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The Food and Drug Administration (FDA) has released guidance on supplemental reprocessing measures that might further reduce the risk of infection associated with the use of duodenoscopes, according to the American Hospital Association (AHA).
The new guidance came out shortly before news broke that Huntington Memorial Hospital in Pasadena, CA, is investigating a suspected pseudomonas bacteria outbreak related to duodenoscopes. Huntington Memorial said it discovered the potential problem in June during a review of lab samples, and it has reported three patient infections to health officials. Similar outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) linked to duodenoscopes have been reported in North Carolina, Pittsburgh, Los Angeles, Chicago, and Seattle.
The new FDA measures, which emerged from an expert panel meeting led by the agency, are intended to supplement strict adherence to the manufacturer’s reprocessing instructions, the AHA said. (Recent research says bacteria survive on endoscopes even after a multi-step cleaning and disinfecting process. See story on that topic included in this issue.)
The guidance says that implementing the measures requires specific resources, training, and expertise, which all healthcare facilities might not have. “Therefore, it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks,” the guidance states. “While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients.” (Access the new guidance at http://1.usa.gov/1IFQO7F.)
In February, the FDA issued safety recommendations to prevent possible microbial infections from reprocessed reusable duodenoscopes. (Those recommendations can be accessed at http://1.usa.gov/1CNpAeh.)
The FDA also has issued regulatory warnings that allege regulatory violations to three duodenoscope manufacturers, according to the AHA. The AHA said Olympus Corp. of the Americas and Hoya Corp. were cited for the following alleged violations:
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failing to report infections associated with their devices to FDA within 30 days;
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failing to adequately develop, maintain, and implement written Medical Device Reporting procedures.
Hoya also was cited for certain alleged violations related to design validation, corrective action, and process control, the AHA said. Fujifilm Medical Systems USA was cited for alleged violations related to design control, corrective action, inspection of parts, process validation, complaint handling, equipment testing, production processes, and device correction or removal, the AHA said.
The FDA letters asked the manufacturers to notify the agency within 15 days of the specific steps they have taken to correct the alleged violations. (For more information on this topic, see these stories in Same-Day Surgery: “Culturing protocols devised for duodenoscopes to prevent CRE,” May 2015, and “ECRI Institute’s top patient safety concerns include scope reprocessing,” June 2015.)
Another recent development is the release of a standard from the Association for the Advancement of Medical Instrumentation (AAMI) titled “ANSI/AAMI ST91:2015, Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities.”
AAMI said that there was no single document to turn to for guidance and existing resources sometimes contradicted each other. The new standard compiles all the information for processing flexible and semi-rigid endoscopes. It offers guidance on precleaning, leak-testing, cleaning, packaging, storage, high-level disinfecting, and sterilizing of flexible endoscopes. (For ordering information, see Resource below. Also, the Association of periOperative Registered Nurses will release a “Guideline for processing flexible endoscopes” in January in the publication “Perioperative Guidelines for Practice.”)
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ST91 is available online for $195 list or $117 with AAMI member discount. The product code is ST91. Web: http://bit.ly/1i2peuX.
