The Risks

Medical imaging devices are complex pieces of equipment, some using strong magnetic fields, ionizing radiation, or acoustic energy. Patients and providers depend on the safe and effective operation of these devices to monitor and identify cancer and other diseases. If this equipment is improperly serviced, it could put technicians and patients at risk for serious injury or result in poor image quality, leading to a delayed or missed diagnosis or repeated imaging procedures, and increased healthcare costs.

A third-party servicing business failed to properly seal this transducer after repair, allowing ultrasound gel to seep into the unit, creating potential contamination and image quality issues and risk of electrical shock for the sonographer.
A third-party servicing business failed to properly seal this transducer after repair, allowing ultrasound gel to seep into the unit, creating potential contamination and image quality issues and risk of electrical shock for the sonographer.
This device has been separated from its support structure and taped together. This jerry-rigged system could fall apart mid-procedure, delaying patient care.
This device has been separated from its support structure and taped together. This jerry-rigged system could fall apart mid-procedure, delaying patient care.

The individuals servicing these devices must be highly trained and their employers regulated to make sure patients are receiving safe and accurate scans. Servicing technicians who work for original equipment manufacturers receive months of training, shadow more experienced technicians, and return for continuing education on new or updated devices –all under the oversight of the Food and Drug Administration (FDA).

However, many medical devices are maintained by unregulated third-party servicer businesses. These businesses are not required to undergo the same rigorous training program and do not have to register with the FDA. This means that some of these highly complicated machines are serviced by firms that are not required to meet any proper quality and safety standards, so their work is done with no oversight.

In May 2018, the FDA estimated that “total number of firms performing medical device servicing in the U.S. is between 16,520 and 20,830,” but said the “precise number of entities that perform servicing of medical devices in the U.S. is not known.”

Without proper oversight, there is an increased risk for serious patient safety and device performance issues. Independent servicing businesses need to accept responsibility for ensuring the return of medical devices to safe and effective operation by adopting appropriate quality systems and investing in the development or adoption of valid servicing protocols, tools, and training.

Increasing accountability and transparency of the third-party service industry is an important step to ensuring the safe and effective operation of all devices.

The third-party servicing business did not replace these filters for at least three years. In fact, after an investigation, it turned out that the third party did not even know these filters existed! Clogged filters create risk of the gantry overheating, potentially resulting in premature failure of such as electronics & high voltage controls. Image quality can also be affected, resulting in artifacts, as the detector modules are very heat sensitive.
The third-party servicing business did not replace these filters for at least three years. In fact, after an investigation, it turned out that the third party did not even know these filters existed! Clogged filters create risk of the gantry overheating, potentially resulting in premature failure of such as electronics & high voltage controls. Image quality can also be affected, resulting in artifacts, as the detector modules are very heat sensitive.
A third-party servicer used aluminum foil to shield some of an MRI system’s cables in the scan room. This can present safety and electrical issues when used within the MRI filter panel that contains high voltage.
A third-party servicer used aluminum foil to shield some of an MRI system’s cables in the scan room. This can present safety and electrical issues when used within the MRI filter panel that contains high voltage.
These high voltage cables for an X-Ray system had been wrapped in vacuum hose from a local hardware store. Use of this kind of unqualified part created infection control issues and increased the risk that the cables could have been damaged, resulting in fire or electrocution hazards.
These high voltage cables for an X-Ray system had been wrapped in vacuum hose from a local hardware store. Use of this kind of unqualified part created infection control issues and increased the risk that the cables could have been damaged, resulting in fire or electrocution hazards.
This picture shows a side-by-side comparison of two signal brush blocks that transmit control information for a CT scanner. The OEM maintenance instructions say to replace this part when wear is within 2 mm of the tip. The third-party servicer failed to do so. The resulting poor connection would have resulted in routine scan aborts, meaning diagnosis would have been delayed.
This picture shows a side-by-side comparison of two signal brush blocks that transmit control information for a CT scanner. The OEM maintenance instructions say to replace this part when wear is within 2 mm of the tip. The third-party servicer failed to do so. The resulting poor connection would have resulted in routine scan aborts, meaning diagnosis would have been delayed.

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