Medical Device Adverse Event Reporting Presents Daunting Challenges

Bradley Lieberman, Manager of Clinical Monitoring Services, IMARC

Site personnel must be empowered to leverage critical thinking when developing and implementing adverse event (AE) reporting procedures in medical device studies, two leading experts say. It might sound like common sense, but it’s not always so self-evident, says Bradley Lieberman, manager of clinical monitoring services at IMARC.

Device studies are often complex but lacking in much commonality from study to study, and that sometimes translates into vague study protocols and expectations regarding how to define and when to report an AE, Lieberman says.

It’s the responsibility of the principal investigator and/or delegated research staff to identify, investigate, and classify AEs, Lieberman notes. They may be found within medical records and abnormal test results, observed directly by staff, or reported by the patient.

When conducting an inspection, the U.S. Food and Drug Administration (FDA) will zero in on “your process for reviewing and reporting” AEs, Lieberman says. Of particular interest to regulators is how long it takes you to report an event. Inspectors will also often focus on discharge summaries, lab results, and imaging reports, he adds.

Webinar—Adverse Event Reporting in Medical Device Studies: Managing/Assessing Events and Maintaining Compliance

Join Lieberman and colleague Michael Marotta July 31 to learn practical strategies for identifying, assessing, and reporting adverse events (AE) for medical device studies at the site level. These expert presenters will discuss solutions to some of the common hurdles that sites face in device AE reporting and will explain how to apply 21CFR812, ICH-GCP E6, ISO 14155, protocol requirements, and IRB policies.

This webinar is FREE for ACRP Members (Become a Member >>)

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Sites face unique challenges when grappling with AE reporting in clinical trials, notes Michael Marotta, project manager at IMARC and previously manager of clinical monitoring services. For example, AE requirements can differ across protocols. Various scenarios include:

  • Any AE even temporarily associated with the use of the device being studied, whether or not it is considered related to the study device, shall be documented on the AE case report form, except those physical assessment findings that are considered to be clinically insignificant.
  • All AEs, regardless of relationship to the device in the trial, are reported so that an adequate determination of device safety can be made.
  • AE reporting will be limited to adverse/serious adverse device effects and commercially available devices.
  • Any untoward medical event (does not include normal post-operative symptoms) is considered an AE.

“FDA will want to know why certain AEs aren’t required to be reported,” Marotta says.

Author: Michael Causey