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Data Quality in the Real World:Ensuring Integrity across the

Medical Device LifecycleModerated 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

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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.

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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 devicesb. 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.

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Learning Healthcare System

Source: Institute of Medicine, Better Care at Lower Cost, 2013.

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A Continuous Learning System

built on Real World Evidence (RWE)

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Manufacturer designs product, conducts clinical

trials

Hospitals evaluate and source products, often based on price

and clinician preference

Product purchased, shipped and received

Product consumption documented at point of

use with UDI in electronic patient record, registriesRWE generated on

performance in routine clinical practice

Demand signals generated

FDA provides regulatory approval based on

clinical trials

Manufacturer markets product based on clinical

trials

Corrective action if needed

Manufacturer designs new products/enhancements

based on real world evidence

FDA provides new regulatory approval

(faster) based on RWE

Manufacturer markets products for specific

populations based on RWE Hospitals evaluate and source

products based on RWE and specific patient needs

Manufacturer markets product based on RWE

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Numerous efforts to generate Real World Evidence (RWE) underway.

European UDI regulation also includes strong focus on RWE.

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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

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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.

Availability: Device is available to fill first request orders.Compatibility: Device is compatible

with related devices or drugs, the use environment or relevant standards.

Patient Satisfaction: Device was perceived to meet or exceed patient expectations of usability and outcome.

Effectiveness: Device produces the effect intended by the manufacturer relative to the medical condition(s).

7 Domains of Product Quality

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Device Identifier

Device Identifier

GUDID AUDI

Global Unique Device Identification Database

GUDID

Additional Unique Device Identification Database

AUDI

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.

ELECTRONIC HEALTH INFORMATION

Device Identifier

Claims dataEHRRegistry Data

MDEpiNet RAPID – AUDI Workgroup

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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?

And now for the experts…

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