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Adverse Event Triggered Event Reporting for Devices: Report of a Food and Drug Administration–Supported Feasibility Pilot of Automated Adverse Event Reporting

Reed, Terrie L. MS; Levy, Daniel MS; Steen, Leslie Tompkins PhD; Roach, James BCS; Taylor, Thomas BA; Call, Karen PT, MBA; Marion, Jill MS, MBA; Drozda, Joseph P. Jr MD

Journal of Clinical Engineering: April/June 2016 - Volume 41 - Issue 2 - p 83–89
doi: 10.1097/JCE.0000000000000151
FEATURE ARTICLES
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Despite US Food and Drug Administration (FDA) requirements for reporting medical device adverse events (AEs), only an estimated 10% of events are actually reported, and many of those lack important data. As part of its plan to strengthen postmarket surveillance of medical devices, the FDA sponsored a pilot project of the Adverse Event Triggered Event Reporting for Devices (ASTER-D) system developed by Outcome Sciences for automated AE reporting.

The objective of this study is to test the feasibility of using ASTER-D to report medical device AEs. This was a cooperative effort of Outcome Sciences, FDA, and Mercy Health. The ASTER-D system enables a new functionality within the electronic health record for initiating AE reports from triggering events with prepopulated patient- and incident-specific data and minimal disruption to clinician workflow. The ASTER-D system employs health information exchange principles to automate medical device safety reporting and create a “safety information exchange” that allows safety information collected by various organizations to be available to others to facilitate postmarket surveillance. Mercy implemented ASTER-D for AEs related to coronary stents occurring in its cardiac catheterization laboratories in the context of Mercy’s automated incident reporting software system and incorporated prototype unique device identifiers to link reports to key device attributes. Mercy succeeded in submitting an AE using ASTER-D to the FDA’s Medical Product Safety Network database. This pilot provides proof of concept of ASTER-D’s functionality. Further testing with greater numbers of AEs, with different devices, and in other healthcare settings, is required.

Corresponding author: Joseph P. Drozda Jr, MD, Outcomes Research at Mercy Technology Services, 14528 South Outer Forty, Chesterfield, MO 63017. He can be reached at Joseph.Drozda@Mercy.net.

Terrie L. Reed, MS, is a senior advisor for Unique Device Identification Adoption at the Food and Drug Administration, where she is involved in a number of pilot projects dealing with UDI adoption in electronic health information.

Daniel Levy, MS, is chief technology officer at Amazing Charts, LLC.

Leslie Tompkins Steen, PhD, is UDI Lead of Standards and Vocabulary at the Food and Drug Administration.

James Roach, BCS, is manager of Data Analytics and Engineering at Mercy Technology Services.

Thomas Taylor, BA, is senior project manager/scrum master at Pearson (formerly Quintiles).

Karen Call, PT, MBA, is clinical safety lead at Mercy Technology, Mercy Technology Services.

Jill Marion, MS, MBA, is director of Medical Product Safety Network (MedSun), Division of Patient Safety Partnerships, at the Food and Drug Administration.

Joseph P. Drozda Jr, MD, is director of Outcomes Research at Mercy Technology Services. His research focus is evaluation of implanted medical devices. He is the principal investigator of the BUILD initiative–an FDA-funded project dealing with UDI implementation.

This work was supported by contract HHSF223201110172C, subcontract 717-00368-3, from the Center for Devices and Radiological Health, US Food and Drug Administration.

Daniel Levy was an employee of Outcome Sciences at the time of the ASTER-D demonstration. Thomas Taylor was an employee of Quintiles, Inc, at the time of this study and during preparation of the manuscript. Outcome Sciences is a division of Quintiles. Joseph Drozda’s nondependent son was an employee of Boston Scientific (a manufacturer of coronary stents) during the time of the ASTER-D demonstration. Terrie Reed, Leslie Tompkins Steen, and Jill Marion are employees of the US Food and Drug Administration Center for Device and Radiologic Health. James Roach and Karen Call declare no conflict of interest.

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.