Section: CONTROL (IC) SURVEILLANCE, PREVENTION

IC 14 April 2016 Page 1 of 38

Section:SURVEILLANCE, PREVENTION, & INFECTION CONTROL (IC)

Subject: Disinfection Sterilization

POLICIES AND PROCEDURES MANUAL Number: IC14

System Department See Appendices I through XIX

Date Effective: 12/22/99

Date Reviewed:5/02, 6/04, 12/05, 6/06, 6/08, 12/10, 2/13, 6/16, 9/16, 2/17, 2/18, 9/19

Supersedes: UNMCP Policy IC14: Disinfection and Sterilization

Table of ContentsSpaulding Classification of Medical Devices Page 2

I. Sterilization p. 3-4

Process Page 3

Appendix I Template for Departments performing Sterilization Page 9

Appendix II Approved sterilizers related to patient care/Approved sterilizers Page 11

Appendix XIII Guidelines for Reprocessing of Single Use devices by Third Party Vendors Page 29

Biological, Chemical & Mechanical Monitoring

Appendix III Approved biological indicators Page 13

Appendix IV Positive biological indicator implant or daily load Page 15

Appendix VII Sterilizer log Page 20

Additional information

Appendix V Requirements for the Acquisition and the use of Sterilizers, Biological Monitors, &/or any Product that affects Sterilization/Disinfection Page 16

II. High Level Disinfection Page 4-6

Process Page 4

Appendix X Template for:High Level Disinfection with Cidex OPA Cidex OPA Test Strip Quality Control Test Page 23-25

Appendix VI Approved solutions and parameters for High Level Disinfection and Pasteurization Page 17

Appendix XI Disinfectant Product Expiration Labels Page 27Appendix XII A -B

A. Clorox® Bleach 1:10 and 1:14 solution labelsB. Clorox® Bleach Dilution Page 28-29

Record Keeping

Appendix IX High level disinfection solution daily log sheets (chemical disinfectant, Trophon) Page 21

Additional Information

Appendix XIII Guidelines for Reprocessing of Single Use Devices by Third Party Vendors Page 37

III. Low Level Disinfection Page 7-8

Process Page 7

Appendix VII Approved Solutions for Low Level Disinfection Page 18

Cleaning of Electronic Equipment

Appendix XIV Electronic Charting Device Cleaning and Disinfection Guideline Page 32-33

Appendix XV Hospital Owned Smart Phones Page 34


Appendix XVII Electronic Thermometers Guidelines Page 36

Toy Cleaning

Appendix XVI Toy Cleaning Guidelines Page 35

Bottled Water Coolers

Appendix XVIII Bottled Water Policy Page 37

References Page 7

Disinfection/Sterilization Policy IC14Purpose: To prevent healthcare acquired infections related to medical devices by providing minimum

standards of practice for sterilization, high-level and low- level disinfection utilized for patient care items or within the patient care areas. Workflow should always be from dirty to clean eliminating possible recontamination.

Spaulding Classification: Spaulding’s classification categorizes medical devices into three categories, 1) critical, 2) semi-critical and 3) non-critical. These classifications assist a clinician in determining the proper method of cleaning to be used before patient care; low-level disinfection, high-level disinfection or sterilization.

1. Critical items enter sterile tissue or the vascular system and must be sterile when used in patient care. Examples of critical items include, but are not limited to the following:

Surgical instruments

Implants

Needles

Cardiac and urinary catheters

Cutting endoscopic instruments that break the mucous membrane barrier

Ultrasonic probes used in sterile cavities2. Semi Critical devices come in contact with non-intact skin or mucous membranes and must

receive high level disinfection or sterilization before patient use. Examples of semi critical items include, but are not limited to the following:

Bronchoscopes

Gastrointestinal endoscopes

Respiratory therapy equipment

Anesthesia equipment

Cystoscopes

Speculums

Laryngoscopes3. Non critical items come in contact with only intact skin and should receive a minimum of low

level disinfection before patient use. Examples of non-critical items include, but are not limited to:

Blood pressure cuffs

Thermometers (with disposable sheaths)

Stethoscopes

Basins

Furnishings and counter tops


I. SterilizationA. Definition and Use

1. A process by which all forms of microbial life, including bacteria, viruses, spores and fungi are destroyed.

2. Patient care items must be sterilized if they enter normally sterile tissue, the vascular system or areas through which blood flows.

3. for areas that perform sterilization: each department must develop a sterilization policy specific to their area and the items sterilized. See Appendix I for a departmental sterilization policy template.

B. The Process1. Removal of visible bio burden from items must begin at point of use, according to

manufacturer instructions. 2. After point of use decontamination, instruments or devices will be placed and transported to

soiled area in a rigid, closed container clearly marked Biohazard. Permanent marking should be on the sides and lid of the container.

3. Once in the soiled area, instruments will be transferred to an appropriate container (rigid with permanent biohazard marking on sides and the lid of the container) and be sprayed with enzymatic presoak. Instruments must be kept moist until reaching decontamination.

4. The container used to transport the instrument to the soiled area must be wiped with a low level disinfectant wipe inside and outside. This container is now ready to transport another contaminated instrument. Store it in an easily accessible location that is marked cleaned and ready for transportation.

5. Once instruments arrive to the Sterile Processing Department, an approved enzymatic cleaner will be used before sterilization process can begin.

6. The sterilization process should be conducted according to the manufacturer’s recommended instructions for use (IFU’s) for instruments and the specific sterilizer. (See Appendix II).

C. Biological/Chemical Monitoring 1. Sterilizers are to be monitored with an approved biological monitor daily, when in use,

weekly or in conjunction with a load, if used less frequently. (See Appendix III). Perioperative Services has biological monitoring requirements specific to their area. See Perioperative Services Policy, Sterilization in Perioperative Services VI 4 for specifics.

2. The lot number of the biological monitor used in conjunction with a load will be the same as the control biological monitor.

3. Any sterilizer load which contains implantable items will be monitored with the appropriate spore test. These items should not be used until the spore test is found to be negative. When medical exceptions dictate documentation should be made acknowledging the situation and at the discretion of the physician.

4. Chemical indicators (appropriate for the type of sterilizer) will be placed in and attached to the outside of any package to receive steam, ethylene oxide, hydrogen, or gas plasma sterilization. This will indicate the package has been exposed to the conditions consistent with sterilization. If indicator displays a failure in sterilization, load must be reprocessed.

5. Bowie Dick test is to be used as the first run of the day on pre-vacuum sterilizers. Bowie-Dick testing should also be done during initial sterilizer installation, after sterilizer relocation, after major repairs, if the sterilizer malfunctions or if there is a process failure.

6. When a biological indicator is positive, immediate action must be taken. (See Appendix IV).

D. Record Keeping1. For each sterilization cycle, the following information should be recorded and maintained:

a. The lot number;b. The specific contents of the lot or load, including quantity, department and a specific

description of the items (e.g. towel packs, type/name of instrument sets);c. The exposure time and temperature, if not provided on the sterilizer recording chart;d. The name or initials of the operator;e. The results of biological testing, if applicable;f. The results of Bowie-Dick testing, if applicable


g. The response of the Chemical Indicator, CI, placed in the PCD (BI challenge test pack, BI challenge test tray, or CI challenge test), if applicable;

Any reports of inconclusive or nonresponsive CI’s found later in the loadThe time and temperature recording chart, printer, or tape will also be dated and maintained, and each cycle will be kept for each sterilizer. Information may be recorded in a paper or Electronic log or filed as individual documentation records.

2. Documentation will be maintained of the time and date of each load processed, the temperature and exposure time, and the general contents of the load (textile packs, implants, instrument packs etc.). Records are reviewed at least every two months by the Director/Supervisor of the testing site and periodically by the Department of Infection Control and Epidemiology. Noncompliance to record keeping will result in non-approval of the sterilizer for patient care. Appendix VIII contains an example form to record this information.

3. Sterilization records of all mechanical, biological and chemical monitoring must be kept and available for review for at least 5 years. A printout strip from the sterilizer showing parameters met for a load can used to meet the mechanical monitoring requirement. Check current regulations before destroying records.

A written mechanism for recall and traceability to a patient must be in place.E. Orientation/In-servicing

Personnel who clean, package items, or perform subsequent disinfection or sterilization, must be educated and trained. This documentation should be done at orientation and on an annual basis, to ensure institution-wide consistency of cleaning and preparation of items. Education modules can be found through the Apollo. The training modules are Disinfection Sterilization, course code: LC10-058 and High Level Disinfection: Cidex OPA, course code: AE13-006.

F. Event Related Sterility 1. Nebraska Medicine ascribes to an event related definition for package sterility. Event

related sterility means that a package is considered sterile unless the package sterility is questioned (i.e. torn, wet or otherwise damaged). Additional considerations in event-related sterility maintenance include the following:a) Environmental sources of contamination (i.e., moisture, vermin)b) Barrier properties of packaging material (i.e., moisture, integrity of the seals).

2. Nebraska Medicine adheres to manufacturer’s expiration date on purchased sterile products.

G. Additional Information1. Sterile disposable single use items intended for human use will not be re-sterilized by

Nebraska Medicine personnel for reuse. Information on single use items reprocessed by an approved third party vendor can be found in Appendix XIII.

2. Implantable objects will not be subjected to immediate-use sterilization.3. Any department using sterilization must have written procedures in their departmental

Infection Control Policy under Section V: Special Policies & Procedures (See Sterilization Policy Department Guideline following this document).

4. For the purchase of any sterilizer, biological monitor, and/or any product that affects microbial control, other than those approved by this policy, refers to Appendix V.

5. A system should be installed to detect ventilation system failures associated with Ethylene Oxide sterilization and to alert personnel with audible and/or visual alarms.

6. For concerns related to the disinfection and sterilization of items potentially contaminated with prions (Creutzfeldt-Jakob disease) refer to guidelines in the policy for Suspected or Confirmed Creutzfeld Jakob Disease IC25.

II. High- Level DisinfectionA. Definition and Use

1. The removal of vegetative forms of microbial life but generally not resistant spores. See Appendix VI for the list and use of solutions approved by Nebraska Medicine for High Level Disinfection.

2. Used for items having contact with mucous membranes but not entering tissue or the vascular system.

http://1welearn01/TPOnline/TPOnline.dll/Home


3. For areas that perform high level disinfection (HLD): each department must develop a HLD Policy specific to their area and the items re-processed. See Appendix X for a departmental

template for Cidex ® OPA.B. Pre-cleaning

a. Non-scope devices1. Removal of visible bio burden from items must begin at point of use, according to

manufacturer instructions. 2. After point of use decontamination, instruments or devices will be placed and transported

to soiled area in a rigid, closed container clearly marked Biohazard. Permanent marking should be on the sides and lid of the container.

3. Once in the soiled area, instruments will begin the process of high level disinfection according to manufacturer instructions for use OR be transferred to an appropriate container (rigid with permanent biohazard marking on sides and the lid of the container) and be sprayed with enzymatic presoak. Instruments must be kept moist until reaching decontamination.

4. The container used to transport the instrument to the soiled area must be wiped inside and outside with a low level disinfectant wipe. This container is now ready to transport another contaminated instrument.

b. Scopes1. Removal of visible bio burden and bedside cleaning must begin at the point of use,

Manufacturer instructions must be followed. 2. After point of use decontamination, Scopes will be placed in a blue scope bag marked

with Biohazard sticker and a patient sticker.3. The blue scope bag will be placed in a tote and transported to the decontamination area

for reprocessing.4. The container used to transport the scope to the soiled area must be wiped inside and

outside with a low level disinfectant wipe after use. C. High Level Disinfection

1. Safety precautions for chemical High Level Disinfection, such as the use of covered containers, personal protective equipment, ventilation, exposure monitoring if required, etc., shall be utilized when handling chemical disinfectants

2. High Level Disinfection can be accomplished with a chemical disinfectant or a Pasteurization process. (See Appendix VI for Approved Methods and Parameters)a. Glutaraldehyde (Cidex) use must be approved. There are some processes where

an approved alternative to Glutaraldehyde may not be available. This should be documented and submitted to Safety Operations for review and approval by Nebraska Medicine.

3. All processing must be done in accordance with the manufacturer’s Instruction For Use relatedTo the equipment, chemical itself, and monitoring indicators.

4. Items must be thoroughly cleaned before disinfection.a. Items with lumens, channels, crevices and joints must be disassembled before

cleaning when the design permits and according to the manufacturers’ written instructions.

b. Items shall be cleaned, rinsed and excess moisture removed before disinfection. Water left on instruments will dilute the germicide.

6. Store scopes in a way that prevents recontamination and promotes drying (e.g., hung vertically). After processing, position scopes and other equipment which requires hanging, in an appropriate manner to facilitate drying. Hanging scopes should not come in contact with sides or base of cabinet.

7. Work flow in the area should go from dirty areas to clean areas. Re-processed items must be protected from contamination, and not stored in soiled utility rooms. Environment should meet industry standards for temperature and humidity. Consult current AAMI standards.


D. Monitoring1. Chemicals for high level disinfection must be checked for efficacy using appropriate test

strips, following all manufacturer guidelines regarding quality control, expiration dates after opening new bottles, and procedure for failure of test strips.

2. High level disinfectant test strips shall be utilized, per manufacturer’s directions, to ascertain that the concentration of the solution is adequate. See Appendix X for Cidex® OPA Test Strip procedure

3. Pasteurization: Departments performing pasteurization must have written procedures following manufacturer guidelines for use and documentation of monitoring temperature

E. Record Keeping1. A log of all chemical testing shall be maintained and available for review for 5 years. High

level disinfected devices and scopes must be identified and able to be traceable back to individual patients. See Appendix IX.

2. All channeled flexible scopes must reprocessed if they are not used within 7 days of reprocessing

1. All channeled scopes must be tagged after reprocessing to indicate when they were last processed. The tags will be color coded as follows:

a. Sunday=whiteb. Monday=redc. Tuesday=purpled. Wednesday=greene. Thursday=bluef. Friday=pinkg. Saturday=orange

3. All NON-channeled flexible scopes will be tagged with the date they were processed and the individual who processed them.

a. CLEAN READY TO USE tag = Name and date processed 4. Rigid scopes (ENT scopes) will be placed in an open peel pack labeled “clean not sterile”

E. Orientation/In-servicing Personnel who perform high-level disinfection must have documented initial orientation and annual training. This must include documented competency, and ongoing monitoring of performance, to ensure institution-wide consistency of cleaning and preparation of items. To meet the annual training requirement, employees must take the following education module through Apollo:

High Level Disinfection: Cidex OPA, course code: AE13-006 And monthly tracers available online at

http://mysite.nebraskamed.com/personal/olympus_rclevenger/IC_Form_Links/Home.aspx

(If you have trouble with accessing contact Infection Control Office 559-5276.)F. Additional Information

1. All solutions & processes used for high level disinfection must be approved by the Infection Control Committee and solutions mixed and stored according to manufacturer recommendations. See Appendix VI for guidance.

2. Opened original manufacturer’s containers and poured solutions being used for disinfection must be labeled with mixing date, expiration date and hazard information. For mixing and expiration date labeling, see Appendix XI.

3. Chemical disposal must be in compliance with the hospital Chemical Safety Manual. (See Nebraska Medicine Waste Handling policy EC10.)

4. SDS information for chemicals can be found at the following link MSDS



http://intranet.nebraskamed.com/App_Files/pdf/employeeResources/ChemicalSafetyManual.pdf

http://intranet.nebraskamed.com/employeeResources/msds.aspx


III. Low Level DisinfectionA. Definition and Use

1. Low level disinfection is a method of disinfection which results in the removal of most vegetative bacteria, fungi and some viruses, but not spores.

2. Used for items that come in contact with intact skin only, not mucous membranes, or non-intact skin, the vascular system, or tissue.

B. The Process1. See Appendix VII for the list of solutions approved by Nebraska Medicine for low level

disinfection. 2. Items to be low level disinfected should be cleaned first and then disinfected. This may

require a two-step process. First remove dust, gross debris and other items from the surface (e.g. scotch tape) then disinfect the surface with the low level disinfectant.

3. Items to be low level disinfected must be exposed to the solution per manufacturer’s recommended contact time.

4. Mixing, use and expiration date of solutions should be in accordance with Manufacturer’s Instruction for Use (check dilution, time of contact, container type, cleaning of container and expiration date if poured from original chemical container.)

5. Wipes containing low level disinfectant are considered acceptable to use if the wipe is still moist. Dry wipes should never be used. NOTE: It is important to keep the wipe containers closed in order to prevent the wipes from drying out.

C. Additional Information1. Only quaternary ammonium germicidal cleaning solutions, not phenolics, will be used for

routine cleaning in the nursery. 2. Low level disinfectants will be kept accessible to nursing staff but secured away from patient access and potential chemical exposure.3. Only EPA approved disinfectants will be used at Nebraska Medicine. Clorox® and PDI Bleach Wipe are currently the only EPA approved sodium hypochlorite and therefore currently the

only one approved for use at this facility. 4. Sodium hypochlorite (bleach) solution or phenolic solution shall be used for the cleaning of

blood spills. Removal of all blood is necessary before final disinfection. Sodium hypochlorite and other germicides are inactivated in the presence of blood.

5. For concerns related to the disinfection of items potentially contaminated with prions (Creutzfeldt-Jakob disease) refer to specific guidelines in the policy for Suspected or Confirmed Creutzfeld Jakob Disease IC25.

6. For the purchase of any sterilizer, biological monitor, and/or any product that affects microbial control, other than those approved by this policy, refers to Appendix V.

7. Chemical disposal must be in compliance with the hospital Chemical Safety Manual. (See Nebraska Medicine Waste Handling policy EC10.)

8. SDS information for chemicals can be found at the following link MSDS9. Additional low level disinfection is also performed by Environmental Services through the

use of ultraviolet radiation disinfection machines.

D. Cleaning of electronic equipmentRefer to Appendix XIV Electronic Charting Device Cleaning and Disinfection Guideline and

Appendix XV Hospital Owned Smart Phones Guidelines Appendix XVII Electronic Thermometers

1. Verify with the equipment manufacturer acceptable products to use for disinfection prior to purchase whenever possible since the warranty could become void with the use of an unacceptable disinfectant chemical.

2. Use hospital approved low level disinfectants unless contraindicated by the manufacturer of the electronic equipment.

3. Notify Infection Control and Epidemiology if a hospital approved low level disinfectant cannot be used.

http://intranet.nebraskamed.com/App_Files/pdf/employeeResources/ChemicalSafetyManual.pdf

http://intranet.nebraskamed.com/employeeResources/msds.aspx


4. Each department is responsible for assurance of cleaning electronic equipment. Environmental Services workers do not clean electronic equipment.

See Appendix XIV for information on cleaning computers and scanners used as bedside charting devices

See Appendix XV for information on cleaning hospital smart phones

Appendix XVII Electronic ThermometersE. Toy Cleaning

Refer to Appendix XVI Toy Cleaning for specifics of cleaning Toys.

F. Cleaning Bottled Water CoolersRefer to Appendix XVIII Bottled Water Coolers for specifics on cleaning this equipment.

G. Orientation/In-servicingPersonnel who clean, or perform subsequent disinfection, need to be educated. To assist with this an educational module is available through the Learning Connection. The program is Low level Disinfection Module, number FE-10-001.

Resources:APIC Text (Association for Professionals in Infection Control and Epidemiology). (2014). APIC: Infection Control and Applied Epidemiology 4th edition Rutala, William A. and Weber, David K. (2011). Sterilization, High Level Disinfection, and Environmental Cleaning.ANSI/AAMI (Association for the Advancement of Medical Instrumentation) ST 79. 2010 Edition. AAMI: Arlington, VA.

ANSI/AAMI (Association for the Advancement of Medical Instrumentation) ST 58. 2013 Edition. AAMI: Arlington, VA.

ANSI/AAMI (Association for the Advancement of Medical Instrumentation) ST 91. 2015 Edition. AAMI: Arlington, VA.

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, Healthcare Infection Control Practices Advisory Committee (HICPAC), Rutala, William A; Weber, David J; Centers for Disease Control, 2008.

Perioperative Standards and Recommended Practices. 2016 Edition. AORN: Denver, CO.

Staff Accountability:Medical Director, Infection Control and Epidemiology (09/19)Manager, Infection Control & Epidemiology (09/19)Infection Preventionists, Infection Control & Epidemiology (09/19)Manager, Sterile Processing (09/19)Infection Control Committee (09/19)

Department Approval

___________________________________________

Administrative Approval

_______________________________________Signed |s|: Dr. Vanschooneveld, M.D. Signed |s|: Terry Micheels, MSN, RN, CIC, FAPIC

Title:

Infection Control Committee Chair, Associate Medical Director of Infection Control Title: Infection Control and Epidemiology Manager

Department: Infectious Diseases


Appendix ITemplate for Departments who perform Sterilization

Purpose: To provide minimum standards of practice for sterilization, including handling and storage of sterilized items in all departments of Nebraska Medicine.

I. PreparationA. Decontamination/Cleaning

1. Contaminated items should be placed and transported in containers clearly marked as contaminated. Permanent marking should be on the sides and lid of the container.

2. All contaminated objects are to be received, cleaned, and decontaminated in an area physically removed or separated from the areas where disinfection or sterilization, packaging and storage occurs.

3. All reusable items and environmental surfaces must be thoroughly cleaned to remove all organic material, i.e., blood, tissue, secretions, before disinfection/sterilization.

4. Brushes and or other cleaning implements used to decontaminate instruments/items prior to sterilization should be cleaned and disinfected as recommended by the manufacturer at least daily or, preferably after each use. Reusable brushes should be allowed to dry when not in use in such a way that mold growth cannot occur. Whenever possible, single-use brushes and other cleaning implements should be used and then disposed of afterwards (ANSI/AAMI ST79 2010).

II. Sterilization ProcessA. Wrapping

1. The packaging material selected and used must maintain the sterility of the contents of the package after sterilization and it must be compatible with the type of sterilizer utilized.

2. Assembly and packaging must be carried out in such a way that the sterilization process is effective.3. The contents, when opened, must be obtainable from the package with minimum risk of possible

contamination, and maximum convenience for the user.

B. ProcessingSterilizer specific – (Insert information here on how you sterilize items in your department - see manufacturer recommendations or refer to Appendix I in your policy for processing parameters)

Brand Name Type of Sterilizer(Example: Steam)

Approved Parameters

(per manufacturer)

Recommended Biological Indicator

C. Drying of steam sterilized items must occur before handling of the items.

III. MonitoringA. Mechanical, biological and chemical monitoring is required. Parameters are sterilizer specific – see

manufacturer’s recommendation or refer to Appendix III for Biological Indicators.B. Report positive biological indicators according to the algorithm found in Appendix IV.

IV. StorageA. Sterile/high level disinfected items shall be stored in an area removed or separated from the cleaning and

processing areas.B. All sterile/high level disinfected items must be stored away from sources of water, windows, doors, exposed

pipes, and vents. Avoid storage in areas with high heat and humidity.C. All sterile/high level disinfected items must be stored at least 10” off the floor, 2” from outside walls, and 18”

from ceiling fixtures. Bottom shelves storing sterile supplies must be solid to prevent soiling. Any exception must be approved by Infection Control and Epidemiology.

D. Items are not to be stored in shipping cartons (outer cardboard boxes) in which they are received from outside vendors.

E. Sterilized items shall be stored to ensure adequate stock rotation.F. Sterile and high level disinfected items should be arranged, handled and stored in a way to protect package

and content integrity (prevent crushing, bending or compressing of enclosed items).


G. Public traffic flow in areas storing sterile supplies should be controlled or supervised unless items are secured.

V. Transportation The transportation system must be enclosed and designed to minimize the risk of personnel exposure to blood borneAnd other disease-producing organisms and the possibility of damage to the instruments and other items being transported. Consideration should be given to the containment or packaging of the items, loading procedures, temperature control in transportation vehicles, and other relevant factors. Vehicles used for transporting contaminated items between buildings should provide for separation of contaminated items from clean and sterile items. Due to potential contamination of the transportation vehicle, the vehicle should be decontaminated on a routine basis and in the event of spills. Transportation personnel should receive training in basic infection prevention and control principles related to their responsibilities. PPE and a bio hazardous spill kit should be available in transportation vehicles. (AAMI 2010)

VI. Off-site transportationA. Vehicles used for transporting contaminated items between health care facilities should provide for separation of

contaminated items from clean and sterile items. Carts housing contaminated items should be secured within the vehicle to prevent damage. Transport vehicles and handling practices should allow for ease of loading and unloading. (AAMI 2010)

B. The procedures for packaging and transporting contaminated items off-site for processing must comply with applicable Department of Transportation (DOT) and state regulations. (AAMI 2010)

VII. Borrowed Instruments A. Instruments requested for use by another area within the control of the Nebraska Medical Center shall be sent in

the state of sterilization they are in when requested. They may be only decontaminated and cleaned or they may be sterile. It is the transporting department’s accountability to inform the receiving department and the receiving department’s responsibility to check the sterility and integrity of the item that was sent. Items with sterility indicators that visually indicate sterility can be considered sterile unless package integrity has somehow been compromised during transport. Items without sterility indicators or which are packaged in such a way that sterility is questioned should be resterilized. Items that are transported off campus via automobile must be wrapped in plastic to protect package integrity. When in doubt items should always be resterilized by the receiving department.

B. Items received from institutions outside the control of the Nebraska Medical Center shall be resterilized unless the physician determines the situation emergent and waiting could cause increased risk for the patient.

VIII. Recall of InstrumentsPositive Biological Indicator – see Appendix IV.

IX. MaintenanceA. Equipment malfunction – see Appendix IV.B. Daily – per manufacturer recommendationsC. Annual Preventative maintenance

X. Special ProceduresA. Creutzfeldt-Jakob disease

Instruments and/or invasive patient care items must be sterilized according to The Nebraska Medical CJD guidelines (see The Nebraska Medical Center Policy for Suspected or Confirmed CreutzfeldJakob Disease IC # 25). Contact Infection Control and Epidemiology for alternatives.

B. Department specificC. Employee Competence Training


APPENDIX IIApproved Sterilizers related to Patient Care

**Any changes in the following practices shall be communicated to the Department of Infection Control and Epidemiology**

Brand name Site Type Biological Indicator Approved parameters

3M Steri-Vac Sterile Processing – South EtO Steris Verify EO test 130F for 60 min

ASP Sterrad 100S Sterile Processing –North HO Cycle Sure 14324 113F for approximately 55 min

Steris Amsco Century x4 Sterile Processing – H Lied Steam 3M Attest 41382/41382F Rapid 5 steam-Plus test pack 1292 270F for min 4 min

Steris Verify Bowie Dick 270ºF for 3 min

Steris Amsco Eagle x2 Sterile Processing – H Lied EtO Steris Verify EO Test 130F for 60 min

Steris Amsco Century x 2 OR University Tower Steam (vacuum) 3M Attest – 1292 272F 6 min pre-vac(wrapped) Bowie Dick/DART 270F 3 min pre-vac

AMSCO Century Series OR-H Lied Steam 3M Attest 1291 270ºF for 3 min - Gravity(x 8 units) 3M Attest 1292 270ºF for 4 min - Prevac


APPENDIX II (cont.’)Approved Sterilizers

**Any changes in the following practices shall be communicated to the Department of Infection Control and Epidemiology**

Brand Name Site Type Biological Indicator Approved Parameters

Sterrad NX Sterile Processing- South H2O2 Cyclesure 4324

Barnstead Biomed Steam Biomed sterilizers (held for backup and used if needed)

Primus PK520 x 2 Bio-containment unit Steam 3M Attest – 1291 272°F for 10 min (vacuum)

3M Attest - 1292 270°F for 30 min (vacuum)252°F for 60 min (gravity)

Amsco Steris 16 & 20 inch VP Aesthetic Surgery Steam Verify LCB 007 270° F for 4 min (prevac)

Verify LCC 310 270° F for 4 min (gravity) Belimed x2 Bellevue Sterile Processing Steam 3M Attest Rapid 5

Steam-Plus Pack


APPENDIX III

Approved Biological Indicators

*These are the minimal requirements indicated by the manufacturer

Biological Indicator Sterilizer Agent Appropriate Load Sterilization Parameters*

3M Attest – 1291 Steam Unwrapped metal/hard goods 270F for 3 min (gravity)Unwrapped metal (porous) 270F for 10 min (gravity)Wrapped metal/hard goods 270F for 10 min (gravity)Container systems 270F for in gravity displacementPatient care trays 270F for 3 min (gravity)

3M Attest – 1292 Steam Fabric packs 250F for 40 min (gravity)270F for 4 min (vacuum)

Wrapped hard goods 250F for 20 min270F for 4 min (vacuum)

Single wrapped hard goods 270F for 4 min (exp. vacuum)Unwrapped hard goods (nonporous) 250F for 15 min

270F for 3 min (vacuum)Unwrapped hard goods (porous) 270F for 4 min (vacuum)Container systems 250F for 40 min (gravity)

270F for 4 min (vacuum)

Cycle Sure Intended to be used as a standard methodfor monitoring of Sterrad sterilizers.It functions as a routine test pack with both a biological sterilization processindicator and a chemical process indicator.


APPENDIX III (cont.’)

Approved Biological Indicators

*These are the minimal requirements indicated by the manufacturer

Biological Indicator Sterilizer Agent Appropriate Load Sterilization Parameters

Steris Verify 3M Attest EtO 130ºF for 60 min 41382 Rapid 5 Steam Plus test pack Steam Challenge 270F for 4min (vacuum)/250°4min (gravity)

Bowie Dick 240F for 5 min

Getting Unispore Steam 270F/ killed at 3 minunwrapped270F/ killed at 5 min/wrapped

Castle Unis pore Steam 134C/ killed at 3 min

unwrapped134C/ killed at 12 minwrapped

Verify LCB 007 Biological and Chemical up to 2 double wrapped 270° F for 4 min (prevac) Integrator Challenge Pack instrument trays, mx wt.

17 pounds each tray Verify Bowie Dick Test ECQ009 Bowie Dick test pack 270° F for 3.5 min (prevac)

Verify LCC 310 Steam unwrapped instrument tray 270° F for 4 min. (gravity) Up to 17 pounds

Verify LCC 003 (Class IV) Steam Immediate release item load 270° F for 4 min (prevac)


Appendix IV – Positive Biological Indicator Implant or Daily Load

START

Take Sterilizer out of Service

Recall all available suspect items from this load

Reprocess all items in a different sterilizer

Notify shift lead or manager and verify sterilizer operational procedure settings and parameters

Immediately retest sterilizer with another biological

Was biological negative?

Yes

No

Notify manager and call maintenance for repairs

Run another biological

Was biological negative?

Yes

No

Notify manager and call maintenance for repairs

Release sterilizer for use

Were any suspect items from the failed load used on patients?

Yes

No

Notify department manager and identify patient/cases where items were used since last negative biological

Call operator and page the Infection Control & Epidemiology (ICE) On-call person giving patient/case information. ICE will work with Sterile Processing Manager or Director to notify surgeons, physicians of identified patients/cases.

ICE will notify Risk Management at 9-6466 Or hospital operator for Risk Management.

The Sterile Processing Department must complete an electronic incident report. Report as anonymous.

After maintenance repairs are complete, run three consecutive test loads with biological indicator

Are all three biological indicators negative?

Yes

No

Maintenance must return for repairs

Release sterilizer for use

All sterilizer repairs are documented and retained by the repair service provider (Biomed or manufacturer) See section D of policy for Record Keeping.

Biological result documents are kept by the department owning the sterilizer for a period of 5 years.

Notes:


APPENDIX V

Requirements for the Acquisition and the use of Sterilizers, Biological Monitors, &/or any Product that affects Sterilization/Disinfection

1. Explanation of the system or productAttach SDS sheet or product use sheet

2. Peer review literature (published material)UsesLimitationConcernsComparison to other products

Advantages/disadvantagesReview Contracts

3. FDA approval (disinfectants/biological monitors)Per clinical approval510K pre-market notification

4. Present written proposal to the Department of Infection Control and Epidemiology and the Disinfection and Sterilization Committee for preliminary approval.

NOTE: A minor change in brand name vs. a change in composition does not need this type of approval, But a letter must be sent to Department of Infection Control and Epidemiology.


APPENDIX VIApproved solutions and parameters for High Level Disinfection and Pasteurization

Brand Name

Generic Name Parameters Efficacy Testing Expiration dates

Cidex®(Use must be approved by Nebraska Medical Risk Council).

Glutaraldehyde >2% (most use 2.4%)

20 minute soak(Drying time depends on item)

Glutaraldehyde Concentration Test (Prior to each use)

See Manufacturer’s Instructions For Use

Cidex OPA®

Ortho-phthalaldehyde

12 minutes @ 20ºC or greater

Cidex OPA Concentration Test (Prior to each use)

Test Strips in manufacturer’s original package Opened: 90 days from date opened or manufacturer’s expiration whichever comes firstUnopened: Use manufacturer’s expiration date on container Cidex OPA still in Manufacturer’s Original Container. Opened: 75 days or manufacturer’s expiration date whichever comes firstUnopened: Use manufacturer expiration date on container Cidex OPA currently in use for high level disinfection: 14 days after being poured from container

Cenorin 520Dryer Model 1010 Pasteurization

30 minute soak in water at least 70° C Process (3 Part): Wash/ pasteurize/Filtered air Dry

Temperature of water is verified weekly with secondary thermometer to assess accuracy of pasteurizer thermometer. Pasteurizer should not cycle if water is not at the correct temperature. A record of water temperatures is kept in the department.

NONE

Acecide Peracetic Acid

Soak for 5mins or more; 10 minutes for spore elimination.

Verify with only Acecide Test Strips per instructions for use.

See the Manufacture instructions for use and expiration date on the bottle.


Appendix VII- Approved Solutions for Low Level Disinfection

Solution1 Available As Expiration Information2 Uses Minimum Concentration

Quaternary AmmoniaAIRKEM A456N

(diluted in water per manufacturer's recommendation)

30 days after dilution EVS has automated dispensers

Super Sani-Cloths Active and effective only if the cloth is still moist

Environmental surfaces, general cleaning

Isopropyl Alcohol Disposable wipes Active and effective only if the cloth is still moist

Some patient equipment per manufacturer

suggestion70%

Alcohol (Ethyl or Isopropyl) Liquid none

60% by volume ( > 70% alcohol is flammable and must be properly used and stored)

Bleach (5.25% or 5.6% sodium

hypochlorite) Only EPA approved bleach

should be used

PDI Bleach Wipe Active and effective only if the cloth is still moist

Most often for blood and body fluids, some

monitors per manufacturer's

recommendation

5000 ppm or 5600 ppm

Clorox in a squirt bottle as a 5.25% or 5.6% dilution

Fresh solutions of diluted bleach are made daily and

dated.Use a new, unopened

bottle of bleach every 30 days for preparing diluted

solutions.

1:10 dilution (5,250ppm)

(1 cup bleach to 9 cups water)See Appendix XII

Phenolics3Stat III (diluted in water per

manufacturer's recommendations)

30 days after dilution

Environmental surfaces, general cleaning-

especially isolation rooms. NOT to be used

around newborns.

EVS has automated dispensers

Gloves must be worn when using any disinfectant.1The manufacturer's recommendation should be used as the guideline when addressing disinfectant needs for their equipment.2Expiration dates for products assume that the container is closed after each use. Containers left open dry out the product and render it ineffective.3Phenolics are not to be used near babies due to neurotoxic effects.


Appendix VII (cont.’) - Approved Solutions for Low Level Disinfection

Approved Solutions for Low Level DisinfectionNote: This table is not an endorsement of specific products.

The purpose of this poster is educational only. The manufacturer’s recommendation should be used as a guideline when addressing disinfectant needs

for specific equipment.

Fisher Scientific Clean WipesProclick order #101006970% Alcohol Wipe (equipment only!)

PDI Germicidal WipesProclick order # 0153361:10 Bleach Wipes

Super Sani ClothProclick order # 1007727Quaternary Ammonia

The above solutions are available from Environmental Services.

Stat IIIPhenolic

A-456-NQuaternary Ammonia

Clorox® in squirt bottleBleach Solution


APPENDIX VIIISTERILIZER LOG

Sterilizer Chemical IndicatorDate Time Load # Items

Wrapped/ Unwrapped Temp Time Pass Fail Initial


Mark expiration dates on all containers: Cidex OPA Bottle=75 days once opened Cidex OPA in soaking container=<14 days Test strips=90 days (Unless the bottle expiration date is first then that is the date of expiration)

**The log is available in Excel upon request from Infection Control & Epidemiology.



**The log is available in PDF upon request from Infection Control & Epidemiology.


APPENDIX XTemplate for High Level Disinfection with Cidex OPA

*Only trained staff with demonstrated competency and annual training should perform disinfection of instruments.

Removal of gross contamination before transport

Items must be decontaminated to make safe for transport.

1. Prepare the instrument at point-of-use for transport to dirty utility areaa. Remove particulate matter or body fluids with a soft cloth dampened in mild soap, or a disinfectant wipe. If

visibly soiled, use a two-step process. Clean with the first wipe, and disinfect with the second.b. Cleaning and decontamination should not occur in hand hygiene sinks. c. Place instrument in a rigid covered container marked with biohazard label.

2. Transport directly to the decontamination room. 3. If trained to do high-level disinfection, begin process.

a. If not trained, leave bag in designated drop off area and notify a trained staff member.b. Instruments should be disinfected within a reasonable time period.c. If high level disinfection process will be delayed ensure device is sprayed with presoak instrument spray or

follow delayed reprocessing protocol if applicable.

A. Preparation and use of Enzymatic solution

Gross body fluid must be removed prior to disinfection using detergent or enzymatic solution, because disinfectants cannot penetrate fats and protein. Follow device manufacturer instructions for cleaning tools and process, either soaked and scrubbed in enzymatic solution, or washed using a cloth and mild detergent. Soaking and scrubbing with enzymatic cleaner is preferred for heavily soiled items. Thorough rinsing is required following either method.

Note: If an Instrument requires the application of a protective cap, apply prior to use of enzymatic solution.Note: Whenever possible, store Cidex OPA and enzymatic solutions in separate designated locations.

1. Don personal protective equipment (PPE), including a minimum of extended wrist gloves, water-resistant gown, mask, and eye protection (shield or goggles).

2. Fill a bath basin with water (1 gallon) and add the appropriate measured volume of enzymatic cleaning solution. Refer to the manufacturer’s recommendations for mixing.

Note: Mixing instructions for V. Mueller Instrument Enzymatic * Single Enzyme * Low Sud Cat. 25134-001: *Add 1-2 ounces per gallon of water for normal cleaning and*Use a new solution of enzymatic cleaner for each device*If using a sink to fill with water and adding enzymatic cleaner, measure and mark the capacity of the

sink to determine the amount of cleaner needed.3. Surfaces should be scrubbed using friction to remove soil. Scrub items under the surface of the solution to minimize

aerosolization of debris.4. Gently empty the basin into the drain. Do not splash. 5. Lumened instruments require manufacturer specific brushes to clean properly, as well as copious flushing of lumens

with enzymatic solution and water rinse.6. Rinse with copious amounts of tap water. Do not touch the instrument to the surfaces of the sink.7. Allow instrument to dry on clean linen.

B. Preparation of Cidex OPA solution1. Maintain PPE, including a minimum of extended wrist gloves, water-resistant gown, mask, and eye protection (shield or

goggles).2. Verify product is within proper use dates or not expired. Open the original Cidex OPA solution bottle and dispense into

the soaking container.


3. If any Cidex OPA remains in the original container, label the bottle/original container with the date of opening and a discard date (date of opening + 75 days, or expiration date, whatever comes first).

4. Label the instrument soaking container with the date of pouring and a discard date (date of pour + plus 13 days*, or manufacturer expiration date whatever comes first).

NOTE: use a calendar to calculate discard dates*The Cidex can be used for up to 14 days. The date that it is poured is day 1

C. Testing efficacy of Cidex OPA solution

The disinfectant is tested each time it is used to ensure that high level disinfection is occurring with each load. 1. The efficacy of the solution must be verified at the time the soaking container is filled and with each load.

a. Efficacy of the Cidex OPA solution is verified by using the test strips b. Completely submerge the indicating pad of the strip into the solution for 1 second and removec. Remove excess solution by standing the strip upright on a paper toweld. Read results at 90 seconds. Do not read past 90 seconds.

2. Cidex OPA test strips (the whole bottle) should be discarded if any of the following occur:a. Test strip bottle cap is left openb. Bottle is found without date label as to when it was openedc. 90 days after the bottle is opened, or manufacturer expiration date, whatever comes first

NOTE: The bottle must be labeled with the opening date and a discard date (date of opening + 90 days)3. Document results4. Ensure each item is documented and is traceable back to the patient it is used on.

D. Quality Control Procedure for Cidex OPA test strips

Quality Control is done each time a bottle of test strips is opened to ensure that strips are reliable to identify failed or inactive solution.

1. Each time a new bottle of Cidex OPA test strips is opened, it should be subjected to the following quality control test.2. Gather timer, paper towel, and clean containers (1 small cup and the usual Cidex OPA soaking container) 3. Verify that Cidex OPA solution is within the appropriate use period (not expired). The current solution in a soaking

container may be used for the positive control.4. Prepare a negative control solution, mixing 1 part water and 1 part solution.

a. For example, If using a medicine cup, use 15 ml water and 15 ml of Cidex OPA solution5. Following the directions for testing (above), submerge 3 test strips in each the negative control solution and the positive

control solution (total of 6 strips)a. The three test strips from the positive control should be fully purple on the indicating pad (when read at 90

seconds).b. The three test strips from the negative control should remain fully blue on the indicating pad or have an

incomplete color change to purple (when read at 90 seconds).6. Document results on the testing log.7. If the results from testing indicate that the test strip is not functioning as expected, do not use strips. Contact the

manufacturer (Advanced Sterilization Products) at 1-888-783-7723

E. High level disinfection and rinsing of the instrument1. Maintain PPE, including a minimum of gloves, gown, and eye protection (shield or googles).2. Immerse the clean instrument completely in the soaking container


3. Cover the container with tight fitting lida. Failure to use Cidex OPA without proper engineering controls (e.g., fume control and personal protective

equipment) may result in allergic reaction, hives, or rash4. Soak for 12 minutes. Set timer. ( If another item is added during the soak, reset timer for all items.)

NOTE: Excessive soaking time is not recommended as it may result in residues that cause patient allergic reaction or tissue discoloration.

5. Remove instrument, rinse thoroughly with tap water (at least 2 gallons), immersing for a minimum of 1 minute. 6. Repeat step 5 (times 2), for a total of 3 rinses (6 gallons). Each rinse requires new, fresh water. Take care not to touch

instrument to the sides of the sink.7. Rinse a final time using 70% isopropyl alcohol (if using a container keep covered).8. Lay the instrument on a clean, dry towel. Allow to air-dry. 9. Use a bleach wipe to disinfect the sink. 10. Once the instrument is dry, store it in such a manner that it is clear the instrument has been disinfected. Examples

include: paper bag or peel pack/pouch labeled “clean, not sterile”.

F. Documentation and labeling of the soaking containers 1. An entry should be made on the log (provided) each time the solution is used and when quality control testing (strip

testing) is done. 2. If there is still solution in the original Cidex OPA bottle, it may be stored for up to 75 days.

a. label the bottle with the date of opening and discard date (date of opening + 74 days)3. Record the date the solution was poured from the original container, and the discard date.

a. Label the soaking container with the pour date and the discard date (date of pour + 13 days) 4. Record the date the test strips are opened.

a. Label the test strip bottle with the open date and discard date (date of opening + 90 days)

G. Packaging and Protection of the disinfected items

High level disinfected items should be protected from contamination until the item is delivered to the point of use.1. Use aseptic technique when handling the instrument. Examples of asepsis include performing hand hygiene and donning

gloves to handle disinfected items.2. Use a paper bag or peel package labeled “clean not sterile.” Plastic baggies should be avoided because they can harbor

moisture.3. Flexible endoscopes should be stored

In a closed cabinet withi. Venting that allows air circulation around the flexible endoscopes

ii. Internal surfaces composed of cleanable materialsiii. Adequate height to allow flexible endoscopes from touching the bottom of the cabinetiv. Sufficient space for storage of multiple endoscopes without touching:

Hanging in a secure vertical position With all removable endoscope components (e.g., valve mechanisms, biopsy valve covers, irrigation tubes)

detached With all accessories removed With scope protectors applied if the protector does not interfere with the flexible endoscope hanging straight or

restrict the air movement around channel openingsAORN: Recommended Practices for Cleaning, Handling, and Processing Anesthesia Equipment, Recommendation 5 and Recommended Practices for cleaning and Processing Flexible Endoscopes and Endoscope Accessories Recommendation IX


H. Cleaning of soaking containersCross contamination can occur when containers are not properly cleaned to remove bioburden and /or chemical residue. 1. Each time the disinfectant soaking containers are emptied, they shall be washed with soap and water. 2. Don PPE. At a minimum, gloves, gown, and eye protection is required.3. Empty the Cidex into the sink.4. Rinse with water.5. Use enzymatic cleaner per manufacturer instructions. Scrub container. Use of gauze for scrubbing is suggested.6. Thoroughly rinse the container, ensuring all residue is removed. 7. Dry the container completely using paper towels.

I. Cleaning, disinfection, and storage of brushesPrompt cleaning of brushes reduces or eliminates microorganisms that create biofilms. There is a risk of cross-contamination when using reusable brushes.

1. Brushes and other cleaning implements should be designed for use on medical devices (e.g. toothbrushes are not acceptable). They should either be single-use, disposable items (recommended) or, if reusable, be decontaminated at least daily. Single use items are preferred.

2. At minimum, brushes should be cleaned and disinfected at the end of the shift, or when heavily soiled. 3. ALL disposable and reusable brushes that are worn should be discarded.4. Clean brushes using manufacturer recommendations, if none exist the use of the enzymatic solution or detergent with

thorough rinse is recommended.5. Follow manufacturer recommendations for disinfectant to use. If none are recommended, soak brushes in sodium

hypochlorite (bleach) and water solution, or other manufacturer recommended cleaning process. 5.25% bleach (household bleach), use 1:10 dilution 8.25% bleach (germicidal/healthcare bleach , use 1:14 dilution

6. Brushes should be hung for storage and allowed to dry. Brushes should not be hung directly on the wall, because the wall surface can’t be cleaned.

Any questions can be directed to Infection Control and Epidemiology 402-559-5276

References

Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings. AORN 2013.

Cidex® OPA Solution Test Strip package insert. Advanced Sterilization Products® 33 Technology Drive, Irvine CA 92618-9824. 2004.


Appendix XI- Use with Avery Labels 5069, 5199, 5997

Disinfectant Product Expiration Labels

Product/Solution Name:__________________________

Date Opened/Poured/Mixed:__________________________Do NOT Use On Or After Date:

__________________________



__________________________



__________________________



__________________________



__________________________



__________________________



__________________________



__________________________



__________________________



__________________________


APPENDIX XII-A Clorox® Bleach Solution Labels (in parts per million [ppm])

Regular Clorox® Formula at 5000 ppm (1:10) Concentrated Clorox® Formula at 5600 ppm (1:14)

1:10 Bleach SolutionContents: Active ingredients: Sodium Hypochlorite.........0.525% Inert Ingredients...............94.75%WARNINGS: Precautionary Statements: Hazard to humans. Causes substantial and temporary eye injury. Do not get in eyes or on clothing. Harmful if swallowed. May irritate skin. For prolonged use, wear gloves.Practical Treatment: If in eyes: Remove contact lenses and rinse with plenty of water for at least 15 minutes. If swallowed: Drink a glass full of water. In either case: Call a physician. If contact with skin: Immediately remove contaminated clothing and wash skin thoroughly with water. Physical and chemical hazards: Strong oxidizer. Do not mix with other household chemicals. To do so will release hazardous gases.

Refer to MSDS for Additional Information.

1:14 Bleach SolutionContents: Active ingredients: Sodium Hypochlorite.........0.56% Inert Ingredients...............94.75%WARNINGS: Precautionary Statements: Hazard to humans. Causes substantial and temporary eye injury. Do not get in eyes or on clothing. Harmful if swallowed. May irritate skin. For prolonged use, wear gloves.Practical Treatment: If in eyes: Remove contact lenses and rinse with plenty of water for at least 15 minutes. If swallowed: Drink a glass full of water. In either case: Call a physician. If contact with skin: Immediately remove contaminated clothing and wash skin thoroughly with water. Physical and chemical hazards: Strong oxidizer. Do not mix with other household chemicals. To do so will release hazardous gases.

Refer to MSDS for Additional Information.

1:10 Bleach SolutionContents: Active ingredients: Sodium Hypochlorite.........0.525% Inert Ingredients...............94.75%WARNINGS: Precautionary Statements: Hazard to humans. Causes substantial and temporary eye injury. Do not get in eyes or on clothing. Harmful if swallowed. May irritate skin. For prolonged use, wear gloves.Practical Treatment: If in eyes: Remove contact lenses and rinse with plenty of water for at least 15 minutes. If swallowed: Drink a glass full of water. In either case: Call a physician. If contact with skin: Immediately remove contaminated clothing and wash skin thoroughly with water. Physical and chemical hazards: Strong oxidizer. Do not mix with other household chemicals. To do so will release hazardous gases.Refer to MSDS for Additional Information

1:14 Bleach SolutionContents: Active ingredients: Sodium Hypochlorite.........0.56% Inert Ingredients...............94.75%WARNINGS: Precautionary Statements: Hazard to humans. Causes substantial and temporary eye injury. Do not get in eyes or on clothing. Harmful if swallowed. May irritate skin. For prolonged use, wear gloves.Practical Treatment: If in eyes: Remove contact lenses and rinse with plenty of water for at least 15 minutes. If swallowed: Drink a glass full of water. In either case: Call a physician. If contact with skin: Immediately remove contaminated clothing and wash skin thoroughly with water. Physical and chemical hazards: Strong oxidizer. Do not mix with other household chemicals. To do so will release hazardous gases.Refer to MSDS for Additional Information.




Appendix XII-B Clorox® Bleach Dilutions

Regular (Old Formula) Clorox®, 5.25%Dilution Mix Ratio Mix Ratio Chlorine % Chlorine parts

per million (ppm)

1:10 1 cup bleach: 9 cups water

240 mls bleach: 2160 mls water

0.525% 5000 ppm

Regular Concentrated (New Formula) Clorox®, 8.25%Dilution Mix Ratio Mix Ratio Chlorine % Chlorine ppm1:14 1 ¼ cup bleach (10

oz.): 1 gallon water300 mls bleach: 3840 mls water

0.56% 5600 ppm

***NOTE Centers for Disease Control and Prevention

recommends a hypochlorite-based solution of 5,000 ppm of available chlorine to kill Clostridium difficile bacterial spores.

A 1:10 dilution of the new formula of concentrated bleach is equivalent to 7831 ppm

Diluted bleach expiration – In an opaque container 30 days In a clear container 24 hours

NM approved PDI Germicidal bleach wipes and Clorox® wipes are acceptable to use, (≥5000 ppm of available chlorine)

OSHA recommends fresh bleach solution mixed daily (every 24 hours), Use an unopened bottle of bleach every 30 days for preparing diluted bleach. Once opened,discard after 30 days. Date and label each bottle according to policy. (website accessed 2/20/18)


Appendix XIII

Guidelines for Reprocessing of Single Use devices by Third Party Vendors

Reprocessing - Reprocessing includes all the steps performed to make a contaminated reusable or single-use device patient ready. The steps may include cleaning, functional testing, repackaging, relabeling, disinfection or sterilization

Selection of ProductsNebraska Medicine, in conjunction with the contracted vendor, will determine those medical devices which may be reprocessed. Only approved devices will be accepted from the reprocessor.

Departments will work with the contracted vendor representatives to ensure compliance with collection of devices for reprocessing and appropriate utilization of reprocessed devices that are returned to the facility. Vendor SelectionNebraska Medicine may use a third party reprocessor for the purposes of reprocessing single use medical devices. The third party reprocessor must have authorization to reprocess medical devices through the FDA. Third party reprocessing vendors must be approved by the Department of Infection Control and Epidemiology.

The reprocessing service will be contracted with FDA registered vendor(s) that operate in accordance with FDA regulations.

Adverse OutcomesAny problems or adverse outcomes related to a reprocessed device shall be immediately brought to the attention of Infection Control and Epidemiology by the department who opened the product.

Definitions used in Reprocessing Medical device reprocessing - is the process of decontamination, cleaning, functional

testing, inspection, packaging, and appropriate disinfection or sterilization as required of medical devices that have been labeled by the original manufacturer as single use.

Cleaning - Removal of all foreign material from objects (e.g., removal of grossly visible body fluids from endoscope surfaces).

Disinfection – A process that eliminates many or all microorganisms except bacterial spores.

Expired – Devices that are unopened and have exceeded the sterility life recommended by the original manufacturer.

Opened-but-unused – Opened-but-unused devices are single-use, disposable devices whose sterility has been breached or compromised, or whose sterile package was opened but not used on a patient, that is, they have not been subjected to possible contamination by blood or body fluids.

Reprocessing – Reprocessing includes all the steps performed to make a contaminated reusable or single-use device patient ready. The steps may include cleaning, functional testing, repackaging, relabeling, disinfection or sterilization.


Re-sterilization – Re-sterilization is the application of a terminal process designed to remove or destroy all viable forms of microbial life, including bacterial spores, to an acceptable sterility assurance level, to a device that has previously undergone a sterilization process.

Single-use device – A single-use device, also referred to as a disposable device, is intended to be used on one patient during a single procedure. The labeling may or may not identify the device as single use or disposable and does not include instructions for reprocessing.

Sterilization – A process that completely eliminates or kills all microorganisms.

Used – Devices that have been in contact with, or exposed to, a patient or blood and/or body fluids in the course of patient care.

Vendor/Reprocessor – Commercial entity contracted by Nebraska Medicine to provide reprocessing services.


Appendix XIV

Electronic Charting Device Cleaning and Disinfection Guideline

Research has illuminated the fact that computer keyboard/mouse are frequently contaminated by potential pathogens and may play a role in the pathogenesis of healthcare associated infections. In order to decrease the risk of transmission of pathogens from keyboards, mice and other electronic devices to patients, such devices will be disinfected at regular intervals.

Stationary computers, Workstations on Wheels (WOW), barcode scanners and accessories are considered contaminated and hand hygiene should be performed before and after use. Disinfection of electronic charting devices will be performed according to the following schedule and procedure:

1. Stationary computer keyboards/mice in patient care areas will be disinfected once daily and when visibly soiled by Environmental Services (EVS) staff using a pre-moistened (not dripping) quaternary disinfecting wipe in combination with friction to remove contamination. Keyboards with covers will be cleaned in the same manner. Unit personnel will clean/disinfect keyboards on an as needed basis and when visibly soiled.

2. Keyboards/mice associated with WOWs will be disinfected using the above procedure prior to the start of each shift and when visibly soiled by Nursing staff. Additionally, WOW carts, barcode scanners, and related accessories (e.g., batteries, cords, carts, stylets, etc.) will be disinfected prior to the beginning of each shift, when visibly soiled and upon exit from an isolation room. If at all possible the WOW and associated accessories should be considered dedicated equipment for an isolation patient.

3. Routine disinfection of WOW includes wiping all surfaces (excluding the monitor) in combination with friction as needed to remove visible contamination. Surfaces include keyboard/mouse, top and bottom of outer shell, handle, cart, scanner, and related accessories (e.g., batteries, cords, carts, stylets, etc.) using hospital approved quaternary wipes. Disinfection of the cart should focus on horizontal surfaces and handles

4. NOTE: Stationary and WOW computer monitors and barcode scanner lenses will be cleaned using pre moistened alcohol wipes ONLY as quaternary disinfectants are damaging to the surface of monitors and lenses.

Cleaning Stationary Computers and WOW After Gross Soilage If the stationary computer or WOW and accessories (cart or scanner) are subjected to gross soil age or major amounts of blood and body fluids (vomit, major blood spill, chemical spill, fecal matter) the following protocol should be observed:

1. Stationary computers grossly soiled will be cleaned by Environmental Services (EVS).2. The outside of the device should be cleaned with a cloth moistened with soap and water (the cloth

should be moist, but not saturated or dripping, so as not to damage the device) followed by disinfection with a cloth moistened with bleach or a phenolic based cleanser. Alternately, a bleach wipe can be used.

NOTE: Phenolic cleansers should not be used in proximity to infants.

3. If the device or cart requires repair, the device must then be labeled with a biohazard tag and sent to Biomedical Instrumentation for inspection. Contact Biomedical Instrumentation at 552-2068 or after hours on-call pager 888-0800 to pick up the device at the front desk (after it has been cleaned) by the unit reporting the contamination.


NOTE: It is very important to have the device picked up by Patient Care Equipment andnot left in the dirty utility room, so that the devices are processed appropriately, and notlost. If there are any questions about the decontamination process, contact the Managerof Support Operations at 552-3153 or the Infection Preventionist available via web on call.

Transportation of WOW and Accessories

1. If the WOW or scanner is present during patient transportation, it should be protected from contamination by placing on a clean towel or in a clean bag.

2. Care should be taken when using the scanner to not set the devices down on contaminated surfaces. When it is possible, the scanner should be set on a clean (recently disinfected) surface, or clean linen.

3. The batteries for the WOW should be disinfected with alcohol wipes before placing on the battery charger.

4. Storing supplies and accessories (e.g., booklets, baskets, supplies) on the WOW carts could impede the disinfection process, and is strongly discouraged.

5. The neuron units must be powered down and unplugged prior to disinfection. Biomed should be contacted for questions regarding the power-down process.


Appendix XV

Hospital Owned Smart Phones

GuidelinesHospital owned smart phones shall be cleaned and disinfected at the end of each shift and as needed (i.e., when visibly soiled, after use in an isolation room, or whenever contamination is suspected etc.).Use Alcohol, bleach wipes, or AF3 Sani wipes to clean smart phones and batteries. Do not apply liquid directly to the phone itself. Dampen a soft cloth or use pre-moistened wipes to gently wipe the unit. Do not allow liquid to pool around the display window. Allow the phone to air dry before use.


Appendix XVI

Toy Cleaning Guidelines

General:Toy cleaning should consist of washing with soap, water and wiping with an approved Low Level Disinfectant (LLD). Toys should rinsed with tap or sterile water to remove the disinfectant residue. A quaternary ammonium or diluted bleach is preferred over a phenolic solution. Phenolic cleaners should not be used for the cleaning of toys for small children due to potential neurotoxicity.

a) General use toys should be easily cleanable. Toys that cannot be cleaned (e.g., stuffed animals) should be given to the child to keep as their personal property or discarded.

b) Toys designed to be played with by several children simultaneously are discouraged.c) Toys (including riding toys) visibly soiled by body fluids will be cleaned before use by another

child. d) Common and/or waiting area toys should be cleaned daily according to the guidelines as

previously stated in this policy. e) Environmental Services (EVS) will be responsible for the cleaning of smaller toys that are

placed in a container and clearly labeled “Dirty”. Large toys, mats and toys on wheels will be cleaned in discharged patient rooms by EVS. Due to their size, these items should not be placed in the soiled utility area. In areas where EVS is not assigned, the manager is responsible for designating responsible personnel.

f) Cleaned toys will be placed in a container that is clearly labeled as “Clean” before returning to patient use. Larger-size cleaned toys will be placed in the clean toy room by EVS staff. Departmental managers (or designees) are accountable for ensuring that the toys in their departments are being cleaned as indicated in this policy.

g) All cloth seat covers from swings, exersaucers, bouncy chairs, etc. will be washed after each patient use and as needed. The seat covers will be washed in a washing machine with detergent and hot water, and dried in a dryer on high heat. The seat covers will be returned in a closed plastic bag to roo 6217. This process is completed by Child Life or volunteers.

Playroom Toys and Equipment:a) Playroom tables, chairs and mats are to be cleaned and disinfected daily by Environmental

Services (or designated personnel). Soap and water is used for visible soiling. Disinfection is achieved by wiping with an approved LLD, and should be done daily.

b) Walls and cupboard doors should be washed when there is visible soiling.c) Equipment (i.e. Video machines, VCR’s, computers) on carts and shelves will be cleaned by

designated personnel at least twice a month using soap, water and wiping with an approved LLD. A quaternary ammonia or bleach solution is preferred over a phenolic.

Isolation Room/Long Term Hospitalization:a) Toys removed from isolation rooms are to be placed in appropriately labeled “dirty toy” container

and cleaned as outlined above.b) Toys used by an individual child for a long period of time, will be cleaned when visibly soiled,

when the toy is removed from the room, and at the time of discharge.c) Toys used in Enhanced Contact isolation or long-term isolation rooms will require approval of

ICE prior to removal, cleaning, and sharing with other patients.

Immunocompromised Patients:a) New toys should be used whenever possible.b) Audio visual equipment, computers, tables, chairs and any other shared equipment must be

wiped down with a LLD before being brought in to the room.


Appendix XVII

Electronic Thermometers Guidelines

Disinfecting the ThermometersA hospital approved low-level disinfectant should be used to wipe all surfaces of the thermometer, handle, probe(s), and recharger. Disinfection should be preceded by gross debris removal with soap and water when needed per manufacturer’s instructions for use.

When electronic thermometers are part of or attached to other pieces of equipment (e.g., Dynamap), then the frequency of cleaning the whole piece of equipment shall occur between patient use and when visibly soiled

Electronic thermometers that are patient/bed dedicated will be cleaned at the following intervals: When a patient is discharged and/or different patient is assigned to the bed Whenever visibly soiled/contaminated After rectal use

Thermometers/probes used for rectal temperatures should be patient dedicated, and cleaned thoroughly following each patient use.


Appendix XVIII

Bottled Water Cooler Policy

Bottled water coolers must be properly cleaned every six months by the contracted bottled water company or designated personnel. The following steps should be used to complete the cleaning procedure when the bottle is changed:1. Unplug the cooler from the electrical outlet. Remove the empty bottle. Check to see if

there is a baffle (found between the cooler top and the reservoir). If there is one, remove it. If the cooler is electric, check for a plastic top and remove it.

2. If there is water remaining in the cooler, empty the reservoir by draining it into a container of your choice. Place a sign on the cooler to alert people not to drink water from the cooler during the cleaning process.

3. Prepare a cleaning solution in an empty clean container using one teaspoon of bleach for each gallon of water. The minimum volume to be prepared should be one gallon. Some coolers may require more than one gallon of cleaning solution.

4. Fill the reservoir with the prepared solution. 5. Wearing gloves, use a long-handled brush to clean the inside of the reservoir with the

cleaning solution. Scrub the baffle and place it upside down in the reservoir. Clean the faucet(s), body, handle(s) and outlets.

6. Let the cleaning solution stand in the reservoir for five minutes.7. Rinse and dry the baffle. Drain all the cleaning solution from the cooler through the faucet(s)

and replace the baffle in the reservoir. Using clear, clean water, rinse the reservoirthoroughly. Drain the water through the faucet(s) several times until there is no evidenceof a chlorine taste and/or odor. Replace the plastic top.

8. Plug the cooler back in to the electrical outlet and allow at least twenty minutes for the water to reach the appropriate temperature. Document cleaning on “Cleaning Log” service sticker on the back of the cooler.

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Section: CONTROL (IC) SURVEILLANCE, PREVENTION