As a nurse and patient advocate, I feel very uncomfortable when I visit a facility and discover their practices do not meet the current guidelines or national standards for endoscope processing. Today, there are so many opportunities to easily get up-to-date information, so why isn’t everyone in our field getting that information?
For many years in my profession I have been told, “If we have been doing it this way all this time and we have no infections, why change?” I’ve also been told, “I’m too busy.”
We all know that the past five years have been challenging, with COVID-19 and the aftermath, and all the mental and economic challenges that come with constant changes to healthcare. Many of us are still struggling and have excuses, but are any of the excuses acceptable? Whose responsibility it is to ensure current information and standards are readily available so that devices can be correctly processed? Who is ensuring there is adequate staffing to comply with the manufacturer’s instructions for use for processing endoscopes?
How often do we hear about a facility breach in protocol that required letters to be sent to patients? The patients usually need to have bloodwork to see if an exposure occurred. Sometimes the alert comes from the Food and Drug Administration—or from the manufacturer itself—regarding a problem identified with a product or device. Who is designated at your facility to receive such alerts and ensure the information is given to management for follow-up?
As professionals, we all fear the word “litigation.” To avoid litigation, healthcare providers must comply with established
standards of care. Standards of care arise from regulations based on state and federal legislation or statutes. Regardless of the term used, they are the law. So to keep our endoscopes patient-ready and safe, it’s our duty to keep abreast of the most current information.
Practice guidelines, such as from AAMI, CDC, AORN and SGNA, are all applicable. Guidelines are developed by professional organizations and their members with expertise. Input can be solicited from the members before the guideline is published. However, when AAMI publishes a national standard (represented as ANSI/AAMI National Standard) it is a very different process.
“Standards are consensus documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. AAMI develops standards documents aimed at enhancing the safety, efficacy, safe use and management of medical devices and health technologies. A standard may recommend to a manufacturer the information that should be included with a product, basic safety and performance criteria, and conformance measures that can be used to assess compliance. The inclusion of design specifications in a standard is permitted when circumstances warrant, but design specifications usually are avoided as they can hinder the advancement of technology. A standard may provide clinical users with guidelines for the use, care, evaluation or processing of medical devices.” ~ AAMI standards webpage
All AAMI documents are peer-reviewed by committee members and then sent out for public comments. AAMI committee members include product users as well as manufacturers. Once a document is completed it must be approved by a majority of the voting committee members. After approval, the document goes to the AAMI board for review and approval. If the document is to be a national standard, then the AAMI board refers the document to the American National Standards Institute (ANSI) for designation as a national standard.
When surveyors visit facilities, they will sometimes ask on what references the facility bases its processes. Some facilities use a combination of AAMI and a professional organization’s guidelines (e.g., SGNA or AORN).
In 2015, AAMI published ANSI/AAMI ST-91, “Flexible and Semi-Rigid Endoscope Processing in Healthcare Facilities.” This should be the bible for endoscope processing activities. Guidelines from other organizations are also applicable if the material is not covered in ST-91. A revised and updated version of ST-91 was published in 2021.
Practice guidelines and facility policies/ procedures are often introduced as standards of care by a prosecuting attorney trying to prove that negligence has occurred, meaning you either complied with them or did not. On the other hand, a defense attorney can use the same guidelines and policies/ procedures as evidence that standards of care were met. Therefore, having policies and procedures to direct safe practice is critical to patient safety. To do this, you should reference your processing policies to the standards and guidelines used.
To comply with standards and guidelines also means compliance with all device processing equipment (e.g., AER) and chemical manufacturers’ instructions for use (IFU). Do you have the staffing, recommended cleaning implements, testing equipment, chemicals, processing equipment, etc., to ensure a device is safe when used on the patient?
Keeping informed is vital. Keeping processing staff updated on all matters pertaining to endoscope processing is the primary responsibility of the department or nurse manager. There are several ways to keep staff updated.
Join the Professional Association for Your Practice Area
The Society for Gastroenterology Nurses & Associates (SGNA), for instance, is a vital resource. All professional organizations have annual meetings as well as local (state) meetings that include educational programs. Seminars are also a good way to meet new colleagues. In addition, seminars often have vendor exhibits where you can see new products that can improve your practices. Join the AAMI, or at least purchase their national standard, ANSI/AAMI ST-91, to use as the baseline for endoscope processing practices.
The Joint Commission, the nation’s oldest and largest standards-setting and accrediting body in healthcare, was established in 1951 as an independent, not-for-profit organization. Its 21-member Board of Commissioners includes physicians, administrators, nurses, employers, quality experts, a consumer advocate and educators. Its offerings include accreditations and certifications, and it influences public policy through its advocacy office in Washington,
D.C. The Joint Commission expects facilities to reference its policies or specific national standards or guidelines used for its policies.
Most professional organizations have online help for questions and access to their guidelines. These same organizations offer memberships that often include regular meetings to provide education and updates on products and endoscopic procedures. Their guidelines may be offered at no cost to their members. Their websites usually have a list of all their member resources.
Sign Up for FDA Alerts
On the FDA webpage, you can subscribe to the Center for Devices and Radiological Health (CDRH) mailing list based on your area of specialty. This will potentially alert you via email regarding pertinent information about medical device issues. While the CDRH was hit with layoffs in April of this year, the organization has not shut down. You can find them here: https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
Attend Seminars and Webinars
Since the COVID-19 pandemic, with social distancing recommended and restrictions being placed on travel, virtually all organizations have relied on virtual education. Since then, it has become the norm for most of us, and today, it’s easier than ever.
Many companies that produce products used in endoscopy offer free educational programs. Contact these companies to sign up for alerts when they offer a program. Most of these programs offer continuing education credits as well. Some companies record their educational programs so you can still partake in the education on-demand when you are available. Many of these programs directly relate to endoscope processing.
Subscribe to Practice-Related Magazines
Practice-related magazines offer new information and educational articles. For example, EndoPro Magazine and Healthcare Purchasing News, to name two. These magazines also have vendor ads where you can learn about new products or services. Make these magazines available to staff.
Documentation
Documentation is important because records can be subpoenaed in a court of law and can be used in court proceedings. Documents may also verify that staff members were properly trained. One of the most important pieces of documentation is employee training records for endoscope processing. The documentation should include details on the training used for all processing equipment, including automated dosing units (to dispense detergents), automated flushing devices, leak testers, automated endoscope reprocessors, equipment to test the accuracy of the leak tester, cleaning effectiveness testing products, and so on.
Documentation should include at a minimum the following information:
- training instructors
- annual competency assessments for all aspects of endoscope processing
- dates of training and tasks/practices covered
- the requirement to comply with manufacturer’s IFU for all equipment and products used
- donning and doffing PPE needed for processing endoscopes
- training provided on all makes and models of endoscopes
- transport of used endoscopes
- leak-testing procedures and verifying the accuracy of the leak tester
- manual-cleaning protocols
- inspection of endoscopes for all phases of endoscope processing
- borescope use (if applicable) to inspect channels of endoscopes
- quality-assurance testing of endoscopes after cleaning and before high-level disinfection (e.g., cleaning effectiveness testing)
- transport of used scopes, transport of processed scopes, storage of scopes
- drying of scopes
- transport and storage of processed endoscopes
- transport of HLD endoscopes to the procedure room
Documentation should also include the results of a return demonstration for each task. In addition, the action taken if any return demonstration failed (e.g., whether the employee was retrained, dates of retraining, by whom, when the second return demonstration was performed, and the results.) Another piece of documentation that is critical is the employee’s annual competency verification for processing activities.
According to ANSI/AAMI ST-91, annual competency verification is “an activity designed to substantiate or confirm the ability of an individual to complete a particular skill, task, complex series of tasks, or behavior necessary to perform effectively.”
Competency assessments should include the following:
- competencies for every make and model of endoscope
- transport of used scopes (including documentation of when point-of-use treatment was performed)
- use of PPE when handling used scopes (including donning and doffing)
- compliance with manufacturer’s IFU for cleaning
- use of specific cleaning brushes/equipment recommended in the IFU
- leak testing/documentation of test results
- verification of leak tester’s accuracy/documentation of results
- selection and use of detergents
- manual cleaning/inspection
- automated flushing devices (if used)
- drying/inspection of scopes
- use of the high-level disinfectant, including MEC testing of the solution before use (if applicable)
- manual HLD (if applicable)
- use of the automated endoscope reprocessor (AER) including interpretation of printout
- use of cleaning effectiveness testing tool with documentation of test results
- transport of disinfected scopes
- storage of scopes
- transport of HLD scopes to the procedure room
Compliance with Stated Policies
It’s one thing to have policies referenced to current standards and guidelines, but are staff members always following those policies? There is no excuse for noncompliance with an endoscope reprocessing policy. Each step in the IFU must be followed to ensure a safe device for the patient. To ensure staff compliance, random audits should be performed, including verification of compliance with the manufacturer’s instructions. This can be done via observation and questioning.
Also, audits can be performed to verify compliance with stated policies. For example, monitor transport of used scopes, documentation records for accuracy, etc. AAMI, as well as other professional organizations, recommend that annual risk assessments be performed to determine needed areas of improvement.
Summary
Endoscope processing personnel need to be kept updated. Encourage your processing staff to achieve certification in flexible endoscope reprocessing and to keep updated in new practices and standards. Encourage competence by supporting their attendance at seminars/webinars. All staff members who attend conferences or webinars should be required to provide
a summary of the information disseminated at the educational program, so the remainder of the staff benefits as well. Virtually all continuing-education programs offer CE credits which support recertification efforts for processing staff.
We have a moral obligation to patients to provide the best care based on the most current national standards and guidelines. It is your responsibility. Get involved! Develop policies and procedures based on these standards and guidelines. Provide in-service opportunities for staff regarding policies and procedures that have been developed or updated. Review your processing policies on a routine basis.
Perform audits to ensure staff compliance with your policies. It’s important to remember that when you don’t comply with a stated policy, you can be found negligent. So, who is processing your endoscopes? What is their competency level? Were they given the tools to provide a patient-safe scope? As W. Edwards Deming said, “Learning is not compulsory; it’s voluntary. Improvement is not compulsory; it’s voluntary. But to survive, we must learn.”
