Immediate-Use Steam Sterilization (IUSS) Tuesday, October 4, :00 pm 1:30 pm EDT

Transcription

1 Tuesday, October 4, :00 pm 1:30 pm EDT Martha L. Young, BS, MS, CSPDT Martha L. Young, LLC

2 Immediate-Use Steam Sterilization (IUSS) Martha Young Martha Young MS, BS, CSPDT Martha L. Young, LLC October 4, 2011 Objectives The importance of training, education, and competency of staff The importance of following manufacturer's instructions for use (IFU) for cleaning, packaging, and sterilization of devices by immediate-use steam sterilization How to monitor the effectiveness of the immediate-use steam sterilization process 10/4/ Association for the Advancement of Medical Instrumentation 2

3 Immediate-Use Steam Sterilization (IUSS) Multi-Society Statement (12 key players) (Published end of 2010) Flash sterilization now referred to as immediate-use sterilization Immediate-use sterilization is broadly defined as the shortest possible time between a sterilized item s removal from the sterilizer and its aseptic transfer to the sterile field. 10/4/ Association for the Advancement of Medical Instrumentation 3 IUSS Aseptic transfer from the sterilizer to the point of use is critical to protect items from contamination Minimize exposure to air and other environmental contaminates Use single wrappers or containers for transport Not to be stored for future use Not held from one case to another 10/4/ Association for the Advancement of Medical Instrumentation 4

4 Implementation of Reusable Rigid Containers for IUSS AORN recommends the use of rigid sterilization containers designed and intended for IUSS Reduce risk of contamination during transport to point of use Ease of presentation to sterile field AORN RP for Sterilization in the Perioperative Practice Setting, RP IV.e 10/4/ Association for the Advancement of Medical Instrumentation 5 IUSS May use F ( C), gravity or dynamic-air removal sterilization cycles Need to know which type of sterilizer using and cycle parameters to determine correct BI PCD No dry time Sterilization times may be longer than 3 to 10 minutes May include extended cycles Manufacturers may not provide an IUSS cycle 10/4/ Association for the Advancement of Medical Instrumentation 6

5 IUSS Must follow the same cleaning, decontaminating, and transporting steps that are done for items that are processed in SPD Cleaning agents, brushes, water quality Sonic cleaner Must wear PPE during cleaning Follow the device manufacturer s IFU If they are not compatible with the packaging (rigid container, etc) or sterilizer manufacturer's IFUs then contact the device manufacturer to resolve the issue Essential to do sterilization monitoring (physical monitors, CIs and BIs) 10/4/ Association for the Advancement of Medical Instrumentation 7 IUSS 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 ( 10/4/ Association for the Advancement of Medical Instrumentation 8

6 IUSS 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. 10/4/ Association for the Advancement of Medical Instrumentation 9 Cleaning ANSI/AAMI ST79:2010 Section 7

7 Steam Sterilization-Update on the Joint Commission s Position User Concerns Surveyor may, among other activities: Ask for manufacturers instructions Ask staff to describe and demonstrate how instruments are cleaned and decontaminated according to those instructions Be concerned about meticulous cleaning and rinsing Joint Commission Perspectives, July 2009, Vol. 29, Issue 7. Copyright 2009 Joint Commission on Accreditation of Healthcare Organizations and personal communications with hospitals that have had surveys, 10/4/ Association for the Advancement of Medical Instrumentation 11 Steam Sterilization-Update on the Joint Commission s Position User Concerns Surveyor may, among other activities: Want instruments cleaned the same way no matter location (CSSD/SPD, OR, ASC, Clinic) Want loaner and other instruments cleaned the same way Want rigid container taken apart for cleaning Joint Commission Perspectives, July 2009, Vol. 29, Issue 7. Copyright 2009 Joint Commission on Accreditation of Healthcare Organizations and personal communications with hospitals that have had surveys, 10/4/ Association for the Advancement of Medical Instrumentation 12

8 Steam Sterilization-Update on the Joint Commission s Position User Concerns Ensure you have the most up-to-date IFUs from the manufacturers of the: Medical devices (standard or extended cycles) Cleaning and disinfection products and equipment Implements (brushes, cloths, etc) Have a method to keep your IFUs up-to-date onesource document site ( ) Joint Commission Perspectives, July 2009, Vol. 29, Issue 7. Copyright 2009 Joint Commission on Accreditation of Healthcare Organizations and personal communications with hospitals that have had surveys, 10/4/ Association for the Advancement of Medical Instrumentation 13 Zimmer Manual Orthopaedic Surgical Instruments Cleaning Instructions G. Manual Cleaning/Disinfection Instructions 1. Completely submerge instruments in enzyme solution and allow to soak for 20 minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush). 2. Remove the device from the enzyme solution and rinse in tap water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficult-to reach areas Rev.3 2.5ML Printed in USA 1987, 2006, 2010 Zimmer, Inc. 10/4/ Association for the Advancement of Medical Instrumentation 14

9 Zimmer Manual Orthopaedic Surgical Instruments Cleaning Instructions 3. Place prepared cleaning agents in a sonication unit. Completely submerge device in cleaning solution and sonicate for 10 minutes at 45-50kHz. 4. Rinse instrument in purified water for at least 3 minutes or until there is no sign of blood or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens, holes and other difficultto-reach areas. 5. Repeat the sonication and rinse steps above. (adds another 13 min) 6. Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe. Total of 49 minutes Rev.3 2.5ML Printed in USA 1987, 2006, 2010 Zimmer, Inc, 10/4/ Association for the Advancement of Medical Instrumentation 15 Zimmer Manual Orthopaedic Surgical Instruments Cleaning Instructions Neutral ph enzymatic and cleaning agents Automated cleaning using a washer/disinfector alone may not be effective Disassemble for cleaning Remove instruments from container for manual or automated cleaning Use a soft-bristled, nylon brush Avoid use of hard water. Softened tap water should be used. Final rinse is purified water ultra-filter (UF), reverse-osmosis (RO), deionized (DI), or equivalent Rev.3 2.5ML Printed in USA 1987, 2006, 2010 Zimmer, Inc., 10/4/ Association for the Advancement of Medical Instrumentation 16

10 Cleaning Clean ASAP Begins at point of use-remove gross soil Body fluids cause pitting and harder to clean Instruments should NOT be decontaminated in scrub or hand sinks Follow manufacturer s validated written instructions Mechanical cleaning equipment is recommended: Provides a higher level of cleaning, and Thermal activity ANSI/AAMI ST79: , 7.4, AORN Care of instruments V, IX, X.c. 10/4/ Association for the Advancement of Medical Instrumentation 17 Cleaning Appropriate cleaning solutions Proper dilution - water lines in the sink for accurate measuring Discard when soiled or according to directions Appropriate cleaning processes Sharps and delicates separate Instruments kept moist until they are cleaned (enzymatic or wet towel not saline) Brushing occurs under water Should be single-use disposable and discarded after every uses or reusable and disinfected or sterilized daily ANSI/AAMI ST79: , 7.5 AORN Care of instruments X 10/4/ Association for the Advancement of Medical Instrumentation 18

11 Brushes and Other Cleaning Implements The device (lumen) manufacturer should provide information regarding brush size and type for cleaning devices with lumens Includes Brush length and diameter Bristle length and diameter ANSI/AAMI ST79:2010 Section and /4/ Association for the Advancement of Medical Instrumentation 19 Water quality helps: Prolong the life of instruments Minimize risk of infection Water impurities Stains on instruments Negative impact disinfectants Affect steam quality (wet packs) Impacts effectiveness and life span of cleaning equipment Water Quality Water quality must meet the manufacturers requirements 10/4/ Association for the Advancement of Medical Instrumentation 20

12 What s wrong with this picture? Poor loading technique-need to disassemble reusable rigid containers (remove disposable filter retention plates) so all surfaces are exposed to the cleaning process 10/4/ Association for the Advancement of Medical Instrumentation 21 Cleaning of Reusable Rigid Sterilization Containers Remove lid Remove all disposable filters and discard Remove filter protector/holder or retention plate from both ends Valve-type closures (reusable filters) must be cleaned according to IFU Usually remove and disassemble for cleaning Remove interior baskets Remove CIs, disposable labels, locks Remove posts/dividers if interfere with cleaning Rigid Container Systems (Part II), IAHCSMM Communique: September/October /4/ Association for the Advancement of Medical Instrumentation 22

13 Cleaning of Reusable Rigid Sterilization Containers Follow manufacturer s IFUs for cleaning agents, tools, methods, and rinsing Cleaning agent Some cannot be exposed to certain chemicals such as high alkaline solutions Follow instructions for loading containers into mechanical cleaning equipment TJC wants these taken apart for cleaning* Rigid Container Systems (Part II), IAHCSMM Communique: September/October 2010, *Joint Commission Perspectives, July 2009, Vol. 29, Issue 7. Copyright 2009 Joint Commission on Accreditation of Healthcare Organizations, and personal communications with hospitals that have had surveys 10/4/ Association for the Advancement of Medical Instrumentation 23 Incorrect or Correct Loading Procedure? Incorrect loading technique-instruments cannot be cleaned in a covered containment device because the instrument surfaces will not come in contact with the detergent or rinse water 10/4/ Association for the Advancement of Medical Instrumentation 24

14 Incorrect or Correct Loading Procedure? Incorrect loading technique-mats should not be placed in the bottom of the trays it prevent (hampers) proper spray coverage of instruments Rigid containers are covered Poor loading technique-instruments are piled on top of each other 10/4/ Association for the Advancement of Medical Instrumentation 25 Manufacturers Obligations for Reusable Medical Devices U.S. FDA labeling regulations (21 CFR 801) Manufacturers responsibility to provide complete and comprehensive written instructions: Handling, Cleaning, Disinfection, Testing, Packaging, and Sterilization Detailed FDA recommendations are provided in the FDA guidance document, Labeling reusable medical devices for reprocessing in health care facilities: FDA reviewer guidance (FDA, 1996). 10/4/ Association for the Advancement of Medical Instrumentation 26

15 HC Personnel Responsibility for Reusable Medical Devices Obtain and review manufacturers current data Standard cycles may not be sufficient for heavy instruments trays and or complex devices Contact device MFR Quality Control or Regulatory Affairs Companies provide updated internet-based electronic copies of MFR recommendations Ensure that they have the necessary resources to follow manufacturers instructions thoroughly 10/4/ Association for the Advancement of Medical Instrumentation 27 Packaging ANSI/AAMI ST79:2010 Section 8.3 and 8.4

16 Correct or Incorrect Packaging? Incorrect: Unless the manufacturer(s) provides validated, written instructions for this packaging technique/change 10/4/ Association for the Advancement of Medical Instrumentation 29 Risk Analysis Is there a risk of a patient acquiring an infection if the manufacturer s instructions for use are not followed? Cleaning, packaging, and sterilization Have you done a risk analysis for sterilization process failures? 10/4/ Association for the Advancement of Medical Instrumentation 30

17 Changes to Medical Devices You Should Not Make Changes should be validated by the medical device manufacturer Doing one ultrasonic cycle to save time when 3 cycles are required Using the basin cycle instead of the instrument cycle on the washer-disinfector/washer-decontaminator to save time Breaking down a tray/container to 25 pounds by placing the instruments with or without their organizing trays in another type of packaging such as a generic rigid container or instrument tray with an overwrap 10/4/ Association for the Advancement of Medical Instrumentation 31 Changes to Medical Devices You Should Not Make Changes should be validated by the medical device manufacturer Changing the original validated non-woven wrapper packaging to a generic rigid container because of surgeon preference Placing peel pouches inside instrument trays or containers 10/4/ Association for the Advancement of Medical Instrumentation 32

18 Changes to Medical Devices You Should Not Make Changes should be validated by the medical device manufacturer Taking instruments from several vendor trays and adding them together in a vendor-provided tray or rigid container system to create a new set Not using the extended cycles provided in the manufacturer s IFUs because they take too long, and effect department efficiency and output Placing instruments sets not validated for extended cycles in an extended cycle which could reduce the instruments functionality and use life 10/4/ Association for the Advancement of Medical Instrumentation 33 Red Flags from Manufacturer s Reps Just clean it like you clean all your other instruments While it does not say it in the instructions for use, you can also do this Use the same sterilization cycle you always use 10/4/ Association for the Advancement of Medical Instrumentation 34

19 Red Flags from Manufacturer s Reps I don t need to provide you with sterilization instructions because once you know how to sterilize one instrument you can sterilize all of them the same way I will help you use any packaging you want We do not have the information you requested so you will need to do the validation testing 10/4/ Association for the Advancement of Medical Instrumentation 35 Validation vs. Verification They Are Not The Same 10/4/ Association for the Advancement of Medical Instrumentation 36

20 Validation Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications. Covers three activities: installation qualification, operational qualification, and performance qualification Performed by device manufacturer Users cannot conduct validation testing ANSI/AAMI ST79:2010 Section /4/ Association for the Advancement of Medical Instrumentation 37 Manufacturer Validation Sterilization efficacy testing is expensive and time-consuming Manufacturer selects most challenging product (master product) in product family to test Biological testing is done in half cycle, fractional cycles, or incremental critical process parameter cycles using BI spore strips, inoculated threads, or direct inoculation ANSI/AAMI ST77:2006 Section /4/ Association for the Advancement of Medical Instrumentation 38

21 Manufacturer Validation Internal temperature mapping is done inside containers or other packaging using multiple calibrated temperature sensors (Section 5.6) Sterilant residual removal testing(section 5.8) Perform sterility maintenance testing, microbial challenge testing, and physical integrity tests to determine if sterility is maintained until the device is opened for use (Section 5.9) Repeat validation testing when design changes are made on device ANSI/AAMI ST77: /4/ Association for the Advancement of Medical Instrumentation 39 User Verification Documented procedures, performed in the user environment, for obtaining, recording, and interpreting the results required to establish that predetermined specifications have been met. AAMI product testing verifies the validated instructions provided by the device manufacturer Product testing does not allow a user to validate a change in the product instructions for use as received from the device manufacturer Packaging, sterilization time, etc. ANSI/AAMI ST79:2010 Section 2.128, Section /4/ Association for the Advancement of Medical Instrumentation 40

22 Immediate-Use Steam Sterilization (IUSS) (Stilled called Flash in ANSI/AAMI ST79) ANSI/AAMI ST79:2010 Sections , , , , , IUSS Quality Monitoring Sterilizer efficacy testing weekly, preferably daily BI PCD must be representative of load Open surgical tray (does not allow for aseptic transfer) Rigid sterilization container Protective organization case Single-wrapped surgical tray Each type of tray configuration needs to be tested so limit number of tray configurations used ANSI/AAMI ST79:2010 Sections /4/ Association for the Advancement of Medical Instrumentation 42

23 IUSS Quality Monitoring Test each sterilization cycle type used: 132 C to 135 C/270 F-275 F Gravity 132 C to 135 C/270 F-275 F Dynamic-air removal NOTE - If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132 C to 135 C [270 F to 275 F] for different exposure times (e.g., 4 minutes and 10 minutes), then only the shortest cycle time needs to be tested. ANSI/AAMI ST79:2010 Section /4/ Association for the Advancement of Medical Instrumentation 43 IUSS Quality Monitoring Use a Class 5 indicator as an internal chemical indicator BI PCD placed on bottom shelf over the drain Otherwise empty chamber When: After Bowie-Dick test if dynamic air-removal sterilizer Physical monitors Document who started sterilizer and who removed items and checked printout Reconcile printout with patient 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 Sections , , AORN:2011 RP for Sterilization IV.h. and IV.h.1. 10/4/ Association for the Advancement of Medical Instrumentation 44

24 Unwrapped Tray Used as the BI PCD BI PCD IUSS (Flash) Sterilization 132 C Gravity Steam Sterilization Process Packaging Used Routinely Is this the correct BI PCD for the load contents? NO 10/4/ Association for the Advancement of Medical Instrumentation 45 BI PCD IUSS (Flash) Sterilization 132 C Gravity Steam Sterilization Process BI PCD Used Daily Packaging Used Routinely Correct BI PCD for Packaging Routinely Used 10/4/ Association for the Advancement of Medical Instrumentation 46

25 Bowie-Dick Test ANSI/AAMI ST79:2010 Section /4/ Association for the Advancement of Medical Instrumentation 47 Bowie-Dick Test Pack Placement in Sterilizer 10/4/ Association for the Advancement of Medical Instrumentation 48

26 Running the Bowie-Dick Test The test pack should be placed horizontally in the front, bottom section of the sterilizer rack, near the door and over the drain, in an otherwise empty chamber. Why? Need rack to prevent formation of superheat which will cause a BD failure 10/4/ Association for the Advancement of Medical Instrumentation 49 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 Sections and /4/ Association for the Advancement of Medical Instrumentation 50

27 Certification ANSI/AAMI ST79:2010 Section 4.2 Benefit of Certification All preparation and sterilization activities should be supervised by a competent, qualified person Demonstrate competencies in all areas of the process Demonstrate comprehensive knowledge of state and federal regulations, OSHA blood-borne pathogens, standard/transmission-based precautions and engineering and work controls Completion of a certification exam and continuing education ANSI/AAMI ST79:2011 Section /4/ Association for the Advancement of Medical Instrumentation 52

28 Benefit of Certification All sterile processing personnel should be certified within 2 years of employment Demonstrate competencies in all areas Certification helps develop Basic level of understanding and knowledge Consistency and standardization of performance Confidence, self-esteem and authority A sense of professionalism Education helps one cease being intimidated by strange situations. - Maya Angelou PATIENT SAFETY ANSI/AAMI ST79:2010 Section /4/ Association for the Advancement of Medical Instrumentation 53 Certification Options CBSPD The Certification Board for Sterile Processing and Distribution, Inc. Independent and international certifying body Accredited by the National Commission for Certifying Agencies (NCCA) Educational books, seminars and tools IAHCSMM International Association of Healthcare Central Service Materiel Management International certifying body Associated with Purdue University Professional association membership Educational books, on-line classes and tools 10/4/ Association for the Advancement of Medical Instrumentation 54

29 CBSPD Exam offered 4 times/year 2.5 hour test Lasergrade/PSI official test site Available tests CSPDT (technicians) Supervisors Managers Surgical instrument techs Flexible GI scope techs Ambulatory surgery techs Vendors take the test of their choice 5 year renewal process 100 points/5 years Certification Options IAHCSMM Exams scheduled anytime 3 hour test Parametric site-based testing facility Available tests CRCST (technicians) CHL (leadership) CIS (instrument specialist) CCSVP (vendor certification) Annual renewal process 12 points/yr/membership in IAHCSMM 10/4/ Association for the Advancement of Medical Instrumentation 55 Why are you still using IUSS to process entire instrument sets, including implants which are released before the BI results are known?

30 Stop this Practice-Patient Safety Issue Do a risk analysis to determine why Loaner sets not arrive on time Manufacturer s written IFUs not arrive with set Lack of inventory to meet the day s surgery schedule, especially if doing block surgeries Lack of personnel, appropriate equipment, cleaning agents, tools, and space in SPD to turn around implants/instruments in desired time 10/4/ Association for the Advancement of Medical Instrumentation 57 Putting Some Teeth into Your Loaner Instrument Policy and Procedure

31 Loaner Instrumentation Issues Have you every received instruments the same morning as the case is scheduled? Do the instruments sometimes arrive without cleaning/sterilization instructions for use (IFUs)? Have you received sets you have never seen before so neither the OR or SPD/CSSD has been inserviced or provided with pre- or post-procedure processing information? 10/4/ Association for the Advancement of Medical Instrumentation 59 IAHCSMM Orthopedic Council of IAHCSMM published in June 2011 IAHCSMM Position Paper on the Management of Loaner Instrumentation IAHCSMM Sample Policy and Procedure Available at on_paper_sample_policy.html In recognition of the need to systematically manage loaner instrumentation and implants. 10/4/ Association for the Advancement of Medical Instrumentation 60

32 Other References HealthVIE.com in-service Getting a Handle on Loaner Instrumentation by Rose Seavey, March, n/3msterileu/ AORN Recommended Practices for Sterilization in the Perioperative Practice Setting published in Perioperative Standards and Recommended Practices, /4/ Association for the Advancement of Medical Instrumentation 61 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) 10/4/ Association for the Advancement of Medical Instrumentation 62

33 Loaner Policy Loaner instruments will not be accepted by the CSSD without the manufacturers tray content lists and the FDA-cleared manufacturers written instructions for disassembly, cleaning, packaging, and sterilization methods and cycles (pictures must be provided and on file within the department for each tray/set). Any deviation from this policy ay result in immediate termination of relationship with responsibility representatives. IAHCSMM Sample Policy & Procedure for Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 63 Loaner Program Should Include Requesting loaner instrumentation or implant (s); Time requirements for pre-procedure and postprocedure processing and inservicing, as needed; Acquisition of loaner items, including a detailed inventory list (preferably with pictures); Obtaining FDA cleared manufacturers written instructions for instrument care, cleaning, assembly, and sterilization; IAHCSMM Position Paper on the Management of Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 64

34 Loaner Program Should Include Cleaning, decontaminating and sterilizing borrowed instrumentation by the receiving facility; Transporting processed loaner instrumentation to the point of use; Post-procedure decontamination, processing, inventory; Returning to the industry representative; and Maintaining records of the transactions. IAHCSMM Position Paper on the Management of Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 65 Loaner Policy Should State responsibility of Surgeons Operating room (OR) Sterile processing department (SPD/CSSD) Sales representatives This is a partnership Responsibilities should be well defined and enforced to ensure patient safety 10/4/ Association for the Advancement of Medical Instrumentation 66

35 It s About Timing It can take 6 to 7 hours to reprocess one set of instruments and there maybe 40 trays for one case IAHCSMM recommends: Healthcare facility requires receipt of loaner trays at least two (2) business days prior to the scheduled case. (sales rep) All first-time vendor sets require three (3) business days for inservicing, inspecting and processing. (sales rep) Need enough time to process without effecting the rest of the departments throughput IAHCSMM Sample Policy & Procedure for Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 67 Communications Need good communication between Surgeon, OR, CSSD, and vendor Surgeon or designee contact vendor to ensure Instruments can arrive in time for scheduled case IFUs arrive before instruments in CSSD unless already on file What happens if the IFU shows up the same day as the case and the CSSD does not have the cleaning equipment, agents or sterilization cycles to process according to IFUs? Surgery postponed? Surgeons and material managers need to understand to order instruments after confirm can process using IFUs IAHCSMM Sample Policy & Procedure for Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 68

36 Communications OR informs CSSD 1 business day before instruments arrive with information about case Quantities Estimated time of use and return Restocking requirements to circumvent IUSS IUSS is not an option because of risk to patient When case booked inform CSSD Day of surgery Doctor, procedure Type of equipment needed IAHCSMM Sample Policy & Procedure for Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 69 Accountability and Documentation Sales Rep brings trays to CSSD Provide packaging list or inventory sheet (preferably with pictures), verify missing instruments ID quantity, catalog number and description of trays Date, surgeons name and procedure Weight upon delivery ( 25 pounds) IAHCSMM Sample Policy & Procedure for Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 70

37 Accountability and Documentation CSSD Personnel/Decontamination Initial log receipt of loaner instruments Date, time, person receiving, Dr. name, name and # of trays, # of instruments, and date removed Perform inventory control Verify types and quantities of instruments and implants so not pay for missing instruments Perform QA check (visually inspect for damage) Follow MFG. written instructions for reprocessing steps Document problems (damage etc.) Tell vendor when to pick up trays IAHCSMM Sample Policy & Procedure for Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 71 Loaner Check List SPD notified of loaners prior to receiving them Received in facility (decontamination) at least 2 working days (48 hours) before scheduled case for existing loaner sets and three working days (72 hours) for new sets before scheduled case days if new set) Inventory list available IAHCSMM Position Paper on the Management of Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 72

38 Loaner Check List FDA-cleared written instructions for cleaning, packaging, and sterilization available Inventory and quality check completed Multiple trays numbered and labeled (patient name, surgeon) Trays do not exceed 25 pounds All instruments in good condition, rusting, pitting Container in good condition, no rusting, tape residue, etc. no IAHCSMM Position Paper on the Management of Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 73 Implants Sales Representative Duties before Surgery: Ensure all loaner items are delivered in sufficient time for CSSD to: Perform routine biological testing if implants are involved and allow adequate time for final results and quarantine; IAHCSMM Sample Policy & Procedure for Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 74

39 Routine Load Release of Implant Loads Physical monitors External process indicator (Class 1) on outside of every package unless internal CI is available Internal CI(s) (Class 3, 4, 5, 6) inside each package A PCD containing a BI and a Class 5 integrating indicator Evaluation of all data by an experienced, knowledgeable person Do not distribute load if any data suggests a sterilization process failure AORN (2010) Sterilization in Perioperative Practice Setting, Recommendation XVI and ANSI/AAMI ST79, Section /4/ Association for the Advancement of Medical Instrumentation 75 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) Class 5 integrating indicator used to release implant in emergency situations.(aami) Emergency situations should be defined. (AAMI) CDC, 2008 Guideline for Disinfection & Sterilization ANSI/AAMI ST79, Section and /4/ Association for the Advancement of Medical Instrumentation 76

40 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, Section , Annex L 10/4/ Association for the Advancement of Medical Instrumentation 77 The Joint Commission New Emphasis for 2011 Exception form (AAMI ST and Annex L) Early release of implant is unacceptable; an exception form must be completed Exceptions guided by policy: multidisciplinary input 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 /4/ Association for the Advancement of Medical Instrumentation 78

41 Importance of Traceability of Instruments and Implants to the Patient Sterilization quality control relies heavily on historical data, especially when quality assurance measures yield conflicting evidence. Recordkeeping is needed for both epidemiological tracking and ongoing assessment of the reliability of the sterilization process. Accountability to the patient and surgeon for the sterility of a reprocessed device requires documentation that can be directly traced to the patient. Traceability of implants is especially important because the consequences of implant-related infections are particularly severe and result in increased morbidity and mortality. ANSI/AAMI ST79, Section /4/ Association for the Advancement of Medical Instrumentation 79 Importance of Traceability of Instruments and Implants to the Patient Sales Representative Duties before Surgery: All trays(s) will be tagged with date, surgeon name(s) and procedure, and placed and/or stored in the designated area. If a healthcare facility has an instrument tracking system with bar coding capabilities, this can be used in place of a tag system (write on the outside tape the name of surgeon, room number, number of trays, and date and time of surgery). After being logged in and tagged, trays may be placed in a specific area waiting for processing. IAHCSMM Sample Policy & Procedure for Loaner Instrumentation, June /4/ Association for the Advancement of Medical Instrumentation 80

42 Questions? References Multi-society Immediate-Use Steam Sterilization statement. Accessed 8/14/2011 at ate_use_statement.pdf Centers for Medicare & Medicaid Services Flash Sterilization Clarification Ambulatory Surgical Center (ASC) Surveys accessed 8/14/2011 at oads/scletter09_55.pdf 10/4/ Association for the Advancement of Medical Instrumentation 82

43 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 (Consolidated Text) Chemical sterilization and high-level disinfection in health care facilities. ANSI/AAMI ST58: /4/ Association for the Advancement of Medical Instrumentation 83 AAMI References Association for the Advancement of Medical Instrumentation (AAMI) Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. AAMI TIR12: /4/ Association for the Advancement of Medical Instrumentation 84

44 How to Purchase AAMI Standards for Your Reference Library Associations for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 A1:2010 (Consolidated Text). Also available to order through AORN and IAHCSMM at AAMI membership prices A free PDF of future amendment(s) may be downloaded by visiting which also includes information on how to update your copy of ST79. Print and save to your hard drive 10/4/ Association for the Advancement of Medical Instrumentation 85 Evidence-Based Guidelines AORN Perioperative Standards and Recommended Practices (2011) Recommended Practices for Sterilization in Perioperative Practice Setting Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment Recommended Practices for Surgical Attire 10/4/ Association for the Advancement of Medical Instrumentation 86

45 How to Purchase 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 10/4/ Association for the Advancement of Medical Instrumentation 87 Evidence-Based Guidelines Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Available at: 10/4/ Association for the Advancement of Medical Instrumentation 88

46 References The Joint Commission, Hospital Accreditation Standards 2011 Joint CommissionOnline, July 2011 accessed 8/14/2011 at: IAHCSMM Sample Policy & Procedure for Loaner Instrumentation and IAHCSMM Position Paper on the Management of Loaner Instrumentation, June htm 10/4/ Association for the Advancement of Medical Instrumentation 89 Closing Reminders Please be sure to fill out the evaluation form: Save the date for these new webinars: The FDA s Unique Device Identification (UDI) Initiative: How Will It Affect Hospitals? Tuesday, October 18, :00 am 1:00 pm EDT IT Baseline Knowledge for the Healthcare Technology Management Professional November 2 and 3, :00 am 12:30 pm EDT 10/4/ Association for the Advancement of Medical Instrumentation 90