The Integrated Clinical Environment-- Creating Big Data Steven Dain MD FRCPC Anesthesiologist, Woodstock Hospital Associate Adjunct Professor, Department of Electrical and Computer Engineering, University of Waterloo Collaborator, MDPNP.org, Open ICE Alliance sdain@uwaterloo.ca

Disclaimers Collaborator, MD Plug and Play Program Funding of program from US DOD, NIST, NSF, NIH, Partners Healthcare and private sources Moral support from US FDA, Health Canada Consultant for DocBox Medical Inc.

http://protomag.com/articles/babel-in-the-ICU

Current State of Affairs Medical Device Networks Very little that’s practical or extensible Proprietary servers and electronic interfaces Difficult or illegal to connect medical devices No usable standards for the electrical interface, syntax nor semantics No easy regulatory pathway for network plug & play for devices from different vendors

Roadblocks to Innovation Absence of smart alarms, automated clinical decision support, and physiologic closed-loop control, etc. No multi-device black box recorders for clinical and forensic use Difficult and expensive to write Apps for Health Inability to collect big data for the ICU and OR

Medical Device “Plug-and-Play” Interoperability Program (MD PnP) Program established 2004 at Mass General Hospital/CIMIT by Dr. Julian Goldman Vender-neutral Lab for experimenting with safe interoperability (standards technologies, products) Contains > $1M devices/network technology – production and research Clinical, biomed, and computer science subject matter experts Develops OpenICE open-source software www.openice.info $18M funding primarily from DOD, NIH, NSF, NIST, private funding

http://www.omg.org/hot-topics/iot-standards.htm

Integrated Clinical Environment Courtesy of DocBox Inc

Easy to Use Device Adapters (4 devices per) Manager Solution (UI, distributed processing) Courtesy of DocBox Inc www.docboxmed.com

and Display a Cognitive Aid using OpenICE Demonstration from the American Society of Anesthesiologists meeting Oct 2015: Safety System to Automatically Detect Cardiac Arrest (Pulseless Electrical Activity) and Display a Cognitive Aid using OpenICE App running on OpenICE www.openice.info Physiologic Monitor Simulator OpenICE App automatically displays correct Page from Stanford Emergency Manual to treat PEA http://bit.ly/ASA_ICE_video PEA page from the Emergency Manual Stanford Emergency Manual http://emergencymanual.stanford.edu Note – this demonstrates CDS Without using the EHR Non-EMR Clinical Decision Support

Apps for Health App to detect pulseless electrical activity from 2 different monitors from 2 different vendors, then displays protocol for treatment Normal ECG No pulsatile flow on SpO2 pleth and Art line No End-tidal CO2 https://www.youtube.com/watch?v=afI2lPCx5_M&feature=youtu.be

Creation of Big Data

Courtesy of DocBox Inc www.docboxmed.com

Courtesy of DocBox Inc www.docboxmed.com

Courtesy of DocBox Inc www.docboxmed.com

Analysis of Raw Alarm Data Manager event_message alarm type device Total Count of Alarm Episodes TOTAL COUNT Total Time Alarming (sec) Total Time Alarming (min) Total Time Alarming (hr) total time min TOTAL TIME (hr) Avg Duration per Alarm Episode (sec) Avg Duration per Alarm Episode (mins) Avg Duration per Alarm Episode (hrs) dbmanager000032 FMS Unsupported tech Patient Monitor 101 2569761 42829.4 713.8 25443.2 424.1 7.1 backup audio failure Ventilator 23 26 890297 14838.3 247.3 15947.2 265.8 38708.6 645.1 10.8 dbmanager000031 3 66535 1108.9 18.5 22178.3 369.6 6.2 ABP REDUCE SIZE 2821 5346 398114 6635.2 110.6 13853.9 230.9 141.1 2.4 0.0 ABP Reduce Size 2525 433121 7218.7 120.3 171.5 2.9 Cannot Analyze QT 657 897 313806 5230.1 87.2 9948.2 165.8 477.6 8.0 0.1 CANNOT ANALYZE QT 240 283085 4718.1 78.6 1179.5 19.7 0.3 Cannot Analyze ST 919 1326 328303 5471.7 91.2 6065.9 101.1 357.2 6.0 CANNOT ANALYZE ST 407 35648 594.1 9.9 87.6 1.5 Resp LEADS OFF 440 738 153058 2551.0 42.5 5514.3 91.9 347.9 5.8 Resp Leads Off 298 177801 2963.4 49.4 596.6 0.2 SpO2 Low Perf 517 984 88909 1481.8 24.7 3600.5 60.0 172.0 SpO2 LOW PERF 467 127120 2118.7 35.3 272.2 4.5 prealarm: end of infusion Syringe Pump 192 127302 2121.7 35.4 2495.8 41.6 1260.4 21.0 0.4 91 22446 374.1 246.7 4.1 ECG LEADS OFF 168 324 76158 1269.3 21.2 2475.5 41.3 453.3 7.6 ECG Leads Off 156 72373 1206.2 20.1 463.9 7.7 alarms silenced 47 73 72304 1205.1 2356.8 39.3 1538.4 25.6 69104 1151.7 19.2 2657.8 44.3 0.7 RL LEAD OFF 66 131 55726 928.8 15.5 2297.0 38.3 844.3 14.1 RL Lead Off 65 82091 1368.2 22.8 1262.9 exp flow sensor error 285 403 93713 1561.9 26.0 2207.7 36.8 328.8 5.5 118 38749 645.8 328.4 Cannot Analyze ECG 540 720 70006 1166.8 19.4 1930.1 32.2 129.6 2.2 CANNOT ANALYZE ECG 180 45802 763.4 12.7 254.5 4.2 Courtesy of DocBox Inc www.docboxmed.com

Courtesy of DocBox Inc www.docboxmed.com

Courtesy of DocBox Inc www.docboxmed.com

Courtesy of DocBox Inc www.docboxmed.com

Benefits of the openICE through Data and Automation Improvement in Operational Efficiencies Equipment Utilization, Supply Purchases, Facility and Staff Utilization, Bed Turnover Times, Specialty Response Times, Equipment servicing and PM cycles Improvement in Care Delivery Reduction of adverse events, adoption of best practices, automation of care pathways, consistency of care Determine needs for further staff education

Benefits of the openICE through Data and Automation Improvement in Care Coordination Shift Handoff, coordination between clinicians, transfer of patient from care environment to care environment, automation of communication. Drives Innovation Ability to create clinical applications as medical devices as modular components for real time decision support, data visualization Open standards based platform

The ICE Alliance is a non-profit organization committed to establishing healthcare environments that are safe, secure, and interoperable Note: The ICE Alliance is hosted by the IEEE-ISTO www.icealliance.org

ICE Alliance Founding Members* NOTE – Not all pending members are shown ICE Alliance Founding Members* Founding Members Liaison Members *As of 10/13/15 Additional founding memberships in process

More Information www.mdpnp.org www.openince.info www.docboxmed.com http://www.fda.gov/MedicalDevices/ScienceandResearch/ResearchPrograms/ucm477390.htm http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?id=32430 https://www.youtube.com/watch?v=afI2lPCx5_M&feature=youtu.be http://www.stahq.org/files/2813/9171/8106/60_Abstract_Goldman.pdf

Medical Device Interoperability Networking of medical devices to share data between: devices devices and external systems between apps for health and one or more device(s) or external system(s) For Closed loop controllers Intelligent systems Smart alarms Data logging