As a follow-up toHAN 00382(distributed September 11, 2015), the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are providing this update to rescind the following recommendation: If healthcare facilities contract maintenance and repair of these devices to third-party vendors, healthcare facilities should verify that these vendors are approved or certified by the manufacturer to provide those services. We are making this change because there are currently no formal standardized programs or processes through which all manufacturers certify third-party vendors. We are also further clarifying that healthcare facilities which hire contractors to perform device reprocessing should verify that the contractor has an appropriate training program (i.e., consistent with what would be required in the healthcare facility) and that the training program includes the specific devices used by the healthcare facility.
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