MITA Publishes New Guidance on Remanufacturing of Ultrasound Devices

02.07.20

Uncontrolled Remanufacturing Is Risk for All Who Interact with Device

WASHINGTON – The Medical Imaging & Technology Alliance (MITA) today published a White Paper on Remanufacturing of Ultrasound Medical Devices, that offers technical guidance to help differentiate remanufacturing from other post-market technical support activities for diagnostic ultrasound systems and transducers.

“Remanufacturing, when performed incorrectly or without applicable oversight, creates risk for users and raises patient safety concerns about how the device performs,” said Wayne Moore, CEO of Acertara Acoustic Laboratories and chair of the MITA Ultrasound Section. “This whitepaper provides a list of some of the risks of uncontrolled remanufacturing, guidance on what remanufacturing is and isn’t and resources to assist in making this determination.”

Currently, the FDA regulates remanufacturing activities and requires remanufacturers to register their facilities with the Agency and list individually the devices on which they are performing remanufacturing. FDA regulation does not extend to servicing activities, so it is essential that technicians know and recognize the difference.

In general, the following kinds of ultrasound device changes can constitute remanufacturing:

  • Control mechanism: The manner by which the actions of a device are directed (e.g., delivery of acoustic output);
  • Operating principle: The mode of operation or mechanism of action through which a device fulfills or achieves its intended use;
  • Energy type: The type of power input to or output from the device;
  • Biocompatibility: Materials which come into contact with patients must be tested to confirm biocompatibility. These materials must also be confirmed to properly endure the approved cleaning materials and procedures that are used to disinfect or sterilize the device;
  • Design: If a design change significantly affects intended use, safety, or efficacy of the device, the activity likely constitutes remanufacturing;
  • Non-valid parts: Replacing parts in a medical device does not necessarily constitute remanufacturing. Replacement parts, however, need to undergo verification and validation to ensure that they meet the device’s original specifications and do not significantly affect the safety or performance of the device;
  • Device listing. Changes that violate the National Recognized Test Lab listing of the device significantly alter the safety of the device and likely constitute remanufacturing; and
  • Parts and module compatibility: OEMs (Original Equipment Manufacturers) assure compatibility of components and modules used in the equipment and interacting with each other. Exchange of components and modules used in the originally released equipment may lead to incompatibilities and subsequent unintended behavior or failure.

The full white paper is also available online on the MITA website.

###

The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. Visit medicalimaging.org. Follow MITA on Twitter @MITAToday.