Several hospitals in the U.S. struggled with dirty, improperly cleaned scopes this year, prompting the ECRI Institute to, yet again; include the safety issue on the 2016 version of its annual list of health technology hazards.
So how can you be sure your healthcare facility is properly cleaning and reprocessing scopes? Stephen M. Kovach, director of education at Healthmark Industries, and Mary Ann Drosnock, manager of clinical education for gastroenterology at Healthmark Industries, outlined 10 best practices to improve the scope cleaning process in a recent webinar.
"In the industry, we've been told there is no or very little risk of infection related to scopes. I believe differently," said Mr. Kovach. "I believe we are not connecting the dots. The problem is not what's limited to what is published in peer-reviewed literature — it includes what is found in nonpeer-reviewed literature, and that's what is important."
To reduce the risk of infection related to scopes, there are many guidelines, standards and regulations healthcare providers can reference to improve their scope practice. Specifically, Mr. Kovach mentioned the following four standards from the Association for the Advancement of Medical Instrumentation/American National Standards Institute:
1. AAMI/ANSI ST79, which deals with steam sterilization
2. AAMI/ANSI ST58, regarding chemical sterilization and high-level disinfection
3. AAMI/ANSI ST41, dealing with ethylene oxide sterilization
4. AAMI/ANSI ST91, which offers a thorough guide to reprocessing flexible and semi-rigid endoscopes
Ms. Drosnock described AAMI/ANSI ST91 — which was just published in April — in further detail, highlighting its best practices for scope reprocessing in any healthcare setting.
"There is a great load of information found in ST91," said Ms. Drosnock. "This includes a definition section, designs of endoscope reprocessing areas, different considerations for personnel, cleaning information, high-level disinfection and how to use and select automated endoscope reprocessors, to name a few."
Here are 10 ST91 best practices highlighted in the webinar.
1. Preclean at the point of use. Precleaning is the procedure that initiates the cleaning process and is performed at the patient bedside. The purpose of this step is to reduce the levels of bioburden on the scope to prevent the risk of biofilm development.
2. Contaminated transport. "After we have performed precleaning and utilized all of the recommended adapters provided by the manufacturer, the scope is now ready to transport to reprocessing," said Ms. Drosnock. Both ST79 and ST91 recommend the contaminated endoscope be transported in a closed, rigid container that is labeled appropriately with a biohazard sign, to meet Occupational Safety and Health Administration and each facility's guidelines.
3. Leak testing. This is the first step that occurs in the reprocessing area. Endoscopes need to be tested for leaks every single time they are used, following the instructions provided by the manufacturer of the respective scope. This step should be completed in water before the device is immersed in the proper detergent solution for cleaning to ensure it is watertight and undamaged.
4. Manual cleaning. According to Ms. Drosnock, "Manual cleaning is the most important step, it will remove more than 99 percent of the bioburden on an endoscope." Every channel and every accessory of every scope should be cleaned, even if it was not actually used in the procedure. Ms. Drosnock also emphasized how important it is to use the proper size brush to clean the scope's different parts. Healthmark offers an endoscope brush guide for this purpose.
5. Rinse. Rinsing must occur after the manual cleaning to remove any chemicals, detergents or loose debris which could be harmful to patients. AAMI also provides information in Technical Information Report 34:2014 on the water quality and purity necessary to properly rinse scopes.
6. Cleaning verification. Both ST79 and ST91 include recommendations to visually inspect and test equipment for residue, cracks and compromised fiber optic bundle integrity. Visual inspection takes place each time the technician touches an endoscope in any step of the process. The cleaning verification step follows the manual cleaning and precedes disinfection or sterilization.
According to ST91, healthcare organizations should monitor their cleaning verification process on a weekly, preferably daily, basis. There are many methods to verify if a scope is clean including monitoring the scope for residual protein, and or hemoglobin, along with other markers as outlined in ST91 and ST79. The use of a borescope such as the flexible inspection scope now allows staff to visually inspect the inside channels/lumens of endoscopes and the standards now support this type of practice.
7. Disinfection or sterilization. When disinfecting or sterilizing scopes, it's important to use the disinfectants and detergents according to the instructions and claims on their respective labels, since instructions can vary.
8. Keeping scopes dry. Moisture can contribute to biofilm formation and promote the growth of organisms. "This is really an up-and-coming area that has had a lot of emphasis placed on it lately," said Ms. Drosnock. "We've never really thought in the past about how dry our scopes are, but I think you'll see in the future…that these endoscopes really need to be dry prior to entering storage. The term I think everybody can relate to is 'bone dry,' that is the condition a scope should in when it is being placed into storage."
9. Storing scopes. In addition to being dry, scopes should be stored hung vertically, not touching each other, with the distal tip hanging freely in a well-ventilated, clean area. ST91 also recommends labeling scopes to clearly identify that they are patient-ready, and storing them with their accessories and valves.
10. Quality process improvement. Performance measures and process monitors used for continuous quality improvement programs are covered at great length in ST91. Instructions for completing a risk analysis are also outlined. "It is so important to me to stress building quality into your processes — up-front, before there is an issue — to ensure the best outcomes for patients," said Ms. Drosnock.
Ultimately, there is no silver bullet when it comes to the scope-cleaning process or any other quality improvements, according to Mr. Kovach, but "an ounce of prevention can yield enormous return for your patient."
Mr. Kovach also reminded viewers that a copy of both ST79 and ST91 can be purchased at www.aami.org. Also, if departments are looking for innovative products to help them meet the standards found in ST91, they can go to Healthmark GI website at www.healthmarkgi.com.
For more information on what markers and tools should be used for user cleaning verification, duodenoscope culturing or other scope-cleaning matters, watch the full webinar video here or access the webinar slides here.