2015-10-22 18:31:13 UTC

CMS is Cracking Down on Reprocessing and Sterilization of Reusable Medical Devices

Oct. 22, 2015

Be prepared for the new CMS survey process, which will monitor reprocessing and sterilization of duodenoscopes.

CMS has prioritized reprocessing and sterilization of reusable medical devices, specifically duodenoscopes, during its survey process. Your facility needs to be prepared. The AGA Center for GI Innovation and Technology recommends starting by assessing your facility’s reprocessing and sterilization procedures, including: training of personnel who reprocess medical devices; adherence to cleaning, disinfection, sterilization and device storage procedures; and infection control policies and procedures.

Under the new CMS policy, upon entering a facility, surveyors will inquire whether the facility performs ERCP using duodenoscopes, and if so, surveyors will request a copy of the manufacturer’s instructions for use for cleaning and disinfecting the duodenoscope, as well as any automatic endoscope reprocessors the facility uses in reprocessing duodenoscopes. Further, surveyors will observe endoscopes being reprocessed and ask the responsible staff to explain and demonstrate how they adhere to manufacturer’s instructions and multisociety guidance.

To help you prepare, CDC has issued a Health Advisory with recommendations and a self-assessment worksheet. CDC explains that a facility using the self-assessment tools will not only protect patients from the potential transmission of infectious diseases, but also be considered more successful in application of infection control procedures and more likely to demonstrate compliance to surveyors.

More on ERCP

A Prospective Multicenter Study Evaluating Learning Curves and Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Among Advanced Endoscopy Trainees: The Rapid Assessment of Trainee Endoscopy Skills Study

Oct. 22, 2017

These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP.

Device Recall: Fujifilm ED-530XT Duodenoscopes

July 24, 2017

If you use this device, Fujifilm will be in touch by October 2017 with next steps for replacing your device(s).

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