Real Risks of Unregulated Third-Party Servicing

Medical imaging has revolutionized healthcare from the start but especially over the past 30 years. Today, patients and healthcare providers depend on the safe and effective operation of medical imaging devices to diagnose, monitor and guide treatment of cancer and other diseases.

To ensure that patients are receiving safe and accurate scans, the individuals servicing these devices must be highly trained and following “best practices” processes.  Accordingly, their employers must be regulated.

Servicing technicians who work for original equipment manufacturers receive extensive 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 servicers who are not required to undergo the same rigorous training program and do not have to register with FDA. This means that some of these highly complicated machines are serviced by businesses that are not required to meet any proper quality and safety Standards.  This means their work is done with no oversight.

Without proper oversight, there is an increased risk for serious patient and operator safety and device performance issues. Below are some examples of what happens when medical imaging equipment is improperly serviced by unregulated third parties: 

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, causing harm to the patient or the healthcare provider.
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 electronics and 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 electronics and 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.

Proper oversight by FDA can help prevent these dangerous situations. FDA should hold all servicing businesses to the same quality, safety, and regulatory requirements, including proper training, implementation of quality and safety controls, adverse event reporting, and registration, to ensure that patients are receiving safe and accurate scans.

Sign our petition if you agree!

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