Infection Control Today - 09/2004: inside central sterile

September 1, 2004

Considerations for Chemicals and Automated Reprocessors UsedWith Flexible Endoscopes

By Lynne A. Thomas, BSN, RN, CGRN

In making a selection of chemicalproducts and automated endoscope reprocessors (AERs), a healthcare facility mustconsider safety for its patients, for its staff, for the environment, and forits endoscope inventory. Product selection committees are often chosen tostandardize products and processes across a multitude of departments andfacilities. Each committee member comes to the table with their own experiencesand preferences for products and processes. This group must consider the risks, benefits, use, and misuseof each alternative.

The first source for information on how to effectivelypre-clean, leak-test, manually clean, reprocess, and dry the flexible endoscopeis the original equipment manufacturer (OEM). The FDA assigns the OEM the responsibility of providingwritten instructions as to the process of rendering a reusable device safe forthe next patient.

The next step involves selecting chemicals to use in cleaningthe flexible endoscope. There are many brand-name and group purchasing organization(GPO)-labeled low-sudsing, pHneutral enzymatic cleaners that are safe forflexible endoscopes.

Regardless of the chemical selected, it must be usedspecifically as directed on the container label. The Food and Drug Administration(FDA) requirements do not vary the instructions to accommodate for hard or softwater conditions. Instructions may direct the user to dilute the enzyme withwater within a specific temperature range, and to agitate (mix) the solutionprior to use. Any instructions not followed may render the process lesseffective. The chosen chemical must be used as directed in the scopes OEMmanual in conjunction with the irrigating devices and cleaning brushesdescribed. The user manual for each AER should be reviewed to ensure thatall conventional and auxiliary channels of each scope in inventory will receiveappropriate chemical exposure. The Material Safety Data Sheet (MSDS) on theselected chemical will cite all necessary precautions for the device, for theuser, and for the environment. MSDS sheets should accompany each carton ofchemicals, 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. Thisstandard for practice minimizes the concern of cross contamination.

The introduction of sponges that contain enzymatic cleanersmay be a new convenience for flexible scope cleaning. While appropriate for thescopes external surfaces, the sponge may not provide the concentration ofsolutions needed for flow through the internal channels, so further processingmay be required.

On its Web site the FDA provides an updated list of chemicalsthat have been awarded a 510(k) status and have been approved for use in thesafe and effective reprocessing of flexible endoscopes. The document, FDA-ClearedSterilants and High-Level Disinfectants with General Claims for ProcessingReusable Medical and Dental Devices, 1/30/02 is available atwww.fda.gov/cdrh/ode/germlab.html. It is within the 510(k) application that thechemicals microbiological efficacy is documented. You may also download MSDSsheets for each product along with information for determining effectiveconcentration levels, information about chemical spills, and instructions on howto neutralize the chemical prior to disposal.

Other factors affecting your choice of chemicals include sizeof rooms used, ventilation, and air exchanges. Preexisting patient diagnosis,such as bladder cancer, may preclude the use of certain chemical disinfectant onflexible 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-describedprocess if your reprocessing is to be automated. The instructions spell outeffective use of the reprocessing chemical including flow dynamics throughappropriate irrigation tubing systems, ultrasonic pulsation, chemical heaters,and rinse cycle variables required for effective rinsing of the chemical. Properpositioning of the scope within the AER basins will ensure protection of thescope from compression, puncture and buckling damage.

Economical considerations include the cost per cycle as itrelates to the number of scopes processed in one load, the cost of thedisinfectant/sterilant per cycle, the cost of chemical or biological monitoringstrips per load, the cost to dispose of the used chemical, and the time lengthof each cycle.

The number of functional scopes in your active inventory mayalso impact AER purchasing decisions. Load volume and total processing times arethe offsetting variables.

It can be very helpful in your decision process to create aspread sheet of all variables relating to time required and chemicals to beconsidered. Local, regional and state laws governing the disposal of chemicalsbeing considered should be noted. The number and type of filter and their changefrequency are also a consideration. Required personal protective equipment (PPE)that must be used (along with the length of time these garments may beconsidered effectively protective) should be listed as well. This protectivereview should include cost considerations of adding a cold water eye washstation and attainment of required chemical spill kits.

Space, electrical, plumbing, and ventilation aspects of theendoscope 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 safeand 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 educationfor 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 selecteddisinfectant?

Are there environmental laws that will impact the disposal ofthe 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 roomwhere chemicals are used?