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When an ASC begins revamping its reprocessing program, a good place to start is with guidelines that can be found easily. Here are some suggestions for where to start:
• Follow the manufacturer’s guidelines. “Every one of our centers is different and has different equipment, but the bottom line is they all have to follow manufacturer’s instructions,” says Laura Schneider, RN, CGRN, CASC, senior director of clinical services at AmSurg in Dallas.
ASCs must base reprocessing education on the instruction manuals, as well as other guidelines. Scope manufacturers also provide useful education online.
“New endoscopes come with two manuals, including an operation manual and a reprocessing manual,” Schneider says. “The reprocessing manual is complicated and over 100 pages, so many people don’t even look at it.” But the manual also contains more easily digestible sections. Schneider suggests designating someone to read and follow the manual, section by section. ASCs also should check manufacturers’ websites regularly for updates and alerts. Sometimes, manufacturers post letters about whether a particular cleaning agent should be used on their devices.
• Know regulatory and other guidelines. ASCs can download infection control and reprocessing guidelines from federal agencies or professional organizations, such as the Society of Gastroenterology Nurses and Associates (SGNA).
SGNA recommends surgery centers follow these nine steps for endoscope reprocessing:1
Other resources include a 12-page reprocessing report by the Healthcare Infection Control Practices Advisory Committee (HICPAC), which is a federal advisory committee to the CDC. The report’s seven steps are similar to other guidelines, but also add visual inspection, storage, and documentation.2 Surgery sites should maintain adherence documentation to each step each time an endoscope is reprocessed. It’s necessary for quality assurance purposes and for patient tracing, according to the HICPAC report.
The FDA also offers advice about reprocessing medical devices with specific guidance on validation methods and labeling.3 The FDA’s guidance includes tips on effective cleaning, including:
- minimizing the soil transfer from one patient to another or between uses in a single patient;
- preventing accumulation of residual soil throughout the product’s use life;
- allowing for successful, subsequent disinfection/sterilization steps.
“Always follow the guidelines,” says Michele McKinley, LVN, CMQ/QE, CQA, senior clinical education specialist at STERIS. “I recommend that all staff should know the guidelines.”
When an ASC’s reprocessing is investigated, the inspector won’t ask management to describe the process. Instead, they’ll approach frontline staff and ask them to demonstrate the process, McKinley warns. “I tell people to teach reprocessing as part of continuing education,” McKinley says. “Do one guideline a week and focus on the manufacturer’s instructions for use each week. That way, the employee is continually learning about the guidelines and instructions for use.”
Financial Disclosure: Editor Jonathan Springston, Editor Jill Drachenberg, Editorial Group Manager Terrey L. Hatcher, Author Melinda Young, and Nurse Planner Kay Ball, RN, PhD, CNOR, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Stephen W. Earnhart discloses that he is a stockholder and on the board for One Medical Passport.