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

 

  1. Precleaning begins in the procedure room right after the insertion tube is removed from the patient;
  2. Leak testing detects damage to the endoscope’s interior or exterior;
  3. Manual cleaning is needed before automated or manual disinfection;
  4. Rinse after manual cleaning;
  5. Visual inspection, which warrants its own step and could be considered a time out or safety stop, is necessary to verify the endoscope is at least visually clean;
  6. High-level disinfection is the standard for reprocessing endoscopes; This includes using automated reprocessing that circulates fluids through all endoscope channels with equal pressure and without trapping air;
  7. Rinse after high-level disinfection;
  8. Dry and purge all channels with air until dry;
  9. Store endoscopes in an area that’s clean, well-ventilated, and dust-free to keep them dry and free of microbial contamination.

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.”

REFERENCES

  1. Society of Gastroenterology Nurses and Associates. Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes. Available at: http://bit.ly/2HSmFJR. Accessed Feb. 21, 2018.
  2. Centers for Disease Control and Prevention. Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the Healthcare Infection Control Practices Advisory Committee. Available at: http://bit.ly/2HyoNpR. Accessed Feb. 21, 2018.
  3. U.S. Food and Drug Administration. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff. Available at: http://bit.ly/2ol6Q5i. Accessed Feb. 21, 2018.