MITA proposes framework for defining ‘service’ versus ‘remanufacturing’

While current FDA standards regulate the remanufacturing of medical devices, regulation of servicing is not a requirement. In addition, few safeguards exist to prevent the crossover of servicing activity with that of remanufacturing, creating increased risks to public health, the safety of patients and providers who use the technology. These risks are elaborated on in the white paper and include electrical shock, overexposure to ionizing radiation, improper dosing and cybersecurity vulnerabilities, among others.

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