Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices

Centers for Disease Control and Prevention HEALTH UPDATE

Please share this information with your management team, infection preventionist and the sterile processing department.

As a follow-up to a health update entitled HAN 00382 and distributed by Centers for Disease Control and Prevention (CDC) on September 11, 2015, the CDC and U.S. Food and Drug Administration (FDA) are providing this update to rescind the following recommendation: if health care facilities contract maintenance and repair of these devices to third-party vendors, health care 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 health care 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 health care facility) and that the training program includes the specific devices used by the health care facility. More>>