NANCY CHOBIN, RN, AAS, ACSP, CSPM, CFER CHOBIN & ASSOCIATES CONSULTING HOT TOPICS IN STERILIZATION AND DISINFECTION

UPDATE - CUSTOM ULTRASONICS RECALL The FDA is revising its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics regarding its November 2015 Recall Order. On November 12, 2015, in accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics (Consent Decree), FDA ordered Custom Ultrasonics to recall, at its expense, all of its Automated Endoscope Reprocessors (AERs).

UPDATE - CUSTOM ULTRASONICS RECALL On November 24, 2015, Custom Ultrasonics submitted a recall strategy to the FDA, which the Agency found inadequate. Custom Ultrasonics has to date made no additional proposals to FDA to recall its AERs. On January 29, 2016, the FDA sent a letter to Custom Ultrasonics reinforcing the terms of the Recall Order and requiring Custom Ultrasonics to remove its AERs from the market. The FDA further notified Custom Ultrasonics that it could take additional measures under the Consent Decree should Custom Ultrasonics fail to initiate or diligently implement the recall or take other required actions.

UPDATE - CUSTOM ULTRASONICS RECALL Because Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the Agency continues to recommend that healthcare facilities using Custom Ultrasonics AERs to transition to alternative methods to reprocess flexible endoscopes as soon as possible, as emphasized in its November 13, 2015 Safety Communication

CUSTOM ULTRASONICS RECALL – WHAT TO DO? Identify and transition to alternate methods to reprocess flexible endoscopes, such as manual high-level disinfection, liquid chemical sterilization, alternative AERs, or other cleaning and sterilization methods according to the endoscope manufacturers' reprocessing instructions. Before transitioning to an alternative method, be sure that the endoscopes your facility uses are compatible with the alternative method by referring to the endoscope manufacturer's reprocessing instructions

JOINT COMMISSION CITES MISTAKES During the first half of 2015, inadequate reprocessing and sterilization of medical equipment, devices, and supplies was among the top “not compliant” citations issued by The Joint Commission. According to a report, 60% of critical access hospitals, 54% of hospitals, and 53% of office-based surgery centers were cited for noncompliance to the infection prevention and control standard IC between Jan. 1 and June 20, 2015.

FDA/CDC RECOMMENDATIONS Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices ( ) The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices.

FDA/CDC RECOMMENDATIONS Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.

FDA/CDC RECOMMENDATIONS Healthcare facilities should arrange for a healthcare 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

FDA/CDC RECOMMENDATIONS Healthcare facilities should provide training to all personnel who reprocess medical devices. Training should be required and provided: Upon hire or prior to provision of services at the facility At least once a year When new devices or protocols are introduced, including changes in the manufacturer’s instructions for use during the device’s life cycle

FDA/CDC RECOMMENDATIONS Personnel should be required to demonstrate competency with device reprocessing (i.e., trainer observes correct technique) prior to being allowed to perform reprocessing independently. Healthcare facilities should maintain current documentation of trainings and competencies. If the healthcare facility hires a contractor for device reprocessing, the facility should verify that the contractor has an appropriate training program and that the training program includes the specific devices the healthcare facility uses. Copies of manufacturers’ instructions for operating and reprocessing each type of reusable device should be readily available to staff and inspectors. This file should include instructions for use of chemical disinfectants

FDA/CDC RECOMMENDATIONS Healthcare facilities should regularly audit (monitor and document) adherence to cleaning, disinfection, sterilization, and device storage procedures. Audits should assess all reprocessing steps Assure all Infection Prevention policies enforce correct device reprocessing.

STERILIZATION/DISINFECTION CONFERENCE This conference is urgently needed to provide updated information on keeping patients safe and complying with the standards. The conference will be May 4-5, 2016 at the Holiday Inn, National Conference Center, East Windsor, N.J. There will be a vendor exhibit May 4 th.

TOPICS WILL INCLUDE: AAMI Standards Decontamination Packaging Rigid Containers Low Temperature Sterilization Steam Sterilization High Level Disinfection Compliance with AAMI ST-91 Endoscope document Best Practices for Processing Flexible GI Scopes What to Expect when a Surveyor calls Competencies for SPD Personnel Dealing with Manufacturer’s Instructions for Use.

THANK YOU! Thank you for all your thoughts and prayers. They were a source of great comfort to me and my family. But, there is still work to be done so I hope to see you in May at the Conference!