AdvaMed Imaging has raised safety concerns over third-party modifications to interventional x-ray equipment used in fluoroscopically guided interventions.
In a technical white paper, the medtech association said adding a component, part, or material without verifying, testing, or validating compatibility to the original equipment manufacturer (OEM), and review by the U.S. Food and Drug Administration (FDA), can introduce potential hazards and negatively impact device safety performance.
AdvaMed said it has observed a "rising problem" of modifying interventional x-ray devices with third-party hardware such as collimators, static transparent filters, c-arm filters, and scatter reduction shields. Modifications are discussed in two distinct groups: direct-in-beam and out-of-beam third-party modifications.
"Third-party modifications can lead to system deterioration (e.g., increased tube loading, mechanical stress, electrical overload)," the paper stated. "Adding a third-party modification to a device can also impact warranty and service agreement terms. Altering OEM device performance, safety specifications, or intended use with a third-party modification may be considered remanufacturing, which creates new reporting and labeling requirements the third party or provider must meet. And third-party modifications can complicate or prevent regular maintenance of the device, reducing device usability or causing serious mechanical issues."
AdvaMed further called for a complete technical assessment before using any third-party modification and provided 14 questions for evaluation of a third-party modification prior to deployment on an OEM device.
Access the paper, "Third-Party Hardware Modification of Interventional X-Ray Equipment: Issues to be Considered Technical White Paper," through AdvaMed, here.
