Key Point: There are ultrasound devices that are not being operated within FDA limits.

Prenatal ultrasound devices can expose fetuses to pulse intensities above the recommended limits. This list was developed primarily by interviewing technicians who maintain and repair medical devices. – Parrish Hirasaki, Ultrasound Autism Connection?

  • A malfunctioning ultrasound device can operate outside of limits.
  • Ultrasound operators are fallible and not always as knowledgeable as they need to be.
  • Older devices are typically resold and kept in continued use.
  • Units in use are not uniformly maintained to a standard.
  • Inspection and approval of medical devices is often by maintenance and repair services that are paid by the facility that owns the devices rather than by the manufacturer of the device or an independent inspector.

 

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