Veterans Health Administration: Health IT Leaders

Transcription

1 SILENT SIGNALS through the NOISE: Device Surveillance Efforts in the Veterans Health Administration and the Potential of Universal Device Identification 1 Tamára L. Box Lead, Health IT VA Clinical Assessment, Reporting, and Tracking (CART) Program National Manager, VHA Web Solutions Office of Informatics and Analytics September 12, 2011

2 Veterans Health Administration: Health IT Leaders First major health care system to broadly adopt an electronic health record system Tens of billions of discrete data and billions of free text clinical reports Infrastructure and desire to facilitate device surveillance through various methodologies 2

3 VHA Use Cases for Device Surveillance 1. Veterans Implant Tracking and Alert System (VITAS) 2. National Cardiac Device Surveillance Program (NCDSP) 3. Clinical Assessment, Reporting, and Tracking Program (CART) 3

4 Veterans Implant Tracking and Alert System Part of one of Secretary Shinseki s Major Initiatives Enhance Veterans Experience and Access to Healthcare System to track all implanted devices (within and outside VA) with the purpose of tracking implants for clinical issues, recall management, etc. Data Linkages/Exchange in development: Cardiology Interventional radiology Ophthalmology Orthopedics Prosthetics Surgery 4

5 VITAS (cont) Centralized repository and authoritative source Not intended to take place of other implant tracking systems Web-based GUI Integrated through VA EHR KEY LIMITATION: Primarily manual entry 5

6 VA National Cardiac Device Surveillance Program Monitors (via remote transtelephonic monitoring) more than 18,000 patients with Pacemakers, Implantable Cardioverter Defibrillators (ICDs), and Cardiac Resynchronization Therapy (CRT) devices Tracks more than 75,000 ICD transmissions per year (number even larger for pacemakers) Robust programmatic and technical support for monitoring of recalls and alerts KEY LIMITATION: Primarily manual entry 6

7 VA Clinical Assessment, Reporting, and Tracking Program (CART) Standardized data capture across all 77(+) VA Cath Labs Point of care, faster than dictation Single national data repository Integrated in VA EHR Core data elements conform to American College of Cardiology s National Cardiovascular Data Registry (ACC-NCDR) Extensible database structure to support modifications and expansion

8 8 CART SITES All VA Cath Labs 2004-Present (N=78; 76 Active)

9 CART and FDA Collaboration Discussions Initiated in CART as Sentinel Patient Safety Network for cath lab device surveillance CART modified to include open text field to capture unexpected problems with devices Monthly reports informally exchanged with FDA (no PHI) Memorandum of Understanding (MOU) drafted in 2007; describes three, incremental levels of data exchange December 2008 MOU Signed Jointly by VA and FDA

10 CART-CL Unexpected Complications

11 Data Exchange Levels LEVEL 1 DATA EXCHANGE LEVEL LEVEL I SUMMARY OF DETAIL Monthly reports including de-identified data related to the unexpected device complication field and including device LEVEL II Reports of unexpected problems with devices that appear to be novel or of specific interest to FDA and CART LEVEL III Reportable device events: MedWatch 3500A Form will be completed and submitted to FDA by the hospital/va clinician where the event originated.

12 Example UED report Procedure Type: PCI Description: Stent-DES Device Name: ENDEAVOR Details: Delivery system malfunction with polymer sticking to the balloon/stent with great difficulty removing the delivery system resulting in difficulty recrossing the stent with high-pressure balloon.

13 CART SITES REPORTING UEDs Early Data: 08/15/ /31/2009

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16 CART-FDA Surveillance August 2006 May 2011 (numbers approximate) 231,071 Procedure Reports Entered in CART Automatic Alert 825 LEVEL I Not Specific to the Medical Device (de-identified no PHI) CART Network Activities: Active sureveillance Monthly discussions with FDA Alerts Recalls Investigative inquiries 138 LEVEL II Potentially Device-Related ( details for novel events no PHI) 21 LEVEL III Could Involve Potentially Device-Related Patient Complications (FDA reportable MedWatch 3500A) 16

17 VA Surveillance Limitations From the three use cases (VITAS, NCDSP, and CART): (VITAS and NCDSP): Manual entry of discrete data (CART): Free text and limited discrete data Mixed record identifiers beyond patient level Complicates data exchange between systems and can cause redundancy No ability to prospectively predictively model event outliers No guarantee high risk patients, recalled products, or UEDs are fully and validly captured. 17

18 Opportunity: Real-Time Locator Services Part of one of Secretary Shinseki s Major Initiatives Improving Healthcare Efficiency Many possible technologies Radiofrequency ID (RFID) active vs. passive tags Infrared Ultrasound Many others

19 Opportunity: Real-Time Locator Services Implementation planned VHA wide for inventory management in Cath/EP labs Rationale Expensive tools (catheters, stents, pacemakers, defibrillators) Recall management/device surveillance Data integration options through CART

20 The Clinical Model REAL-TIME LOCATOR SERVICES FDA (MedWatch) CART Additional Interfaces (e.g., Hemodynamics) VITAS Inventory Tracking NCDSP

21 VHA Health Information Exchange Through RTLS / CART with UDI: Personal Health Record (MyHealtheVet) iehr (VA-DoD Joint EHR effort) VLER (Veterans Lifetime Electronic Record) NwHIN (Nationwide Health Information Network 21

22 Thank You Tami Box 22