By Colleen Keith, MSN RN, and Michelle Day, MSN RN CGRN
In recent years, there has been an increased discussion in the healthcare arena concerning the proper, consistent cleaning and reprocessing of endoscopes. Healthcare facilities failure to protect patients from the risk of exposure to disease has made headlines. Reacting to those headlines, accreditation agencies and health departments are increasing their surveillance of practices of scope reprocessing.
There are many challenges in any healthcare setting whether it is an acute care hospital, ambulatory surgical center or physicians office to ensure consistent cleaning and disinfection procedures can be followed by any trained member of the healthcare team. The key to consistency is training key personnel (e.g., RNs, LPNs/LVNs or nursing assistive personnel) to process all endoscopes.
SGNA has been a leader in establishing evidence-based standards and guidelines in endoscope reprocessing. Below are some thoughts and practical insights for frequently asked questions concerning scope reprocessing:
How can I ensure that our scopes are cleaned properly?
Initial training and core competencies should be completed before any staff cleans and reprocesses a scope for patient use. Then, annual competencies should be completed by the units staff education coordinator. Random observation enhances staff awareness of the importance of consistent processing of all endoscopes. The RN in the procedure room should always do a visual check of the endoscope immediately before use on the patient for any visual warnings that the scope was improperly processed.
How often should we process stored scopes?
While other professional organizations have recommended that a scope should be reprocessed after five days before using it on a patient, SGNA has not released an official position on this issue. The interval of storage after which endoscopes should be reprocessed before use has had limited investigations. SGNA strives to ensure our practice documents are based on a solid body of evidence, and in the absence of this, we will continue to investigate the issue and amend our position as appropriate.
There is some available data that suggests contamination of properly stored scopes is negligible for intervals of seven to fourteen days, generally occurs only on the exterior of the instruments and typically involves common skin organisms rather than significant pathogens. To discourage any microbial contamination, SGNA recommends that endoscopes be stored in a vertical position to facilitate drying with caps, valves and other detachable components removed per the manufacturers instructions. The storage area should be in a clean, well-ventilated and dust-free area that will protect it from contamination. Reprocessing of flexible gastrointestinal endoscopes according to the infection control measures is critical to the safe and successful treatment of patients. Diligence in application of all steps of reprocessing remains paramount in the safe delivery of endoscopic services.
SGNA is currently reviewing research proposals for SGNA research grants to investigate the interval of storage after which endoscopes should be reprocessed before use. We also continue to monitor the development of greater evidence on this topic.
Should I be tracking scopes?
Institutions should have an infection control surveillance program that would enable patients to be recalled if there was a type of infection outbreak. There are a number of ways of accomplish this task. A basic method is to keep a patient log that includes the scope model and serial number.
What types of competency standards should units adopt for individuals who reprocess endoscopes and accessories?
SGNA supports that the reprocessing of gastrointestinal endoscopes and accessories be performed by individuals who meet competency requirements in the following topics:
1. Standard precautions
2. Personal protective equipment
3. OSHA rules on occupational exposure to blood-borne pathogens
4. Reprocessing procedures for endoscopes and accessory equipment
5. Mechanisms of disease transmission
6. Maintenance of a safe work environment
7. Safe handling of high-level disinfectants (HLD) and sterilants
8. Procedures for waste management
Scope reprocessing is clearly a major factor in preventing the spread of pathogens to our patients. However, it is only one piece of the larger infection prevention effort within a unit. For example, environmental cleaning of the procedure room is essential. Clostridium difficile (C. diff) is of particular concern. Facilities should also have specific environmental protocols to encompass specific infections such as C. diff and Methicillin-resistant Staphylococcus aureus (MRSA).
As such, units must give attention to the full range of practice standards. SGNAs standards and guidelines and position statements on infection prevention, based on a thorough evidence base, give endoscopy units the proven processes and methodologies they need to ensure safe, effective patient care.
Michelle Day, MSN, RN, CGRN, has 15 years of experience in GI/endoscopy at Hartford Hospital and has been certified since 2002. She recently accepted the position of hepatology coordinator for the new Comprehensive Liver Center at Hartford Hospital in Hartford, Conn. She has been a member of SGNA for 15 years and has served in multiple volunteer leader roles with the Society, including serving as chair of the SGNA Practice Committee, instructor for SGNAs Train the Trainer program, and member of SGNAs Infection Prevention Champions Task Force.
Colleen Keith, MSN, RN, CGRN, has 23 years of experience in GI and has been certified since 1991. She currently serves as the Director of Surgical Services and Ambulatory Services at the Kings Daughters Hospital and Health Services in Madison, Ind. She is the past-president of the American Board of Certified Gastroenterology Nurses. Among her other volunteer duties, she currently serves on the SGNA board of directors and is the liaison to the SGNA Practice and Research committees, and serves on the editorial board of Gastroenterology Nursing.
Q&A with Michelle Day, MSN RN CGRN
ICT spoke with Michelle Day, MSN RN CGRN, hepatology coordinator at the Comprehensive Liver Center at Hartford Hospital in Hartford, Conn., and chair of the SGNA Practice Committee.
Q: SGNA reviewed the FDAs Draft Guidance document on processing/reprocessing medical devices last year and provided comments. What did SGNA find through its review?
A: As a leader in the industry, SGNA first participated in a workshop with the FDA to discuss the factors that affect reprocessing of reusable devices. SGNAs Practice Committee subsequently reviewed and commented on the FDA draft guidance document, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Overall, we noted that the FDA draft guidance reinforced statements in SGNAs practice standards and guidelines, which we felt was validation that SGNAs standards and guidelines remain a flagship for the industry. In addition, we were encouraged that the FDA draft guidance addresses the need for manufacturers instructions for assembly, disassembly and reprocessing to be logical and easy to follow. SGNA was also pleased to see that the FDA is adamant that the process begins at the point of use and that cleaning, disinfection and sterilization are recognized as distinct processes.
Q: SGNA will soon release an updated Standard of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes. Tell me more about the revised standard what was updated? How does this new standard compare to what the FDA recommends?
A: SGNA practice guidelines and position statements address issues affecting the practice of gastroenterology nursing, and we are mindful of how a change in our documents can broadly affect change in practice. We strive to ensure our practice documents remain current and are based on a body of evidence. Recently published and revised guidelines, such as the abovementioned FDA draft guidance as well as the multi-society guidelines on reprocessing flexible gastrointestinal endoscopes (2011), necessitated a review of SGNAs Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes document (2009). Generally, the flow of SGNAs document was updated to better reflect the steps of reprocessing.
There continue to be items in need of further study, including interval of storage of endoscopes, new technology of AERs and microbiological surveillance testing (ASGE, 2011).
Q: How can SGNA help reprocessing personnel understand the importance of proper reprocessing and help them develop competencies for improved patient outcomes? And if nurses are the ones performing some of these reprocessing duties (especially in outpatient care), what are the challenges of this sort of multi-tasking and how does it impact the aforementioned outcomes?
A: Well-published occurrences of endoscopy-related infections have been attributed to lapses in adherence to accepted practice guidelines. The rapid pace of endoscopy units and multiple role expectations of endoscopy staff make it especially challenging. There is a narrow margin of safety in reprocessing, and reprocessing staff must be educated and trained in reprocessing. It is essential to designate a person to monitor compliance for the reprocessing staff that includes the initial and annual competence, providing continuing education and maintaining a quality assurance program.
SGNA supports that the reprocessing of gastrointestinal endoscopes and accessories be performed by individuals who meet competency standards. To achieve this and maintain a safe environment, SGNA recommends a broad set of competency requirements. (See Practical Insights on Endoscope Reprocessing.)
SGNA is developing an Infection Prevention Champion program, with a pilot launching in May. The Champions Program will be available to all endoscopy nurses and associates, and encourages champions to work with management to ensure effective infection prevention in the GI setting. This program will include tools to assist the designated champion to develop competencies for reprocessing of endoscopes and accessories. Other tools that will be available include infection prevention annual competencies templates, checklist for environmental cleaning, checklist for reprocessing processes, reprocessing error procedure template, teaching and mentoring tools and a list of clinical experts willing to act as resources.
Q: It can be challenging for healthcare professionals to stay updated on the latest standards and guidelines. What is SGNA doing to help and encourage GI/endoscopy nursing personnel?
A: It can indeed be challenging, and SGNAs foundation rests on our dedication to the safe and effective practice of gastroenterology and endoscopy nursing. As such, SGNA offers many resources in this area in an effort to provide a central resource.
First and foremost, SGNA makes our position statements, practice standards and guidelines available to the profession on our Web site, www.sgna,org, free of charge. Whether or not a nurse or associate is a member of SGNA, we want that individual to have access to this critical information that helps her/him better perform and ensure the best in patient care.
For SGNA members, we offer an active online discussion forum where members can discuss practice issues with other members across the country. Members also receive Gastroenterology Nursing, which is the only journal devoted exclusively to GI nursing. The journal provides top-quality articles, editorials and case reports.
We offer Train the Trainer: The Nurse Managers Guide to the Reprocessing Competency. This program for nurse managers provides a guide to infection control, reprocessing steps and hands-on training for reprocessing scopes.
SGNA continues to work on providing additional resources in this area. Three more recent initiatives include the development of the SGNA Nurse Fellowship Program, the SGNA Scholars Program and the SGNA Infection Prevention Champions Program. The first two programs are a direct result of our new strategic initiative around evidence-based research and practice education. We are coordinating with the Joanna Briggs Institute and the TCU Center for Evidence-based Practice and Research: A Collaborating Center of the Joanna Briggs Institute to train nurses on how to translate evidence into practice and on how to build a repository of evidence related to GI/endoscopy. The greater the evidence base, the more SGNA can provide standards and guidelines that help our profession and patients.
And, as mentioned, the SGNA Infection Prevention Champions Program will include up-to-date guidelines and information related to the endoscopy unit from various sites, including those from regulatory agencies and industry resources.