18/11/2015. Sterile Processing for the Infection Preventionist: What you need to know? November 19, Welcome! House Keeping

Transcription

1 SM 3M Health Care Academy Sterile Processing for the Infection Preventionist: What you need to know? November 19, 2015 Welcome! Topic: Sterile Processing for the Infection Preventionist: What you need to know? Facilitators: Christophe de Campeau, 3M Sandra Velte, 3M Speakers: Jacqueline Daley HBSc, MLT, CIC, CSPDS For more information: House Keeping From the GoToWebinar page: Click on the orange box with a white arrow to expand your control panel (upper right-hand corner of your screen). Type a question in the question box and click send. 3 1

2 House Keeping Continuing Education Each 1 hour web meeting is approved by IAHCSMM, CBSPD and is 3M Health Care Provider approved by the California Board of Registered Nurses CEP 5770 for one contact hour. Post webinar Link to Course Evaluation CS Tech CE Certificate Included Forward to others in attendance 4 Jacqueline Daley HBSc, MLT, CIC, CSPDS Manager Infection Prevention, Clinical Epidemiology and Vascular Access Service Sharp Metropolitan Medical Center 3M Educational Consultant Speaker s Bureau Sage Products 5 Learning Objectives Identify the impact of standards, guidelines, recommended practices and regulatory agencies on the Central Sterile Department/Sterile Processing Department as it relates to Infection Prevention Review the role of the Joint Commission in the Sterile Processing Department (SPD) as it relates to Infection Prevention Discuss best practices for monitoring the sterilization process and why biological indicators are considered the most effective method for monitoring the sterilization process Understand the importance of procedures for recall of potentially contaminated equipment and supplies List three areas of concern in the Sterile Processing Department (SPD) that impacts infection prevention 6 2

3 Role of Sterile Processing Department (SPD) The importance of this [SPD] role in the prevention of nosocomial [HAIs] is clear: reusable medical devices improperly handled, disinfected, or sterilized provide a source of contamination and increase the risk of transmission of infection to both patients and the staff involved in reprocessing procedures. Pugliese, Gina and Hunstiger. Central Services, Linens and Laundry. In Hospital Infections. Edited by John V. Bennett and Philip S. Brachman. 3 rd ed. 7 Standard, Guidelines and Professional Bodies Association for Professionals in Infection Control and Prevention (APIC) Position Statements Association of perioperative Registered Nurses (AORN) Recommended Practices Society for Healthcare Epidemiology of America (SHEA) The Joint Commission (TJC) Infection Prevention and Control Standards Association for the Advancement of Medical Instrumentation (AAMI) Society of Gastroenterology and Associates, Inc (SGNA) American Society for Gastrointestinal Endoscopy (ASGE) 8 Government and Regulatory Agencies Center for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Environmental Protection Agency (EPA) Office of Pesticides Program-Antimicrobials Division (OPP-AD) is responsible for all regulatory activities associated with antimicrobial pesticides. Regulates items used to sanitize and disinfect environmental surfaces and sterilants such as ethylene oxide Food and Drug Administration (FDA) Medical instruments and device approval through the 510K process Approval of products used as sterilants and high-level disinfectants with general claims for reprocessing reusable medical and dental devices Center for Medicare Medicaid (CMS) Conditions of Participation Hospital Infection Worksheet Sec 3.A. Reprocessing Semi-Critical Equipment; Sec 3.B. Reprocessing of Reusable Critical Equipment, Instruments and Devices: Sterilization Local and state regulations 9 3

4 Association for Professionals in Infection Control and Prevention (APIC) Impact on Sterile Processing Endorses standards and guidelines through participation on committees such as AAMI and Healthcare Infection Control Practices Advisory Committee (HICPAC), Centers for Disease Control & Prevention (CDC). Development of Position Statements **Important information for infection preventionists regarding media attention on an outbreak involving reusable surgical instruments. Infection preventionists can play an important role in collaboration with the perioperative team and the facility s sterile processing department (SPD)/surgical reprocessing professionals to ensure the proper cleaning and sterilization of surgical instruments. Develops competencies for infection preventionists to ensure a clear understanding and management of risks in department to include the practices in Central Sterile / Sterile Processing Allows for assessment of practices in this domain 10 Association for Professionals in Infection Control and Prevention (APIC) Supports initiatives that actively promote certification of sterile processing personnel Provides a course on Disinfection and Sterilization: Best Practices in Reprocessing Surgical Instruments Helps healthcare professionals in all settings ensure compliance with regulatory standards for sterile processing and adhere to recommended best practices. ** Association of perioperative Registered Nurses (AORN) Recommended Practices Cleaning and care of surgical instruments and powered equipment Selection and use of packaging systems for sterilization Evaluating, selecting, and using packaging systems and for packaging the items to be sterilized and used in the perioperative setting Sterilization Provides guidance for sterilizing items in the perioperative setting 4

5 The Joint Commission: 2015 Hospital Accreditation Standards Top Standards Compliance Issues for 2014 Ambulatory Surgery 41% IC The organization reduces the risk of infections associated with medical equipment, devices, and supplies. 22% IC The organization identifies risks for acquiring and transmitting infections. Office-Based Surgery Practices 39% IC The practice reduces the risk of infections associated with medical equipment, devices, and supplies. 19% IC The practice identifies risks for acquiring and transmitting infections. 17% IC Based on the identified risks, the practice sets goals to minimize the possibility of transmitting infections independent practitioners and staff. Joint Commission Perspectives, April 2015, Volume 35, Issue 4 14 The Joint Commission LD , EP2 The hospital provides care, treatment, and services in accordance with licensure requirements, laws and regulations LD Patients with comparable needs receive the same standard of care, treatment, and services throughout the hospital LD The hospital considers clinical practice guidelines when designing or improving processes. IC The organization reduces the risk of infections associated with medical equipment, devices and supplies. The hospital implements infection prevention and control activities when doing the following: EP1- Cleaning and performing low-level disinfection of medical equipment, devices, and supplies. EP2 - The hospital implements infection prevention and control activities when doing the following: Performing intermediate and high-level disinfection and sterilization of medical equipment, devices, and supplies. The Joint Commission: 2015 Hospital Accreditation Standards 5

6 The Joint Commission Issues with High-Level Disinfection (HLD) Evidence-based Guidelines Standard IC , EP 1 - Lack of having and/or lack of using current evidencebased guidelines for cleaning, disinfection, high-level disinfection, and sterilization practices is a frequently identified issue and includes knowledge of guideline content and accessibility of guidelines (electronic or manual) for staff use. Orientation, Training, and Competency Standard IC lack of orientation, training, and competency (initial and ongoing) of all staff involved in processing or handling semi-critical and critical devices that require high-level disinfection or sterilization. The Joint Commission Perspectives February 2014 The Joint Commission Issues with High-Level Disinfection (HLD) Quality Control and Quality Monitoring Standard IC , EP 2 - lack of quality control for high-level disinfection and the lack of quality monitoring for sterilization. Supervisory and Infection Prevention and Control Staff Fourth most frequently identified issue involves the participation and collaboration of staff in monitoring high-level disinfection and sterilization processes. Record Keeping Fifth most frequently noted issue involves documentation. The Joint Commission Perspectives February 2014 The Joint Commission s Office of Quality Monitoring Findings from non-complying organizations include: Mistaken belief that the risk of passing bloodborne pathogens or bacterial agents to patients is low Staff lack the knowledge or training required to properly sterilize or high-level disinfect equipment Staff do not have access to or lack knowledge of evidence-based guidelines Lack of leadership support Frequent leadership and staff turnover makes sterilization or high-level disinfection of equipment a low priority Lack of a culture of safety that supports the reporting of safety risks Processes for sterilization or high-level disinfection are not followed (i.e., staff take short-cuts) Time frames for proper sterilization or high-level disinfection of equipment are not followed No dedicated staff person to oversee the proper sterilization or high-level disinfection of equipment 6

7 The Joint Commission s Office of Quality Monitoring (cont d) Facility design or space issues prevent proper sterilization or high-level disinfection of equipment (e.g., processing takes place in a small room that is also used for storage) Lack of monitoring or documentation of sterilization or high-level disinfection of equipment, which makes it difficult to track the use of equipment on a specific patient, complicating the patient notification process when an outbreak occurs Equipment is spread throughout the facility and may be processed or stored in numerous locations, making it difficult to track the equipment for documentation purposes. Joint Commission Problematic Standards EC The hospital manages risks associated with its utility systems EP 6: In areas designed to control airborne contaminants (such as biological agents, gases, fumes, dust), the ventilation system provides appropriate pressure relationships, air exchange rates and filtration efficiencies Move from clean to dirty Decontamination negative pressure Prep and Pack positive pressure Sterile storage positive pressure The Joint Commission Survey The Joint Commission will survey for: Orientation, training and competency of the health care worker (HCW) who process medical equipment, devices and supplies Levels of staffing and supervision of the HCW who process medical equipment, devices and supplies Standardization of the process regardless of whether it is centralized or decentralized Ongoing quality monitoring Observation against the manufacturers guidelines and the organization procedures. The Joint Commission Perspectives. October 2009 Vol 29 (10) 7

8 CDC Health Alert Network (HAN) The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines. September 11, 2015, 12:15 EDT (12:15 PM EDT) CDCHAN TJC / CMS Patient Healthcare Facilities Our wake up call from the Joint Commission and CMS ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 (Consolidated Text) Under continuous review and maintenance. 8

9 Continuous Quality Improvement (CQI) AAMI ST 79 Section 11 CQI programs are used to assess and improve all components of the sterilization process Desired outcome of improving patient care by consistently delivering sterile product to the user No single right way to implement CQI Team approach Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Section 11 What are the key parts of the process? Cleaning and Decontamination Preparation and Packaging Sterilization Sterile Storage and Distribution Record Keeping Recall Procedures Risks in Sterile Processing Instruments requiring extended cycles Original packaging changed for sterilization Flexible endoscopes not properly processed for patient use Late arrival of loaner instruments to allow for reprocessing according to IFU and quarantine implants for BI results Wrong BI process challenge device is run during routine testing Improperly reprocessed eye sets with improper reprocessing to prevent TASS Daily verification of mechanical cleaning equipment not done at least daily Manufacturer s IFU for cleaning not followed Young, Martha Top 10 Risk in Sterile Processing. AAMI Horizons Spring

10 Sterilization Risk Analysis Risk analysis = risk assessment + risk management + risk communication The sterilization risk analysis should be part of the overall infection prevention and control risk analysis in accordance with accreditation agency requirements. Risk assessment (FMEA) Risk management (ANSI/AAMI ST79, Root cause analysis) Risk communication (Recall procedure) It should be performed annually and should be reevaluated whenever significant changes occur. Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause Sterilization Risk Analysis Failure Modes and Effects Analysis (FMEA) Proactive risk assessment Assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. Root Cause Analysis Reactive/Retrospective Process identify deficiencies or root cause for the error or adverse event Cause and effect fishbone diagram Answers the Why questions Based on analysis, identify improvements and implement to avoid recurrence Manual or Mechanical? If you can t clean it, you can t sterilize it! CLEANING AND OTHER DECONTAMINATION PROCESSES 10

11 Personal Protective Equipment (PPE) Portal of Exit/Entry Liquid-resistant covering with sleeves Heavy-duty latex free or plastic gloves Surgical face mask (impervious to fluid and high filtration) Safety glasses that wrap around the eye or face shield Disposable hair covering Proper footwear Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause The purpose of decontamination is to prevent the spread of infection. Cleaning and other Decontamination Processes To be rendered safe to handle, some medical devices require only thorough cleaning; others, because of occupational exposure considerations, must be cleaned and subjected to a microbicidal process. Some devices can be prepared for patient reuse following the decontamination process, whereas others must be prepared and subjected to terminal sterilization (e.g., steam sterilization of surgical instruments). (Clause 7.1) The type of decontamination required for a particular contaminated device depends on the biohazard that the device presents. (Clause 7.1) The written [instructions for use] IFU of the device manufacturer should always be followed. (Clause 7.2.2) Surgical instruments and other items composed of more than one part or piece (e.g., metal tracheostomy tubes, procedure needles, dental handpieces, laparoscopic instrumentation, trumpet valves) should be disassembled to expose all surfaces to the cleaning process. (Clause 7.4.1) Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Sec. 7.1 & &

12 For all reusable, the first and most important step in decontamination is thorough cleaning and rinsing. (Clause 7.5.1) Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause Polling Question How do you monitor the cleanliness of instruments after the decontamination process? a. Visual inspection only b. Visual inspection plus a cleaning monitoring product c. We do not monitor the cleaning process 35 PACKAGING The primary functions of a package containing a medical item are to allow the sterilization of the contents, to maintain the sterility of the contents until the package is opened, and to provide for the removal of the contents without contamination. Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A:2012 & A4:2013 Clause 8.2 Rationale 12

13 Packaging Concerns Paper-Plastic Pouches The plastic laminate used in paper plastic pouches is impervious to the sterilant and, therefore, might prevent the sterilant from reaching the surface of anything with which the plastic side is in physical contact. Therefore, paper plastic pouches should not be used within wrapped sets or containment devices unless the practice has been validated by the packaging manufacturer and verified by product testing in the health care facility. ANSI/AAMI ST77:2013 Rigid Container Systems (Manufacturer Standard) Ergonomic issue The combined weight of the containment device, the instruments, and any accessories or wrappers shall not exceed 25 pounds When containment devices, including their contents and any accessories or wrappers, are too heavy, sterilization and/or drying could be compromised in commonly available hospital sterilization cycles. Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 &A4:2013 Clause & Rationale The first step in being able to monitor the steam sterilization process is to know the type of steam sterilizer that is used. STEAM STERILIZATION Steam Sterilization Type of Steam Sterilization Process Gravity Displacement Dynamic-Air-Removal Prevacuum Steam-flush pressure-pulse (SFPP) Critical Parameters Time Temperature Saturated Steam 39 13

14 Immediate Use Steam Sterilization (IUSS) (Formerly Flash Sterilization) Process designed for the steam sterilization of patient care items for immediate use High temperature ( C / F) Gravity or dynamic-air-removal No dry time No storage Gravity Displacement - Cycle Time Examples Minimum cycle times at 121 C/250 F for gravity displacement steam sterilization cycles for sterilizers >2 cubic feet Load Contents Time (Min) Wrapped instruments 30 Textile packs 30 Wrapped utensils 30 ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: Table 4 Dynamic Air Removal - Cycle Time Examples Minimum cycle times for dynamic-air-removal steam sterilization cycles >2 cubic feet Load Contents Temp Time (Min) Wrapped instruments Textile packs Wrapped utensils Unwrapped, non porous items (e.g. instruments) 132 C/270 F 135 C/275 F 132 C/270 F 135 C/275 F 132 C/270 F 135 C/275 F 132 C/270 F 135 C/275 F Unwrapped non porous/porous in mixed load 132 C/270 F 135 C/275 F 4 3 ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: Table 5 14

15 Table Top Gravity Steam Sterilizers Load Contents Temp Time (Min) Unwrapped instruments on tray or glassware 132 C/270 F 135 C/275 F 3 Wrapped trays of instruments, instruments in peel pouches 132 C/270 F 135 C/275 F 5 Packs, wrapped 121 C/250 F 30 ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: Table 4 Gravity Displacement - Cycle Time Examples Minimum cycle times for immediate-use steam sterilization cycles >2 cubic feet Gravity displacement Load Contents Temp Time (Min) Unwrapped nonporous items (e.g., instruments) 132 C/270 F 135 C/275 F 3 3 Unwrapped nonporous and porous items in mixed load 132 C/270 F 135 C/275 F ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: Is it done yet? Sterilization Monitoring - not as simple as it looks! 15

16 Design the sterilization process to prevent error and break the chain of infection? (SCARR) Standardize the process Checklists - outline all the steps Automate the process Reduce the number of steps and handoffs Redundancy (double checks) Quality Control Monitoring and verifying the cleaning process Sterilization process monitoring monitoring of every package and sterilization load routine monitoring of sterilizer efficacy qualification testing of the sterilizer after installation, relocation, sterilizer malfunction, major repairs, and sterilization process failures periodic product quality assurance testing Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 &A4:2013 Clause 10.4, Table 6, Probability Assurance level of 10-6 Sterilization Assurance Individual sterilization monitors does not indicate sterility Need the combination of all monitors to give an assurance of sterility Physical + Chemical + Biological = Probability of sterility (1 in a million chance that an item is not sterile) 16

17 Reasons for Testing the Sterilization Process Ensure probability of sterility of processed medical devices Detect sterilization failure ASAP: quarantine medical devices until final BI result known Verify a corrected failure ASAP get sterilizer back into service Control costs Remove medical devices involved in failures before patient use Helps determine if events during sterilization process met parameters Provides verification of adherence to policies/procedures Promote patient safety and improve outcomes Sterilization Process Monitoring Devices Each monitoring tool plays a distinct and specific role in sterilization process monitoring, and each is indispensable to sterility assurance. Physical monitors time, temperature and pressure recorders, displays, digital printouts, tapes and gauges Chemical indicators (CIs) - (Classes 1-6) external/internal CIs Bowie-Dick (BD) type tests Biological indicators (BIs) Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 10.4, Table 6 & 7 Biological indicators provide the only direct measure of the lethality of the sterilization process. BIOLOGICAL INDICATOR MONITORING 17

18 CDC Guidelines Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process because they measure the sterilization process directly by using the most resistant organisms (i.e., Bacillus spores) and not by merely testing the physical and chemical conditions necessary for sterilization. Ref: page 76 Biological Indicator Monitoring Routine load release Testing of each non-implant and implant load Routine sterilizer Establishing a regular pattern of testing the efficacy efficacy monitoring of the sterilization process Sterilizer qualification testing Periodic product testing Testing of the sterilizer after events occur which could affect the ability of the sterilizer to perform Testing of routinely processed items to ensure the effectiveness of the sterilization process and to avoid wet packs ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause , Table 7 Sterilization Process Monitoring Devices Process challenge device (PCD) designed to simulate the product to be sterilized constitutes a defined resistance to a sterilization process and used to assess effective performance of the process placed in the most challenging area in the sterilizer for sterilant penetration BI BI and a Class 5 integrating chemical indicator Class 5 integrating chemical indicator Class 6 Emulating Indicator Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause

19 Routine Sterilizer Efficacy Monitoring Routine load release non-implant implant load Routine sterilizer efficacy monitoring Establishing a regular pattern of testing the efficacy of the sterilization process for both gravity and dynamic air-removal testing. BI PCD Every load Daily plus every implant load Weekly plus every implant load BD type test Daily Immediate Use Steam Sterilizer (IUSS) BI PCD representative of tray routinely processed Each type of tray configuration in routine use should be tested separately Perforated, mesh bottom, open surgical tray Rigid sterilization container system Protective organizing case Single-wrapped surgical tray Empty load on bottom shelf over drain BD type test if dynamic-air-removal Daily Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause , , Table 6 & 7 Routine Sterilizer Efficacy Monitoring Table-top sterilizers BI PCD representative of package or tray routinely processed and most difficult to sterilize BI PCD should contain items normally present during routine sterilization Full load in cold point (check with sterilizer manufacturer) Biological Indicator - Monitoring Frequency Weekly, preferably daily Every load with an implant Some sterilization systems (e.g., Ethylene Oxide) require every load monitoring Why monitor every load? Universal standard of patient care Cost and impact of a recall To be certain all implants, including those in loaners, are appropriately monitored Ensure every type of sterilization cycle used is monitored Ensure every type of packaging used in flash sterilization is monitored Reduce risk and cost of healthcareassociated infections (HAIs) ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause

20 Routine Load Release-Non-Implant Loads Physical monitors External process indicator (Class 1) on every package Internal CI (Class 3, 4, 5 or 6) inside every package If desired, a PCD containing a BI BI and a Class 5 integrating chemical indicator Class 5 integrating chemical indicator Class 6 Emulating Indicator Evaluation of all data by an experienced, knowledgeable person Do not distribute load if any data suggests a sterilization process failure If desired, a PCD containing a BI If a BI PCD is not used in each load Do not know spores were killed Need to do a recall when a positive BI is obtained More frequent monitoring less to recall and reduce chance of patient receiving a nonsterile medical device Immediate Use Steam Sterilization Cycles (IUSS) Class 5 or Class 6 PCD for Releasing IUSS Loads Representative of load Open surgical tray Rigid sterilization container Protective organization case Use as internal CI and to release non-implant loads ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause Routine Load Release-Implant Loads What is an Implant? According to FDA, device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also implants. 21 CFR 812.3(d) Only BI results can be used to release implants BIs within a PCD should be used to monitor every load containing implants (see ). The PCD should include a Class 5 integrating CI The load should be quarantined until the results of the BI testing are available (CDC, 2008). Immediate use steam sterilization (IUSS) should not be used for implantable devices except in cases of emergency when no other option is available. ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: Name of Sample - Implant Exception Form Implant prematurely released Patient Surgeon Reason for premature release What could have prevented premature release ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3;2012 & A4:2013 Annex L 20

21 Polling question How often does your Sterile Processing Department monitor with a biological indicator? a. Every load b. Once a day c. Daily plus implants d. Once a week 61 Other Required Testing For both gravitydisplacement and dynamic-air-removal sterilizers Steam sterilizer installation, relocation, or repaired and the time it is released for use in the health care facility. Three consecutive cycles should be run, one right after the other, with a BI PCD Dynamic-air removal sterilizers Bowie-Dick type test run three consecutive cycles in an empty chamber, one right after the other, with the each test result demonstrating sufficient air removal ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: , Table-top sterilizers BI PCD representative of package or tray routinely processed and most difficult to sterilize BI PCD should contain items normally present during routine sterilization Full load in cold point (check with sterilizer manufacturer) Three consecutive cycles 62 Other Required Testing Immediate Use Steam Sterilization (IUSS) BI PCD representative of tray routinely processed Select a tray configuration to be tested Perforated, mesh bottom tray, open surgical tray Rigid sterilization container system Protective organizing case Single-wrapped surgical tray Empty load on bottom shelf over drain Three consecutive cycles ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: &

22 Sterile items should be stored in a manner that reduces the potential for contamination. STERILE STORAGE Sterile Storage Separate area with restricted access Proper ventilation (at least 4 air changes/hour, positive pressure to corridor) to protect against dust, moisture and extremes of temperature (~24ºC /75ºF) and humidity (<70%) Free of insects and vermin Sterile items should be stored away from outside walls (at least 2 inches), off the floor (at least 8-10 inches) and away from the ceiling (18 inches) Stored to prevent physical damage (dragging, sliding, crushing, bending, compressing or puncturing) Sterile packages should be minimally handled to reduce the risk of contamination of the contents Should not be stored next to sinks or under exposed water or sewer pipes or in locations where they may become wet Should not be stored on floor or windowsills Shelf life is event related Sterile packages transported to the point of use should be protected to prevent contamination ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: Quality in the Sterile and Clean Storage Area Protect Clean and Sterile Supplies from Contamination NO OUTSIDE SHIPPING CONTAINERS OR CORRUGATED CARDBOARD / CARTONS Mature Indian Meal Moth Larvae Pupating in Corrugated Cardboard* * Photo courtesy of Department of Entomology, University of Nebraska-Lincoln. Photographer: Jim Kalisch. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012, A4:2013 Section

23 RECORD KEEPING Documentation - Manual or Electronic Labeling on product Lot or load control number Date of processing Sterilizer number Cycle number Expiration date or statement: Contents sterile unless package is open or damaged. Please check before using. Electronic system Reduction of human error Past records available with a touch of a finger Accessibility to all load records at any time All load information in one location ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: Documentation - Electronic or Manual Sterilizer and load records Load contents Date and time of cycle Exposure time and temperature Initials of operator Biological results Chemical indicator results Records of sterilizer repair, maintenance and calibration Maintain records for time determined by risk manager 23

24 Risk Communication RECALL PROCEDURES Recall Procedures Written policies and procedures for the recall of items from issued or stored loads should be developed in cooperation with the infection prevention and control committee and risk management of the individual health care facility. These policies and procedures should be documented, and records should be maintained. If cause of failure immediately identified and confined to one load or item e.g., using incorrect sterilization cycle No recall, correct problem and reprocess load If cause of failure not identified Quarantine load, recall all items processed since last negative BI Determine cause of failure ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: Polling question How many times in the last 12 months has your facility conducted a recall? a. 0 b. 1-2 c. 2 or more d. Not sure 72 24

25 Areas of Concern Areas of Concerns that Impact Infection Prevention Processing of endoscope Inadequate processing Culturing of endoscope Cleaning verification How clean is visibly clean? Immediate Use Steam Sterilization ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: Toxic Anterior Segment Syndrome (TASS) Most cases of TASS appear to result from inadequate instrument cleaning and sterilization Loaner instrumentation Timelines not met to allow for proper processing Product testing Product testing should always be performed when major changes are made in packaging, wraps, or load configuration, such as dimensional changes, weight changes, or changes in the type or material of packaging or wrapper. 74 Summary Infection Preventionist collaboration with the Sterile Processing Department (SPD) is key Include SPD in your Joint Commission tracer and rounding activities Ensure that all policies and procedures are evidence-based and up to date Quality does not automatically translate into patient safety Monitoring of the sterilization process is necessity for maintaining patient safety Be aware of publications in the media that impacts patient safety, healthcare environment and perioperative setting including the Sterile Processing Department Conduct regular risk assessments of the various processes and potential problems using tools such as FMEA and RCA when issues arise that impact patient safety Be aware of the concerns in the SPD 25

26 SM 18/11/2015 CMS OSHA The Joint Commission State Regulators Thank you! Questions? 77 Next Month s Webinar Hot Topics from the 3M Sterilization Tech Line December 10,

27 Acknowledgments SPD staff pictures used with permission. Reprinted from ANSI/AAMI ST79:2010, A1:2010, & A2:2011 & A3:2012 & A4:2013 with permission of Association for the Advancement of Medical Instrumentation, Inc. (C) 2011 AAMI All rights reserved. Further reproduction or distribution prohibited. AAMI Sterilization Standards ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 2nd edition (Incorporates Amendment 1:2010, A2,2011, A3:2012, and A4:2013) ST58 Chemical sterilization and high-level disinfection in health care facilities, 3rd edition ST91 Flexible and semi-rigid endoscope processing in health care facilities ST40 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities, 2nd edition TIR34 Water for the reprocessing of medical devices ST41 Ethylene oxide sterilization in health care facilities: Safety and effectiveness, 4th edition (Incorporates 2010 Erratum). ST81 Information to be provided by the manufacturer for the processing of resterilizable medical devices, 1st edition TIR12 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 3rd edition TIR30 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, 2nd edition TIR55 Human factors engineering for processing medical devices TIR63 Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection ST65 Processing of reusable surgical textiles for use in health care facilities, 2nd edition PB70 Liquid barrier performance and classification of protective apparel and drapes in health care facilities, 2ed TIR11 Selection of surgical gowns and drapes in health care facilities, 2nd edition 80 How to Purchase AAMI Standards for Your Reference Library AAMI documents can be purchased through AAMI by credit card using the following four options: Internet: Call: Fax: Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD

28 References The Joint Commission: 2015 Accreditation Standards Joint Commission Perspectives, April 2015, Volume 35, Issue 4 CDC Health Advisory Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. CDC Health Alert Network. September 11, 2015, 12:15 EDT (12:15 PM EDT) CDCHAN Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities. ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3;2012 & A4:2013 Association for the Advancement of Medical Instrumentation (AAMI). Containment devices for reusable medical device sterilization. ANSI/AAMI ST77:2013 Recommended Practices for Sterilization in the Perioperative Practice Settings. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc, 2015 Rutala, William A, Weber, David J and HICPAC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Brachman, Philip S. Epidemiology of Nosocomial Infections. In Hospital Infections 3rd edition, edited by John V. Bennett and Philip s. Brachman pp IAHCSMM Central Service Technical Manual, 7 th Edition. Seavey, Rose. AAMI Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys. AAMI References Recommended Practices for Cleaning and Sterilizing Intraocular Surgical Instruments. From the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Registered Nurses. Special Report prepared February 16, Occupational Safety and Health Administration. 29 CFR Occupational Exposure to Bloodborne Pathogens ; Final Rule. Federal Register December 6, Archibald, Lennox K. and Hierholzer, Walter J. Principles of Infectious Diseases Epidemiology. in Hospital Epidemiology and Infection Control 3rd edition. C. Glen Mayhall, Editor Pp Sehulster, Lynn and Schultz, Janet. Central Sterile Supply. In Hospital Epidemiology and Infection Control 3rd edition. C. Glen Mayhall, Editor Pp Steam Sterilization Update on The Joint Commission s Position. June 16, The Joint Commission Perspectives. October 2009 Vol 29 (10) Reason, James Human error: models and management. BMJ 2000: Nick Mamalis, MD, Toxic Anterior Segment Syndrome Journal of Cataract and Refractive. Surgery 2006; 32: AAMI / FDA Reprocessing Summit. October Sterilization and Reprocessing A Matter of Patient Safety. Horizons Spring 2012 Martha Young (2012) Top 10 Risks in Sterile Processing. Biomedical Instrumentation & Technology: Reprocessing, Vol. 46, No. sp12, pp Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes. SGNA 2012 Guidelines for Use of High Level Disinfectants and Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes. SGNA 2010 Multiple Society guideline on reprocessing flexible gastrointestinal endoscopes: American Society for Gastrointestinal Endoscopy and the Society for Healthcare Epidemiology of America. References ucing_cre_infections.pdf