A third-party reprocessor is a company other than Medtronic that recycles and remanufactures sensors intended for use with your hospital’s Nellcor™ pulse oximetry system. One manufacturer found that "91% of the third-party reprocessed sensors would fail one or more of [the original manufacturer’s] performance standards and 79% would not pass quality inspection."1
The FDA requires that single-use devices that are remanufactured by the original manufacturer or a third-party reprocessor for an additional use be validated. The expected validation includes: "(1) demonstration that the device can be adequately cleaned and disinfected or sterilized, (2) that the physical characteristics or quality of the device will not be adversely affected by these processes, and (3) that the device continues to comply with applicable FDA requirements."2 Reprocessors, as well as the original device manufacturers, are considered manufacturers by FDA and are subject to the following requirements: Quality System Regulation, Medical Device Reporting, Registration and Listing, Labeling, Premarket Approval or Premarket Notification, Medical Device Corrections and Removal, and Medical Device Tracking.2 For more information, please visit the FDA website. There are many third-party reprocessors of the Nellcor™ sensors and Medtronic has no involvement or oversight of their reprocessing procedures; therefore, the original sensor warranty will no longer apply.
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