Nurse recounts her journey to endoscope reprocessing upgrade

Over the next several years we advanced to using an "auto-disinfector." This eliminated the pressure from physicians to release scopes faster for use because the scope couldn’t be released until the automated cycle was complete. However, we discovered that the "auto-disinfector" was diluting the glutaraldehyde to such a degree that it was no longer effective after six cycles. Since we had no chemical strips to test glut’s efficacy in those days, we used the same glutaraldehyde solution for the full two weeks.

This problem led to the acquisition of a newer mechanical disinfector. After using it for one-to-two years we were told it had "bacteria" (referred to as biofilm nowadays) within the processor and water lines. We tried to self-disinfect the processor, but the procedure was so cumbersome that we actually went back to manual soaking.

While these processing issues were going on, one of my nursing colleagues developed a severe sensitivity to glutaraldehyde and latex gloves. We had a dedicated endoscopy technician by then, but we were in a tough spot because we were still using this chemistry in the department for reprocessing.

In the late l980s we renovated to create a new bronchoscopy area for our AIDS patients. Because of our bad experiences with the two previous processors, we decided to look for new technologies that might be available. Also, we didn’t like soaking scopes overnight. We used ethylene oxide sterilization when we could, but it always meant the scopes could be used only once that day. We were a busy academic center, so our schedule was full and the turnover demand for disinfected scopes was high.

With the assistance of our director of sterile processing, we found a new technology on the market that was going to meet our requirements of providing consistently safe endoscopes for use on our patients. We were the first center in the northeastern U.S. to purchase a low-temperature sterile processing system that used an oxidative chemistry. We were pleased because having this new option meant that we didn’t need to use the glutaraldehyde or ethylene oxide as much. We used this oxidative chemistry processor as often as we could.

My story is probably a very typical history of flexible scope reprocessing that can be told by many others around the country. The ’80s represented the dawn of new endoscopic technologies and minimally invasive therapies, and everyone was trying to develop the best ways to reprocess these very expensive reusable devices. My story illustrates both the fear of change and the halting progress many departments have made in trying new technology and developing best practices in such a new medical environment.

There are a number of practical benefits to be gained by switching to an oxidizing high-level disinfectant. For example:

• When used properly, oxidative formulations help protect workers, patients, endoscopes, and the department. Endoscopy staff is protected because there are no inhalation risks and no fear of anyone developing asthma or sensitivity. Patients are protected because the chemistry is active in the presence of soil, so any residual debris is cleaned away.

• Oxidizing high-level disinfectants effectively remove even adherent residues that have had prolonged exposure to cross-linking chemistries (dialdehydes). They will extract residues from external and internal surfaces of endoscopes, AERs and tubing, and from soaking containers.

• Oxidizing chemistries are free-rinsing so no chemistry remains after only one rinse and there is no fear of causing inflammation in a patient’s intestinal mucosa.

• Oxidizing disinfectants are also compatible with a wide variety of scope materials. They actually remove discoloration on scope surfaces and will not leave the black spots on the floor, on scrubs or in storage cabinets that you see when a department uses aldehyde chemistries.

• There is no need to reinvent the wheel or change procedures – oxidizing disinfectants fit neatly into existing manual and automated protocols.

Just as I had the opportunity during my career to improve our processes by trying a new automated system with a low-temperature oxidative chemical process, today’s departments have a very new oxidative option to try. A new product available now has all the "bells and whistles" any GI department could ask for. For example, it’s a ready-to-use high-level disinfection formulation that offers a host of benefits. It can be used for both manual and automated processes. It is not an inhalation risk and requires no special venting, no measuring, no mixing, and no special disposal protocols. It’s also non-staining, has a reuse life of up to 21 days, and requires only one rinse and no heating. It is tuberculocidal, bactericidal, virucidal at 8 minutes, and passed the AOAC Sporicidal test with a contact time of six hours. It is biodegradable and water soluble. Even the container can be recycled.

So why would any GI department not want to switch? I have found that the fear of change and lack of solid, factual information can be more powerful than a desire for process improvement. So, the question is, how can you help your department embrace a change for the better? Using this new oxidizing high-level disinfection formula as an example, here are the steps:

We’ve all heard comments like, "If our process isn’t broken, why fix it?" and, "Is the new stuff proven?" These are valid questions, and they deserve to be addressed with careful thought and good information. First, is the process really not broken? Be prepared to question the current department process; are staff members having sensitivity to current chemistries? Are scopes processed on time, every time? Are the scopes in excellent condition? Is the process as easy, safe and fast as it could be for the staff? Can things be done better? The answers will help staff see the process more objectively.

In answer to "is it proven," present the facts. Oxidative chemistries are proven – they have been in use in healthcare settings for more than 20 years. Oxidative chemistries exhibit excellent cleaning, disinfecting and sterilizing properties, and there is plenty of science to prove this. The disinfectant supplier can help you acquire documentation and present to your staff.

In particular, educate the department about the real-world benefits they will personally experience. It’s easier to change when staff appreciates the improvements they will see in their own daily routine.

Discuss the challenge of biofilm and how it can build up on the scopes, contribute to infection and be very difficult to kill. Clinical studies now confirm that biofilms are resistant to glutaraldehyde and OPA and actually continue to thrive, release from the surface, travel, and form a new biofilm elsewhere. In the Association for the Advancement of Medical Instrumentation Standard 79, published in 2006, there is a statement that reads, "Once biofilm forms, direct friction and/or oxidizing chemicals are needed to remove it."

Explain how the new chemistry can be used for manual processing or in automated AERs. Most AERs are cleared by FDA independently of a specific chemistry, so the end-user has a choice of which disinfectant/sterilant to use. (There is an FDA website that provides information on all cleared (for market) sterilants and high level disinfectants: www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm133514.)

A manager of an endoscopy department needs to be able to make the business case to materials management for switching a processing chemistry. This would include the safety aspects, productivity gains, quality outcomes and of course, the costs. For this new oxidizing chemistry, for example:

• Productivity is increased because:

• Quality outcomes are improved:

• Cost benefits include:

Manufacturers often provide opportunities for facilities to test a product, and this new chemistry is no exception. Arrange for a trial and have your staff conduct it to get hands-on experience with the new chemistry. Document important data like the number of scopes processed in one batch of chemistry, the number of reprocessing cycles completed in a day, and the condition of the endoscopes before and after processing with the oxidative formulation.

Have the staff report their findings, including their comparison with aldehydes related to ease of use, time savings and staff sensitivity. Since the best teacher is personal experience, the staff will convince themselves of the value of a change. This is also a great opportunity to discuss best practices and the SGNA guidelines for changing processing technology.

References

1. Position Statement, Multi-society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes. Gastrointestinal Endoscopy, vol. 58, no. 1, 2003.

2. ASGE Guideline, Infection Control during GI endoscopy. Gastrointestinal Endoscopy, vol. 67, no. 6, 2008.

3. SGNA Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes, 2008.

4. ASGE Technology Status Evaluation Report, Automated Endoscope Reprocessors. Gastrointestinal Endoscopy, vol. 69, no 4, 2009.

5. Understanding Oxidative Chemistries. R.R. Rahl. (May, 2006) Healthcare Purchasing News, p 32.

6. Guideline for Use of High Level Disinfectants & Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes. (2007) SGNA

7. Association for the Advancement of Medical Instrumentation, Standard 79, 2006. FDA Web site: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm133514.

8. Bacteria Resistant to Glutaraldehyde and OPA from Washer-Disinfectors in the United States. G. McDonnell, A. Fiorello, C. Fisher, D. Shaffer, Z. Svetlikova and M. Jackson. (2009) Abstract presented at SGNA 36th Annual Course, May 15-20, St. Louis, MO

9. Sporicidal Activity of Disinfectants as One Possible Cause for Bacteria in Patient-Ready Endoscopes. N. Miner, V. Harris, T. Ebron and T-D Cao. (2007) Gastroenterology Nursing, vol. 30, no 4, p 285.

10. Chemical Colitis Due to Glutaraldehyde: Case Series and Review of the Literature. E. Ahishali, O. Uygur-Bayramicli, C. Dolapcioglu, R. Dabak, A. Mengi, A. Isik, E. Ermis. Digestive Disease Science, December 2008.

11. A Case Report of Occupational Asthma due to Glutaraldehyde Exposure. T. Ong, K. Tan, H Lee, P. Eng. (2004) Annals of Academy of Medicine. Vol. 33, no 2.

12. A Case of Occupational Bronchial Asthma and Contact Dermatitis Caused by Orthopthalaldehyde Exposure in a Medical Worker. H. Fujita, M. Ogawa, Y. Endo. (2006) J. Occup Health, vol 48, p 413.

13. Anaphylaxis Following Cystoscopy with Equipment Sterilized with Cidex OPA (orthopthalaldehyde): A review of Two Cases. D.E. Cooper, A. White, A. Werkema, B. Auge. (2008). J. Endourology. Vol. 22, no 9. September.

14. Oropharyngeal and laryngeal burn resulting from exposure to endoscope disinfectant: A case Report. A. Senchak, J. Bager, B. Cable. (2008) ENT-Ear, Nose & Throat Journal. Vol. 87, no 10, p. 580.

15. Worker Safety and Glutaraldehyde in the Gastrointestinal Lab Environment. N. Cohen, C. Patton. (2006). Gastroenterology Nursing. Vol. 29, no 2, p. 100.

16. STERIS Corp. product information.