Kaiser Permanente Implant Registries

Transcription

1 Kaiser Permanente Implant Registries Implant Identification, Classification, & Future Plans FDA UDI Workshop September 2011 Elizabeth Paxton, MA Director of Surgical Outcomes and Analysis Kaiser Permanente

2 Kaiser Permanente Implant Registries Overview Background Kaiser Permanente Implant Registries Current process for implant identification and attribute classification Challenges of current identification and meaningful classification Opportunities & challenges for UDI/registry integration Keys to successful UDI/registry integration 2

3 Background KP Implant Registries Track and monitor over 300,000 cardiac and orthopedic implants Hip & Knee Replacement Shoulder Replacement Anterior Cruciate Ligament Hip Fracture Spine Purpose of implant registries Track and monitor implant revision rates Identify patients at risk for failures/revisions Assess post-market implant performance Identify best clinical practices Immediately identify and notify patients w/recalled implants Provide foundation for research ICD Pacemaker Stents Heart Valve

4 Data Collection: KP Implant Registries Standardized documentation Pre-op Operative Follow-up Implant registry database Demographics Surgical techniques Implant characteristics Outcomes

5 Data Collection: KP Implant Registries 5

6 Data Collection: KP Implant Registries 6

7 Data Collection: KP Implant Registries CATALOG NUMBER MANUFACTURER LOT # DePuy Catalog #, Manufacturer & Lot # Extracted from EHR CATALOG NUMBER DESCRIPTION ARTICUL/EZE M METAL ON METAL FEMORAL HEAD 36MM /14 CONE Catalog # Linked to Registry Product Master List CATALOG NUMBER TYPE MATERIAL HEAD Metal on Metal Manual attribute classification based on descriptions with validation from clinicians and manufacturers 7

8 Data Collection: KP Implant Registries Data Sources Pre-op form Data Acquisition & Quality Data mapping, quality and transport Data Aggregation & Storage SAS Analytics Data Extraction Information Delivery Annual report Operative form Post-Op form Data entry shell Data cleaning & quality checks Total Joint Registry SQL Database Data Mining Data queries Ad hoc requests Personalized profiles Hospital Claims Membership Mortality Business Rules Data extract, transfer and load Data cleaning & quality checks Domains Patient demographics Implant characteristics Surgical techniques Outcomes Multivariate logistic regression Predictive Modeling Survival Analysis Web-based reports Risk calculator Research projects Recalls / advisories

9 Current Implant Registry Challenges Lack of standardized format, symbologies Synchronization and maintenance of master product list Changes in implant names and catalog numbers New implants constantly introduced Resource intensive to maintain Manual process for classification of meaningful implant characteristics Examples of description in text format SOL SYS STEM STD 10.5 MM 6.3 IN PC ZIRC CER FEM HEAD 32MM +0 14/16 TPR Transmittal from EHR to registries database EHR addendums not transmitted to separate SQL registry database Lack of bi-directionality 9

10 Current Implant Registry Challenges Barcode scanning challenges/accuracy of input Missing bar codes, some symbologies not scannable in our system Multiple competing bar codes on same package w/different symbologies Linear barcodes split into two lines, opposite sides of the package (front and back) with partial data. Barcode scanning time consuming for front line staff Catalog #s/serial/lot entered in different fields

11 Opportunities for UDI/Registry Integration Standardized format of device identifiers Linkage of catalog # imbedded in UDI to registry product master list w/detailed implant attributes Centralized repository & maintenance of UDI master product list w/device attributes Increased efficiency Standardization of implant names & attributes Improved accuracy in EHR documentation of device Improved device identification in EHRs for recall situations Potential to harmonize device attributes for comparative effectiveness research 11

12 Challenges w/udi and Registry Integration Device attributes need to go beyond identification and provide clinically meaningful classifications Examples: femoral head size, rotating versus fixed, type of bearing surface Manufacturer/Clinician collaboration needed to establish Standards required for implant names and attributes Structural changes to EHR, supply chain item master and registry architecture Mapping of UDI to existing clinical, supply chain, registry systems Seamless integration w/historical registry implant identification and classification Additional programming to extract key components from UDI (e.g., Mfr, Catalog #, Lot #, etc) 12

13 Challenges w/udi and Registry Integration EHR transmittal to registries Interfaces/batch processing/queries/reports Backwards compatibility from Registry to EMR Updates/chart addendums not automatically transmitted to registry and vice versa Barcode scanning challenges/data entry accuracy Maintenance, quality, linkage to UDI database master product list Common data language and structure among systems to transact information

14 Keys to Success for UDI/Registry Integration Allocation of necessary time and resources to map and adapt existing system architectures Integration/collaboration across supply chain, clinical systems, EHRs, and registries Methods to ensure accurate entry of UDI in registries, clinical systems, and EHRs (e.g., quality checks built into architectures) Reliable and updated UDI master product database with clinically meaningful attributes Easy to download and integrate with existing registries Sharing key learnings across healthcare systems Global harmonization for international collaborations, surveillance, comparative effectiveness research 14