ANSI/AAMI ST91: 2015 Flexible and semi-rigid endoscope processing in health care facilities Cathy Rocco, RN, MSN, CNOR 039877-150908 1

Disclaimer This presentation reflects the techniques, approaches and opinions of individual presenter. This Advanced Sterilization Products (“ASP”) sponsored presentation is not intended to be used as a training guide. Before using any medical device, review all relevant package inserts with particular attention to the indications, contraindications, warning and precautions, and steps for the use of the device(s). I, Cathy Rocco, am compensated by and presenting on behalf of ASP, and must present information in accordance with applicable FDA requirements. Third party trademarks used herein are trademarks of their respective owners. 039877-150908

Objectives: By the end of this presentation, the learner should be able to: Understand ST91 as it relates to Flexible Endoscope Reprocessing Determine best practices for your facility utilizing national standards and recommended practices List the differences between AAMI ST91 and other national standards and guidelines 039877-150908 3

AAMI The Association for the Advancement of Medical Instrumentation (AAMI), founded in 1967, is a nonprofit, international membership organization dedicated to improving the safety and efficacy of medical instrumentation and healthcare technologies AAMI is the recognized developer of medical device standards worldwide – managing over 150 technical committees and publishing more than 100 technical documents Begin by sharing with the audience that you find value in regulations and standards. First or paramount thought that comes to mind is that the creation of regulations or standards, whether it is based on experience, evidence based practice, trial and error, implementation will create a safer environment for whatever the purpose of the regulation is intended. Safer is the key word. AAMI is the guru of sterile processing, it would really behoove operating personnel to understand where these standards originated from. Many of AAMI’s standards, are incorporated into AORN’s Perioperative Standards and Recommended Practices. Review slide. 039877-150908

AAMI’s Membership Government agency representatives (FDA) Industry representatives Government agency representatives (FDA) Individuals/Users Statewide biomedical societies Students Professional organizations (AORN, IAHCSMM, APIC, SGNA) AAMI membership is comprised of different entities, i.e. hospitals, industry, and government agencies that have voting members. If you attend a meeting that is open, the voting members are similar to the Knights of the Round Table, and spectators are positioned outside of this table or horseshoe for observation. There is extreme deliberation when a standard is being developed. While industrial players are cordial at the table, there is still a political tone. It is important to know that The Joint Commission looks to see if a department has the most current standard of ST 79 in their central sterile processing department. If you ever have an opportunity to attend one, it is worth the experience.

American National Standards Institute (ANSI) Formed in 1918 from 5 engineering societies and 3 government agencies Coordinates and promotes consensus of U.S. standards of American products used worldwide Does not develop standards – accredits the procedures for openness, balance, consensus and due process Generally when one sees quotes from AAMI, it is denoted as ANSI/AAMI Standards. The American National Standards Institute is a private non-profit organization, formed in 1918, that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organization also coordinates U.S. standards with international standards (ISO) so that American products can be used worldwide. While a somewhat outdated example by today’s use of digital cameras, standards ensure that people who own cameras can find the film they need for that camera anywhere around the world. ANSI accredits standards that are developed by representatives of other standards organizations, such as AAMI, government agencies, consumer groups, companies, and others. These standards ensure that the characteristics and performance of products are consistent, that people use the same definitions and terms, and that products are tested the same way. Similar to using Robert’s Rules of Orders or APA (American Psychological Association) style commonly used today in colleges as the formal standard used in the presentation of research papers. C words 039877-150908

Understanding Recommended Practices Standards and Recommended Practices (RP) can contribute significantly to the enhancement of cleaning and reprocessing medical instruments. By definition: “A recommended practice provides guidelines for the use, care and/or processing of a medical device or system” (AAMI, 2015). RPs enhance procedures and practices that will help ensure a device is used safely and effectively and that its performance can be maintained. 039877-150908 7

Common Terminology in AAMI Standards Shall: Indicates requirements to be followed strictly to conform to the standard Should: Indicated that among several possibilities one is recommended as particularly suitable but does not exclude others Terms used by from AMMI…shall, should, may, can and must 039877-150908

Common Terminology (continued) May: Used to indicate that a course of action is permissible within the limits of the standard Can: Used as a statement of possibility and capability Must: Used only to describe “unavoidable” situations including those mandated by government regulation 039877-150908

Why Develop AAMI National Standard for Flexible Endoscope Reprocessing? At least 11 million gastrointestinal endoscopies are performed each year and the number of procedures is increasing (Cullen et al, 2009; SGNA, 2012). Risks of failures… Breach of host barriers Person-to-person transmission of pathogens Environmental pathogens Device damage Inefficient use of the device Toxic reactions in patients These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these devices and accessories. 039877-150908 10

Why develop ? (continued) This document specifically addresses: Functional and physical design criteria for endoscope reprocessing area Education, training, competency verification, and other personnel considerations Processing recommendations Installation, care, and maintenance of AERs Quality control and quality process improvement 039877-150908 11

Design of Endoscope Reprocessing Area Space “should” facilitate both infection prevention and patient and employee safety. Work Flow (Unidirectional) & Traffic Flow Negative pressure/positive pressure/air flow/ventilation Appropriate lighting to facilitate proper inspection Eye wash station locations Required utilities – medical grade air, water quality Patient Volume/types of endoscopes Quantity and type(s) of processing equipment Location of AER Scopes/equipment storage requirements Temperature/humidity monitoring Supply/chemical storage requirements 039877-150908 12

Personnel Guidelines Provides guidelines for policies and procedures including: Education Certification “recommended” Training and competency verification Hand hygiene criteria Immunizations Hepatitis B Attire Proper PPE No exam gloves for decontamination 039877-150908 13

Training, Competency & Education “Should” be completed… Upon initial hire Annually At designated intervals When new endoscope models, updated IFUs, processing equipment or chemicals are introduced 039877-150908 14

Who can train employees? Facility personnel providing orientation, competencies or training “should”: Complete facility-specific education and competency verification related to the role of “educator” Maintain competence including new technologies Use regulatory and evidence-based professional guidelines Participate in ongoing activities related to education of personnel Periodically re-educate and re-assess competency of processing personnel with documentation of training 039877-150908 15

Education and Training “should” include… Procedures for cleaning, disinfecting or sterilizing, packaging and storing endoscopes including connectors for cleaning/AER connections Knowledge of and access to current National Standards Decontamination processes Operation of automated processes and equipment Workplace safety Documentation of quality monitoring results 039877-150908 16

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Hand Hygiene Hand Hygiene is not only hand washing… P & P “should” be developed and communicated Co-written/Co-approved through IP Fingernails “should” be short and clean…no artificial nails or nail tips Each facility “should” develop their own policy regarding nail polish as this subject remains unresolved and requires further studies 039877-150908 18

Personnel Attire All personnel “should” wear clean uniforms provided by and donned at the facility and laundered by a health care-accredited facility Changed daily or as needed and not worn outside facility All head and facial hair, except eyelashes and eyebrows, should be covered with a surgical type hair covering No jewelry or wrist watches Shoes should have non-skid soles and sturdy enough to prevent injury if something is dropped on the foot Cover apparel “should” be worn when outside the processing area 039877-150908 19

Cleaning and High-Level Disinfection (HLD) “Meticulous” attention to all steps is critical Pre-cleaning at the point of use Transporting Leak testing (wet/dry per manufacturers IFU) Cleaning Rinsing Inspecting or testing for cleaning verification HLD and monitoring the process Drying and alcohol flush Storage 039877-150908 20

Transportation of Dirty Endoscopes Each endoscope should be isolated and transported to the processing area Maintain components of the scope with the scope Transport in a closed system System should be marked as biohazard meeting OSHA guidelines System should be large enough to loosely coil endoscope Forceps/wires/sharp objects should be transported in a separate container 039877-150908 21

Automated Endoscope Reprocessors (AER) Designed for cleaning and HLD for endoscopes and components. More efficient than manual processing Standardizes required rinses for chemicals If cycle is interrupted, repeat entire cycle Quality of rinse water varies and “may” re-contaminate endoscopes Ensure quality testing of AER is performed according to manufacturer’s IFU 039877-150908 22

Qualities to consider when purchasing an AER What features does the AER provide? Is it FDA cleared? Can it reprocess devices in your current inventory? What accessories can the AER process? Is the HLD/LCS solution FDA cleared? Do I have enough space for the AER? Specific utilities/specifications/circulation? Recommended preventive maintenance? Who is certified to perform PM? 039877-150908 23

Qualities to Consider (continued) Does the AER have cleaning claims? Is it clear how those cleaning claims are applied to current practice? Are there limitations to the cleaning claim? Proper rinses per HLD/LCS IFU? Self-disinfect cycle? Drying/alcohol flush capabilities? Built in safety alarms? MEC Verification? Data verification of each cycle performed? Printout with required documentation of each completed cycle 039877-150908 24

Processing Endoscope Accessories Ex: air/water/suction valves, biopsy port covers, water bottles, tubing, etc. The same standard of inspection, cleaning and HLD is “required” Reusable devices that break the mucosal barrier “require” mechanical cleaning and sterilization Components disassembled and cleaned Water bottles per the manufacturer’s IFU or at least daily 039877-150908 25

Storage of Reprocessed Endoscopes Hung vertically with distal tip hanging freely Well-ventilated, clean area Sufficient space between/around other endoscopes Angulation in open position Removable parts detached from endoscope AORN (2016) “recommends” endoscopes stored in a closed cabinet with venting without touching the bottom of the cabinet and sufficient space for storage of multiple endoscopes without touching. 039877-150908 26

Storage (continued) Temperature and humidity “should” be monitored where endoscopes are stored Do not use manufacturer-provided case for storage Internal channels “should” be dry with medical grade forced air (appropriate PSI according to IFU) Detachable parts “should” be stored as a unique set with specific endoscopes for traceability Valves “should” be dried and lubricated according to the manufacturer’s IFU If sterilized, store in container/packaging they were sterilized in with an agreed upon maximum shelf life 039877-150908 27

Have you ever felt like this??? How am I ever going to remember all these steps??? 039877-150908

How do you know if an endoscope is clean and ready for patient use? CDC “recommends” a policy and procedure ensuring the end user can determine whether a scope has been cleaned and HLD or sterilized. For quality assurance, a tag or label “should” be attached to each endoscope and “should” include: Date of processing Name(s) of personnel who performed the processing Date of HLD/sterilization Now for the question that is on everyone’s mind……. 039877-150908 29

“Hang Time” for HLD Endoscopes “The accepted time interval for the storage of processed endoscopes before they can no longer be considered safe for patient use is not well defined” (AAMI, 2015). Limited number of studies “Available data suggests risk of contamination is “negligible” when storage is done according to the endoscope manufacturer’s IFU and/or standards related to endoscope processing” (AAMI, 2015). Currently there are no studies that show prolonged “hang time” as a risk factor to patient safety 039877-150908 30

Existing “Hang Time” Guidelines SGNA standards “recommend” reprocessing after 7 days Veterans Affairs follows a directive to reprocess after 12 days of hang time Gastro Assoc of Australia when 72 hours has elapsed, except for duodenoscopes, bronchoscopes and linear EUS scopes when 12 hours has elapsed. Enteroscopes when 12 hours has elapsed if no continuous air flow provided during storage New Zealand, Scotland and Ireland – up to 72 hours if stored correctly Canadian Standards Assoc – “should” be reprocessed if storage exceeds 7 days 039877-150908 31

Risk Assessment for Maximum “Hang Time” Guidelines and RPs provide recommendations for maximum duration of storage times before next patient use. Complexity and type of endoscope Condition of endoscope after processing Transportation method from processing to storage Condition of storage environment Manufacturer’s IFU for storage Research studies Patient population Quality of final rinse water 039877-150908 32

Risk Assessment (continued) Based on the risk assessment, each facility “should” develop policies and procedures to address maximum hang times. Each facility “should” address specifics of what to do when maximum hang times have been exceeded. Limited data for definitive answers to best practices so….. Do what works best for your facility…. follow your policy and procedure once established! 039877-150908 33

Table 2—Endoscope storage risk assessment checklist Storage of high-level disinfected endoscopes Yes No Action Endoscopes are stored so that residual fluid does not remain in the channels   Endoscopes are stored, with their detachable parts dismantled, in a manner that keeps them secure and together with the endoscope as a unique set Endoscopes are stored in a vertical non- coil position Tracking is available for each endoscope, including last episode of HLD If a storage cabinet is used, all manufacturer's written IFU should be followed and documented Storage of sterilized endoscopes Endoscopes are rotated according to policy Storage conditions are monitored according to ANSI/AAMI ST79 Endoscopes are identified and labeled 039877-150908 34

Routine Testing of Stored Endoscopes Numerous incidents of contaminated endoscopes have been traced to a failure in processing… User errors related to HLD procedures and/or drying procedures Physically compromised endoscopes or AERs Contaminated water supply during processing 039877-150908 35

Routine Testing (continued) Currently no universal consensus of the value of routine testing Numerous studies have identified non-environmental pathogens likely to be found in improperly reprocessed endoscopes Involve Risk Management, Laboratory and Infection Prevention as part of a Quality Assurance program At the time of printing for this document, AAMI is aware of the CDC considering microbial sampling of endoscopes 039877-150908 36

Quality Control Product identification and traceability Documentation and record-keeping Verification and monitoring of the cleaning process adhering to national standards and guidelines Monitoring of HLD/sterilization Personnel performance and work practices Product recalls Quality process improvement 039877-150908 37

Quality Assurance & Safety Programs At a minimum, facilities “should” establish comprehensive quality assurance programs to include but not limited to: Identity of personnel involved Identify all areas within facility that process endoscopes Keep accurate inventory records of equipment Identify storage location Compatibility of endoscopes with reprocessing protocols (AERs) 039877-150908 38

Quality Assurance (continued) Visual inspections and testing of equipment Process monitors for equipment Documentation for patients and personnel Education, training and competency verification programs 039877-150908

Documentation AER ID, soaking container and cycle number Load contents Patient’s name and unique patient identifier Procedure, physician, serial number of item Shelf-life date, lot # and date opened of HLD/LCS 039877-150908 40

Documentation (continued) Exposure time and temperature Date and time of cycle, HLD/LCS type and concentration Name or initials of operator Results of MEC/BI/CI/spore test strip/quality control of test strips 039877-150908

Verification and Monitoring of the Cleaning Process Several technologies have the capability of measuring residual organic soil and microbial contamination. Consideration “should” be given to the use of an appropriate monitoring verification process depending on the IFU of the product used Published studies have evaluated specific markers to determine cleaning efficacy… Proteins Carbohydrates Hemoglobin Adenosine Triphosphate (ATP) Enzyme that detects specific bacteria 039877-150908 42

Verification (continued) Basic components should include establishing a reasonable benchmark and rapid, easy-to-perform reliable methods. Benchmarks “may” become more definitive as more data becomes available. Each facility “should” formulate policies and procedures for verification of cleaning efficacy. Frequency of testing “should” occur on a regular basis, weekly or preferably daily (Drosnock 2014, Alfa 2014). 039877-150908 43

Inadequate Processing and Recalls Supervisor, Risk Manager and/or Infection Prevention notification Time & date of cycle in question Identification of HLD modality CI and any other useful information for validity 039877-150908 44

Inadequate Processing (continued) Root cause analysis Remove equipment from service if necessary Determine if recall is necessary Have written protocol in place for recall 039877-150908

Recall Procedure, Order and Summary A recall procedure “should”: Be written Outline the circumstances for issuing a recall order Designate the person/people authorized to issue a recall order; and Designate responsible personnel for reporting on the execution of a recall order 039877-150908 46

Recall Order “should”: Include all items processed back to the last negative BI or failed MEC indicator (if applicable) Be immediately communicated to affected areas and followed by a written order Identify products to be recalled by lot number, product or patient name or other information Identify the people or areas to whom the order is addressed 039877-150908 47

Recall Order (continued) Require the recording, kind and quantity, or products in the recall, and Specify the action to be taken by the people receiving the order. Outline the circumstances for issuing a recall order Designate the person/people authorized to issue a recall order; and Designate responsible personnel for reporting on the execution of a recall order 039877-150908

Recall Summary Report “should”: Identify the circumstances that prompted the recall order Specify the corrective actions taken to prevent a recurrence State the percentage of products actually in the recall in terms of number of products intended to be recalled, and Provide verification that the recalled items were reprocessed or destroyed 039877-150908 49

Risk Analysis = Risk Assessment + Risk Management + Risk Communication Risk Assessment – Identification of the source of a failure, assessing the consequences and how prepared a facility will be to manage the failure. Risk Management – Determining which failures require management and selecting/implementing action plans to control the failures. Risk Communication – Interactive dialogue between SPD personnel, Endoscopy and Infection Prevention actively informing other concerned parties, including patients (recall procedure). 039877-150908 50

Risk Analysis (continued) The Processing Risk Analysis “should” be a part of each facility’s Infection Prevention and Risk Control Analysis. “Should” be performed at least annually “Should” be re-evaluated whenever significant changes occur 039877-150908 51

Evaluating and Monitoring Effectiveness of the HLD Process “Should” be an ongoing effort to maintain control and determine methods for improvement. “Should” be re-evaluated whenever significant changes occur “Should” be audited for compliance Development of a CQI Program to include: Training, continuing education and competency verification Product ID and traceability Monitoring cleaning/HLD/sterilization effectiveness Product testing and product recalls Workplace safety training 039877-150908 52

Key Differences in Guidelines AAMI It is “recommended” that devices are subjected to high-level disinfection (HLD) after each use. Flexible and semi-rigid endoscopes “should” be sterilized when possible and practical. A source of treated water for final rinsing (AAMI TIR34). Temperature of cleaning solution “should” be monitored and documented SGNA High-level disinfection (HLD) is recognized as the standard for reprocessing of gastrointestinal endoscopes. Sterilization of endoscopes is indicated in the rare occasions when it is used as a critical medical device, where there is potential for contamination of an open surgical field. Rinse with clean water according to disinfectant and endoscope manufacturer’s recommendations. Does not address temperature of cleaning solution. 039877-150908 53

Key Differences in Guidelines (continued) AAMI Clean gloves (latex free) “should” be worn when handling clean endoscopes and accessories Detachable parts “should” be stored as a unique set with a specific endoscope SGNA Does not address necessity for wearing gloves when handling clean endoscopes and accessories Does not address unique sets of detachable parts 039877-150908 54

Questions? 039877-150908

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