Data Quality in the Real World: Ensuring Integrity across the Medical Device Lifecycle

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1 Data Quality in the Real World: Ensuring Integrity across the Medical Device Lifecycle Moderated by Karen Conway, GHX Panelists: Steven Luxenberg, MD, U.S. FDA CDRH Dennis Black, BD Robert Lynch, Franciscan Missionaries of Our Lady Health System (former) Susan A. Morris, Cerner Corporation Slide 1

2 How Does UDI help create Real World Evidence? By promoting incorporation of UDIs into electronic health information, a vast quantity of untapped real-world data from clinical experience with devices housed in EHRs and other electronic information sources may become available for use in understanding the benefit-risk profiles of medical devices. Slide 2

3 International Medical Device Regulatory Forum 9 December 2013 the benefits of UDI can only accrue if all stakeholders, from the manufacturer to healthcare providers and patients, use UDI throughout their workflow systems. A globally harmonized and consistent approach to UDI is expected to increase patient safety and help optimize patient care by facilitating the: a. traceability of medical devices b. adequate identification of medical devices through distribution and use c. identification of medical devices in adverse events; d. reduction of medical errors; e. longitudinal capture of data on medical devices. Slide 3

4 Learning Healthcare System Source: Institute of Medicine, Better Care at Lower Cost, Slide 4

5 A Continuous Learning System built on Real World Evidence (RWE) Slide 5

6 FDA FDA provides regulatory new regulatory approval based approval on (faster) clinical based trials on RWE Manufacturer markets products based for specific on clinical populations trialsbased on RWE Hospitals evaluate and source products, often based based on RWE on price and and specific clinician patient preference needs Manufacturer designs new product, products/enhancements conducts clinical based on real trials world evidence Corrective action if needed Manufacturer markets product based on RWE Demand signals generated RWE generated on performance in routine clinical practice Product purchased, shipped and received Product consumption documented at point of use with UDI in electronic patient record, registries Slide 6

7 Numerous efforts to generate Real World Evidence (RWE) underway. European UDI regulation also includes strong focus on RWE. Slide 7

8 Case for Quality: Product Quality Outcomes Analytics information to make better purchase decisions that improve patient access to high quality medical devices. Requires accurate, consistent, standardized data capture, reporting and analysis by healthcare delivery organizations Slide 8

9 7 Domains of Product Quality Effectiveness: Device produces the effect intended by the manufacturer relative to the medical condition(s). Patient Satisfaction: Device was perceived to meet or exceed patient expectations of usability and outcome Safety: Device does not compromise the clinical condition or the safety of patients, or the safety and health of users. Reliability: Device system or component is able to function under stated conditions for a specified period of time. Usability: Device minimizes the risk of user errors by patients or clinicians. Compatibility: Device is compatible with related devices or drugs, the use environment or relevant standards. 7 6 Availability: Device is available to fill first request orders. Slide 9

10 MDEpiNet RAPID AUDI Workgroup ELECTRONIC HEALTH INFORMATION Device Identifier Global Unique Device Identification Database GUDID GUDID Device Identifier Additional Unique Device Identification Database AUDI AUDI Device Identifier Claims data EHR Registry Data AUDI is designed to be a resource for clinically relevant (discrete) data. that is not contained in the GUDID. e.g., data in the Instructions for Use Specific to device type, e.g., drug eluting stent, replacement joint, etc. Slide 10

11 Slide 11

12 And now for the experts What will it take to get to the promise of real world evidence and the value of UDI? How do we manage, capture, and use UDI-related data across the medical device lifecycle? Slide 12

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