MITA Calls for FDA Registration for Third-Party Medical Device Servicers

Third-party vendors who service medical equipment and devices should be held to the same standards levied by the U.S. Food & Drug Administration (FDA) as all service groups, said the Medical Imaging & Technology Alliance (MITA).

In its new white paper, “Understanding Accountability in Medical Device Servicing,” MITA outlined a problem where third-party services function in a “regulatory grey area.” The FDA maintains regulatory oversight of original equipment manufacturers (OEM), but third-party business do not have to abide by the same accountability mechanisms, raising red flags for patient safety and device performance.

“Servicers employed by device manufacturers are held to account by the [FDA]. Healthcare facilities are held accountable by accreditation systems,” said Patrick Hope, MITA executive director. “Unfortunately, no authority – public, private, or otherwise – holds third-party servicing businesses accountable for their actions or the quality and safety of their work. When interacting with highly complicated medical devices designed to detect life-threatening disease, this is troubling, to say the least.”

Consequently, he added, the industry must push for “crystal-clear accountability.”

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In this white paper, MITA takes an in-depth look at the three main groups that regularly service medical devices – OEMs, healthcare facility staff, and third-party businesses, and then lays out the existing accountability framework in which they all operate. While OEMs must follow strict FDA registration, adverse events reporting, and quality management system maintenance requirements, and healthcare organizations are held accountable by the Joint Commission, third-party vendors are ruled mainly by voluntary standards, according to a statement from MITA.

To address this problem, MITA is advocating for all third-party servicers to adopt a minimum quality standard that falls in line with Code of Federal Regulations Title 21 Part 820. Doing so would ensure they are properly registered with the FDA and would report malfunctions, serious injuries, or deaths.

“If there is any takeaway from this document, it is that patient assume and deserve safe servicing,” Hope said. “They should have confidence that devices from which they are receiving care always perform safely and effectively, no matter who has been servicing the device.”

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