnosisCan be done in embedded device or via networkCan be automated or user directed

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Clinical Documentation

EMR or procedure documentationSubset of medical device data is often usedCombination of automated or user-generated dataMay require data validation step

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SurveillanceDisplay of device data in locations beyond the medical deviceContinuous steam of data Near real time requirementHighly variable transmission distancesWide variety of client devicesImplemented as “slave” monitor or part of broader workflow

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MessagingCan include audio, text data and waveformsBroadcast or narrow cast Contextual clinical data often requiredMay require escalationMay track event driven messages to conclusionMay include complex rules-driven Wide variety of client devices

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Report Generation

Fulfillment of order workflowDiagnostic report generationProcedure documentationReport generation, review and approval workflowStructured or unstructured dataManagement reporting

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Data Management

Supports patient management and order workflowEvent reviewMay include annotation or editing of dataData queueing for review or analysisStorage and retrievalData archiving with appropriate retrievalTeaching file generationClinical trial and research support

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Device Specific Workflows

Basic templates: diagnostic, monitoring, and therapeuticDevice specific variations and combinations of preceding workflowsIV pump Drug Error Reduction Systems (DERS)QA requirements

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