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Date ArticleType
11/1/2015 Regulatory
CDC/FDA Notice on Reusable Medical Devices

CDC/FDA - Partial Rescind Notice - Immediate Need for Healthcare Facilities to Review Procedures for Reusable Medical Devices 

On September 11, 2015, the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) issued a health alert HAN 00382 advising healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent lapses in compliance with recommended reprocessing procedures have led to increasing numbers of patient notifications about possible exposures. 

On October 2, 2015 a partial rescind notice - HAN 00383 was issued  as a follow-up to HAN 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.

CDC is making this change because there are currently no formal standardized programs or processes through which all manufacturers certify third-party vendors.  CDC is 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.