The World of Connectivity –
Building a Strategy to Support
Medical Device Integration
and Alarm Management
Presented by
Izabella Gieras, MS, MBA, CCE
Jennifer Jackson, MBA, CCE
Huntington Memorial Hospital
Cedars-Sinai Medical Center
October 23, 2015
Huntington Hospital
Courtesy of Huntington Hospital
Huntington Hospital
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625 licensed beds
Bariatric & Stroke Center
Magnet Recognition
3 Davinci Robotic Systems
18 Operating Rooms (4 MIS suites)
Skills Labs
5 Cath Labs & IR Suites
9000 medical devices
Courtesy of Huntington Hospital
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280 applications
450 servers with 200+ TB storage
1000+ wireless access points
4500+ end user computing devices
300+ hospital owned smart phones
60 Clinical & Information Technology
employees
Agenda
 Background
 Healthcare Environment
 Healthcare Technology Management at Huntington Hospital &
Cedars-Sinai Health System
 Medical Device Integration
 Alarm Management
Background
Healthcare Environment
Regulatory Requirements
Patient Environment
Healthcare Technology
Management
in
Medical Device Integration
Medical Device Integration
Connectivity – the physical interconnections between
medical devices, the network, and the hardware and
software required to capture data
and make it available for use in
the Electronic Health
Record (EHR) or other
clinical applications.
www.diabetesmine.com
ECRI Institute Top 10 Health
Technology Hazards
www.ecri.org
1. Alarm Hazards: Inadequate Alarm Configuration Policies and
Practices
2. Data Integrity: Incorrect or Missing
Data in EHRs and Other
Health IT Systems
IT systems
AAMI Survey 2012
Survey of healthcare technology management professionals in 1,900
different U.S. hospitals placed interoperability issues top of the list
AAMI’s list of Top 10 Medical Device Challenges:
• Medical devices and systems on the IT network (cited by 72 % of
respondents)
• Integrating device data into electronic health records (EHRs)
(cited by 65 % of respondents)
www.aami.org
WHI (West Health Institute) Report
Improving interoperability between medical devices and EHRs in
hospitals could save more than $30 billion a year while improving
patient care and safety.
• Increased capacity for treatment as a result of shorter lengths of stay ($18
billion)
• Increased clinician productivity because of less time spent entering device
data manually into EHRs ($12 billion)
• Avoidance of redundant testing ($3 billion)
• Reduction of adverse events ($2 billion).
www.westhealth.org
WHI Report continued
• More than 90% of hospitals use six or more types of devices that could
be integrated with EHRs.
 Examples: patient monitors, defibrillators, ECG machines, vital sign
monitors, ventilators and infusion pumps.
• Yet only a third of hospitals integrate any medical devices with EHRs,
and those that do, on average, integrate only three types of devices.
 The cost of medical device integration can range from $6,500 to $10,000
per bed in one-time costs, plus up to 15% of that in annual maintenance
costs.
Business Case for Huntington Hospital
Huntington’s EHR Implementation Vision Statement
A clinical and operationally focused implementation that will
integrate business and clinical information systems to
support the goal of using technology to improve quality,
patient safety, productivity and physician alignment.
Business Case for Huntington Hospital
continued
Huntington’s EHR Partner Philosophy
Create an environment where all devices are integrated and
contextually aware to ensure the right data is present in the right
format at the right time to improve health outcomes.
Across the care continuum, medical devices contain life-critical
information. It is essential for health care providers and patients
to harness this information to make the best decisions regarding
health.
http://cerner.com/solutions/Medical_Devices/
Huntington Hospital Timeline
6/2012 – 2/2014
Implementation
2/2014 – 3/2014
Readiness & Go
Live
3/2014 – 6/2014
Stabilization
6/2014 - Today
Optimization
Beyond Today
IMPLEMENTATION
EHR Implementation Scope
 Full EHR Implementation





40+ solutions
Financial ERP
Revenue Cycle
Clinical
Physician
6/2012–2/2014
Implementation
 Complete workflow re-design with new functionality





House-wide CPOE & Physician Documentation
Bar-coded Medication Administration
Device Integration expansion (from ~30 to 200 beds)
Imaging Voice Recognition
Patient Portal
Device Integration Scope
 Wired and Wireless Physiological Monitors
 PICU: 8
 CCU: 30
 Surgery:19
 PACU:17
 ED:56
 Telemetry: 43
 Endo:3
 Anesthesia Gas Machines
 Main Surgery: 16
 L&D: 3
 Endo:1
 Angio: 1
 Cath Lab: 1
 Fetal Monitors: 30
6/2012–2/2014
Implementation
Device Integration Considerations
 Clinical needs assessment
 Device types
 Wireless vs Wired
 Software version
 Age of equipment
 Physical location
 Type of mounts
 Position
6/2012–2/2014
Implementation
EMR Device Setup
6/2012–2/2014
Implementation
Datalux device
(workstation)
CE (Connectivity
Engine) device
Device Integration Validation
 Liaison with the Anesthesiologists and clinicians
6/2012–2/2014
Implementation
 Device Validation Tool
 Spreadsheet with collected data to enable repeatability
 Test every device and every data element
 Schedule for testing
 Overnight or early hours in Surgery
 CE device and adapter tweaking
 Testing workstation
 Cheat sheet binder
 Close collaboration between CT (Clinical Technology), IT and
end users
Testing Station in CT
6/2012–2/2014
Implementation
Device Integration Validation
6/2012–2/2014
Implementation
READINESS & GO LIVE
Go Live Readiness
 End user training
2/2014 – 3/2014
Readiness &
Go Live
 Completion of Final Testing
 Mock Go Lives and Detailed Walk through of Cutover
 Multiple layers of Readiness Assessments
 Departmental Leader Readiness Assessment
 Go No Go Decision
 Steering Committee
 Board
Downtime the Night of Go Live
 Downtime was scheduled for 2 ½ hours
2/2014 – 3/2014
Readiness &
Go Live
 Downtime was actually 6 ½ hours due to issues encountered
 EHR Login issue
 PACS & Pyxis Conversion
Communication Plan
 Posters, Memo, and Tray liners (Patients & Visitors)
 Team Shirts – Teal (staff) and Grey (physician)
 Shift Change Meetings (Super users & Technical Staff)
 Leadership Touch base
 Regular Project Newsletter
 Daily Reminders to Staff
 SharePoint Communication site
 Hot Sheets – Color Coded by
Discipline
2/2014 – 3/2014
Readiness &
Go Live
STABILIZATION
Stabilization
Clinical Technology support
 Proper training to all CT staff
 Sign off before go live
 Service work flow
 Response time
 Logging calls
 Collaboration between IT, Nursing Informatics and end users
 Spare par level
 Configured datalux device
 Downtime procedures
3/2014 – 6/2014
Stabilization
Service Workflow
3/2014 – 6/2014
Stabilization
OPTIMIZATION
Optimization
 Evaluating capability for integration for all new
Clinical Technology purchases
 Questions added for the procurement of
equipment
 Assessment of available applications from EMR
vendor for overall consolidation
 Upgrades every 12-18 months
6/2014 - Today
Optimization
BEYOND TODAY
Updated Timeline
Beyond Today
2010 - 2011
Early Pilot
• Wired CCU Monitors
2012-2014
Strategy & Phase I
• Wired & Wireless
Monitors (Critical
Care Areas)
• Anesthesia Gas
Machines
• Fetal Monitors
• Blood Gas
Analyzers
• Lab Instruments
• Point of Care
Alarm Mgmt Building the
Foundation
2015
Phase I optimization
2015 
Planning for Future
• Expand Wired
&Wireless Monitors
• Vents
Alarm Mgmt Implementation
• Pumps
• Balloon Pumps
• EKG Machines
• Vital Sign Monitors
• Other Devices?
HEALTHCARE TECHNOLOGY
MANAGEMENT
IN
ALARM MANAGEMENT
Alarm Mgmt – Building the Foundation
and Beyond
What Huntington Has Done
2003
- Committee was formed in response to the initial TJC SEA on
Clinical Alarms
2013
- Formation of Clinical Alarms Management Committee
2014
- Alarms survey
- Preliminary data collection (labor intensive process)
- Invited “middleware” vendors for presentations to evaluate
strengths and shortcomings of each system
- Evaluated medical equipment inventory with clinical alarms
- Invited to the AAMI National Alarms Coalition
What Huntington Has Done cont.
2015 (completed and in progress)
- Changed alarm settings on two nursing units (case study)
- Defined critical equipment with critical alarms
- Completed a Risk Assessment tool on critical equipment
- Reviewed alarm settings for each critical equipment
- Performed a short alarm management model survey
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Update the hospital policy (addressed many 2016 deliverables)
Upgrade of all central stations/servers to PicIx
Evaluate a middleware vendor for alarm management solutions
Create and deploy educational initiatives
Prioritized technologies (monitors, vents, infusion pups, etc)
Updated alarm default settings
Rhythm
Asystole
VTach
Default
4 seconds (adjustable)
Rate >150 > 3 PVCS
Rhythm
Non Sustained VT
Ventricular Rhythm
Run PVCs
Pair PVCs
R on T PVCs
Ventricular Bigeminy
Ventricular Trigeminy
PVCs
Multiform PVCs
Pacer Not Capture
Pacer Not Pace
Missed Beat
Pause
SVT
AFib
Irregular HR
Cannot Analyze ECG
Default
On
On, >14 PVCS
On, > 2 PVCs (not adjustable)
On
On
On
On
On, >10/minute
On
On
On
On
2 seconds
On, > 150/minute, > 5 SVBs
On
On
On
Recommended Change
None
None
Recommended Change
Off
On >20 PVCS
Off
Off
Off
Off
Off
Off
Off
Off
Off
Off
None
None
None
None
None
Courtesy of Huntington Hospital
Izabella Gieras, MS, MBA, CCE
Director, Clinical Technology
Izabella.Gieras@huntingtonhospital.com
Jennifer Jackson: Introduction
Biomedical Engineer
Clinical Engineer
Hospital CE-IT Leader
Medical Device Interoperability Advocate
ACCE 2015 Professional Achievement in
Technology Award/Professional
Development Award
CIMIT Edward M. Kennedy Award for
Health Care Innovation in 2007 as
member of the Medical Device “PnP”
Interoperability Team
Cedars Sinai: Leading the Quest
Established in 1902, Cedars-Sinai Medical Center is renowned for:
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Providing the highest quality patient care
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Expanding scientific and medical knowledge through research that
benefits patients
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Educating healthcare professionals for the future
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Improving the health status of the community
Overview of Cedars Sinai
 Established in 1902 and located in Los
Angeles, California
 By the Numbers, from our 2014
Community Report:
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886 licensed beds, Level I Trauma Center
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251,803 Patient days
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630,269 Outpatient visits
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Approximately 690 per day
Approximately 1730 per day
85,305 Emergency Department visits
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Approximately 235 per day
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$43.4 million in research funding from NIH and
other federal sources

$652.6 million in total quantifiable community
benefits, including the unreimbursed cost of
caring for Medicare patients
 Primary service area includes 3.3 million
people
Cedars Sinai: Not All Our Heroes Practice Medicine
From the HIMSS Analytics Press Release:
"Cedars-Sinai is one of the most fully deployed and automated facilities we have encountered in the
HIMSS Analytics Stage 7 program. With all of their progress on device integration, including fully
integrated smart pumps, Cedars-Sinai has approached a new level of patient safety, even among
stage 7 facilities.”
-John Hoyt, executive vice president of HIMSS Analytics
CEDI Mission Statement
In close collaboration with clinicians,
administrators, and other technology
groups, Clinical Engineering and Device
Integration (CEDI) promotes quality
patient care through the appropriate and
safe use of medical device technology.
Clinical Engineering and Anesthesiologists meeting
to discuss the hardware mounting related to CSLink Anesthesia Record implementation.
Clinical Engineering and nursing working together to plan out unit
closures for the nurse call replacement.
We strive to be a center of
excellence for innovative and
robust solutions that promote
leadership in delivering
healthcare related services.
The Clinical Engineering & Device Integration Team
•Biomedical Equipment
Technicians
•Image Guided Systems
Technicians
•Clinical Systems
Specialists
•Clinical Systems
Engineers
•Project Specialists
•Administrative Staff
What Makes Us Different
in the way we manage medical device systems
Unique organizational structure
Independent department within IT
Work side-by-side with applications and
technical teams
Unique job roles
Image Guided Systems Technicians
Much more clinical than a ‘typical’ BMET,
working side by side with surgeon
during procedures to ensure the
technology is properly aligned and
functioning
Clinical Systems Specialists
Stronger IT skill set than a ‘typical’ BMET
More of the technical lifecycle within one department
Building device records in the EHR
Testing and maintaining orders/results interfaces
Project management
Technical support
System optimization
Reporting up into IT…and we are thriving…
CIO
Manager EIS
Finance
Chief
Technology
Officer
Director,
Clinical
Engineering
Chief
Application
Officer
Director, R&D
Servers, SAN
Device
Integration
EPIC
Application
support
Wearables
integration
Security
Clinical
Communication
PACS/VNA
Systems
Integration
Network
Nurse
Call/RTLS
Mobile device
team
Clinical
Engineering
New
technology
evaluation
OR Clinical
Engineering
clinical and operational benefits of technology
interoperability,
48
Director,
Research
Computing
IRB
collaboration
Director,
Business
Systems
CMMS
Peoplesoft
Snapshot of CSMC Medical Device Connectivity
Infusion Pumps
•1523 Infusion pump brains wirelessly communicate
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Within infusion pump system: used to push datasets and download logs
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With EHR: bidirectional interface; order goes to pump, flow rate and volume
goes to patient chart
Patient Monitoring
•~255 telemetry patients’ data imported to EHR (288 max – will increase in 2016)
•690 multi-parameter monitoring devices imported to EHR
•120 terminal servers in critical care areas for connection to ventilators, urimeters, CCO
monitors, BIS monitors, etc..
•85 anesthesia machine ‘systems’
•Mobile vital signs collection – data validated instantly
•Currently trialing wireless pulse oximetry devices with integration to alarm management
and EHR
Snapshot of CSMC Medical Device Connectivity
Cardiology
•35 EKG carts are wireless
•Orders/results for cath lab hemodynamic systems
•Ambulatory blood pressure system integrated (PDF report uploaded)
•Pacemaker reporting system integrated (PDF report uploaded)
Fetal monitoring
•24 Fetal monitors (LDR + Prenatal Clinic) interfaced with fetal monitoring system, then to
EHR
•Additional integration with smartphone application for near-real time remote monitoring
Alarms/Alerts
•Nurse Call alarms/patient requests– sent to smartphones
•Pulse Oximetry and some cardiac monitoring – sent to smartphones
•Medical Device (“aux”) jack in each room for technologies not ready for network
connectivity (i.e. chair exit alarm devices)
•Tele monitor based alarms managed through central monitoring, filtered
Additional Supporting Evidence on the Need for Device
Integration
For Device Integration in OR/Procedure Areas
Anesthesia Information Management Systems: A Review Of
Functionality And Installation Considerations
JM Ehrenfeld et all (2011)
Called out benefits with device integration with anesthesia information management
systems
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Specific to Positive Impact on Patient Safety
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Provision of real-time intraoperative decision support
Allows the anesthesia care team to focus on the patient, rather than recording vital signs
Better legibility and availability of historical records
More precise recording of intraoperative data & patient responses to anesthesia
Specific to positive impact on Anesthesia Practice
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•
•
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Provides precise, high-resolution records which can be used for educational purposes
Enables researchers to rapidly find rare events or specific occurrences across a large number of
cases
Facilitates individual provider performance tracking
Allows better quality assurance functionality through the creation of more complete and precise
records
Integration with other hospital databases can allow assessment of short and long term patient
outcomes
Provision of additional legal protection via the availability of unbiased, precise information
For More Automated Medication Administration
Executive Summary: the State of the Science on Safe Medication
Administration symposium.
KG Burke (2005)
Provides great summary of the problem
•It’s estimated that five medication errors occur per 100 medication administrations.
•Adverse drug events (ADEs) occur at an estimated rate of 6.5 per 100 hospital
admissions.
•One of every three ADEs related to medication errors occurs during administration.
•It has been estimated that 56% of medication errors are related to prescriptions.
•IV medications and infusion pumps are also being increasingly viewed as safety
concerns.
Quite simply put:
“Currently available smart pumps will fail to generate meaningful improvements in
patient safety until they can be interfaced with other systems such as the electronic
medical record, computerized prescriber order entry, bar coded medication
administration systems, and pharmacy information systems.”
For More Automated Medication Administration
The impact of traditional and smart pump infusion technology on nurse
medication administration performance in a simulated inpatient unit.
P Trbovich (2010)
Discusses benefits of smart pumps
• Pre-defined drug library uploaded to each pump
• Each drug has a set of limits
• Provides feedback to nurse
• Dose or infusion rate is too high or too low for that medication
• Intended to catch majority of potential programming errors
• Can catch estimated 58% of potential medication errors
Also discusses the opportunities for error
• Current state can catch only estimated 58% of potential medication errors
• Nurse can still bypass using the library (time-saving)
• Still allows for programming errors within the set limits
Anesthesia Information System & IV Pump Integration
IMPLEMENTATION ACROSS THE
ENTERPRISE: TWO CASE STUDIES
Device Integration in the OR/Procedure Areas
•91 anesthesia machines converted
•Devices integrated per machine:
o
o
o
o
o
o
Philips monitor
Anesthesia machine
BIS monitor
CCO monitor
INVOS monitor
Tangent
o Neuron (as the data concentrator)
•Total devices
integrated/communication with EPIC –
490
o 4 different configurations were
created for the different areas
All stakeholders involved with
configuration and developing technical
support model
Clinical and Technical support during
Supporting complex technology integrations
Pump Integration
IV Pump Integration went into production at Cedars-Sinai on June 7, 2014.
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All adult inpatient locations using barcoded medication administration protocols
as of January 2014
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Considered an improvement to patient safety:
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Improved our compliance with drug library use
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Reduced the frequency of reprogramming or editing the pump program
before starting an infusion
From CS-Link to IV Pump:
Drug Name, Dose, Flow Rate
From IV Pump to CS-Link:
Flow Rate, Volume Infused
Pump Integration Workgroup Structure
New pump
deployment
Interfaces
Drug
Dataset
alignment
EPIC 2012
integration
Workflow
analysis
Testing
Steering
Committee
Training
Workflows, workflows, workflows
Training and assessment
clinical and operational benefits of technology
interoperability,
61
6/7/2014
6/9/2014
6/11/2014
6/13/2014
6/15/2014
6/17/2014
6/19/2014
6/21/2014
6/23/2014
6/25/2014
6/27/2014
6/29/2014
7/1/2014
7/3/2014
7/5/2014
7/7/2014
7/9/2014
7/11/2014
7/13/2014
7/15/2014
7/17/2014
7/19/2014
7/21/2014
7/23/2014
7/25/2014
7/27/2014
7/29/2014
7/31/2014
8/2/2014
8/4/2014
8/6/2014
8/8/2014
8/10/2014
8/12/2014
8/14/2014
8/16/2014
Total Number of In-Scope Medication Orders
12,500
93%
93%
12,000
11,000
92%
91%
Pump Integration
Go-Live
June 7, 2014
91%
92%
92%
92%
92%
92%
92%
91%
91%
11,500
90%
89%
88%
88%
10,500
87%
86%
10,000
85%
Number of medication adminitrations initiated
using Pump Integration (% of total in scope)
Cedars-Sinai Pump Integration Utilization
shown as % of in-scope medication orders
94%
My “one-liner” about medical device integration
Medical Device Integration
standardizes clinical and technical
workflows. If done right, you’ve
spent more time defining the
nontechnical processes than talking
about the technology itself.
Jennifer Jackson
Director, Clinical Engineering & Device Integration
jennifer.jackson@cshs.org
@giengiakson
THANK YOU AND QUESTIONS
clinical and operational benefits of technology
interoperability,