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CDC, FDA urge providers to adhere to device sanitation protocols
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The CDC and FDA are urging health care facilities and providers to review cleaning, disinfecting and sterilizing protocols for reusable medical devices after recent media accounts reported that patients may have been exposed to infection due to lapses in basic sanitation practices.
According to the CDC’s health advisory, nonadherence to cleaning procedures involved failure to follow reprocessing instructions for medical devices, such as surgical instruments and endoscopes, provided by manufactures.
“Recent infection control lapses due to noncompliance with recommended reprocessing procedures highlight a critical gap in patient safety,” the advisory said. “Health care facilities should arrange for a health care professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assessment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer.”
The CDC and FDA recommend that health care facilities:
- train all new staff members who reprocess medical devices and provide follow-up training at least once a year and when new devices or instructions are introduced;
- require staff members to demonstrate competency in device cleaning before reprocessing devices on their own;
- maintain current documentation of trainings and reprocessing activities, including maintenance records for reprocessing equipment, sterilization records, and records confirming disinfectants were tested and properly replaced;
- verify that any hired contractor has an appropriate training program;
- have copies of manufacturers’ instructions readily available to staff and inspectors;
- regularly monitor adherence to cleaning, disinfection, sterilization and device storage procedures in all areas where reprocessing is conducted, including prompt cleaning before disinfection or sterilization procedures, disinfecting devices in accordance with manufacturers’ instructions and monitoring sterilizer and endoscope reprocessor performance;
- provide feedback to staff regarding their competency in sterilization procedures;
- allow adequate time for reprocessing to ensure all steps recommended by the devices’ manufacturers have been followed;
- consider scheduling procedures to ensure there is enough time for reprocessing;
- train health care personnel to be able to readily identify properly reprocessed devices that are ready for patient use;
- outline policies and procedures to identify, notify and follow patients in the event of a reprocessing error or failure; and
- follow manufacturer recommendations for maintenance and repair of medical devices.
For more information:
Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
CDC’s 2008 Guidelines for Disinfection and Sterilization in Healthcare Facilities
The Association for the Advancement of Medical Instrumentation (AAMI) guidelines
FDA’s MedWatch Adverse Event Reporting program