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Medical devices

Nontuberculous Mycobacteria (NTM) infections associated with heater-cooler devices

In the last few years, the FDA has focused on increasing awareness of Nontuberculous Mycobacteria (NTM) infections associated with heater-cooler devices and the subsequent risks to patients in health care facilities.  The FDA reports that there were 32 reports of infections associated with heater-cooler devices or bacterial heater-cooler device contamination between 2010 and 2015, but

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Reprocessing of Reusable Medical Devices

The FDA requires manufacturers of reusable medical devices to provide reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended. Developing and validating these instructions can be a complex and highly specialized activity. Guidance on this process can be found in a document created by

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