The Medical Imaging & Technology Alliance (MITA) announces the publication of a new white paper, Understanding Accountability in Medical Device Servicing. The document provides an overview of the types of organizations and entities that perform medical device servicing and the degree to which they are held accountable by federal regulations, accreditors, and voluntary industry-established standards, MITA officials say.
“As this white paper makes clear, when servicing complex medical devices, crystal-clear accountability is indispensable to ensuring the devices’ ongoing safety and efficacy,” says MITA Executive Director Patrick Hope. “Servicers employed by device manufacturers are held to account by the U.S. Food & Drug Administration. Healthcare facilities are held accountable by accreditation systems. 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.”
After defining the three primary entities that regularly maintain or service medical devices, including the device’s original equipment manufacturer (OEM), healthcare facility staff, and other third-party servicing businesses, the white paper outlines the current accountability frameworks in which these entities operate.
For OEMs, the principal oversight mechanisms are developed by the FDA and include strict pre- and post-market requirements for device manufacturers such as registration, reporting of adverse events, and maintenance of a quality management system.
Servicers directly employed by healthcare organizations are held accountable principally by rigorous accreditation systems such as those implemented by the Joint Commission.
In contrast to the FDA regulatory oversight of OEMs and the accreditation systems binding healthcare organizations, third-party servicing businesses are not bound by any such accountability mechanisms, according to MITA. Beyond voluntary standards, third-party servicing businesses operate within a regulatory grey area that raises significant concerns for patient safety and device performance, says the white paper.
“If there is any takeaway from this document, it is that patients assume and deserve safe servicing,” says Hope. “They should have confidence that the devices from which they are receiving care always perform safely and effectively, no matter who has been servicing the device. For this reason, third-party servicing businesses should be held to certain minimum requirements, including the adoption of a Quality Management System conformant with 21 CFR 820, making themselves known to the FDA via registration, and reporting of notable malfunctions and any deaths and serious injuries.”
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