10/11/2013. Immediate-Use Steam Sterilization in the OR. House Keeping. House Keeping. Questions. Martha Young, MS, BS,

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1 3M Infection Prevention Solutions Learning Connection Immediate-Use Steam Sterilization in the OR Martha Young, MS, BS, October 8, 2013 House Keeping Questions 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. 3M All Rights Reserved House Keeping Continuing Education Each 1 hour web meeting qualifies for 1 contact hour for nursing. 3M Health Care Provider is approved by the California Board of Registered Nurses CEP Post webinar Link to Course Evaluation CE Certificate Included Forward to Others in Attendance 1

2 Disclosure Martha Young, MS, BS, CSPDT President Martha L.Young, LLC Providing SAVVY Sterilization Solutions to Healthcare Potential Conflicts of Interest Educational Consultant to 3M Learner Objectives 1. Define Immediate-Use Steam Sterilization 2. Review AORN and AAMI Recommended Practices 3. Discuss ss Hot Topics Related to IUSS The Joint Commission National Patient Safety Goals NPSG Implement evidence-based practices for preventing surgical site infections. Element of performance Implements policies and practices aimed at reducing the risk of surgical site infections. These policies and practices meet regulatory requirements and are aligned with evidence-based guidelines (for example, the Center for Disease Control and Prevention [CDC] and/or professional organization guidelines). The Joint Commission Hospital Accreditation Standards (HAS) 2

3 Evidence-Based Guidelines Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) Association of Perioperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices (2013 Edition) Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Regulations & Recommended Practices Establish State-Of-The-Art For Sterile Processing Sterilization Process Should Follow Recommended Practices Hospitals ASCs Ambulatory Health Centers (AHCs) (Clinics) Doctor Offices Dental Facilities 3

4 The Joint Commission Joint CommissionOnline July 2011 Surveyors received in-depth training on sterilization processes through AAMI Since being trained citing for noncompliance for HLD/sterilization has gone from 10% to 40% Survey to ANSI/AAMI ST79 Expect up-to-date ANSI/AAMI ST79 to be available to employees *Louise Kuhny, TJC Standards and Survey Process, AORN webinar 9/22/2011.To order access at: Objective 1 Define Immediate-Use Steam Sterilization Is This An IUSS Cycle? Q: Recently a healthcare facility told me they were no longer using IUSS to process instruments in the OR because they were using: Sterilization containers Dynamic-air-removal D i i l steam sterilization ti cycle ºF ( ºC), 4 minutes A: Yes it is IUSS because it has no dry time 4

5 Is This An IUSS Cycle? Q: OR is using: Containers Dynamic-air-removal steam ºF ( ºC), 4 minutes 6 minute dry cycle sterilization cycle A: Yes this is an IUSS cycle Because the dry time is shorter than the 30 minutes recommended by the instrument manufacturer so there is a chance that the instruments, especially lumens, are not dry AAMI Definition for IUSS Process designed for the cleaning, steam sterilization, and delivery of patient care items for immediate use. Previously known as flash sterilization. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Definition 2.61 IUSS Should Meet The Following Criteria Cycle selection includes: Type of cycle Gravity-displacement or dynamic-air- removal Dynamic-air-removal should be used unless gravity cycles recommended d by device manufacturer ( ) ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and Overview 5

6 IUSS Should Meet the Following Criteria Cycle selection includes: Temperature ºF ( ºC) Time in a dynamic-air-removal air removal sterilizer Standard (e.g., ºF, 4 min) or Extended (e.g., ºF, 10 min) ( ) Use the same cycle in OR as used in sterile processing (SP) Follow the device manufacturer s written IFU ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and Overview IUSS Should Meet the Following Criteria Cycle selection includes: Dry time: 0 to 1 minute or shorter than stated in IFU so contents wet Containerize Transfer immediately using aseptic technique Open immediately, do not store for later use unless indicated by containment device manufacturer (8.8.5) ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and Overview Implementation of Reusable Rigid Containers for IUSS AORN recommends the use of rigid sterilization containers validated for IUSS and cleared by FDA Reduce risk of contamination during transport to point of use Ease of presentation tti to sterile fild field AORN Recommended Practices for Sterilization, 2003 Recommendation VII.a.2, VII.e. 6

7 When to Use IUSS Should be used only when there is insufficient time to process by the preferred wrapped or containerized method intended for terminal sterilization. Instrument dropped or otherwise contaminated by touching area outside of sterile field Not another one available or an instrument to substitute AORN Recommended Practice for Sterilization, 2013 Recommendation VII.a. When to Use IUSS Should only be used in selected clinical situations and in a controlled manner* Selected clinical situations Define what is an emergency* Risk to patient being under anesthesia greater than the risk associated with IUSS Implant in case of defined emergency with no other available option Exercise clinical judgment Impossible to predict every situation where IUSS may be appropriate *AORN Recommended Practices for Sterilization, 2013 Recommendation VII., VII.f. Personnel communications with Ramona Conner (AORN), Rose Seavey, Cynthia Spry When to Use IUSS Should only be used in selected clinical situations and in a controlled manner Do not eliminate or modify any processing step No short cuts or skipped steps because of time Follow instrument manufacturer s IFU Cleaning/decontamination (manual, possible mechanical washer, ultrasonic, treated water) Packaging (use FDA cleared IUSS packaging, clean and inspect containers after every use) Sterilization process (including cycle time, temperature, and dry time) Monitoring of cycle (physical monitors, chemical and biological indicators) AORN Recommended Practices for Sterilization, 2013 Recommendation all sections of VII 7

8 When Not to Use IUSS Should not be used as a substitute for sufficient instrument inventory. Should have enough inventory to supply the cases for the day without using IUSS AORN Recommended Practice for Sterilization, 2013 Recommendation VII.a. When Not to Use IUSS Implants should not be sterilized for immediate use ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and Overview AORN Recommended Practices for Sterilization, 2013 Recommendation VII.f. CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, A Polling Question Are you processing implants in IUSS? Yes No Don t know Don t process implants 8

9 An Evaluation of IUSS Practice A major concern regarding IUSS is that its convenience may lead to nonemergent, inappropriate use. Abuse of IUSS has potential to: Increase risk for development of SSI Increased health care costs Direct thermal injury to the patient Scott L Zuckerman, et al. American Journal of Infection Control 40 (2012), accessed at: An Evaluation of IUSS Practice Even if used appropriately, the stresses associated with an urgent need for the instrument may lead to skipped steps in the sterilization process and wide variability in practice. Intraoperative contamination is the only acceptable reason to immediately sterilize instruments. Scott L Zuckerman, et al. American Journal of Infection Control 40 (2012), accessed at: An Evaluation of IUSS Practice Record rationale for IUSS If IUSS is occurring inappropriately according to the current guidelines Change practices Use a safety checklist to ensure appropriate and correct indications for IUSS have been met Scott L Zuckerman, et al. American Journal of Infection Control 40 (2012 ), accessed at: 9

10 An Evaluation of IUSS Practice Safety checklist to ensure appropriate and correct indications for IUSS have been met Surgical instrument made unsterile and/or unusable (i.e., dropped to contaminate area) Surgical case cannot be completed safely without contaminated surgical instrument There are no remaining surgical instruments available that can accomplish identical goal of contaminated surgical instrument Scott L Zuckerman, et al. American Journal of Infection Control 40 (2012), accessed at: An Evaluation of IUSS Practice Safety checklist to ensure appropriate and correct indications for IUSS have been met There is no available surgical instrument on the scrub technician s tray There is no surgical instrument available in the operative suite or supply room Scott L Zuckerman, et all American Journal of Infection Control 40 (2012), accessed at: Disadvantages of Using IUSS Immediate use steam sterilization may be associated with increased risk of infections to patients. Time constraints may result in pressure on personnel to eliminate or modify one or more steps in the cleaning and sterilization process. Risk of contamination during transport of items to the point of use and during presentation to sterile field. AORN Recommended Practices for Sterilization, 2013 Recommendation VII., VII.e. 10

11 Polling Question Do you use a safety checklist to ensure appropriate and correct indications for IUSS have been met? Yes No Don t know Don t use IUSS Objective 2 Review AORN and AAMI Recommended Practices Cleaning Clean, package and sterilize according to the manufacturer s IFU For cleaning need: Equipment (3 sinks, may need a mechanical and ultrasonic washer) Cleaning agent Tools (brushes) Water quality (potable water for first rinse and deionized, distilled, or RO for final rinse) ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and Overview AORN Recommended Practices for Sterilization, 2013 Recommendation VII 11

12 Cleaning Appropriate cleaning processes Disassemble instruments Brushing occurs under water Wear appropriate PPE Fluid-resistant face mask and eye protection Liquid-resistant gown Heavy-duty, waterproof long and cuffed gloves Liquid-resistant shoe coverings ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section AORN Care of Instruments, 2013 Recommendation X Cleaning Agents Compatible with medical device cleaning equipment Use according to cleaning agent manufacturer s written IFU: Use within shelf life Dilute appropriately Calculate volume of cleaning agent sink or solution container (A3:2012) Monitor and document water/cleaning agent temperature and ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section Brushes and Other Cleaning Implements Brushes and other cleaning implements should be single-use, disposable items and discarded after every use If brushes are reusable, they should be disinfected or sterilized at least daily (CDC says after each use) Manufacturer should provide correct brushes to use -Appropriate type -Size (diameter and length) -Bristle type -Material ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , CDC, 2008 Guideline for Disinfection & Sterilization 12

13 Packaging Recommended by instrument manufacturer s IFU Do not change original container packaging unless receive written validated IFU from instrument manufacturer Provide protection for aseptic presentation Unwrapped trays not recommended ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Introduction and Overview AORN Recommended Practices for Sterilization, 2013 Recommendation VII Packaging Rigid sterilization containers Use items immediately Do not store for later use Do not hold from one procedure to another AORN Recommended Practices for Sterilization, 2013 Recommendation VII.a.2. Sterilization Process Monitoring Monitoring Tools Physical monitors Chemical indicators Biological indicators Process challenge devices (PCDs) Test or challenge pack 13

14 Biological Indicators Use for Release of implant and non-implant loads Routine monitoring of the sterilization process Qualification testing of the sterilization process Product testing ti (will not discuss, see Section 10.9, 10.10) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section Monitoring Biological indicators (BIs) and BI process challenge devices (PCDs) not appropriate for cycle being tested Information on appropriate BI PCDs to use is covered in ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 10 And BI and BI PCD manufacturer s IFU ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section 2.95 Process Challenge Device (PCD) Definition Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process. Representative of load and creates the greatest challenge Equal to or greater than the most difficult item to sterilize Placed in most difficult area in sterilizer for the sterilant to penetrate ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section

15 BI PCD IUSS 270ºF/132ºC Dynamic-air-removal Steam Sterilization Process BI PCD Used Daily Packaging Used Routinely Is this the correct BI PCD for the packaging routinely used? Incorrect The BI PCD does not represent the packaging routinely used which means you may miss a sterilization process failure BI PCD IUSS 270ºF/132ºC Dynamic-air-removal Steam Sterilization Process BI PCD Used Daily Packaging Used Routinely Correct BI PCD Represents packaging routinely used Correct or Incorrect BI PCD? Incorrect- no basket in container 15

16 Polling Question Are you using the correct BI and BI PCD in the IUSS cycles being tested in your facility? Yes No Need to investigate! Not responsible for monitoring IUSS Question Asked of TJC at IAHCSMM May 2012 Question: We use a 1 hour and 3 hour BI in our implant loads so we can release the implant in 1 hour. Is that correct? Answer: No because each of those BIs are designed for and FDA cleared for different cycles This is an example of operator error and not using critical thinking Follow the BI and BI PCD manufacturer s IFU Joint Commission Observations BI test and control results not being recorded Need BI test and control to be from same lot These slides were prepared based on what the author learned from a Joint Commission presentation at annual IAHCSMM meeting in May

17 Positive Biological Indicator (BI) Control Incubate a positive BI control each day a test vial is incubated in each incubator Positive control BI should be from same lot number as test BI Good Science ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , , Positive Biological Indicator (BI) Control Purpose is to verify the test system is working and ensure Proper incubation temperature Placed into correct incubator Incubator is functioning Presterilization viability of test spores Capability of medium to promote growth of test spores ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , , Positive Biological Indicator (BI) Control Read and record test and control results upon completion of incubation time If control test BI from lot fails: Test spores are non viable or dead Improper incubation Test results are invalid Determine why and rerun BI and load ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , ,

18 Polling Question Are you running a control BI from the same lot number as the test BI in each incubator each day a test BI is incubated? Yes No Don t know Bowie-Dick Test Testing sterilizer performance daily Bowie-Dick Test monitors efficacy of air removal and steam penetration in C/ F dynamic-air-removal sterilizers (i.e., vacuum-assisted sterilizers) Detects: Air leaks Inadequate air removal Inadequate steam penetration Presence of non-condensable gases Air or gases from boiler ANSI/AAMI ST79 :2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section Bowie-Dick Test Follow the sterilizer and Bowie-Dick test pack instructions for use Run a warm up cycle Place one pack on bottom shelf of sterilizer rack over drain Run not more than 3.5 to 4 min, ºC/ ºF, no dry time ANSI/AAMI ST79:2010 & A1:2010 & A2:2012 & A3:2012 & A4:2013 Section

19 Bowie-Dick Test Uniform color change Use If not uniform, shut down and report to supervisor Remain in use Retest Call for repair Re-qualify if major repair ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections AORN Recommendation Internal Chemical Indicator (CI) For IUSS Use a Class 5 or Class 6 CI within each sterilization container Class 6 indicators are cycle-specific and should be used only in the specific cycles for which h they are labeled. l AORN Sterilization 2013 Recommendation VII.c.3. Routine Load Release of Implant Loads Physical monitors Read and initial External process indicator (Class 1) on outside of every package unless internal CI is available Read before package is issued or opened in OR Internal CI(s) (Class 3, 4, 5, 6) inside each package Read before package is placed on sterile field AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f.2., XX.h.1. AORN Sterile Technique 2013 Recommendation VI.a.2, VI.f.2, VI.f.4 ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section ,

20 Routine Load Release of Implant Loads A PCD containing a BI and a Class 5 integrating indicator -Quarantine until BI results available Evaluation of all data by an experienced, knowledgeable person Do not distribute load if any data suggests a sterilization process failure AORN Sterilization in Perioperative Practice Setting, 2013, Recommendation XVI ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section Routine Load Release of Implant Loads Each load should be monitored if it contains implantable objects. If feasible, implantable items should not be used until the results of spore tests are known to be negative. (CDC) Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule. (AAMI) CDC, 2008 Guideline for Disinfection & Sterilization ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section , Routine Load Release of Implant Loads Class 5 integrating indicator used to release implant in emergency situations. Emergency situations should be defined. Class 6 emulating indicators cannot be used to release implants early or as a replacement for a BI ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section ,

21 Early Release of Implant Loads Exception form for premature release of implantable device/tray in defined emergency situations -Name of implant -Name of patient -Name of surgeon -Reason for premature release -What could have prevented the premature release -Critical that this documentation be fully traceable to the patient ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section , Annex L The Joint Commission New Emphasis for 2011 Exception form (AAMI ST79, 10.6 and Annex L) Early release of implant is unacceptable; an exception form must be completed WHO can authorize early release of implants? Signature not required Should be a department of surgery policy Suggest it be a surgeon These slides were prepared based on what the author learned from a Joint Commission presentation at IAHCSMM in May 2011 Routine Load Release of Non-Implant Loads Physical monitors Read and initial External process indicator (Class 1) on outside of every package unless internal CI is available Read before package is issued or opened in OR Internal CI(s) (Class 3, 4, 5, 6) inside each package Read before package is placed on sterile field AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f.2., XX.h.1. AORN Sterile Technique 2013 Recommendation VI.a.2, VI.f.2, VI.f.4 ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section ,

22 Routine Load Release of Non-implants Optional monitoring of load with a PCD containing a -BI -BI and a Class 5 CI -Class 5 integrating 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 ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 & A4:2013 Section Polling Question Are you releasing implants before the BI results are available? Yes, with Early Release form Yes, without paperwork No, never Don t know Don t process implants Immediate-Use Steam Sterilization Cycles (IUSS) Routine Efficacy Testing Sterilizer Qualification Testing Weekly, preferably daily BI PCD in empty pycycle After major event BI PCD in 3 consecutive empty py cycles ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections ,

23 Immediate-Use Steam Sterilization Cycles (IUSS) Routine Efficacy Testing Representative BI PCD* using one or more BIs and one or more CIs in the empty tray configuration Perforated, mesh bottom, open surgical tray Rigid sterilization container system Protective organizing case Single type of tray configuration Each type of tray configuration used should be tested used should be tested Qualification Testing Representative BI PCD* using one or more BIs and one or more CIs Select one representative tray configuration * No commercial BI PCDs are available for IUSS sterilization ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Sections , Immediate-Use Steam Sterilization Cycles (IUSS) Routine Efficacy Testing Representative BI PCD Placed on bottom shelf over the drain Otherwise empty chamber Weekly, preferably daily After Bowie-Dick test if dynamic air-removal Qualification Testing Representative BI PCD Placed on bottom shelf over the drain Otherwise empty chamber Three consecutive cycles Before Bowie-Dick test if dynamic air-removal ANSI/AAMI ST79:2010 & A1:2010 & A:2011 & A3:2012 & A4:2013 Sections and When To Do a Recall Sterilization process failure (BI, CI, or Physical Monitor) Quarantine load, remove sterilizer from service, investigate cause of failure If cause of failure immediately If cause of failure not identified identified and confined to one Quarantine load, recall all items load or item (e.g., using processed since last negative BI incorrect sterilization cycle) Determine cause of failure Major repair-qualification No recall, correct problem testing and reprocess load Minor repair-return to use ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Section , Figure 12 23

24 Running a BI PCD in Every Load and Quarantining Standardization of BI monitoring policy Less chance of human error (human factors issue) Ensure meeting recommended practices requirements related to monitoring of cycles and packaging used Ensure monitoring all loads with implants Quicker detection of IUSS container failures resulting from poor functioning mechanical filters or leaks due to damaged gaskets Running a BI PCD in Every Load and Quarantining Quicker detection and correction of process failures Eliminates recalls Reduce patient risk because less patients involved Save money Peace of mind IUSS AORN Documentation Item(s) processed Patient on whom the items were used Type of cycle (e.g., gravity-displacement, dynamic-airremoval) Cycle parameters used (e.g., temperature, duration of cycle) Monitoring results Day and time cycle was run Operator information (person who initiated cycle and retrieved item from cycle) Reason for IUSS AORN Sterilization 2013 Recommendation VII.g.1. 24

25 IUSS Documentation Document monitoring results along with name of patient Ideally, every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it is used or in whom it is implanted. * *AORN Recommended Practices for Sterilization, 2013 Recommendation VII.g. ANSI/AAMI ST79:20120 & A1:2012 & A2:2011 & A3:2013 & A4:2013 Section Objective 3 Discuss Hot Topics Related to IUSS JC Surveys: Observations About IUSS Won t cite an organization for sterilizing instruments for immediate use Will check to see if data is being collected when IUSS is used Check to see if action is being taken to reduce IUSS based on data If not will cite under performance improvement standards John Rosing, OR Manager, Oct

26 JC Surveys: Observations About IUSS Data Collection Collect number of IUSS episodes attributed to lack of instruments OR leadership evaluates data Collect C t routinely and aggregate monthly OR leadership submits data to Infection Control committee for evaluation Data presented to hospital s finance department to justify purchase of more instruments John Rosing, OR Manager, Oct Polling Question Are you collecting data monthly on when IUSS is done and why in order to reduce its use? Yes No Don t know Benchmark for IUSS Benchmark against yourself No national benchmark available for IUSS Goal is to decrease the use of IUSS Improve patient outcomes Determine monthly IUSS rates to determine trends Divide number of IUSS cycles per month by the number of cases per month Also divide number of IUSS per month by the number of trays used February 2011 Clinical Issues-Calculating flash sterilization rates, AORN, available for members at

27 Benchmark for IUSS Take a more detailed look at each service to identify Types of instrument being IUSS Specific surgeons whose procedures require higher numbers of IUSS Time of day instruments are IUSS Reasons for IUSS Document to allow tracing February 2011 Clinical Issues-Calculating flash sterilization rates, AORN, available for members at IUSS Sterilization AORN Documentation Item(s) processed Patient on whom the items were used Type of cycle (e.g., gravity-displacement, dynamic-airremoval) Cycle parameters used (e.g., temperature, duration of cycle) Monitoring results Day and time cycle was run Operator information (person who initiated cycle and retrieved item from cycle Reason for IUSS AORN Sterilization 2013 Recommendation VII.g.1. Benchmark for IUSS Develop an action plan to decrease IUSS based on data Develop policies and procedures for quality monitoring of IUSS Monitor compliance with each step Analyze postoperative SSI that may be related to IUSS February 2011 Clinical Issues-Calculating flash sterilization rates, AORN, available for members at

28 Risk Assessment: How to Eliminate IUSS As part of the effort to reduce surgical site infections, conduct periodic risk assessment for surgical site infections in a time frame determined by the hospital. * Conduct a risk assessment to determine the reasons the healthcare facility is using IUSS Determine how to eliminate all reasons except contamination intraoperatively *The Joint Commission Hospital Accreditation Standards (HAS) NPSG , EP4 Risk Assessment: How to Eliminate IUSS Management teams from the OR, SP, ICP and risk management work together Develop policies and procedure to ensure IUSS is not done for convenience Abuse of IUSS has potential to increase risk for development of SSI Scott L Zuckerman, et al. American Journal of Infection Control 40 (2012) Polling Question Have you done a risk assessment to determine how to eliminate all reasons for IUSS except contamination intraoperatively? Yes No Don t know 28

29 IUSS Summary Use critical thinking skills Be knowledgeable about evidence-based recommended practices and standards (AAMI, AORN, CDC) Appropriate training and education Certification Certification Board (CBSPD) ( IAHCSMM ( IUSS Summary Do not process implants by immediate use except in documented emergency situations and no other option is available Only process devices and loads that have been validated with the specific cycle employed Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing. Reduce Patient Risk Keep Up-to-date on recommended practices Follow manufacturer s most up-to-date written IFU Don t take shortcuts Eliminate i IUSS except in emergency situations ti 29

30 Thank You Questions? References 30

31 Evidence-Based Guidelines Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) ANSI/AAMI ST79 Recommended Practice If You Have This AAMI Document ANSI/AAMI ST79: 2006 What To Purchase Purchase ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated d Text) What To Download Free ANSI/AAMI ST79:2006 and A1:2008 & A2:2009 Purchase ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text) Download A4:2013 PDF and replace pages ANSI/AAMI ST79 Recommended Practice If You Have This AAMI Document ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (Consolidated Text) What To Purchase What To Download Free Download A2:2011 PDF and replace pages Then download A3:2012 and replace pages Then download A4:2013 and replace pages Download A3:2012 PDF and replace pages Then download A4:2013 and replace pages 31

32 ANSI/AAMI ST79 Recommended Practice If You Have This AAMI Document ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text) What To Purchase Most up to date to purchase What To Download Free Download A4:2013 PDF and replace pages How to Purchase AAMI Guidelines for Your Reference Library 1. Order at: In search field near top right corner of screen type in specific standard (ST58, etc) 2. Phone order at or Also available to order through AORN and IAHCSMM at AAMI membership prices How to Purchase AAMI Guidelines for Your Reference Library A free PDF of present and future amendment(s) may be downloaded by visiting ml, which also includes information on how to update your copy of ST79 when free amendments are available. Print and save to your hard drive. 32

33 Evidence-Based Guidelines AORN Perioperative Standards and Recommended Practices (2013) -Recommended Practices for Sterilization -Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment -Recommended Practices for Sterile Technique AORN Standards for Your Reference Library AORN Standards can be purchased through AORN using the following options: Internet: Call: x 1 or x 1 (Monday- Friday, 8AM to 4:30PM mountain standard time) Fax: By mail: AORN, Inc., Customer Service/Book Orders, 2170 South Parker Road, Suite 300, Denver, CO , USA Evidence-Based Guidelines Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Available at no cost: rilization.html 33

34 References for Rigid Containers Rigid Container Systems (Part I), IAHCSMM Communique: July/August 2010 Available at: ssonplans/cis_lessons/cis_220.html Rigid Container Systems (Part II), IAHCSMM Communique: September/October 2010 Available at: _lessonplans/cis_lessons/cis_221.html References for Biological Indicators and Process Challenge Devices Martha Young. Load Control Monitoring Using Process Challenge Devices. 3M Sterile U, Feb Available at: on/3msterileu/ References for Biological Indicators and Process Challenge Devices Martha Young. Sterilizer Qualification Testing Using Process Challenge Devices. 3M Sterile U, July Available at: on/3msterileu/ 34