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Marcia R Patrick, MSN, RN, CIC Tacoma, WA November 7, 2013.

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1 Marcia R Patrick, MSN, RN, CIC Tacoma, WA November 7, 2013

2 I have nothing to declare No off-label use of medications will be discussed Use of brand names and images is for illustration only, no endorsement is implied

3  Be familiar with the salient points of the CMS Infection Control Worksheet  Discuss three critical injection practices to prevent transmission of bloodborne pathogens in the ASC  Describe at least three critical elements in safely and adequately performing high- level disinfection in the ASC

4  Requires all ASCs that accept money from CMS meet specific Infection Control requirements  Result of disease outbreaks in ambulatory pts.  IC requirements included in all accreditation surveys ◊ Accreditation Association for Ambulatory Health Care (AAAHC) ◊ American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) ◊ American Osteopathic Association (AOA) ◊ The Joint Commission (TJC)  A good idea regardless of accreditation surveys!  It’s all about patient safety

5 Requires:  Licensed, qualified IC person  Written Infection Control Plan  Which IC standards are being followed- CDC (various), AORN, specialty, etc.  Surveillance plan for infections  Method of notifying DOH of reportable dz  Education of staff in infection control

6  Hand hygiene- wash or alcohol-based hand sanitizer, appropriate times  Use of gloves, other personal protective equip.  Needle and medication safety: One needle, one syringe, one patient, one time  Single dose vials are single patient use  Proper placement & use of sharps containers  Sterilization & disinfection  Environmental cleaning  Point of care testing devices (blood glucose )

7 Goals of an Infection Prevention and Control Program  Protect patients  Protect workers  Ensure compliance with infection prevention and control regulations and other requirements, guidelines and recommendations  Promote “zero tolerance” for infections

8 Elements of the Infection Surveillance, Prevention & Control Program 1. Risk Assessment based on services provided, locale, population 2. Written Infection Prevention and Control Plan 3. Authority Statement 4. Infection Control Service description 5. Surveillance Plan

9 6. Goals and Measurable Objectives 7. Prevention & Control Strategies 8. Communication and Reporting 9. Emergency Management & Planning 10. Education 11. Evaluation of Program Effectiveness Elements, continued

10 ◊ Provides a basis for infection prevention activities and annual surveillance plan ◊ Identify at-risk populations in your facility- high volume, high risk, or problem-prone procedures ◊ Assist in focusing surveillance efforts ◊ Meet regulatory and other requirements

11 Facility Risk Assessment Epidemiologic principles to address ◊ Volumes ◊ Populations served ◊ General and specialty services ◊ Staff ◊ Surveillance data ◊ Geographic location and size ◊ Epidemiologically important organisms

12 Assessment Summary ◊ Who is at risk for infection ◊ What types of infections ◊ Recommendations to reduce risks Facility Risk Assessment

13 Surveillance Plan  Surveillance methodology – how  Surveillance indicators/events - what ◊ Risk assessment - why ◊ Reasons for selecting indicators ◊ Committee/leadership recommendations ◊ New services, procedures, treatments  Comparative databases used  Outbreak identification and response

14 Authority Statement Example: The Board of Directors (Medical Director/Quality Committee) authorizes and supports the Director (Manager/etc.) of Infection Prevention to institute appropriate infection control measures within the facility. This includes authority to employ whatever methods necessary when, in their judgment, there is a reasonable possibility of immediate danger to any patient(s), personnel or others in the facility.

15 Infection Prevention & Control Service  Composition ◊ Based on organization size, type, services, needs, regulations & requirements ◊ Personnel: number, qualifications, core competencies, (office) location, hours ◊ Medical Director/Epidemiologist/ID consultant  Leadership support  Authority  Reporting structure, other responsibilities

16  Identify & prioritize goals ◊ Based on risk assessment ◊ Team effort & leadership approval  Goals should address at least: ◊ Limiting acquisition & transmission of pathogens ◊ Limiting unprotected exposure to pathogens ◊ Enhancing hand hygiene ◊ Minimizing risk associated with procedures, devices & equipment  Develop measurable objective(s)

17 Program Goals  Provide cost-effective program ◊ Healthcare Associated Infections = increased cost ◊ Infection Control programs = decreased cost  Limited reimbursement from CMS for preventable harm, also other payers

18 Prevention & Control Strategies  Identify prevention & control strategies  Base on risk for transmission, care setting, diseases in community  Hand hygiene program  Minimize risk associated with procedures, devices, equipment

19 Communication & Reporting Communication systems ◊ Internal ◊ External Reports ◊ What is reported ◊ How it is reported (written, verbal) ◊ Who receives the information ◊ How often

20 Education Education Education & training for ◊ Health care providers, ancillary staff  New employee orientation, competency evaluations  Annual and as needed infection control education ◊ Leaders ◊ Infection Prevention and Control personnel List offerings for the year – Plan a calendar

21 Emergency Management & Planning Must involve collaboration ◊ Internal ◊ External (local emergency mgmt, health dept.) Plan for ◊ Recognition ◊ Response (including influx of infectious pts.) ◊ Containment ◊ Communication (internal & external)

22 Evaluation of Program Effectiveness Evaluate goals & program, ability to meet Measure success or failure, why ◊ Rate reduction- highlight accomplishments! ◊ Processes improved/Compliance improved Infection Control Program resources ◊ Personnel ◊ Non-personnel (computers, clerical support) Collaborate Establish new goals and objectives

23  The written Plan documents the existence of your IC Program  The Plan should incorporate all the elements required or included in your program  Reviewed and updated as things change, at least annually

24 Tips for Developing Written Plan  Identify regulations & requirements  Identify guidelines you will use  Develop outline of Infection Prevention and Control program  Can use the examples given  Network with others  Consider incorporating your plan into your annual report

25 Demonstrate collaboration throughout plan ◊ Leaders, managers, caregivers & others ◊ Collaborate in program development, implementation, evaluation, and assessment of resources Assign responsibility for annual review Include the essential elements Distribute your plan widely

26 Single most important procedure for preventing healthcare-associated (nosocomial) infections Underwood MA. APIC Text 2005 CDC Guideline for Hand Hygiene in Healthcare Settings, Hand Hygiene

27 Definitions Antiseptic – antimicrobial substances (e.g. alcohol, CHG, triclosan) applied to the skin to reduce microbial flora Alcohol-based hand rub – alcohol-containing preparation applied to the hands to reduce the number of viable microorganisms Antimicrobial soap – detergent containing antiseptic agent Waterless antiseptic agent – an antiseptic agent that does not require use of exogenous water

28 A 24-year-old man who had quadriplegia due to a traumatic spinal cord injury was found on routine surveillance cultures to have methicillin-resistant Staphylococcus aureus (MRSA) colonization of his anterior nares. He had no history of MRSA infection or colonization. To assess the potential implications of the patient's MRSA carriage for infection control, an imprint of a health care worker's ungloved hand was obtained for culture after the worker had performed an abdominal examination of the patient. The MRSA colonies grown from this handprint on the plate (CHROMagar Staph aureus), which contained 6 µg of cefoxitin per milliliter to inhibit methicillin-susceptible S. aureus, are pink and show the outline of the worker's fingers and thumb (Panel A). With the use of a polymerase-chain-reaction assay, the mecA gene, which confers methicillin resistance, was amplified from nares and imprint isolates. After the worker's hand had been cleaned with alcohol foam, another hand imprint was obtained, and the resulting culture was negative for MRSA (Panel B). These images illustrate the critical importance of hand hygiene in caring for patients, including those not known to carry antibiotic-resistant pathogens. New England Journal of Medicine Why we use hand sanitizers

29 1. Before entering patient room 2. Before touching patient 3. Before donning gloves 4. Before handling meds, linen, clean supplies 5. Between dirty and clean tasks 6. After touching patient or their environment 7. After handling soiled linen, dressings, etc. 8. On removing gloves 9. On leaving the room

30 Surgical Hand Antisepsis State of the science: waterless surgical scrub solutions 1. Alcohol-based surgical hand-scrub Prewash hands and forearms with non-antimicrobial soap, dry, then apply per manufacturer's instructions 2. Antiseptic surgical hand-scrub Chlorhexidine (CHG) & Povidone Iodine (PVI) most common

31 Artificial Nails  HCWs more likely to harbor gram negative pathogens on their fingertips  Outbreak of Pseudomonas aeruginosa in NICU attributed to artificial fingernails  Artificial fingernails epidemiologically implicated in several other outbreaks  Do not wear artificial fingernails or extenders when having direct contact with patients at high risk (e.g., those in intensive-care units or operating rooms) (IA)

32 ◊ Skin underneath rings is more heavily colonized than comparable areas of skin on fingers without rings ◊ Study: 40% of nurses harbored gram-negative bacilli (e.g., E. cloacae, Klebsiella, and Acinetobacter) on skin under rings & certain nurses carried the same organism under their rings for several months ◊ In a more recent study involving >60 intensive care unit nurses, multivariable analysis revealed that rings were the only substantial risk factor for carriage of gram-negative bacilli and S. aureus and that the concentration of organisms recovered correlated with the number of rings worn ◊ Rings are not appropriate in the OR ◊ Earrings/necklaces must be covered in OR CDC Guideline for Hand Hygiene in Healthcare Settings, 2002


34  Perform hand hygiene before accessing and preparing medications  Disinfect (scrub) all vial tops & IV ports/hubs, locks with alcohol for 15 seconds before accessing (includes needleless systems) ◊ Let dry 15 seconds  A needle should never be left inserted into a medication vial septum for multiple uses ◊ This provides a direct route for microorganisms to enter the vial and contaminate the fluid  Use 5 micron filter needle for ampule

35  A new sterile needle and syringe used for each injection and each entry into vial  Do not use bags or bottles of intravenous solution as a common source of supply for more than one patient  Leftover parenteral medications should never be pooled for later administration  Single-use medication vials (e.g., propofol) should never be used for more than one patient  Assign multi-dose vials to a single patient whenever possible

36  Sanitize hands before any contact with IV tubing or bag handling or change  Keep IV bags in plastic overwrap until ready for use (if out, date & discard in 30 days)  Begin administration within one hour of spiking IV bag/bottle (USP 797) or a soon as possible (APIC)- otherwise discard bag

37  NEVER set an unlabeled syringe down or leave it unattended  NEVER administer a medication from an unlabeled syringe that you did not draw up & have control of from time drawn up to time given  NEVER draw up an oral or topical liquid into an injection syringe

38 Discard medications upon expiration or any time there are concerns regarding the sterility Date multidose vials when first entered & discard at 28 days or manufacturer’s expiration date, whichever is first ◊ Discard unopened vials at manufacturer’s expiration date ◊ Discard opened single dose vial/ampule discarded immediately after use on patient ◊ Discard prepared syringes at end of procedure-do not save for next case

39  Best if irrigation solutions are discarded between patients  Warming irrigation solutions: ◊ T max <113°F, lower (104°) if IV fluids included (record temp daily) ◊ NEVER warm in microwave (any pt care item!)  Medication containing irrigations: obtain from Pharmacy - single patient use

40 Hand hygiene before & after Glove if contact with mucous membranes anticipated Administer all eye & ear products using “ no touch ” technique to prevent contamination If break in technique discard the container ASAP Prefer single patient use

41 ◊ Sanitize hands ◊ Prevent contamination of bulk containers; use smallest available ◊ Small size can be dedicated to single patient and then discarded ◊ Remove desired amount with a sterile applicator or tongue blade (no double-dipping) or squeeze onto a sterile gauze in a clean area


43 Risks in Invasive Procedures Both Inside and Outside the Traditional OR Improper environment Inadequate cleaning, disinfection, and sterilization ◊ Staff not trained adequately ◊ Antiquated equipment ◊ Borrowed equipment ◊ Improper use of equipment ◊ Compromised cleaning procedures

44 Definitions Cleaning: removal of all soil from objects/surfaces Decontamination: removal of all pathogenic microorganisms from objects to ensure they are safe to handle Disinfection: elimination of many or all pathogenic organisms with the exception of bacterial spores Sterilization: complete elimination, destruction of all microbial life CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008


46 Cleaning  Defined as the physical removal of all visible soil, dust, and other foreign materials  Effective cleaning will reduce microbial contamination on environmental surfaces & equipment  Cleaning is the first and most important step before disinfection or sterilization can occur CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

47 Presoaking  Prevents soils & proteins from drying on the instruments  Softens soils and assists with removal  Prevents biofilm development  Presoaking the instruments should ideally occur immediately following the surgical procedure  Sprays, foams, available AAMI ST ; p. 53

48 Enzymatic Detergents  Detergents are defined as substances capable of dislodging, removing and dispersing solid or liquid soils from a surface being cleaned  Enzymatic detergents usually consist of a detergent base with a neutral pH to which one or more enzymes and a surfactant is added AAMI ST79, 2010, 7.5.2, p.55

49 Manual Cleaning  Follows presoaking  Instruments washed submerged under water to prevent potential exposure to microorganisms through aerosolization  Use a basket to lift out sharp items  Staff must wear PPE including eye and face protection  Some endoscope washers may allow you to eliminate manual cleaning AAMI ST 79, 2010, 2.17, p.8

50 Ultrasonics for Delicate Instruments (e.g. eye instruments)  Effectiveness is based on cavitation: sonic waves generate minute bubbles on instrument surface  Bubbles then expand, become unstable, then collapse or implode  Implosion generates very localized vacuum areas that literally dislodges/sucks off the soil  Must clean machine per instructions AAMI ST79, 2010, , p. 57


52 Washer Disinfectors  Mechanically cleans instruments using a spray action called impingement ◊ Impingement is the water force making contact with the instrument  Several cycle processes; final step is heated air drying  Render instruments safe to handle

53 Spaulding Classification for Medical Devices In 1972, Dr. Earl Spaulding developed a system for classifying medical instrumentation and equipment ◊ Non-critical – devices that touch intact skin, environmental surfaces – LOW LEVEL DISINFECTION ◊ Semi-critical – devices in contact with intact mucous membranes or skin that is not intact – HIGH LEVEL DISINFECTION ◊ Critical - (high risk) devices enter sterile tissue or bloodstream – STERILIZATION APIC Text, 2009, p

54 Device classificationExamplesSpaulding process classification EPA Product Classification Critical (enters sterile tissue or vascular system) Implants, scalpels, needles, other surg. Instruments Sterilization- sporicidal chemical; prolonged contact Sterilant/ disinfectant Semi critical (touches mucous membranes) Flexible endoscopes, laryngoscopes, ET tubes, vaginal specula High level disinfection- sporicidal chemical; short contact Sterilant/ disinfectant Hydrotherapy tanks Intermediate level disinfection Hospital disinfectant with label claim for tuberculocidal activity Non critical (touches intact skin) Stethoscopes, tabletops, bedrails, blood pressure cuffs Low level disinfection Hospital disinfectant without label claim for tuberculocidal activity

55 Low Level Disinfection  Kills most bacteria, some viruses, some fungi  Appropriate for non critical medical devices and environmental surfaces  Quaternary ammonium compounds (Quats) are low level disinfectants ◊ Many quats are effective against TB and Hepatitis B  OK for use on blood spills and in OR environment CDC Guideline for Disinfection & Sterilization in Healthcare Facilities, 2008

56 Have a written procedure for cleaning ALL environmental surfaces and equipment ◊ What, who, when, how ◊ EPA-registered hospital disinfectant/detergent ◊ Pop-up wipes very handy for small surfaces ◊ Spray bottles discouraged, use nozzle top ◊ Use original containers or manufacturer's label APIC Text, 2009, Ch 100

57 Intermediate Level Disinfectants  Kills Mycobacterium tuberculosis, vegetative bacteria (e.g. Staphylococcus aureus), most viruses & fungi  Most phenolic disinfectants are classified as intermediate level  Appropriate for hard surfaces, floors, non- critical medical devices  Phenolic disinfectants are used cautiously where there are infants APIC Text, 2009, Ch 100

58 A process (usually liquid chemicals or wet pasteurization) that eliminates: ◊ Many or all pathogenic microorganisms on inanimate objects ◊ Except large numbers of bacterial spores ◊ Short exposure times (<30 minutes) CDC Guideline for Disinfection & Sterilization in Healthcare Facilities, 2008

59 Any instrument that will touch mucous membranes or non-intact skin ◊ Flexible endoscopes ◊ Ultrasound probes, vaginal and anal, used with sheath ◊ Brushes used to clean instruments for HLD ◊ Laryngoscope blades ◊ Vaginal specula & related equipment ◊ Diaphragm fitting rings APIC Text 2009, p.21-6.

60  Endoscopes- GI, GU, can’t tolerate high heat  Sometimes for arthroscopes, laparoscopes ◊ Large studies of HLD arthroscopes have shown no increased risk of infection compared to sterilized arthroscopes  Follow label directions for soak time, temperature, use life, shelf life, product restrictions ◊ No OPA for urology scopes per label on some OPA products  Use in well-ventilated area, wear PPE  Many HLD products are similar: compare  NEVER use HLD for environmental cleaning! APIC Text 2009, p.21-3.

61 FDA-Approved Agents for Chemical High-Level Disinfection Use for temperature-sensitive devices ◊ Glutaraldehyde (> 2.0%) Cidex, Metricide, etc.* ◊ Ortho-phthalaldehyde – OPA (0.55%) many brands ◊ Hydrogen peroxide-HP (7.5%) Sporox ◊ Peracetic acid-PA (0.2%) Steris ◊ HP (1.0%) and PA (0.08%) Peract ◊ HP (7.5%) and PA (0.23%) Endospore (no test strips!) ◊ Glutaraldehyde (1.12%) and Phenol/phenate (1.93%) Sporicidin ◊ 2% Activated Hydrogen Peroxide (Resert XL) *Brand names used for illustration only, no endorsement is implied. APIC Text 2009, p.21-3.

62 High-Level Disinfection Glutaraldehyde and Ortho-phthalaldehyde – OPA ◊ Various formulations and brands  Ready to use or requires activation (mixing)  14, 28 and 72 day formulations (maximum use days) ◊ Must use test strips to assess concentration prior to each use  Minimum Effective Concentration (MEC) specific to each product ◊ Product must be rinsed thoroughly  Sterile or potable water (dependent upon intended use of instrument) ◊ Maintain log ◊ Must be neutralized for disposal (Glycine)

63  Immediately: wet wipe down outside of scope  Take to soiled utility room (cart or tray, “enclosed”)  Leak test (if fails, stop and send scope for repair)  Initiate cleaning process- enzymatic soak  Scrub and flush all channels, ports, valves, etc.  Rinse, rough dry  Immerse in HLD for product label-designated time, flush and fill all channels to prevent air bubbles  Rinse x 3, rinse channels with alcohol, blow dry  Hang vertically to store, closed cabinet preferred APIC Text 2009, p.21-3.

64  Perform some or all of the functions: leak testing, cleaning, disinfection, alcohol rinse and air drying of scopes  MUST ensure all lumens are properly connected to the system APIC Text 2009, p.21-6.

65 Minimum Effective Concentration (MEC) Test Strips  Dilution of chemical occurs during routine use  Test strips for monitoring the MEC, specific to each product; test prior to each use, log  Do not use test strips beyond expiration date  QC test & document when opening a new bottle; refer to manufacturer’s protocol AORN Perioperative Standards & Recommended Practices, 2012, p. 489

66 Tray/ Equipment Date Processed Solution Expiration Date Test Strip Expiration Date MEC Test Result (+ Pass or - Fail) Solution Temperature Solution Soak Time Initials Test Strip Example - Fail - Fail + Pass + Pass IMPORTANT! Solution must be discarded by expiration date, EVEN when MEC test passes

67 Cleaning/Disinfection in Endoscopy Key Infection Prevention Interventions for cleaning and processing endoscopes ◊ Keep the scope moist – enzymatic soak ◊ Transport in covered container ◊ Consistent and complete cleaning of all channels ◊ Manual cleaning includes  Valves  Channels  Connectors  All detachable parts  Brushes Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes, 2011 SGNA published updated guidance 9.12

68 ◊ Leak testing and scope inspection ◊ Processing: Per manufacturer  Chemical  Automated endoscope washer- disinfector  Use alcohol for final rinse, blow air ◊ Hang to dry (vented cabinet designed for hanging and storage of scopes) ◊ Do not store in case! Cleaning/Disinfection in Endoscopy Setting (2)

69 Cleaning/Disinfection in Endoscopy Setting (3) Documentation log ◊ Patient name ◊ Type of scope - Serial number ◊ Date and time of processing ◊ Enzymatic soak time if manual ◊ Chemical indicator results ◊ Machine – bay number ◊ Soak time if manual ◊ Soak temperature ◊ Attach print-out if available

70 ENDOSCOPY REPROCESSING LOG Today’s Date: ___________________ Results Of Pre-Process Test:___________ Disinfectant: ____________________ Expiration Date Of Test Strips:__________ Activation Date: _________________ Patient Name Processor # Load #ScopeLeak Test Cleaning Time Soak Time Soak temp RinseAlcohol Purge Initials

71  Training of ALL staff responsible for cleaning instruments, scopes, equipment (vacations?)  Post the procedure in work area  Ensure proper equipment, PPE, supplies available  Competency evaluation initially & at least annually  Maintain training records  Periodic visual monitoring of practice  Consider microbiological monitoring if indicated AAMI ST , 4.2, p. 37


73 Types of Sterilizers Thermal (Heat) ◊ Moist (Tabletop or large; Gravity, & High Speed Vacuum) ◊ Dry Chemical ◊ ETO (ethylene oxide, “gas”) ◊ Other chemicals- H 2 O 2 gas plasma (Sterrad); Steris ◊ Ozone- commercial use ◊ Radiation- commercial use Example of a tabletop steam autoclave. CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 59

74 Steam Gravity Sterilization  Low cost, quick turnover, no toxic chemicals, accommodates large loads  Steam enters the chamber by gravity & displaces air (so steam can penetrate load)  Takes longer for steam to reach required temperature  May not penetrate complex instruments CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p

75 Steam Pre-Vacuum or High Speed Vacuum, Pulse Vacuum  Low cost, quick turnover, no toxic chemicals, accommodates large loads  Air is removed (so steam can penetrate load) by a pump before steam at an elevated temperature is rapidly introduced, then rapidly removed at end to facilitate drying  Will penetrate complex instruments CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 59

76  Mechanical convection – more efficient and temperature is more uniform  340°F for 60 minutes, dental 320°F for 2 hours  Used for powders and oils that can tolerate high temperatures  See AAMI ST40 Dry Heat Sterilization AAMI ST79, 2010, 8.5.8, p. 81 CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 68

77 Ethylene oxide (EtO/EO);  Used for heat & moisture sensitive devices  Lengthy aeration time must follow each cycle to allow removal of harmful residuals before opening chamber doors  EtO/EO is associated with human tumors  Alarms, ventilation and training of staff promote safe use of this agent Low Temperature Sterilization CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 61

78 Hydrogen Peroxide Gas Plasma Sterilizer CDC Guideline for Disinfection & Sterilization in Healthcare Settings, 2008, p. 61

79  Use the correct wrapper for the type of sterilization to be performed, items to be packaged  Wrappers must have a 510k that specifies what it can be used for (ETO, steam, etc.)  Same for peel packs AORN Standards & Recommended Practices, 2012, p

80 Peracetic Acid Sterilizer Steris 1 gone by Feb. 2, 2012 Steris 1e FDA Approved

81 Definition: ◊ AAMI: “process designed for the steam sterilization of patient care items for immediate use” ◊ AORN: “should be used only when there is insufficient time to sterilize the item by the preferred wrapped or container method”  Not recommended outside of the ambulatory surgical center where it can be used in a controlled manner  Should never be used as a substitute for sufficient inventory Flash Sterilization- Now Called “Immediate Use Steam Sterilization” AAMI ST79, 2010, 8.8, p. 86

82 Immediate Use Sterilization Acceptable only for items:  AAMI guidelines for implants  AORN guidelines for implants  Single instruments only (not trays)  Urgently needed  Cleaned well  Used close to point of sterilization  Adequately covered or protected from contamination  Use mechanical, chemical, and biological indicators AORN Standards and Recommended Practices, 2012, p

83 Considerations:  Risk of burns from hot instruments  Recontamination of instruments during transport  Keep logs of all immediate using (process surveillance)  Monitor number of times used, what procedures, and why – use as dept PI  Monitor staff training and performance Immediate Use Sterilization AORN Standards and Recommended Practices, 2012, p

84 Quality Assurance for Steam Sterilization Critical Parameters for each load ◊ Steam ◊ Temperature ◊ Pressure ◊ Time AAMI ST79, 2010, p

85 Class I – External, time, temp, pressure indicator, says item went through autoclave (tape) Class II – Bowie Dick, checks for air removal Class III – Internal, time & temp, rarely used today Class IV – Internal, reacts to two or more parameters, rarely used today Class V – Integrators, melted chemical pellet, reacts to all parameters, all steam cycles Class VI – Emulating indicators, cycle specific Biological – gold standard, shows kill of organisms AORN Standards and Recommended Practices, 2012, p


87 Sterilization Monitoring: Mechanical Indicators  Cycle time, temperature, & pressure is displayed on the sterilizer gauges with each instrument load  Printout or graph documents these indicators  If these fail, load is no good.

88 Sterilization Monitoring: Chemical Indicators (CI)  The CI is a process indicator that signals the item has been exposed to sterilization process (temperature, time, etc.)  A CI is affixed to outside of package & used with every load  An indicator is also placed inside the pack to verify steam penetration  Peel-packs have a single indicator  If these fail, load is no good

89 Sterilization Monitoring: Biological Indicators (BI)  Closest to being the ideal monitor & measure of effectiveness by challenging the sterilization process against a resistant spore (Bacillus sp.)  Use BI daily if sterilizer is used frequently  Also, use a BI for every implant & EtO run  Policy for positive tests- who to notify, id instruments used, recall? “IC Communication” report

90 Biological Indicators (BI)  Compare capsules for color change at regular intervals  Length varies with the product; rapid readout 1-3 hours, or 24 hours  Read and record results  Positive test = sterilization process has failed due to improperly processed load, failure to meet temperature or exposure parameters, mechanical problems, etc. Yellow = PositivePurple = Negative

91 Documentation: Note the Control is positive the Biological is negative

92 Positive BIs  Remove sterilizer from service until problem resolved  Consider recalling packs processed since last “good” load  Check sterilizer records or logs to see if all other critical parameters were met  Repeat the BI in 3 separate loads ◊ If all are negative and critical parameters are met, place it back into use ◊ If one or more continue to be positive  Have machine serviced  Repeat BI using a different manufacturer or lot of indicators AAMI ST79, 2010, , p. 114

93 Storage of Clean/Sterile Supplies Store at least ◊ 8-10” from the floor ◊ 18” from the ceiling ◊ 2” from outside walls Solid bottom shelf Closed cabinets Avoid overfilled drawers NO RUBBER BANDS! AORN Standards & Recommended Practices, 2012, p. 559

94 Time-Related vs. Event-Related Sterility Historically, sterile items had an expiration date… yet items don’t suddenly convert from sterile to non-sterile Event-related sterility states the product does not have an expiration date providing the package is intact (e.g. wrapping intact, package is not wet, etc.) Sterility is event related, not time related! AORN Standards & Recommended Practices, 2012, p. 560

95 Reuse of Single Use Devices (SUDs)  Manufacturers cite “single use only” on many of their products (e.g. cardiac caths, orthopedic bits/blades, DVT sleeves, etc.)  Re-use of these products can result in significant financial savings  Concern with the risk of infection and injury when the devices are re-used  Must consider regulatory, medical, ethical, legal, & economic issues before proceeding forward  3 rd party reprocessing acceptable when premarket requirements are met (FDA 510(k)) (

96 Vendor-Supplied Equipment Vendor ◊ Must wear appropriate attire in OR ◊ Name badge; should meet employee criteria for medical screening and immunization ◊ Bring written cleaning, disinfection, sterilization instructions from manufacturer of device Equipment ◊ Must be delivered to the CS decon for cleaning and sterilization (with instructions) ◊ Allow adequate time for processing ◊ Record “borrowed” equipment contents, vendor name, patient or case number involved, surgeon name, date and time, keep a log AORN Standards & Recommended Practices, 2012, p. 558

97 CMS and accreditation requirements are all about patient safety Risk assessment, written plan, evaluation of program, document Hand hygiene, hand hygiene… Safe injection practices Cleaning, disinfection, sterilization Environmental cleaning


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