AdvaMed Releases White Paper Addressing Considerations of Third Party Hardware Modification of Interventional X Ray Equipment

AdvaMed Releases White Paper Addressing Considerations of Third-Party Hardware Modification of Interventional X-Ray Equipment

WASHINGTON, D.C. - AdvaMed, the Medtech Association, recently published a technical white paper outlining concerns with third-party modification of interventional X-ray equipment, which can pose unforeseen risks for patients and providers.

While interventional X-ray equipment can help providers perform less-invasive clinical procedures, deployment of third-party hardware and modifications without verifying, testing, or validating compatibility to the original equipment manufacturer (OEM) and review by the U.S. Food and Drug Administration (FDA) for safety and effectiveness can introduce potential hazards and negatively impact device safety performance.

From the paper: "Unauthorized third-party modifications to interventional X-ray equipment represent a considerable risk to patient and operator safety. Adding a component, part, or material to a device could result in significant change to the original safety and performance specifications of the device."

The white paper further calls for a complete technical assessment before using any third-party modification to mitigate potential harm. To ensure this, collaboration on this effort is needed among regulatory agencies, healthcare providers, and industry stakeholders in order to establish and enforce guidelines for the safe and effective use of any third-party medical imaging device modifications.

The white paper comes on the heels of AdvaMed receiving accreditation from the premier American National Standards Institute (ANSI) to develop industry standards for medical device innovation. As an ANSI-accredited organization, AdvaMed will begin by developing standards for medical imaging technologies, including applications important to all of medtech, such as cyber security and artificial intelligence.

The full third-party hardware modification white paper is available below.

Complete the form to download the Hardware Modification White Paper:

###