Risk Analysis:

Application of evidence-based practice principles can help in identifying potential practice gaps in documentation, education and environment.

Documentation

Documentation includes data management systems, missing data elements and accountability for each step in reprocessing. Documentation of flexible endoscope reprocessing is required at a minimum of five critical touch points, i.e., precleaning, leak testing, manual or automated cleaning, high level disinfection and storage.  Documentation is required to provide a way to determine each of these steps has been completed, who was responsible for completing each step, and whether the conditions for the process were met at each step. All endoscope reprocessing guidelines involve nine specific steps for flexible endoscope reprocessing. These steps are:

• Point of use or precleaning
• Transport to the decontamination area
• Leak testing
• Manual cleaning / automated cleaning
• Visualization
• High level disinfection
• Alcohol purge and low pressure critical or instrument forced air drying
• Storage
• Clean transport to the point of use

Each step is important in flexible endoscope reprocessing and will be addressed in the following paragraphs.

Precleaning allows for immediate removal of gross organic tissue or bioburden both inside the channels and on the outside surface of the scope.  It must be done at the point of use because the scope needs to be connected to the processor to use the suction and air features to aid in removing bioburden.  Precleaning should be documented with a time stamp that indicates when precleaning was done and who did it. Most scope manufactures recommend cleaning and decontamination steps begin within one hour after the scope is removed from the patient.  If this time frame is not met, then the scope will require extended cleaning, meaning more work for the staff member responsible for scope reprocessing. 

The second step is protected transport.  Protected transport serves several purposes. The first is to protect the scope from damage. Guidelines recommend using a rigid container and making sure the container does not leak residual fluids after precleaning. A key consideration when choosing a rigid container is sufficient size to coil the scope loosely in order to prevent curling memory in the scope. It is also necessary to make sure the transport container has a highly visible universal biohazard symbol where everyone can see the container has a contaminated medical device.  This universal biohazard symbol is mandated (must do) by the Occupation Safety and Healthcare Association (OSHA).  This label is not negotiable, it must be visible.

Once the scope arrives in decontamination, the leak test is performed on ALLflexible endoscopes.  This is a preventive safety measure to make sure there is no damage to the integrity of the channels or the outside sheathing of the working mechanisms in the scope.  Leak testing can be automated or done manually and can be either dry or wet.    The leak test in the automated endoscope reprocessor (AER) does not replace this initial leak test.  The leak test function in the AER is intended to prevent fluid invasion by maintaining a positive low pressure inside the scope.)   Leak testing before cleaning is a required documentation step and identifies if the leak test passed or failed and who did the leak test.  Leak testing has been identified as the most frequently skipped test in endoscope reprocessing and has the least amount of documentation associated with it.  If the leak test fails, it should be repeated. If it fails again, the scope should be sent for repair.

Manual cleaning, the fourth step in flexible endoscope reprocessing, is a complex business.  Detergent selection can include enzymatics or surfactant-based solutions, which must be used at the recommended concentration, contact time, and temperature.  Of these, temperature is the most difficult to control.  Keep in mind enzymatics work best in warmer water, while surfactant-based detergents work in a broader range of temperatures.  For enzymatics, the cooler the temperature the longer the contact time.  Quality of the water is also important. Water that is considered potable or drinkable should be used in the sink.  Sometimes a particulate filter may be required to make sure minerals and debris in the pipes do not come in contact with your sink water.  Be sure to read the manufacturer's instructions for use (IFU) to achieve the proper ratio of detergent to water in order to get the proper concentration. An easy way to do this is to use measuring cups to make sure your pumps of detergent delivery equal the requirements on the detergent label. 

Brushes or channel cleaning devices such as Pull Thru™ should only be used on one scope before discarding if they are disposable.  If they are reusable, they must be cleaned and either sterilized or high level disinfected between each scope cleaning.  If using cleaning devices from the scope manufacturer, follow the manufacturer's instructions for use.  Remember you have different size channels, so you may need different size brushes or cleaning devices.  Syringes need to be handy to make sure you can get fluid such as detergent solution or rinse water into the channels.   Follow your scope IFU and your detergent IFU for manual cleaning.

If you are doing automated flushing of the channels you will need to follow the manufacturers’ IFU for that device.  You are responsible for making sure the scope is validated by the manufacturer to be used with their device and the hookups or attachments needed to do a thorough rinsing flushing are compatible with your scope and flushing device.

The fifth step, visualization, is the newest called-out step to be recommended for flexible endoscope reprocessing.  Visualization involves inspecting the air/water valves, suction/biopsy port, knobs, the distal tip of the scope and the light guide handle.  The duodenoscope has an additional inspection site at the elevator working unit.  Magnification for visualization should be at least 10X.  Visualization occurs immediately after cleaning and before the endoscope is placed in the AER or in the manual disinfection basin.  If you discover debris or soil, you can reclean the scope before it goes in the AER or basin, keeping you from wasting a high-level disinfection cycle.  If you discover damage, tag the scope and send it out for repair.    Even though the visualization step is newer to the endoscopy reprocessing area, Central Sterile Processing staff have used it for a long time.

High level disinfection is the sixth step.  This step can be completed using a manual method or an AER.  For both methods you will need to use chemistry that's compatible with the scopes.  Manual high-level disinfection should have the minimal recommended concentration (MRC) measured before the scope is immersed in the disinfectant.  If you are using an AER, follow the instructions for use for testing the MRC.  Make sure all channels and surfaces of the scope have contact with the disinfectant.  Follow the appropriate time for contact and temperature.  Follow rinsing instructions as directed by the manufacturer.  Each chemistry has very specific instructions for use.  One of the most frequently seen gaps in endoscope reprocessing is documentation of the MRC and the person who verified the results.

The seventh step is an alcohol purge and drying of the endoscope. Several commonly used American guidelines recommend purging the internal channel with an alcohol flush to facilitate drying, while other guidelines suggest performing a risk analysis to determine if alcohol purging is necessary.   All guidelines recommend that drying of internal channels needs to be done using low pressure critical or instrument air.  Studies have shown syringe air purging is not sufficient to dry the internal channels of the scope.   Drying of the scope has been identified as being just as important as cleaning of the scope in preventing infections.  Drying prevents microbial growth while the scope is stored, which is the eighth step.  Scopes can be stored in traditional vertical hanging cabinets or they can be stored in drying cabinets.  Validated drying cabinets have individual channel connectivity to ensure drying of the channels and external surfaces; scopes can be dried and stored horizontally.

The final step is clean transport of the scope from the storage area or AER to the point of use.  This may be a procedure room or another department within the facility.  The scope can be transported in a rigid container similar to the contaminated transport container.  Please note: the staff person needs to make sure the container has been cleaned before using it.  After use of the scope, the same container can then be used for contaminated transport of the scope to the decontamination room.

Most small scopes such as bronchoscopes, cystoscopes, laryngoscopes, etc.  can be terminally sterilized using all low temperature sterilization methods.  Terminal sterilization of the flexible scope allows it to be packaged and stored according to the packaging manufacturer's instruction for use for shelf life.  Some of these methods must meet channel length and lumen diameter specifications; these methods require approximately 30 minutes.  Longer flexible scopes can only be terminally sterilized in low temperature sterilization using ethylene oxide, a method that requires 12-16 hours.  High level disinfection is still considered the benchmark for reprocessing long flexible scopes such as gastroscopes and colonoscopes.

All of these steps are critical to providing a clean, disinfected, and safe scope for every patient.  This is a complex and challenging process.  Documenting steps provides a way to verify that all steps have been completed in the flexible endoscope cleaning, reprocessing and tracking process and provides the ability to track all completed steps for every patient.

Education

Due to the challenges and complexity of flexible endoscope reprocessing all professional society guidelines recommend a comprehensive orientation and training program.  It should include discussions on microbiology, chemistries, OSHA bloodborne pathogens, and infection control.  AORN 2018 recommends training and ongoing competency verification for the following activities:

• controlling and maintaining an environment that supports processing actions
• precleaning at the point of use
• transporting
• leak testing
• manual cleaning
• inspecting
• HLD, liquid chemical sterilization, packaging and sterilization
• storage
• maintaining records of processing and procedures for traceability
• quality assurance measures

Continuous updating and changes in medical device technology require staying current with technology, updated or new manufacturers’ instructions for use, and professional society guideline changes.

Environmental

Providing a safe working environment is crucial for staff safety.  When staff recognize their safety is important and there are mechanisms in place to help them stay safe, the staff can concentrate on doing their jobs and doing them effectively.  This can require multiple layers of safeguards to be in place.  The first layer might be traffic flow patterns.  The physical layout of the workplace can provide challenges and teams need to recognize this.  Minimizing access of staff and non-staff to high risk areas can help decrease infection transmissions associated with exposure to outside contaminants.    Introduction of outside contaminants can increase the possibility that patients will experience exposure to contaminated medical devices such as flexible endoscopes.

The Hospital Infection Control Practices Advisory Committee (HICPAC) provides guidance on environmental working conditions for health care facilities.  The Committee also provides information on isolation practices, works with the Centers for Disease Control, and writes policy statements related to nosocomial infections.  All guidelines strongly recommend a separate dedicated area for reprocessing flexible endoscopes with a “one-way work flow.”  This reprocessing area should not be located in the procedure room.

Other recommendations include separate handwashing sinks and eye wash stations in addition to the work sinks in the decontamination room and other areas where chemistries are being used.  Air exchanges, heating, ventilation and air conditioning should be appropriate for chemicals being used in the decontamination room.  Temperature, humidity and air exchanges should be monitored on a regular basis.  The decontamination area should be a negative pressure room to makes sure contaminants stay within the enclosed work space.

One of the biggest safety concerns for staff is having adequate and proper personal protective equipment (PPE) to wear while reprocessing flexible endoscopes.  In the decontamination area, guidelines recommend that workers wear the same PPE protection worn by their counterparts in the decontamination area of the Central Sterile Processing Department. This means hair cover, goggles or face shield, mask, impervious or leak proof gowns with sleeves, heavier duty gloves that cover the cuffs of the gown, and shoe covers.  Exam gloves are not acceptable for cleaning and decontaminating scopes.  The hospital is responsible for providing PPE supplies, but it is the responsibility of the staff member to utilize them correctly.  This is an OSHA requirement.

Citations or recommendations are given by hospital accreditation auditing agencies such as The Joint Commission, the American Association for Accreditation of Ambulatory Surgery Facilities, or DNV-GL (a merger of two companies, Det Norske Veritas and Germanischer Lloyd).  All agencies have similar criteria for passing an audit inspection.  Maintaining accreditation is vitally important for the healthcare facility.  Loss of accreditation can mean the loss of reimbursement from the Centers for Medicare and Medicaid Services.  When CMS no longer reimburses a non-accredited facility, other insurance companies may follow their lead, and reimbursement for all types of procedures and care will not be approved. 

Reprocessing

Endoscope reprocessing is considered a significant patient safety risk by the Emergency Care Research Institute (ECRI).  ECRI is responsible for identifying patient safety issues and ranking them in order of severity.  Flexible endoscope reprocessing has been identified as the #2 patient safety issue.  This means auditors will be closely reviewing the activities within the departments where endoscope reprocessing takes place.

Findings from flexible endoscope reprocessing can be identified at each step.  Some of the most frequent discrepancies identified during an audit are included in the following table. Any of the missing elements in the Citation Table may result in a recommendation.  Many facilities use a checklist identifying what needs to be documented at each step, which allows new as well as more seasoned staff member to verify they have completed and documented all steps.

No one can do it all.  It takes a village, or at least everyone responsible for flexible endoscope reprocessing, to achieve best practice and keep patients safe.  The professional society guidelines suggest forming multidisciplinary teams to look at processes.  When multidisciplinary teams perform risk assessments each member bring a level of expertise to the table for discussing and making suggestions for practice.  A strategic team brings resources to help identify areas that need improvement based on the most current regulations and guideline recommendations.  Each member has spheres of influence and resources available to move change forward.

Endoscopy suites can elevate practice by supporting the certification of staff.  Nurses become certified as CGRNs through the American Board of Certification for Gastroenterology Nurses, Inc. (ABCGN).  The International Association of Healthcare Central Service and Materials Management (IAHCSMM) offers a certification for the endoscopy nurses and technicians responsible for endoscope reprocessing.   The Certification Board for Sterile Processing and Distribution (CBSPD) provides certification for flexible endoscope reprocessors (C.F.E.R.).  This certification is for both nurses and technicians. The Society of Gastrointestinal Nurses and Associates (SGNA) is a professional organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing. SGNA carries out its mission by advancing the science and practice of gastroenterology and endoscopy nursing through education, research, advocacy and collaboration, and by promoting the professional development of its members in an atmosphere of mutual support.  SGNA has two levels of certification for associate members, the GI Technical Specialist (GTS) and the Advanced GI Technical Specialist (AGTS).  SGNA also has an Infection Prevention Champions Program.  All of these certifications help staff members to stay current with best recommended practice and know when new recommendations are published.

Another strategy for improving or sustaining best practice is to conduct ongoing audits for each reprocessing step.  Doing regular audits and keeping staff aware of both expected and unanticipated surveillance help the staff stay focused on completing all reprocessing steps accurately.  Regular audits provide a measurement for administration to determine compliance with completing the steps in endoscope reprocessing accurately and completing documentation at each required step.  Audits also let the staff know their work is important.

Lastly, there must be documentation excellence.  Documentation serves several purposes. First, documentation provides a tracking method to determine what scope was used on what patient and identifies all of the staff members involved in cleaning, decontamination, high level disinfection, storage and transport. Second, if a patient or staff member experiences an exposure or transmission, the infection prevention team must be able to trace which patients the scope has been used on and who performed all the steps in reprocessing. Finally, it allows for identifying trends and areas where practice may need to be improved.

Flexible endoscope reprocessing is challenging and carries a high risk for patient safety.  Staff members need to have adequate training and resources to be able to do the best job possible in keeping patients safe.  There are multiple steps identified in reprocessing and each step requires meticulous attention to detail.  Being fully engaged during reprocessing activities and completing assignments to the best level possible will help keep patients safe.

ECRI Institute has recognized flexible endoscope reprocessing as the number two technology hazard affecting patient safety in health care facilities.  Staff members responsible for the care and handling of flexible scopes need to have the sufficient time to complete all of the reprocessing steps without interruption or distractions.  Administrators need to be aware of the time constraints with endoscope reprocessing and provide adequate resources, so staff can concentrate on their jobs.  As patient advocates it is our responsibility to do the right thing for the right reason.

The complete circle of protection for patients includes all the steps in reprocessing, a comprehensive orientation, ongoing education and skills verification, and oversight by leadership.  This type of program increases the probability of safe scopes for each and every patient.