Lessons Learned from the Medical Device Interoperability Program (MD PnP) at Partners HealthCare / Mass. Gen Hosp

Transcription

1 S.M.A.R.T. Medical Device Informatics Thinktank Improving Structured Device Data Capture AHRQ February 24, 2015 Lessons Learned from the Medical Device Interoperability Program (MD PnP) at Partners HealthCare / Mass. Gen Hosp Julian M. Goldman, MD Director, Program on Interoperability, Mass General Hospital Medical Director, Partners HealthCare Biomedical Engineering Anesthesiologist, MGH/Harvard Medical School Chair, ISO TC 121 Contact information:

2 A B Does it matter how UDI data gets from A to B?

3 UDI Data can t exist in a vacuum STRUCTURED + Context Patient data Procedure data Attempted or successful use/insertion? Diverse medical devices not only implantables infusion pumps, pacemaker programmers, Physiological monitors, etc. Requires ecosystem to support time-aligned data acquisition. Requires a deliberate architecture

4 Manually entering Compression Boot data in MGH EMR Step 1 find and read device number under OR table J Goldman, MD / MGH

5 How will data from electronic medical devices be entered into UDI data ecosystem?

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7 Medical Device Plug-and-Play Interoperability Program (MD PnP) Founded in 2004, the MD PnP research program is a multi-institutional community with Lab based at Massachusetts General Hospital (MGH), with grant support from NIH/NIBIB, NSF, DoD/TATRC, and NIST Mission: lead the adoption of open standards and technologies for medical device interoperability to improve patient safety

8 MD PnP Lab at MGH/Partners Vender-neutral sandbox for experimenting with device interoperability solutions (standards technologies, products) with diverse collaborators Contains $1M device and network infratructure OpenICE open source software:

9 Ebola medical device technology project Nov

10 Architecture Standard for the Integrated Clinical Environment ASTM F2761 Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) Part 1: General requirements and conceptual model Provides a standards-based logical architecture intended to support safe interoperable medical systems Recognized by FDA 8/2013:

11 Integrated Clinical Environment From ASTM F Clinicians ICE System Apps e.g. PCA Safety, Smart Alarms, Remote Notification, Team coordination EMR/CIS ICE External Interface ICE Supervisor (runs apps) ICE environment provides: Patient ID management Common time reference Data logging (black box recorder) Medical Device or other equipment ICE Network Controller Medical Device or other equipment ICE Data Logger Medical Device or other equipment Patient and Family

12 OpenICE Open-Source Research Platform (MGH) Based on ASTM F2761 integrated clinical environment (ICE) IEEE nomenclature; OMG DDS pub/sub messaging middleware Apps Caregiver External Network ICE Supervisor Network Controller Black Box Recorder Data Logger Adapter PulseOx Adapter Pump Adapter Patient Mon. Patient Testbed funded in part by NIH, NSF, and DoD Prototype Healthcare Intranet to Improve Health Outcomes

13 OpenICE Platform (link to lab) New IEEE-based non-profit has been formed to accelerate OpenICE development and adoption (contact me for information)

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15 Draft unpublished data Consolidated 4 Hospital Summary (Draft) Device Type Count StdDev Offset Average Offset Maximum Offset Medical Devices (Excl. Workstations & Wall Clocks) :32:34 0:33:26 16:42:10 All devices :22:12 0:25:58 16:42:10 Networked Devices that Auto-Sync 291 0:02:16 0:00:53 0:31:16 Stand-alone Devices 950 1:46:38 0:46:06 16:42:10 Hospital A 52 0:31:11 0:30:25 1:52:00 Hospital B 495 1:41:23 0:32:55 16:42:10 Hospital C 468 0:47:12 0:17:10 13:39:28 Hospital D 717 1:27:24 0:26:35 13:18:47

16 Incorrect dates Draft unpublished data Device Location Device Location (Room) Device Type Manufacturer/ Model Date Picture Taken Date on Device Device Offset (DAYS) General Unit Patient Tower Bladder Scanner BVI /7/2011 1/8/ D Adult ER Adult ER Emergency Department Emergency Department Bladder Scanner Bladder Scanner Verathon Medical/ BVI 9400 Verathon Medical/ BVI /22/ /2/ D 11/22/ /16/2011-6D OR Hallway 1 Imaging System Volcano S5 Cart Monitor 7/8/2011 7/7/2011 1D Neuro Angio Neuro Angio Radiology Display *N/A* 11/21/ /18/2011-3D PACU PACU Ultrasound Sonosite M- Turbo 11/29/2011 1/1/ years NICU NICU Ventilator Drager/ Evita XL 11/29/ /1/ years

17 E-card: MD PnP Program: