The Medical Imaging & Technology Alliance (MITA) recently sent a letter to the U.S. Food and Drug Administration (FDA) alerting the agency that the company iFixit, which bills itself as having “replacement parts for every gadget,” has inappropriately posted proprietary service manuals for use by unregulated medical device service providers.
“Uncontrolled release of these materials to unregulated entities that are not required to have appropriate processes or safety controls in place raises the risk of improper servicing of medical devices,” said Patrick Hope, executive director of MITA and the letter signatory. “These actions raise the question as to why unregulated third parties continue to deny any responsibility for adopting appropriate quality and safety controls.”
As the letter notes, “Adequate performance of medical device servicing activities is not dependent only on possession of certain materials. Knowledge of and compliance with FDA regulatory requirements is essential to the performance of these activities in a way that results in the safe and effective operation of the medical device. We request that FDA take immediate action to implement consistent quality, safety, and regulatory requirements for everyone who services a medical device, including requiring all servicers to register with the FDA, file Medical Device Reports, and implement a quality management system.”
The letter also emphasized the MITA view that operating within a quality management system is essential to performing servicing activities in a way that consistently results in the safe and effective operation of the medical device. A quality system is necessary to ensure that medical devices reliably meet applicable requirements and specifications.
“Safe and effective servicing is not merely the acquisition of certain documentation or materials—it is the implementation of and adherence to a set of policies, practices, and procedures which consistently return the device to a state of safe and effective operation. Why won’t unregulated servicers even register and make themselves known to the FDA? What is it about their business practices that warrants this degree of opacity?” Hope concluded.
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