Point of Use (ANSI/AAMI 6.2-6.3)

Gross contaminant is removed with water

Instruments are sorted: Sharps removed

Instruments are sorted: Instruments placed back in original container.

Instruments are sorted: un-used instruments placed in bottom of basket.

Instruments are sorted: Towel placed on top of unused instruments

Instruments are sorted: Used instruments placed on top of towel.

Enzymatic pre-cleaner applied to used instruments.

Water moistened towel placed over instruments.

No other non-compliances observed.

Soiled Transport (ANSI/AAMI 6.4)

Soiled items are contained.

Soiled items are transported covered.

Transportation devices is labeled e.g. Soiled/Biohazard.

No other non-compliances observed.

Decontamination

Environment

Temperature is 16 - 18 deg C (60-73F) (ANSI/AAMI 3.3.6.5)

Humidity - Not to exceed 60%. (ANSI/AAMI 3.3.6.6)

Air Exchanges - 10 per hour. (ANSI/AAMI 3.3.6.4)

Negative air pressure. (ANSI/AAMI 3.3.6.4)

Area is clean. (ANSI/AAMI 3.4)

Surfaces/cabinets are nonporous. (ANSI/AAMI 3.3.7.1)

Lighting is sufficient. (ANSI/AAMI 3.3.6.7)

Temperature & humidity is checked and documented daily. (ANSI/AAMI 3.3.6.5-3.3.6.6)

Staff know how procedure for documenting and reporting out of range readings.

Soiled and clean areas are separated physically or procedurally. (ANSI/AAMI 3.3.7.1)

Handwashing sink is separate from decontamination sink. (ANSI/AAMI 3.3.6.8)

Handwashing sink has hands free operation. (ANSI/AAMI 3.3.6.8)

Handwashing sink is located next to exit door. (ANSI/AAMI 3.3.6.8)

Area is secure from general traffic and labeled appropriately. (ANSI/AAMI 3.4)

Chemistries

Water level is sufficient to submerge 1 tray. (ANSI/AAMI 7.5.6)

Solutions are diluted appropriately. (ANSI/AAMI 7.3)

Sinks are marked.

Appropriate solutions are utilized - Manual - Enzymatic for pre-cleaning. (ANSI/AAMI 7.5.3.2)

Appropriate solutions are utilized - Manual - Detergent for wash. (ANSI/AAMI 7.5.3.2)

Appropriate solutions are utilized - Manual - Low foaming/sudsing. (ANSI/AAMI 7.5.3.2)

Appropriate solutions are utilized - Manual - Treated water for final rinse. (ANSI/AAMI 7.5.3.2)

No other non-compliances observed.

Process Flow

Items are pre-cleaned. (ANSI/AAMI 7.3)

Appropriate items are submerged and cleaned under water to prevent aerosolization. (ANSI/AAMI 7.6.3.2)

Appropriate brushes are available and in good condition. (ANSI/AAMI 7.5.6)

Reusable brushes are cleaned on a routine basis - staff can articulate how & when. (ANSI/AAMI 7.5.6)

Disposable brushes are not reused. (N.2.2.7)

Lumens are brushed and irrigated. (ANSI/AAMI 7.5.3.2)

Lumened instruments are cleaned according to MIFUs (may include borescope and/or ultrasonic methods).

Instruments are disassembled per manufacturer's recommendations. (ANSI/AAMI 7.2.2)

Containers are cleaned per manufacturer's recommendations. (ANSI/AAMI 7.5.9)

Manufacturer's cleaning instructions are available for all items. (ANSI/AAMI 7.5.6)

TOSI (Test Object Surgical Instrument) is a test used to demonstrate the effectiveness of the washing/ultrasonic cleaning process in addition to quality controls performed on temperatures and/or detergents. It uses a synthetic soil developed to mimic the properties of blood and other proteinaceous contaminants but is sterile and will not contaminate instruments being processed.

Verification of ultrasonic cleaning process is performed (TOSI). (ANSI/AAMI 7.5.5)

Verification of washer cleaning process is performed (TOSI)(ANSI/AAMI 7.5.5)

Verifications of cleaning processes are logged/documented.

Safety

Approved eyewash station is available and in working condition. (ANSI/AAMI 3.3.8)

If eyewash station is attached to a sink hot water is disabled

Eyewash station is tested weekly and documented

Eyewash station is located in decontamination or within 10 seconds of chemicals

Staff know what MSDS is and where to find them. (ANSI/AAMI 4.2.2)

All chemicals have an MSDS on file

Staff know facility procedures for: Handwashing (ANSI/AAMI 4.2.2)

Staff know facility procedures for: Bloodborne Pathogens Exposure (ANSI/AAMI 4.2.2)

Staff are wearing appropriate PPE: Waterproof gown with sleeves.

Staff are wearing appropriate PPE: Decontamination gloves (not procedural) (ANSI/AAMI 4.5.2)

Staff are wearing appropriate PPE: Disposable cap (ANSI/AAMI 4.5.2)

Staff are wearing appropriate PPE: Faceshield/goggles (ANSI/AAMI 4.5.2)

Staff are wearing appropriate PPE: Mask (ANSI/AAMI 4.5.2)

Staff are wearing appropriate PPE: Shoe covers (ANSI/AAMI 4.5.2)

No other non-compliances observed.

Assembly - Prep & Pack

Environment

Temperature - 20 - 23 deg C ( 68 - 73 deg F) (ANSI/AAMI 3.3.6.5)

Humidity - 30% - 60% (ANSI/AAMI 3.3.6.6)

Air Exchanges - 4 per hour (ANSI/AAMI 3.3.6.4)

Positive Air Pressure (ANSI/AAMI 3.3.6.4)

Area is clean (ANSI/AAMI 3.4)

Surfaces are non-porous and easy to clean (ANSI/AAMI 3.3.7.2)

Lighting is sufficient (ANSI/AAMI 3.3.6.7)

Temp & Humidity is checked and documented daily -3.3.6.6(ANSI/AAMI 3.3.6.5-3.3.6.6)

Staff know procedure for documenting and reporting out of range readings.

Work Area

Is clean and organized. (ANSI/AAMI 3.4)

Contains appropriate supplies to reduce time away from assembly area: (ANSI/AAMI 3.3.7.2)

Lighted magnification is available.

Set Assembly

There is a computer tracking system in place and is used appropriately

Set sheets are accurate, organized and easy to read

Containers/Baskets are labeled to match set sheets

All instruments are inspected for: Sharpness (ANSI/AAMI 8.4.3)

All instruments are inspected for: Functionality (ANSI/AAMI 8.4.3)

All instruments are inspected for: Insulation integrity (ANSI/AAMI 8.4.3)

All instruments are inspected for: Cleanliness (especially lumens, bone instruments)(ANSI/AAMI 8.4.3)

All instruments are inspected for: Dryness (ANSI/AAMI 8.4.3)

Instruments are disassembled/assembled per manufacturer's recommendations (MIFUs) (ANSI/AAMI 8.4.1)

Lumens are flushed with sterile or distilled water (ANSI/AAMI 8.3.8)

Peel pouches are not placed in instrument sets (ANSI/AAMI 8.3.4)

Indicator/Integrator is placed in challenging location and all levels of multi-level trays (ANSI/AAMI 10.5.2.2.2)

Packaging
Containers/baskets are inspected for: (ANSI/AAMI 8.4.3)

Sets are wrapped appropriately. (ANSI/AAMI 8.3.1)

Filters and locks are placed appropriately. (ANSI/AAMI 8.3.3)

Sets are labeled appropriately - wrapped items are labeled on tape. (ANSI/AAMI 8.3.2)

Peel Pouches (ANSI/AAMI 8.3.4)

Are appropriate size.

Are sealed appropriately

Double peel pouches are appropriate size not folded

Peel pouches are placed plastic to plastic and paper to paper

Peel pouches are correct modality.

Are labeled appropriately with accurate descriptions

Are labeled on the plastic side not the paper side.

Manufacturers' Instructions for Use (MIFU)

Wrap/Container/Peel Pouch IFUs available (ANSI/AAMI 8.2)

Peel Pouch validation for double peel pouching available (ANSI/AAMI 8.3.4)

Safety

Sets adhere to AAMI recommended weight limit of 25lbs. (ANSI/AAMI 8.4.2)

Work Stations are at appropriate heights (ANSI/AAMI 3.3.7.1)

Staff assembling manual cleaned instruments are wearing gloves

Staff inspect sets for sharps prior to reaching into the baskets (ANSI/AAMI 7.4.1)

Proper body mechanics are used when lifting sets and pushing carts (ANSI/AAMI 6.5.4)

No other non-compliances observed.

Sterilization

Equipment Maintenance (ANSI/AAMI 9.4)

Sterilizers are clean and in working order

Sterilizers are cleaned on a routine basis per manufacturer's recommendations (MIFU)

Preventative maintenance is performed per manufacturer's recommendations

Preventative maintenance is documented and available for review

Daily maintenance is performed per manufacturer's recommendations (MIFU):

Printers are in working order for accurate cycle verification.

Loading Sterilizer (ANSI/AAMI 8.5.1)

Items w/similar sterilization parameters are placed in the same load

Sets are positioned to facilitate air removal, steam penetration and drying

Containers are placed beneath wrapped items and peel pouches (ANSI/AAMI 8.5.6)

Peel Pouches are placed plastic to plastic and paper to paper (ANSI/AAMI 8.5.2)

Peel Pouches are positioned on their side not flat

If liners are used they are approved for use - manufacturer's IFUs on file (ANSI/AAMI 8.5.1)

Difficult to dry sets are not placed over the drain

Sets are placed flat not on their sides (ANSI/AAMI 8.5.3)

Packages are checked for: (ANSI/AAMI 8.3.1)
Load stickers/labels "Lot Control Identifier" are applied containing: (ANSI/AAMI 10.3.1)
Sterilizer Records (ANSI/AAMI 10.3.2)
Each load documentation includes:
Cycle Selection (ANSI/AAMI 8.6.1)

Appropriate cycles are posted near sterilization equipment

All items have manufacturer's recommendations on file

Cycle Verification

Physical Parameters are verified at end of cycle and tape is initialed/signed (ANSI/AAMI 10.3.2)

CI, BI, PCD are opened, read, and documented prior to release of load (ANSI/AAMI 10.6.1)

Load Removal (ANSI/AAMI 8.8)

Load is placed in a low traffic area

Load is placed in an area away from vents, doors, windows, drafts

Load is not touched until items are cool

Loads are not released prior to cooling - if removed they are opened for flash

Documentation procedure is in place for early release of implants

Immediate Use Sterilization

Devices sterilized for immediate use should have the same level of cleaning and preparation as instruments being terminally sterilized. The most current AORN recommendations state: "Immediate-use sterilization" should be performed only if all of the following conditions are met:

The device manufacturer's written instructions on cycle type, exposure times, temperature setting, and drying times (if recommended) are available and followed.

Items are disassembled and thoroughly cleaned with detergent and water to remove soil, blood, body fats, and other substances.

Lumens are brushed and flushed under water with a cleaning solution and rinsed thoroughly.

Items are placed in a closed sterilization container or tray, validated for flash sterilization, in a manner that allows steam to contact all instrument surfaces.

Measures are taken to prevent contamination during transfer to the sterile field.

No other non-compliance observed.

Sterile Storage

Environment

Temperature - 24 - 29 deg C ( 75 - 85 deg F) (ANSI/AAMI 8.9.2)

Humidity - Not to exceed 70%

Air Exchanges - min 4 per hour

Positive Air Pressure

Area is clean (ANSI/AAMI 3.4)

Surfaces are non-porous (ANSI/AAMI 3.3.7.2)

Temp & Humidity is checked and documented daily (ANSI/AAMI 3.3.6.5-3.3.6.6)

Staff know procedure for documenting and reporting out of range reading

Shelving / Bins

8" - 10" from floor (ANSI/AAMI 8.9.2)

18" below ceiling or sprinkler heads

2" from outside walls

If open shelving bottom shelf has barrier or solid shelf

Shelves and bins are free of dust

Shelves / bins are labeled with locations, set and peel pouch names

Shelves are organized to facilitate quick location of sets

There is an index for set location

Sets

Sets are placed to protect the integrity of packaging (ANSI/AAMI 8.9.2)

Stacked sets do not compromise sterility (ANSI/AAMI 8.9.2)

Items are rotated 1st in 1st out (ANSI/AAMI 8.9.3)

Items are rotated based on packaging IFUs validated Shelf Life (ANSI/AAMI 8.9.3)

If dust covered:
Sterile Delivery (ANSI/AAMI 8.10.1)

Items are cool prior to delivery

Package integrity is maintained during transport

Delivery Cart is clean and functional (ANSI/AAMI 8.10.2)

Sterile items are covered for transport

Safety

Appropriate eye protection is available when handling chemicals (ANSI/AAMI 4.5.2)

Appropriate Gloves are worn when handling chemicals

Proper body mechanics are used when lifting sets and pushing carts (ANSI/AAMI 8.4.2)

Mittens are worn for burn protection (ANSI/AAMI 8.8.1-8.8.2)

Alarms for EtO are in place and in working order

Staff are monitored on a routine basis for EtO exposure

Sterilizer Testing

DART Warm-up performed prior to testing per manufacturer's instructions

Bowie Dick / DART

Performed daily on sterilizers programmed with prevacuum cycle (ANSI/AAMI 10.7.6.1)

Bowie Dick/Dart is placed horizontal on bottom shelf over drain (ANSI/AAMI 10.7.6.3)

Procedure in place for failed tests (ANSI/AAMI 10.7.6.5)

Staff know procedure for failed tests

3 tests are performed after installation, major repairs, re-location (ANSI/AAMI 10.8.1)

Leak Test performed weekly per manufacturer's instructions

Biological Indicator - Process Challenge Device - PCD

Testing is performed minimally weekly preferably daily (ANSI/AAMI 10.5.3.2)

Each type of cycle is tested - per manufacturer's instructions (ANSI/AAMI 10.5.3.2)

PCD is placed horizontal on bottom shelf over drain (ANSI/AAMI 10.7.2.2)

A PCD is used for each wrapped load (ANSI/AAMI 10.5.4)

BI is incubated in a timely manner (ANSI/AAMI 10.7.2.3)

A control is incubated daily (ANSI/AAMI 10.7.2.3)

Results are read and documented daily in a timely manner. (ANSI/AAMI 10.7.2.3)

Procedure in place for failed tests. (ANSI/AAMI 10.7.5)

Staff know procedure for failed tests.

3 tests are performed after installation, major repairs, re-location. (ANSI/AAMI 10.8)

Incubators are maintained per manufacturer's recommendations

Recall Policy and Procedure

Recall procedure in place for positive tests and wet loads (ANSI/AAMI 10.11.2)

Staff know recall policy and procedure

Policy and Procedure is based on AAMI Guidelines and facility IC and Risk Management requirements"

No other non-compliances observed.

Staffing Considerations

Responsibility for performing sterilization processes should only be assigned to personnel that are competent in all aspects of disinfection and sterilization procedures as well as safety precautions. Staff should have documented competencies in:

All phases of decontamination: sorting, disassembly/reassembly, manual and mechanical cleaning methods, microbicidal processes, equipment operation, standard/transmission-based precautions, and engineering and work-practice controls

The operation of all sterilizing systems.

The principles of sterilization and infectious disease transmission; infection control, and all aspects of sterilization.

Staff safety related to medical device processing and sterilization.

Any other opportunities for improvement.

General

Loaner Trays

Sterile processing is notified of loaners prior to receiving them.

Instruments are received in facility at least two working days (48 hours) for existing loaner sets and three working days (72 hours) for new sets before scheduled case.

Inventory list is provided/available.

FDA-cleared manufacturer written instructions (IFU) are available for cleaning, packaging and sterilization processes.

Inventory and quality check is completed.

Multiple trays are numbered and labeled (with patient and surgeon).

Trays do not exceed 25 pounds.

All instruments are in good condition, with no rusting or pitting.

Container is in good condition, with no rusting, tape, residue, etc.

Inventory performed prior to returning instrumentation.

Start of the SPD Day Cleaning

Unnecessary equipment/supplies are removed.

Damp dust from the top to bottom: Sterilizers, All reachable flat surfaces (furniture, work tables, shelving, countertops, sinks.

SPD Terminal Cleaning

All floors wet vacuum or single-use mop.

Work tables

Countertops

Sinks

Pass-through window

Computer accessories

Light switches

Door handles and push plates

Telephones and mobile communication devices

Computer accessories

Chairs and stools

Trash and linen receptacles

Housekeeping is performed on a routine scheduled basis (ANSI/AAMI 3.4)

Traffic control limits entry to SPD (ANSI/AAMI 3.2.4)

Staff can describe what IFUs/MIFUs are and where they can find the.

Attire is hospital approved - jewelry is kept to a minimum - no false nails etc. (ANSI/AAMI 4.4-4.5.1)

Personal objects are not stored in SPD

Disposable/Single Use Devices are not reprocessed (ANSI/AAMI 5.3)

Quality checkpoints are in place, documented, assessed and reported (ANSI/AAMI 11.2.1)

Non-conformities are reported by the customer, documented, assessed and reported

Policy and Procedures are up to date and are based on Regulatory Guidelines

Policy and Procedures are adhered to

Staff know and understand Policy and Procedures

Documentation is complete (ANSI/AAMI 10.3.2)

Audits are performed on Documentation to ensure logs are complete and accurate (ANSI/AAMI 11.2.1)

Competencies are in place and performed on a routine basis (ANSI/AAMI 4.3.1)

There is a routine training and in-service plan in place and adhered to (ANSI/AAMI 4.3.1)

Reports of processing outcomes are sent to Infection Prevention and Control Periodically (i.e., IUSS utilization; wet packs, other PI).

No other non-compliances observed

Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.