FDB to demonstrate how enhanced medical device structured data subset can support CQO movement at AHRMM Conference 2019

July 26, 2019
Augmented Unique Device Identifier (AUDI) information on coronary artery stents can be used to enhance surgical point-of-care and outcomes studies.

FDB (First Databank, Inc.), a provider of drug and medical device knowledge, has announced that Patrick Lupinetti, JD, Senior Vice President for Legal Services and Medical Device, will co-present a session entitled “ Medical Device Data Your Clinicians Need at the Point of Care” at the AHRMM19 Conference, July 28 - 31 in San Diego, CA. The session will take place on Monday, July 29, 2019 from 1:30 - 2:30 PM.

FDS said the need for regularity and consistency in medical device information has been one of the primary drivers behind the Food and Drug Administration’s development of the Unique Device Identifier (UDI), which creates a framework that can be employed in a wide variety of healthcare applications. Leveraging quality data is critical in the Cost, Quality, and Outcomes (CQO) Movement, and the health care supply chain can improve patient outcomes by delivering clinically-relevant medical device data - Augmented Unique Device Identifier (AUDI) information – at the point of care. Complementing the GUDID, these AUDI attributes and specifications can meet an existing need in the selection and utilization of devices for patient care, safety, and outcomes.

Mr. Lupinetti will be joined by co-presenter Dr. James Tcheng, Professor of Medicine, Duke University School of Medicine. These clinical and data experts will share preliminary insight about a pilot study with a library of additional attributes for coronary artery stents (e.g., stent diameter, restenosis rate, and more) and how that potentially can impact both surgical point-of-care and outcomes studies. The study provides a model for a more expansive use of AUDI elements with other categories of devices.

Mr. Lupinetti commented: “The foundation for the creation of a reliable database of medical device information laid by the UDI initiative has been in place for five years, and there is now an opportunity to build upon it to provide systems and tools that support and enhance clinical practice. The notion of clinicians having easy access to all the device information they need at the point of care may be groundbreaking, but it’s altogether feasible with existing data management capabilities. Our objective is to demonstrate how much improvement can be made and how readily clinicians can be afforded a broad range of device specifications, material descriptions and other relevant attributes in the operating room or in interventional labs.”

The session is ideal for all parties involved in making, using or managing medical devices: manufacturers whose product data will be made more widely and easily accessible to their customers; health care distributors and group purchasing organizations (GPOs) that can utilize the UDI for operational efficiency; hospitals and health care organizations that can leverage the UDI to benefit from a clinically-integrated supply chain; and for all health care industry professionals looking to support value-based care.

Attendees may also visit FDB at booth #805 to learn how FDB Prizm brings clarity to medical device information by enabling actionable insight to improve clinical, operational, and financial outcomes.