Considerations for Chemicals and Automated Reprocessors Used With Flexible Endoscopes
By Lynne A. Thomas, BSN, RN, CGRN
In making a selection of chemical products and automated endoscope reprocessors (AERs), a healthcare facility must consider safety for its patients, for its staff, for the environment, and for its endoscope inventory. Product selection committees are often chosen to standardize products and processes across a multitude of departments and facilities. Each committee member comes to the table with their own experiences and preferences for products and processes. This group must consider the risks, benefits, use, and misuse of each alternative.
The first source for information on how to effectively pre-clean, leak-test, manually clean, reprocess, and dry the flexible endoscope is the original equipment manufacturer (OEM). The FDA assigns the OEM the responsibility of providing written instructions as to the process of rendering a reusable device safe for the next patient.
The next step involves selecting chemicals to use in cleaning the flexible endoscope. There are many brand-name and group purchasing organization (GPO)-labeled low-sudsing, pHneutral enzymatic cleaners that are safe for flexible endoscopes.
Regardless of the chemical selected, it must be used specifically as directed on the container label. The Food and Drug Administration (FDA) requirements do not vary the instructions to accommodate for hard or soft water conditions. Instructions may direct the user to dilute the enzyme with water within a specific temperature range, and to agitate (mix) the solution prior to use. Any instructions not followed may render the process less effective. The chosen chemical must be used as directed in the scopes OEM manual in conjunction with the irrigating devices and cleaning brushes described. The user manual for each AER should be reviewed to ensure that all conventional and auxiliary channels of each scope in inventory will receive appropriate chemical exposure. The Material Safety Data Sheet (MSDS) on the selected chemical will cite all necessary precautions for the device, for the user, and for the environment. MSDS sheets should accompany each carton of chemicals, and may also be downloaded at www.msdssearch.com.
Enzymatic solutions are not usually microbiocidal. Consequently, they need to be prepared as a fresh solution with each use. This standard for practice minimizes the concern of cross contamination.
The introduction of sponges that contain enzymatic cleaners may be a new convenience for flexible scope cleaning. While appropriate for the scopes external surfaces, the sponge may not provide the concentration of solutions needed for flow through the internal channels, so further processing may be required.
On its Web site the FDA provides an updated list of chemicals that have been awarded a 510(k) status and have been approved for use in the safe and effective reprocessing of flexible endoscopes. The document, FDA-Cleared Sterilants and High-Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices, 1/30/02 is available at www.fda.gov/cdrh/ode/germlab.html. It is within the 510(k) application that the chemicals microbiological efficacy is documented. You may also download MSDS sheets for each product along with information for determining effective concentration levels, information about chemical spills, and instructions on how to neutralize the chemical prior to disposal.
Other factors affecting your choice of chemicals include size of rooms used, ventilation, and air exchanges. Preexisting patient diagnosis, such as bladder cancer, may preclude the use of certain chemical disinfectant on flexible scopes used for endoscopic urological examinations. Your AER may narrow (or even eliminate) some chemical choices.
The AER selected must be compatible with the OEM-described process if your reprocessing is to be automated. The instructions spell out effective use of the reprocessing chemical including flow dynamics through appropriate irrigation tubing systems, ultrasonic pulsation, chemical heaters, and rinse cycle variables required for effective rinsing of the chemical. Proper positioning of the scope within the AER basins will ensure protection of the scope from compression, puncture and buckling damage.
Economical considerations include the cost per cycle as it relates to the number of scopes processed in one load, the cost of the disinfectant/sterilant per cycle, the cost of chemical or biological monitoring strips per load, the cost to dispose of the used chemical, and the time length of each cycle.
The number of functional scopes in your active inventory may also impact AER purchasing decisions. Load volume and total processing times are the offsetting variables.
It can be very helpful in your decision process to create a spread sheet of all variables relating to time required and chemicals to be considered. Local, regional and state laws governing the disposal of chemicals being considered should be noted. The number and type of filter and their change frequency are also a consideration. Required personal protective equipment (PPE) that must be used (along with the length of time these garments may be considered effectively protective) should be listed as well. This protective review should include cost considerations of adding a cold water eye wash station and attainment of required chemical spill kits.
Space, electrical, plumbing, and ventilation aspects of the endoscope reprocessing cycle as it relates to chemicals and AERs should also be reviewed prior to making a final determination.
A strategic plan to review all of the options discussed should be made with a team approach so that the final outcome is one that will be safe and effective for long run. Your ultimate choice will have impact on patients, healthcare providers and the environment for years to come.
Lynne A. Thomas, BSN, RN, CGRN, is vice president of education for Integrated Medical Systems International, Inc.
Questions to Ask Yourself
Do I have the user manual for all scopes?
Do I have cleaning adapters for all scopes?
Are these chemicals used elsewhere is the facility?
Is the enzymatic cleaner appropriate for all flexible scopes?
Is the disinfectant appropriate for all flexible scopes?
Are chemical indicators needed?
Are biological indicators needed?
Do I have the user manual of the AER?
Is the AER compatible with all endoscopes?
Can the AER be programmed to be used with the selected disinfectant?
Are there environmental laws that will impact the disposal of the selected chemicals?
Is the PPE currently used effective with selected chemicals?
Do I have appropriate spill kits?
Is there an eyewash station with cold water access in the room where chemicals are used?