On September 11, 2015 the United States Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) issued a health advisory to clinicians and medical facilities highlighting the importance of ensuring the proper cleaning, disinfection, and sterilization of reusable medical devices(http://emergency.cdc.gov/han/han00382.asp). This advisory was released in response to patients being informed that they could be at an increased risk of infection due to improper cleaning protocols caused by the failure to follow manufacturer’s detailed protocols.
Although significant attention has been given to the risk of infection with the use of complex medical equipment such as duodenoscopes, the risk of infections caused by the incomplete removal of agents such as bioburden or sterile crud, which is the first and most critical step in sterile processing, extends to all reusable medical devices. These lapses have led to patients being forced to undergo tests for hepatitis B and HIV, and have been associated with instruments used in hospitals, clinics, ambulatory surgical centers, and doctors’ offices.The advisory recommended that all of these institutions review their current cleaning processes to ensure that they are compliant with manufacturer’s recommendations, that staff are trained appropriately, and that staff are given sufficient time to performed the necessary cleaning, disinfection, and sterilization processes.
The main recommendation of the advisory is that all healthcare facilities should have their reprocessing procedures assessed immediately by a healthcare professional with expertise in device reprocessing. Specifically, it should assess that:
• Reprocessing is performed correctly
• Sufficient time is allowed to ensure that all cleaning steps (including those to remove bioburden and sterile crud) recommended by the device manufacturer can be performed
Furthermore, individuals who are responsible for cleaning and sterilizing reusable medical devices should receive adequate and regular training, and should also be required to demonstrate competency. Manufacturer’s instructions for operating cleaning, disinfection, and sterilization equipment should made readily available to both staff and any site inspectors.Cleaning should be performed promptly after equipment has been used, but before disinfection and sterilization. During the disinfection step attention should be paid to the manufacturer’s recommendations. Finally, the performance of the sterilizer should be monitored at regular intervals.