- Email: [email protected]
Reprocessing of flexible endoscopes: Scientific rationales and patient safety implications
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Reprocessing of Flexible Endoscopes: Scientific Rationales and Patient Safety Implications
Jr. J. Hudson Garrett PhD, MSN, MPH, FNP-BC, PLNC, IP-BC, FACDONA, FAAPM, FNAP Adjunct Assistant Profe Cindy Winfrey MSN, RN, IP-BC, CIC, FACDONA Director PII: DOI: Reference:
S1096-2883(19)30067-1 https://doi.org/10.1016/j.tgie.2019.150628 YTGIE 150628
To appear in:
Techniques in Gastrointestinal Endoscopy
Received date: Accepted date:
6 August 2019 28 August 2019
Please cite this article as: Jr. J. Hudson Garrett PhD, MSN, MPH, FNP-BC, PLNC, IP-BC, FACDONA, FAAPM, FNA Cindy Winfrey MSN, RN, IP-BC, CIC, FACDONA Director , Reprocessing of Flexible Endoscopes: Scientific Rationales and Patient Safety Implications, Techniques in Gastrointestinal Endoscopy (2019), doi: https://doi.org/10.1016/j.tgie.2019.150628
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc.
Reprocessing of Flexible Endoscopes: Scientific Rationales and Patient Safety Implications
Corresponding Author: J. Hudson Garrett Jr., PhD, MSN, MPH, FNP-BC, PLNC, IP-BC, FACDONA, FAAPM, FNAP Adjunct Assistant Professor of Medicine Division of Infectious Diseases University of Louisville School of Medicine Global Chief Clinical Officer Pentax Medical Email: [email protected] Address: 501 East Broadway, Suite 100, Louisville, Kentucky 40202 Conflict of Interest: Dr. Garrett is an employee of Pentax Medical, a division of Hoya Corporation.
Co-Author: Cindy Winfrey, MSN, RN, IP-BC, CIC, FACDONA Director, Global Clinical Affairs Pentax Medical Email: [email protected] Conflict of Interest: Ms. Winfrey is an employee of Pentax Medical, a division of Hoya Corporation.
Abstract Proper reprocessing of flexible endoscopes in gastroenterology practice is a critical element of a comprehensive patient safety and infection control strategy in both the inpatient and outpatient healthcare setting. This effort requires an interprofessional approach consisting of collaboration between the endoscopist and multiple other facility stakeholders including reprocessing professionals, nursing, infection prevention and control, biomedical engineering, and patient safety professionals. Recent advancements in human factors engineering has demonstrated a high reliability in validated and standardized reprocessing efforts for flexible endoscopes with properly trained reprocessing personnel and appropriate resources to execute the overall reprocessing process. A continued and concerted effort must be paid to maintaining the safety of these devices through focus on personnel, processes, and a continued innovative engineering of the devices themselves. While flexible endoscopes play a pivotal role in delivering diagnostic and therapeutic medical capabilities to endoscopists, their use is not without risk and require a comprehensive approach to medical device hygiene and integrated infection prevention and control. Keywords: Reprocessing, Infection Prevention, Infection Control, Endoscope Safety, High Level Disinfection, Medical Device Hygiene, Medical Device Safety
The Importance of Flexible Endoscope Reprocessing and Clinical Implications Flexible endoscopes are used for a wide variety of diagnostic and therapeutic needs in gastroenterology and are handled by multiple stakeholders including the physician, registered nurse, endoscopy technician, reprocessing technician, and biomedical engineering. Because these devices are used widely throughout healthcare, flexible endoscopes must only be reprocessed by specially trained technicians and maintained according to the manufacturer’s instructions for use. The literature has documented multiple outbreaks associated with flexible endoscope reprocessing failures and breaches in cleaning protocols.1 In recent years, the United States Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have investigated outbreaks with flexible endoscopes across multiple healthcare settings.2 These outbreaks have resulted in changes in regulatory guidance and medical device clearances from the FDA, and additional oversight and clinical guidance related to evidence-based practices in reprocessing these devices from the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC). In 2016, CDC released formal guidance detailing best practices associated with reprocessing of flexible endoscopes. This guidance included the following core elements3: 1. Administrative Support, Leadership, and Formal Policies and Procedures 2. Documentation on the Methods, Products, and Validation Mechanisms for Device Reprocessing, High Level Disinfection, and/or Sterilization 3. Inventory Management of Flexible Endoscopes 4. Physical Setting where Reprocessing is performed 5. Education, Training, and Competencies 6. Risk Assessment and Quality Assurance 7. Unresolved Issues
Both inpatient and outpatient healthcare facilities should carefully adhere to the CDC’s recommendations and also review relevant clinical guidance from professional associates and industry standards. Careful adherence to these standards and best practices will improve patient safety and reduce potential device contamination risks.4 The FDA has also identified several design challenges associated with flexible endoscopes that can increase the risk for cross-contamination and associated device risk5: ▪
Long, narrow interior channels (lumens), including those with internal surfaces that are not smooth, have ridges or sharp angles, or are too small to permit a brush to pass through
▪
Hinges
▪
Sleeves surrounding rods, blades, activators, inserters, etc.;
▪
Adjacent device surfaces between which debris can be forced or caught during use
▪
O-rings
▪
Valves that regulate the flow of fluid through a device (stopcocks)
▪
Devices with these or other design features that cannot be disassembled for reprocessing
Meticulous attention must be paid to the handling, reprocessing, and maintenance of all flexible endoscopes. Resources are available for the implementation of best practices associated with the management of flexible endoscopes from multiple clinical associations.
Current Spaulding Classification Scheme Medical devices are currently reprocessed utilizing the Spaulding Classification Scheme. The Spaulding Classification Scheme breaks down medical devices into three basic categories: noncritical, semi-critical, and critical items. Critical items are those that come in contact with sterile body cavities and require sterilization as a minimum level of disinfection for reprocessing. Common examples of critical items include surgical instruments, implants, and catheters. Next, the Spaulding Classification addresses semi-
critical items, which are medical devices that come in contact with mucous membranes, but not sterile body cavities. These devices require a minimum of high-level disinfection (HLD) in order to be safely reprocessed. Common examples of semi-critical devices include flexible endoscopes, laryngoscopes, and oral retractors. Currently, flexible endoscopes are classified as semi-critical devices. It is important to note that while the minimum level of disinfection for this category is HLD, some devices do permit sterilization if validated by the manufacturer. Lastly, the Spaulding Classification has a third category which is noncritical items. These items are most commonly utilized within healthcare and are items that come into contact with intact skin only. These items require a minimum of low level disinfection, but preferably intermediate level disinfection. Commonly used noncritical devices include blood glucose meters, stethoscopes, and pulse oximeters. Each of the items addressed in the Spaulding Classification carries some level of risk, but with proper cleaning and disinfection, the potential risk to the patient can be greatly reduced. It is important that physicians and healthcare providers carefully follow all manufacturer’s instructions for use related to reprocessing and instrument handling 6.
Overview of Endoscope Reprocessing In the United States, the Food and Drug Administration (FDA) defines reprocessing as a validated process used to render a contaminated medical device suitable for a subsequent single use by carefully adhering to the manufacturers reprocessing steps (i.e., product labeling)7. In addition, standardized professional guidelines along with infection control procedures have been developed for the reprocessing of endoscopes. These guidelines and procedures serve to guide persons responsible for reprocessing to minimize the risk of cross-contamination and/or subsequent reprocessing failure resulting in potential transmission of infectious agents8.
The reprocessing of flexible endoscopes is a multi-step process. Table 1 summarizes the steps to reprocess endoscopes using high-level disinfection along with the objective and rationale for each step. This section outlines the reprocessing steps currently utilized by manufacturers to create their reprocessing instructions for use (IFU). The following section will address additional implications of endoscope reprocessing in the context of patient safety3. [Insert table 1]
Infection Control Recommendations for Flexible Endoscope Reprocessing and Quality Surveillance Routine surveillance cultures of flexible endoscopes have not been routinely recommended historically according to previous recommendations from the CDC. In 2017, a combined guidance document from both the CDC and the FDA published evidence-based recommendations for culturing and sampling of duodenoscopes based on the consensus of a multidisciplinary working group. These recommendations were initiated as a result of a two-part FDA 522 Regulatory Study which evaluated both postreprocessing duodenoscope bioburden contamination and also a human factors engineering analysis of the reliability of executing reprocessing instructions for use provided by manufacturers with a group of relevant stakeholders (i.e. reprocessing technicians and registered nurses). These new clinical studies continue to be utilized by the FDA to evaluate new flexible endoscopes being submitted to the agency for potential infection control and patient safety concerns 10.
Multi-Disciplinary Collaboration and Executive Support There are a variety of personnel in the healthcare continuum of care that are involved in the use of a flexible endoscope. In order to maintain complete traceability of these medical devices, multiple internal stakeholders must work in collaboration with each other to build a comprehensive system of endoscope tracking and monitoring. Ultimately, executive and departmental leadership must be fully engaged and
allocate both sufficient human and physical resources to ensure that flexible endoscopes are selected, used, reprocessed, and stored according to the manufacturer’s instructions for use. Reprocessing personnel should be fully integrated into the gastroenterology team and be familiar with the clinical utilization of all devices for which they have reprocessing responsibility. The gastroenterologist should also be familiar with the institution’s reprocessing processes and allocate sufficient time between clinical cases for all flexible endoscopes and associated reusable devices to be properly reprocessed 8.
Patient Safety Implications of Flexible Endoscope Reprocessing The CDC has recommend a core set of infection prevention and control practices that should be applied across multiple aspects of patient care in all healthcare settings- both inpatient (e.g., acute, long-term care, rehabilitation, behavior health) and outpatient (e.g., physician and nurse practitioner offices, clinics, urgent care, ambulatory surgical centers, imaging centers dialysis centers, physical therapy, rehabilitation centers and alternative medical clinics). Utilization of these required set of core practices is essential to providing safe and high-quality patient care regardless of the delivery setting. These core practices include the following health care providers (HCP): individuals having direct patient contact and/or potential for exposure to patients and or infectious materials and individuals not directly involved in patient care (e.g., clerical staff, environmental services, volunteers) who could be exposed to infectious materials in a healthcare setting. Additionally, there are essential elements of a reprocessing program for flexible endoscopes. To achieve the goal of a reliable, high quality reprocessing program healthcare facilities must have an infrastructure that supports management, training and competencies, and quality management11.
Stringent adherence to reprocessing instructions is highly effective but patient safety can be compromised by factors that impact the effectiveness of reprocessing. Endoscope-related factors
include complex design features such as long, narrow interior channels and sharp angles, hinges, Orings, a variety of endoscope models that require different cleaning procedures and brushes, scope age and the service history of the endoscope. Other device-design related factors include post-market design changes that do not take into account how the changes impact the ability to properly clean and disinfect the device and lack of communication between manufacturers and/or between manufacturers and device users when medical devices used for reprocessing are modified and instructions are revised. Personnel factors include inadequate number of staff to support volume, inadequate training and/or understanding of the manufacturer’s validated instructions for manual reprocessing, flushing pumps, and automatic endoscope reprocessors (AERs), frequent interruptions and/or time pressure for rapid endoscope turnaround, inadequate training and/or understanding of correct chemical use and lack of mindfulness and understanding of risk. Characteristics of reprocessing that can impede its effectiveness include numerous steps that are prone to human error that must be followed sequentially and meticulously, lack of quality control measures to detect problems or reprocessing lapses, lag time or a delay in reprocessing, improper or inappropriate use of chemicals, inadequate cleaning prior to HLD or sterilization and inadequate drying before storage. The use of AERs and flushing pumps can also introduce additional factors such as issues related to water supply or quality, equipment malfunction, contamination, or the use of incorrect connectors12.
Reprocessing Instructions for Use (RIFU) Manufacturers of reusable medical devices are responsible for labeling that includes adequate instructions for use. RIFUs should be complete, understandable, and reasonably implemented by the user. These validated reprocessing instructions are intended to ensure that the device can be used safely and for the purpose for which it is intended. Problems with patient safety can arise when HCPs
are unsure of how to incorporate equipment or chemicals not specifically listed in the endoscope manufacturer’s RIFU.
The instructions should describe any accessories that are needed for safe reprocessing. If the device requires any special protection during reprocessing (e.g., valves, plugs or stoppers to prevent ingress of chemicals), they should be described in detail. Any special tools, sizes and types of brushes (including custom brushes), flush port connectors and connector size specifications, trays, test kits, specific types of sterilization wraps or containers, and part numbers should also be identified. The instructions should provide sufficient detail so that the user can purchase the correct items, including any custom cleaning accessories, or identify a source for the purchase of such items. If tools not listed in the endoscope manufacturer’s RIFU are used, they should conform to specifications and performance standards of the products listed in the endoscope manufacturer’s RIFU13.
To mitigate problems that could occur from improper selection of detergents and high-level disinfectants, the medical device manufacturer should provide a reference list of products that have been shown to be compatible with the materials used in the construction of the specific model of endoscope. In the case of high-level disinfectants, the list should include only products that have received FDA 510(k) clearance for claims as a high-level disinfectant. The RIFU should guide the user to follow the selected product manufacturer’s label instructions for concentration, temperature and soak time. Users should understand that using untested products and not following instructions for use is not safe and could lead to endoscope damage and/or unsuccessful reprocessing.
When the endoscope manufacturer RIFUs do not include the use of AER, leadership and reprocessing personnel must understand it is the AER manufacturer that may be responsible for any product-related
claims. These claims usually include cleaning, disinfection, sterilization, rinsing, drying, biocompatibility, reprocessing instructions, required channel adapters, efficacy validation, and should comply with regulatory requirements and/or professional guidelines. Confirming with the AER manufacturer that the AER has instructions for use and efficacy data for the specific model of endoscope and accessories should be done prior to use of the AER in order to ensure patient safety14.
When considering the use of a sterilization process, always check with the endoscope manufacturer to ensure the system, solutions and processes selected are safe to use with the specific endoscope. Check with the sterilizer manufacturer to ensure they have performed microbial validation studies to support their sterilization claims for the specific endoscope and accessories. Chemical and/or biological indicators recommended by the sterilizer manufacturer should be used to monitor the process and ensure sterilization efficacy.
We have discussed factors that impact the effectiveness of reprocessing and safely incorporating equipment or chemicals not specifically listed in the endoscope manufacturers RIFU. These represent potential failure points in reprocessing because of a lack of knowledge, understanding or compliance. Education and training should include this information and user knowledge and application should be assessed as part of an overall quality strategy to avoid equipment damage and/or reprocessing failures12.
Clinical Approaches to Novel Reprocessing Technologies Engaging all stakeholders including manufacturers, healthcare facilities and staff, accreditation organizations, professional organizations and government agencies in solving problems related to reprocessing medical devices will build collaboration and lead to advances in solving these problems.
The FDA is working with standard-setting groups to develop a series of best practices and gain consensus. Technical information reports and new standards will provide manufacturers guidelines for designing devices that can be adequately reprocessed and identify methods and criteria for validating that reprocessing has achieved the desired result. Based on research conducted by the FDA and others, the following design features likely facilitate cleaning, disinfection and sterilization and may reduce the likelihood of reprocessing failures15.
Smooth surfaces, including smooth inner surfaces of the long, narrow interior channels (lumens).
The ability to disassemble devices with multiple components.
Non-interchangeable connectors for critical connections (For example, tubes used with endoscopes for direct patient connection that cannot be interchanged with tubing used for waste drainage).
Clear identification of connecting accessories, such as drainage tubing.
Clear indication and identification of components that must be discarded after patient use and cannot be reprocessed or reused.
Disposable components for the hardest to clean areas.
Designs that address how fluid flows through the device, and areas of debris build-up within devices.
Although changes in endoscope design and novel reprocessing technologies may improve efficiency and quality of the reprocessing process, incorporating the latest technology won’t innately guarantee improved outcomes. Proper protocols must still be followed, stakeholders need to collaborate and hold each other accountable and a culture of patient safety should be maintained in order to make the biggest impact towards decreasing the risk for healthcare acquired infections.
People, Process, Product In order for reprocessing procedures to achieve high-reliability, the healthcare team must maintain a regular and intense focus on compliance with all evidence-based guidelines and the manufacturer’s instructions for use. Healthcare Leadership must properly resource the reprocessing department to ensure that all instruments are handled appropriately, properly maintained, and correctly stored. The primary focus for driving safety must be on the Healthcare Personnel or the People. An engaged frontline team will assist with infection prevention and control efforts 3. Additionally, manufacturers of endoscopic equipment should provide Instruction for use (IFUs) that emphasize both quality indicators for HLD and redundancy of operations. This extra layer of education and instruction is supported by data and FDA guidance.
Second, healthcare facilities must build robust, and human-factors engineered facilities and optimized processes to facility proper reprocessing of endoscopes. While it is certainly not feasible to always have optimized reprocessing facilities, healthcare facilities should ensure that technicians have appropriate resources to properly disinfect all flexible endoscopes. Personnel should have their flexible endoscope reprocessing and handling competency verified annually. Physicians can also benefit from interactive continuing education based on preventive damage to flexible endoscopes. Gastroenterologists and healthcare facilities should work collaboratively with flexible endoscope manufacturers to established model and device-specific competencies, in-service training, and preventive maintenance programs that decrease the clinical risk of the flexible endoscope inventory.
Lastly, healthcare providers and facilities must utilize technologies that are both efficacious and safe. All patients deserve the safest possible care, and a multidisciplinary approach is necessary to optimize
Comment [RA1]: There should probably be some mention on quality control. This section puts much of the onus on the healthcare facility, however, recent data and FDA mandate would argue that the manufacturer needs to provide IFUs that account for user error, namely redundancy and quality indicators.
clinical resources, decrease associated risk, and improve patient safety associated with the use of flexible endoscopes.
Future Directions in Endoscope Safety Physicians, while the clinical users of flexible endoscopes, are one critical component in the device management and infection control process. Physicians, clinical societies, regulators, healthcare facilities, and patients have each called for manufacturing innovations by original equipment manufacturers to improve the ability for end users to more easily clean and disinfect the endoscope. Many flexible endoscope manufacturers have re-engineered their devices and created disposability of high-risk components to mitigate risks, conducted extensive human factors-validated reprocessing studies, and created innovative reprocessing instructions for use and in-service tools. Continued innovation in people (reprocessing and gastroenterology personnel), process (device reprocessing and maintenance processes), and product (engineering innovation) are needed to further reduce the risk for device crosscontamination and associate adverse impacts to patients and healthcare providers.
References
1. Rahman MR, Perisetti A, Coman R, Bansal P, Chhabra R, Goyal H. Duodenoscope-associated 2.
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infections: update on an emerging problem. Digestive diseases and sciences. 2019;64(6):14091418. doi:10.1007/s10620-018-5431-7. United States Food and Drug Administration (FDA). Infections Associated with Duodenoscopes. Retrieved From: https://www.fda.gov/medical-devices/reprocessing-reusable-medicaldevices/infections-associated-reprocessed-duodenoscopes. Accessed June 1, 2019. Centers for Disease Control and Prevention (CDC). Essential elements of a reprocessing program for flexible endoscopes: Recommendations of the healthcare infection control practices advisory committee (2017). Retrieved from https://www.cdc.gov/hicpac/pdf/flexible-endoscopereprocessing.pdf. Accessed June 1, 2019. Weber DJ, Rutala WA. Assessing the risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines. Am J Infect Control. 2013;41(5 Suppl):S67-71. United States Food and Drug Administration (FDA). Device Design, Retrieved From: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusable MedicalDevices/ucm454626.htm#design, Accessed June 1, 2019. Association for the Advancement of Medical Instrumentation (AAMI). Flexible and semi-rigid endoscope reprocessing in health care facilities (ANSI/AAMI ST91: 2015). Arlington, VA. United States Food and Drug Administration (FDA). Reprocessing medical devices in health care settings: Validation methods and labeling (2015). Retrieved From: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocum ents/ucm253010.pdf. Accessed June 1, 2019. Petersen BT, Cohen J, Hambrick III RD, et al: Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update. Gastrointestinal endoscopy, 85(2), 282-294, (2017). Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes 2018. Chicago, IL. Retrieved From: https://www.sgna.org/Portals/0/SGNA%20Standards%20of%20infection%20prevention%20in% 20reprocessing_FINAL.pdf?ver=2018-11-16-084835-387. Accessed June 1, 2019. United States Food and Drug Administration (FDA). Duodenoscope Surveillance Sampling & Culturing: Reducing the Risks of Infection. Retrieved From: https://www.fda.gov/media/111081/download. Accessed June 1, 2019. Centers for Disease Control and Prevention (CDC). Core infection prevention and control practices for safe healthcare delivery in all settings – Recommendations of the healthcare infection control practices advisory committee. (2017). Retrieved From: https://www.cdc.gov/hicpac/pdf/core-practices.pdf. Accessed June 1, 2019. United States Food and Drug Administration (FDA). The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication. Retrieved From: https://www.fda.gov/medical-devices/safetycommunications/fda-continues-remind-facilities-importance-following-duodenoscopereprocessing-instructions-fda. Accessed June 1, 2019. United States Food and Drug Administration (FDA). Working together to improve reusable medical device reprocessing. (2018). Retrieved From: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusable MedicalDevices/ucm454626.htm#design. Accessed June 1, 2019.
14. United States Food and Drug Administration (FDA). Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation. Retrieved From: https://www.fda.gov/medicaldevices/reprocessing-reusable-medical-devices/information-about-automated-endoscopereprocessors-aers-and-fdas-evaluation. Accessed June 1, 2019. 15. United States Food and Drug Administration (FDA). Factors Affecting Quality of Reprocessing. Retrieved From: https://www.fda.gov/medical-devices/reprocessing-reusable-medicaldevices/factors-affecting-quality-reprocessing. Accessed June 1, 2019. 16. United States Food and Drug Administration (FDA). FDA Report on the quality, safety, and effectiveness of servicing of medical devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA). (2018). Retrieved From: https://www.fda.gov/downloads/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmend mentstotheFDCAct/FDARA/UCM607469.pdf. Accessed June 1, 2019.
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Figure 5.
Table 1. Flexible Endoscope Reprocessing Steps 9 Step Pre-Cleaning
Objective - Rationale
Occurs in procedure room immediately after removal of insertion tube and before removing scope from the light source and suction pump. Removes organic soils (e.g., blood, body fluids) decreasing bioburden. Decreases likelihood that soils will dry on scope. Once pre-cleaned, the soiled endoscope is transported in a closed puncture resistant container to reprocessing area. All subsequent steps should be performed in the reprocessing area. Leak Testing Detects damage to interior channels and exterior surfaces Consists of dry – before immersion to minimize the risk of damage to parts that cannot tolerate fluid exposure AND wet – pressurized endoscope is submerged in clear water and all surfaces checked for bubbles indicating leaks. Scope is removed from water and allowed to depressurize. If leak detected remove scope from service and contact manufacturer for next steps. Manual Cleaning: The Use medical grade detergent formulated to effectively remove proteins, fats, carbohydrates and various chemical salts that exist in blood and most critical step in other body fluids in addition to being materially compatible with the removing the microbial model of scope being cleaned. burden from an Detergent should be freshly prepared and used according to the detergent endoscope. manufacturer’s instructions. Use low-foaming detergents so device can be visualized while cleaning. Cleaning should occur while the scope is submerged in the detergent solution to prevent splashing and aerosolization of bioburden and to insure the scope is in contact with the detergent. Use lint-free cleaning tools and brushes specified by the scope manufacturer and follow all cleaning steps outlined in the reprocessing instructions for use. Rinse after manual Rinse all removable parts and the scope with clean water to remove residual debris and detergent; purge water from all channels using forced cleaning air; dry the exterior of the scope with a lint-free cloth to prevent dilution of the high-level disinfectant used in subsequent steps. Visible Inspection Use magnification and adequate lighting. Inspect for cracks, discoloration, retrained debris. Repeat manual cleaning if it is determined scope is not visually clean. Remove damaged scopes and accessories from service for repair or disposal. High-level Disinfection Follow the scope manufacturer’s validated device specific instructions for high-level disinfection (i.e., destruction of all viable microorganism but not (HLD) necessarily all bacterial spores). The scope and all removable parts must be completely immersed in the HLD. Flush HLD into all channels. All channels must be filled so no air pockets remain, and all surfaces are in complete contact with the HLD. Use HLD at the temperature and time recommended by the HLD manufacturer. Rinse After HLD Following the scope manufacturer’s instructions, thoroughly rinse all surfaces and removable parts and flush all channels to remove chemical residue.
Drying
Storage
Thorough rinsing prevents exposure and potential injury to skin and mucous membranes from chemical residues. Follow the scope manufacturer’s instructions for drying. All channels and the surface of the scope must be dried before storage to prevent an environment that allows microorganisms to survive and multiply. Moisture promotes the formation of biofilm which may result in decreased efficacy of detergents and high-level disinfectants. An endoscope that is not dry should be reprocessed before use. Conventional storage includes hanging scopes in a vertical position with all caps, valves and other detachable components removed. Scopes should hang freely to prevent damage and contact with one another. Endoscopes must be stored in an area that is clean, well ventilated and dust free. Endoscopes must be stored in a manner that keeps them completely dry and free from environmental and human contamination.
Adapted from: SGNA Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes, CDC Essential Elements of a Reprocessing Program for Flexible Endoscopes, Multisociety Guideline on Reprocessing Flexible GI Endoscopes, and FDA Reprocessing Medical Devices in Healthcare Settings
Reprocessing of Flexible Endoscopes: Scientific Rationales and Patient Safety Implications
Jr. J. Hudson Garrett PhD, MSN, MPH, FNP-BC, PLNC, IP-BC, FACDONA, FAAPM, FNAP Adjunct Assistant Profe Cindy Winfrey MSN, RN, IP-BC, CIC, FACDONA Director PII: DOI: Reference:
S1096-2883(19)30067-1 https://doi.org/10.1016/j.tgie.2019.150628 YTGIE 150628
To appear in:
Techniques in Gastrointestinal Endoscopy
Received date: Accepted date:
6 August 2019 28 August 2019
Please cite this article as: Jr. J. Hudson Garrett PhD, MSN, MPH, FNP-BC, PLNC, IP-BC, FACDONA, FAAPM, FNA Cindy Winfrey MSN, RN, IP-BC, CIC, FACDONA Director , Reprocessing of Flexible Endoscopes: Scientific Rationales and Patient Safety Implications, Techniques in Gastrointestinal Endoscopy (2019), doi: https://doi.org/10.1016/j.tgie.2019.150628
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc.
Reprocessing of Flexible Endoscopes: Scientific Rationales and Patient Safety Implications
Corresponding Author: J. Hudson Garrett Jr., PhD, MSN, MPH, FNP-BC, PLNC, IP-BC, FACDONA, FAAPM, FNAP Adjunct Assistant Professor of Medicine Division of Infectious Diseases University of Louisville School of Medicine Global Chief Clinical Officer Pentax Medical Email: [email protected] Address: 501 East Broadway, Suite 100, Louisville, Kentucky 40202 Conflict of Interest: Dr. Garrett is an employee of Pentax Medical, a division of Hoya Corporation.
Co-Author: Cindy Winfrey, MSN, RN, IP-BC, CIC, FACDONA Director, Global Clinical Affairs Pentax Medical Email: [email protected] Conflict of Interest: Ms. Winfrey is an employee of Pentax Medical, a division of Hoya Corporation.
Abstract Proper reprocessing of flexible endoscopes in gastroenterology practice is a critical element of a comprehensive patient safety and infection control strategy in both the inpatient and outpatient healthcare setting. This effort requires an interprofessional approach consisting of collaboration between the endoscopist and multiple other facility stakeholders including reprocessing professionals, nursing, infection prevention and control, biomedical engineering, and patient safety professionals. Recent advancements in human factors engineering has demonstrated a high reliability in validated and standardized reprocessing efforts for flexible endoscopes with properly trained reprocessing personnel and appropriate resources to execute the overall reprocessing process. A continued and concerted effort must be paid to maintaining the safety of these devices through focus on personnel, processes, and a continued innovative engineering of the devices themselves. While flexible endoscopes play a pivotal role in delivering diagnostic and therapeutic medical capabilities to endoscopists, their use is not without risk and require a comprehensive approach to medical device hygiene and integrated infection prevention and control. Keywords: Reprocessing, Infection Prevention, Infection Control, Endoscope Safety, High Level Disinfection, Medical Device Hygiene, Medical Device Safety
The Importance of Flexible Endoscope Reprocessing and Clinical Implications Flexible endoscopes are used for a wide variety of diagnostic and therapeutic needs in gastroenterology and are handled by multiple stakeholders including the physician, registered nurse, endoscopy technician, reprocessing technician, and biomedical engineering. Because these devices are used widely throughout healthcare, flexible endoscopes must only be reprocessed by specially trained technicians and maintained according to the manufacturer’s instructions for use. The literature has documented multiple outbreaks associated with flexible endoscope reprocessing failures and breaches in cleaning protocols.1 In recent years, the United States Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have investigated outbreaks with flexible endoscopes across multiple healthcare settings.2 These outbreaks have resulted in changes in regulatory guidance and medical device clearances from the FDA, and additional oversight and clinical guidance related to evidence-based practices in reprocessing these devices from the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC). In 2016, CDC released formal guidance detailing best practices associated with reprocessing of flexible endoscopes. This guidance included the following core elements3: 1. Administrative Support, Leadership, and Formal Policies and Procedures 2. Documentation on the Methods, Products, and Validation Mechanisms for Device Reprocessing, High Level Disinfection, and/or Sterilization 3. Inventory Management of Flexible Endoscopes 4. Physical Setting where Reprocessing is performed 5. Education, Training, and Competencies 6. Risk Assessment and Quality Assurance 7. Unresolved Issues
Both inpatient and outpatient healthcare facilities should carefully adhere to the CDC’s recommendations and also review relevant clinical guidance from professional associates and industry standards. Careful adherence to these standards and best practices will improve patient safety and reduce potential device contamination risks.4 The FDA has also identified several design challenges associated with flexible endoscopes that can increase the risk for cross-contamination and associated device risk5: ▪
Long, narrow interior channels (lumens), including those with internal surfaces that are not smooth, have ridges or sharp angles, or are too small to permit a brush to pass through
▪
Hinges
▪
Sleeves surrounding rods, blades, activators, inserters, etc.;
▪
Adjacent device surfaces between which debris can be forced or caught during use
▪
O-rings
▪
Valves that regulate the flow of fluid through a device (stopcocks)
▪
Devices with these or other design features that cannot be disassembled for reprocessing
Meticulous attention must be paid to the handling, reprocessing, and maintenance of all flexible endoscopes. Resources are available for the implementation of best practices associated with the management of flexible endoscopes from multiple clinical associations.
Current Spaulding Classification Scheme Medical devices are currently reprocessed utilizing the Spaulding Classification Scheme. The Spaulding Classification Scheme breaks down medical devices into three basic categories: noncritical, semi-critical, and critical items. Critical items are those that come in contact with sterile body cavities and require sterilization as a minimum level of disinfection for reprocessing. Common examples of critical items include surgical instruments, implants, and catheters. Next, the Spaulding Classification addresses semi-
critical items, which are medical devices that come in contact with mucous membranes, but not sterile body cavities. These devices require a minimum of high-level disinfection (HLD) in order to be safely reprocessed. Common examples of semi-critical devices include flexible endoscopes, laryngoscopes, and oral retractors. Currently, flexible endoscopes are classified as semi-critical devices. It is important to note that while the minimum level of disinfection for this category is HLD, some devices do permit sterilization if validated by the manufacturer. Lastly, the Spaulding Classification has a third category which is noncritical items. These items are most commonly utilized within healthcare and are items that come into contact with intact skin only. These items require a minimum of low level disinfection, but preferably intermediate level disinfection. Commonly used noncritical devices include blood glucose meters, stethoscopes, and pulse oximeters. Each of the items addressed in the Spaulding Classification carries some level of risk, but with proper cleaning and disinfection, the potential risk to the patient can be greatly reduced. It is important that physicians and healthcare providers carefully follow all manufacturer’s instructions for use related to reprocessing and instrument handling 6.
Overview of Endoscope Reprocessing In the United States, the Food and Drug Administration (FDA) defines reprocessing as a validated process used to render a contaminated medical device suitable for a subsequent single use by carefully adhering to the manufacturers reprocessing steps (i.e., product labeling)7. In addition, standardized professional guidelines along with infection control procedures have been developed for the reprocessing of endoscopes. These guidelines and procedures serve to guide persons responsible for reprocessing to minimize the risk of cross-contamination and/or subsequent reprocessing failure resulting in potential transmission of infectious agents8.
The reprocessing of flexible endoscopes is a multi-step process. Table 1 summarizes the steps to reprocess endoscopes using high-level disinfection along with the objective and rationale for each step. This section outlines the reprocessing steps currently utilized by manufacturers to create their reprocessing instructions for use (IFU). The following section will address additional implications of endoscope reprocessing in the context of patient safety3. [Insert table 1]
Infection Control Recommendations for Flexible Endoscope Reprocessing and Quality Surveillance Routine surveillance cultures of flexible endoscopes have not been routinely recommended historically according to previous recommendations from the CDC. In 2017, a combined guidance document from both the CDC and the FDA published evidence-based recommendations for culturing and sampling of duodenoscopes based on the consensus of a multidisciplinary working group. These recommendations were initiated as a result of a two-part FDA 522 Regulatory Study which evaluated both postreprocessing duodenoscope bioburden contamination and also a human factors engineering analysis of the reliability of executing reprocessing instructions for use provided by manufacturers with a group of relevant stakeholders (i.e. reprocessing technicians and registered nurses). These new clinical studies continue to be utilized by the FDA to evaluate new flexible endoscopes being submitted to the agency for potential infection control and patient safety concerns 10.
Multi-Disciplinary Collaboration and Executive Support There are a variety of personnel in the healthcare continuum of care that are involved in the use of a flexible endoscope. In order to maintain complete traceability of these medical devices, multiple internal stakeholders must work in collaboration with each other to build a comprehensive system of endoscope tracking and monitoring. Ultimately, executive and departmental leadership must be fully engaged and
allocate both sufficient human and physical resources to ensure that flexible endoscopes are selected, used, reprocessed, and stored according to the manufacturer’s instructions for use. Reprocessing personnel should be fully integrated into the gastroenterology team and be familiar with the clinical utilization of all devices for which they have reprocessing responsibility. The gastroenterologist should also be familiar with the institution’s reprocessing processes and allocate sufficient time between clinical cases for all flexible endoscopes and associated reusable devices to be properly reprocessed 8.
Patient Safety Implications of Flexible Endoscope Reprocessing The CDC has recommend a core set of infection prevention and control practices that should be applied across multiple aspects of patient care in all healthcare settings- both inpatient (e.g., acute, long-term care, rehabilitation, behavior health) and outpatient (e.g., physician and nurse practitioner offices, clinics, urgent care, ambulatory surgical centers, imaging centers dialysis centers, physical therapy, rehabilitation centers and alternative medical clinics). Utilization of these required set of core practices is essential to providing safe and high-quality patient care regardless of the delivery setting. These core practices include the following health care providers (HCP): individuals having direct patient contact and/or potential for exposure to patients and or infectious materials and individuals not directly involved in patient care (e.g., clerical staff, environmental services, volunteers) who could be exposed to infectious materials in a healthcare setting. Additionally, there are essential elements of a reprocessing program for flexible endoscopes. To achieve the goal of a reliable, high quality reprocessing program healthcare facilities must have an infrastructure that supports management, training and competencies, and quality management11.
Stringent adherence to reprocessing instructions is highly effective but patient safety can be compromised by factors that impact the effectiveness of reprocessing. Endoscope-related factors
include complex design features such as long, narrow interior channels and sharp angles, hinges, Orings, a variety of endoscope models that require different cleaning procedures and brushes, scope age and the service history of the endoscope. Other device-design related factors include post-market design changes that do not take into account how the changes impact the ability to properly clean and disinfect the device and lack of communication between manufacturers and/or between manufacturers and device users when medical devices used for reprocessing are modified and instructions are revised. Personnel factors include inadequate number of staff to support volume, inadequate training and/or understanding of the manufacturer’s validated instructions for manual reprocessing, flushing pumps, and automatic endoscope reprocessors (AERs), frequent interruptions and/or time pressure for rapid endoscope turnaround, inadequate training and/or understanding of correct chemical use and lack of mindfulness and understanding of risk. Characteristics of reprocessing that can impede its effectiveness include numerous steps that are prone to human error that must be followed sequentially and meticulously, lack of quality control measures to detect problems or reprocessing lapses, lag time or a delay in reprocessing, improper or inappropriate use of chemicals, inadequate cleaning prior to HLD or sterilization and inadequate drying before storage. The use of AERs and flushing pumps can also introduce additional factors such as issues related to water supply or quality, equipment malfunction, contamination, or the use of incorrect connectors12.
Reprocessing Instructions for Use (RIFU) Manufacturers of reusable medical devices are responsible for labeling that includes adequate instructions for use. RIFUs should be complete, understandable, and reasonably implemented by the user. These validated reprocessing instructions are intended to ensure that the device can be used safely and for the purpose for which it is intended. Problems with patient safety can arise when HCPs
are unsure of how to incorporate equipment or chemicals not specifically listed in the endoscope manufacturer’s RIFU.
The instructions should describe any accessories that are needed for safe reprocessing. If the device requires any special protection during reprocessing (e.g., valves, plugs or stoppers to prevent ingress of chemicals), they should be described in detail. Any special tools, sizes and types of brushes (including custom brushes), flush port connectors and connector size specifications, trays, test kits, specific types of sterilization wraps or containers, and part numbers should also be identified. The instructions should provide sufficient detail so that the user can purchase the correct items, including any custom cleaning accessories, or identify a source for the purchase of such items. If tools not listed in the endoscope manufacturer’s RIFU are used, they should conform to specifications and performance standards of the products listed in the endoscope manufacturer’s RIFU13.
To mitigate problems that could occur from improper selection of detergents and high-level disinfectants, the medical device manufacturer should provide a reference list of products that have been shown to be compatible with the materials used in the construction of the specific model of endoscope. In the case of high-level disinfectants, the list should include only products that have received FDA 510(k) clearance for claims as a high-level disinfectant. The RIFU should guide the user to follow the selected product manufacturer’s label instructions for concentration, temperature and soak time. Users should understand that using untested products and not following instructions for use is not safe and could lead to endoscope damage and/or unsuccessful reprocessing.
When the endoscope manufacturer RIFUs do not include the use of AER, leadership and reprocessing personnel must understand it is the AER manufacturer that may be responsible for any product-related
claims. These claims usually include cleaning, disinfection, sterilization, rinsing, drying, biocompatibility, reprocessing instructions, required channel adapters, efficacy validation, and should comply with regulatory requirements and/or professional guidelines. Confirming with the AER manufacturer that the AER has instructions for use and efficacy data for the specific model of endoscope and accessories should be done prior to use of the AER in order to ensure patient safety14.
When considering the use of a sterilization process, always check with the endoscope manufacturer to ensure the system, solutions and processes selected are safe to use with the specific endoscope. Check with the sterilizer manufacturer to ensure they have performed microbial validation studies to support their sterilization claims for the specific endoscope and accessories. Chemical and/or biological indicators recommended by the sterilizer manufacturer should be used to monitor the process and ensure sterilization efficacy.
We have discussed factors that impact the effectiveness of reprocessing and safely incorporating equipment or chemicals not specifically listed in the endoscope manufacturers RIFU. These represent potential failure points in reprocessing because of a lack of knowledge, understanding or compliance. Education and training should include this information and user knowledge and application should be assessed as part of an overall quality strategy to avoid equipment damage and/or reprocessing failures12.
Clinical Approaches to Novel Reprocessing Technologies Engaging all stakeholders including manufacturers, healthcare facilities and staff, accreditation organizations, professional organizations and government agencies in solving problems related to reprocessing medical devices will build collaboration and lead to advances in solving these problems.
The FDA is working with standard-setting groups to develop a series of best practices and gain consensus. Technical information reports and new standards will provide manufacturers guidelines for designing devices that can be adequately reprocessed and identify methods and criteria for validating that reprocessing has achieved the desired result. Based on research conducted by the FDA and others, the following design features likely facilitate cleaning, disinfection and sterilization and may reduce the likelihood of reprocessing failures15.
Smooth surfaces, including smooth inner surfaces of the long, narrow interior channels (lumens).
The ability to disassemble devices with multiple components.
Non-interchangeable connectors for critical connections (For example, tubes used with endoscopes for direct patient connection that cannot be interchanged with tubing used for waste drainage).
Clear identification of connecting accessories, such as drainage tubing.
Clear indication and identification of components that must be discarded after patient use and cannot be reprocessed or reused.
Disposable components for the hardest to clean areas.
Designs that address how fluid flows through the device, and areas of debris build-up within devices.
Although changes in endoscope design and novel reprocessing technologies may improve efficiency and quality of the reprocessing process, incorporating the latest technology won’t innately guarantee improved outcomes. Proper protocols must still be followed, stakeholders need to collaborate and hold each other accountable and a culture of patient safety should be maintained in order to make the biggest impact towards decreasing the risk for healthcare acquired infections.
People, Process, Product In order for reprocessing procedures to achieve high-reliability, the healthcare team must maintain a regular and intense focus on compliance with all evidence-based guidelines and the manufacturer’s instructions for use. Healthcare Leadership must properly resource the reprocessing department to ensure that all instruments are handled appropriately, properly maintained, and correctly stored. The primary focus for driving safety must be on the Healthcare Personnel or the People. An engaged frontline team will assist with infection prevention and control efforts 3. Additionally, manufacturers of endoscopic equipment should provide Instruction for use (IFUs) that emphasize both quality indicators for HLD and redundancy of operations. This extra layer of education and instruction is supported by data and FDA guidance.
Second, healthcare facilities must build robust, and human-factors engineered facilities and optimized processes to facility proper reprocessing of endoscopes. While it is certainly not feasible to always have optimized reprocessing facilities, healthcare facilities should ensure that technicians have appropriate resources to properly disinfect all flexible endoscopes. Personnel should have their flexible endoscope reprocessing and handling competency verified annually. Physicians can also benefit from interactive continuing education based on preventive damage to flexible endoscopes. Gastroenterologists and healthcare facilities should work collaboratively with flexible endoscope manufacturers to established model and device-specific competencies, in-service training, and preventive maintenance programs that decrease the clinical risk of the flexible endoscope inventory.
Lastly, healthcare providers and facilities must utilize technologies that are both efficacious and safe. All patients deserve the safest possible care, and a multidisciplinary approach is necessary to optimize
Comment [RA1]: There should probably be some mention on quality control. This section puts much of the onus on the healthcare facility, however, recent data and FDA mandate would argue that the manufacturer needs to provide IFUs that account for user error, namely redundancy and quality indicators.
clinical resources, decrease associated risk, and improve patient safety associated with the use of flexible endoscopes.
Future Directions in Endoscope Safety Physicians, while the clinical users of flexible endoscopes, are one critical component in the device management and infection control process. Physicians, clinical societies, regulators, healthcare facilities, and patients have each called for manufacturing innovations by original equipment manufacturers to improve the ability for end users to more easily clean and disinfect the endoscope. Many flexible endoscope manufacturers have re-engineered their devices and created disposability of high-risk components to mitigate risks, conducted extensive human factors-validated reprocessing studies, and created innovative reprocessing instructions for use and in-service tools. Continued innovation in people (reprocessing and gastroenterology personnel), process (device reprocessing and maintenance processes), and product (engineering innovation) are needed to further reduce the risk for device crosscontamination and associate adverse impacts to patients and healthcare providers.
References
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infections: update on an emerging problem. Digestive diseases and sciences. 2019;64(6):14091418. doi:10.1007/s10620-018-5431-7. United States Food and Drug Administration (FDA). Infections Associated with Duodenoscopes. Retrieved From: https://www.fda.gov/medical-devices/reprocessing-reusable-medicaldevices/infections-associated-reprocessed-duodenoscopes. Accessed June 1, 2019. Centers for Disease Control and Prevention (CDC). Essential elements of a reprocessing program for flexible endoscopes: Recommendations of the healthcare infection control practices advisory committee (2017). Retrieved from https://www.cdc.gov/hicpac/pdf/flexible-endoscopereprocessing.pdf. Accessed June 1, 2019. Weber DJ, Rutala WA. Assessing the risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines. Am J Infect Control. 2013;41(5 Suppl):S67-71. United States Food and Drug Administration (FDA). Device Design, Retrieved From: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusable MedicalDevices/ucm454626.htm#design, Accessed June 1, 2019. Association for the Advancement of Medical Instrumentation (AAMI). Flexible and semi-rigid endoscope reprocessing in health care facilities (ANSI/AAMI ST91: 2015). Arlington, VA. United States Food and Drug Administration (FDA). Reprocessing medical devices in health care settings: Validation methods and labeling (2015). Retrieved From: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocum ents/ucm253010.pdf. Accessed June 1, 2019. Petersen BT, Cohen J, Hambrick III RD, et al: Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update. Gastrointestinal endoscopy, 85(2), 282-294, (2017). Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes 2018. Chicago, IL. Retrieved From: https://www.sgna.org/Portals/0/SGNA%20Standards%20of%20infection%20prevention%20in% 20reprocessing_FINAL.pdf?ver=2018-11-16-084835-387. Accessed June 1, 2019. United States Food and Drug Administration (FDA). Duodenoscope Surveillance Sampling & Culturing: Reducing the Risks of Infection. Retrieved From: https://www.fda.gov/media/111081/download. Accessed June 1, 2019. Centers for Disease Control and Prevention (CDC). Core infection prevention and control practices for safe healthcare delivery in all settings – Recommendations of the healthcare infection control practices advisory committee. (2017). Retrieved From: https://www.cdc.gov/hicpac/pdf/core-practices.pdf. Accessed June 1, 2019. United States Food and Drug Administration (FDA). The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication. Retrieved From: https://www.fda.gov/medical-devices/safetycommunications/fda-continues-remind-facilities-importance-following-duodenoscopereprocessing-instructions-fda. Accessed June 1, 2019. United States Food and Drug Administration (FDA). Working together to improve reusable medical device reprocessing. (2018). Retrieved From: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusable MedicalDevices/ucm454626.htm#design. Accessed June 1, 2019.
14. United States Food and Drug Administration (FDA). Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation. Retrieved From: https://www.fda.gov/medicaldevices/reprocessing-reusable-medical-devices/information-about-automated-endoscopereprocessors-aers-and-fdas-evaluation. Accessed June 1, 2019. 15. United States Food and Drug Administration (FDA). Factors Affecting Quality of Reprocessing. Retrieved From: https://www.fda.gov/medical-devices/reprocessing-reusable-medicaldevices/factors-affecting-quality-reprocessing. Accessed June 1, 2019. 16. United States Food and Drug Administration (FDA). FDA Report on the quality, safety, and effectiveness of servicing of medical devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA). (2018). Retrieved From: https://www.fda.gov/downloads/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmend mentstotheFDCAct/FDARA/UCM607469.pdf. Accessed June 1, 2019.
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Table 1. Flexible Endoscope Reprocessing Steps 9 Step Pre-Cleaning
Objective - Rationale
Occurs in procedure room immediately after removal of insertion tube and before removing scope from the light source and suction pump. Removes organic soils (e.g., blood, body fluids) decreasing bioburden. Decreases likelihood that soils will dry on scope. Once pre-cleaned, the soiled endoscope is transported in a closed puncture resistant container to reprocessing area. All subsequent steps should be performed in the reprocessing area. Leak Testing Detects damage to interior channels and exterior surfaces Consists of dry – before immersion to minimize the risk of damage to parts that cannot tolerate fluid exposure AND wet – pressurized endoscope is submerged in clear water and all surfaces checked for bubbles indicating leaks. Scope is removed from water and allowed to depressurize. If leak detected remove scope from service and contact manufacturer for next steps. Manual Cleaning: The Use medical grade detergent formulated to effectively remove proteins, fats, carbohydrates and various chemical salts that exist in blood and most critical step in other body fluids in addition to being materially compatible with the removing the microbial model of scope being cleaned. burden from an Detergent should be freshly prepared and used according to the detergent endoscope. manufacturer’s instructions. Use low-foaming detergents so device can be visualized while cleaning. Cleaning should occur while the scope is submerged in the detergent solution to prevent splashing and aerosolization of bioburden and to insure the scope is in contact with the detergent. Use lint-free cleaning tools and brushes specified by the scope manufacturer and follow all cleaning steps outlined in the reprocessing instructions for use. Rinse after manual Rinse all removable parts and the scope with clean water to remove residual debris and detergent; purge water from all channels using forced cleaning air; dry the exterior of the scope with a lint-free cloth to prevent dilution of the high-level disinfectant used in subsequent steps. Visible Inspection Use magnification and adequate lighting. Inspect for cracks, discoloration, retrained debris. Repeat manual cleaning if it is determined scope is not visually clean. Remove damaged scopes and accessories from service for repair or disposal. High-level Disinfection Follow the scope manufacturer’s validated device specific instructions for high-level disinfection (i.e., destruction of all viable microorganism but not (HLD) necessarily all bacterial spores). The scope and all removable parts must be completely immersed in the HLD. Flush HLD into all channels. All channels must be filled so no air pockets remain, and all surfaces are in complete contact with the HLD. Use HLD at the temperature and time recommended by the HLD manufacturer. Rinse After HLD Following the scope manufacturer’s instructions, thoroughly rinse all surfaces and removable parts and flush all channels to remove chemical residue.
Drying
Storage
Thorough rinsing prevents exposure and potential injury to skin and mucous membranes from chemical residues. Follow the scope manufacturer’s instructions for drying. All channels and the surface of the scope must be dried before storage to prevent an environment that allows microorganisms to survive and multiply. Moisture promotes the formation of biofilm which may result in decreased efficacy of detergents and high-level disinfectants. An endoscope that is not dry should be reprocessed before use. Conventional storage includes hanging scopes in a vertical position with all caps, valves and other detachable components removed. Scopes should hang freely to prevent damage and contact with one another. Endoscopes must be stored in an area that is clean, well ventilated and dust free. Endoscopes must be stored in a manner that keeps them completely dry and free from environmental and human contamination.
Adapted from: SGNA Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes, CDC Essential Elements of a Reprocessing Program for Flexible Endoscopes, Multisociety Guideline on Reprocessing Flexible GI Endoscopes, and FDA Reprocessing Medical Devices in Healthcare Settings