Safe medical devices act relates to electrical safety

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Question

The Safe Medical Devices Act relates to electrical safety as well as malfunctions of medical devices. Which of the following statements about the Safe Medical Devices Act (SDMA) are true? An incident report must be completed on any serious patient or employee injury, illness or death in which a device may have played a role. An incident report must be completed only on patient deaths in which a device may have played a role. Medical device incident reports are completed and sent to the manufacturer only.

Reference no: EM133758066

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