Tracing Sterilization April 26, 2019 Mary Cole, MSN, CJCP, CIC Consultant Joint Commission Resources, Inc.

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IC.02.02.01 Medical Equipment, Devices, and Supplies The hospital reduces the risk of infections associated with medical equipment, devices, and supplies – implements infection prevention and control activities

IC.02.02.01 Medical Equipment, Devices, and Supplies Low level disinfection Intermediate and high level disinfection and sterilization Disposal Storage Reprocessing single-use devices

Spaulding Classification

#1 most frequently cited clinical standard #1 issue in Immediate Threat to Life

Sterilization

Approach to IC-Related Standards Regulation (i.e. OSHA) Condition of participation – if deemed Manufacturer instructions Evidence-based standards or guidelines Consensus documents or position papers Incorporate into facility-based risk assessment and policy

Point of Use Procedure completed Precleaning with water or a product recommended for pre-cleaning with manufacturer’s instructions- for-use followed, that is applied at point-of-use to remove blood, body-fluids, and bioburden from items that are to be re-processed based on manufacturer’s instructions-for-use and evidence- based guidelines

Transport To Decontamination Area Items are contained to protect the transporter and others from contents within the container Items are to be kept moist during transport to prevent hardening of blood, body fluids, or bioburden The type of container used is based on what is being transported All containers must be leak-proof, puncture-proof, and labeled as biohazardous Examples: bins with lids, impermeable bags, etc.

Transport to Decontamination Area Frequent Findings Surgical instruments were not transported from the point of use to the soiled utility room in a leak proof puncture resistant container with the biohazard symbol or color red in accordance with policy. Facility did not follow manufacturer’s instructions for use and/or evidence-based guidelines identified by the organization to transport soiled instruments Soiled surgical instruments were not transported in accordance with facility policy. Staff were not following the organizations defined step by step process for handling and transporting soiled instruments for example: Staff were transporting dirty instruments in an open tray covered with a towel. This is a paraphrases of frequent survey findings

Transport to Decontamination Area What can you do to ensure compliance? Ensure compliance with OSHA regulations Review manufacturer instructions for specialty equipment Choose evidence based guidelines and standards carefully Perform a risk assessment Write a policy that can be implemented and enforced based on regulation, manufacturer instructions, and chosen evidence based guidelines and national standards Standardize training and competency assessment for staff using the instruments, regardless of setting Hold staff accountable This is a paraphrases of frequent survey findings

Clarification From SIG

Clarification From SIG

Environmental Controls Temperature AAMI: 18°C to 24°C [65°F to 75°F] Humidity AAMI: 30% to 60% Airflow © Sylvia Garcia-Houchins Physical factors such as temperature, humidity, air exchanges, ventilation exhaust, adequate space and equipment can also affect the disinfection and sterilization process. Physical properties of CSP and decentralized reprocessing areas should meet local building code requirements as well as specific requirements established by the manufacturer’s of equipment and supplies used in these locations. In the absence of local guidance the following physical areas are recommended. © Sylvia Garcia-Houchins © Sylvia Garcia-Houchins

Ventilation Risk point Teach staff to own their work area Areas can pass regular testing and be non-compliant at survey Teach staff to own their work area Expected airflow Testing process Identify weaknesses in the environment Identify variables in workflow

Cleaning Detergent dilution Manual Ultrasonic Follow IFU’s Remove all parts Rinse Inspect

Cleaning Agents Follow IFU’s Volume and temperature of water is essential to the efficacy of the product Change solution after every use Monitor water temperature per IFU’s

In Decontamination Setting Personal Protective Equipment (PPE) is worn and includes: Hair covering/cap Face mask/shield Fluid resistant gown Gloves used should be durable to prevent tearing and leaking of chemicals and/or contaminated fluids when the user’s hands are under water Note a distinct flow and separation of dirty and clean processes that minimizes the risk of cross- contamination

Decontamination Cleaning Process Demonstrate Labeling of sinks Standard work with low/no variation Job aids

Decontamination Manual and or mechanical Brushes reusable or disposable Ensure entire instrument is disassembled, cleaned and rinsed including valves, channels, connectors and all detachable parts in accordance with manufacturer’s instructions © Sylvia Garcia-Houchins

Separation of Clean and Dirty

Preparation of Instruments Cleaned Dried Inspected for cleanliness, flaws, and damage, assembled Packaged according to the manufacturer’s written IFU

Table Top Sterilizers Mostly used in clinics, dental specifically Water quality is very important Review and follow IFU’s

Sterilization The choice of sterilant must be in compliance with manufacturer’s instructions for both the device or instrument and the sterilizer. The sterilization process must be monitored using chemical, biological, and physical indicators as outlined by the manufacturer.

Sterilization Cleaning, maintenance, and record keeping/documentation of sterilizer(s) based on manufacturer’s IFU Cycles of sterilizer – test all cycles that your sterilizer is capable of performing regardless of the cycle you use most often

Steam Sterilization Is the most commonly used process for sterilizing instruments, trays, and cassettes According to the CDC, steam under pressure is the process of choice whenever possible as it is considered safe, fast, and the most cost-effective for health care facilities Steam sterilizers come in many different sizes, and sterilizer cycles can vary among manufacturers.

Steam Sterilization Items to be sterilized must be: Clean and free of protein (blood) or other organic material Packaged so that the steam can penetrate Loaded correctly

How Do You Ensure Proper Sterilization? Physical monitoring Chemical indicators Biological indicators

Air Removal (Bowie Dick, DART) An air removal test designed to detect inadequate air removal in pre-vacuum sterilizers. Air not removed from the sterilizer chamber prevents steam from contacting the items in a load and therefore interferes with sterilization. Follow manufacturer instructions for how to perform the test and frequency of testing. If a sterilizer fails the air removal test, the sterilizer should not be used until it passes inspection by sterilizer repair personnel.

Physical Monitoring Involves checking the sterilizer gauges, computer displays, or printouts Documenting in your sterilization records that pressure, temperature, and exposure time have reached the levels recommended by the sterilizer manufacturer Since these parameters can be observed during the sterilization cycle, this might be the first indication of a problem

Chemical Indicators (CI) Important to note that CIs alone do not confirm that an item is sterile Uses sensitive chemicals that change color when exposed to high temperatures or combinations of time and temperature External and internal indicators Should be used for every item sterilized regardless of type of container or packaging Indicators should be placed in the location specified by the indicator and container manufacturer

Chemical Indicators A chemical indicator should be used inside every package to verify that the sterilizing agent has penetrated the package and reached the instruments inside If the internal chemical indicator is not visible from the outside of the package, an external indicator should also be used. Chemical indicators help to differentiate between processed and unprocessed items, eliminating the possibility of using instruments that have not been sterilized

Biological Indicators (BI) Provide a defined resistance to the sterilization process BI results must be acceptable in order for an operator to use the sterilizer to produce sterile goods AAMI recommends running a biological a minimum of once per week, many facilities run one every day

Biological Indicators (BI) Run with all loads containing an implantable device May also be adversely affected by air leaks and air that the vacuum system has failed to remove

Common Findings With Sterilization Not pre-cleaning at point-of-use Quality monitoring parameters (physical, chemical, and biological) not being consistently conducted or documented as per manufacturers’ instructions for use or evidence-based guidelines Approximating use of cleaning products with no means of accurate measurement; not following manufacturers’ instructions for use

Common Findings With Sterilization No documentation reflecting routine cleaning or preventative maintenance of the sterilizer(s) Lack of standardized processes for cleaning the same types of equipment Inconsistent or lack of staff orientation or on-going training on sterile processes

Common Findings With Sterilization Lack of a process to document or follow-up on equipment failures Not following sterilization evidence-based guidelines

Disassembly of Instruments Gaskets should be removed, stopcocks opened, and instruments should be completely disassembled as specified by the instrument manufacturer’s instruction during the cleaning and sterilization process Rib spreader, gomco Risk assessment

Hinged items Hinged items are to be opened to assure access to proper cleaning

Peel Packs Peel packs should be sized to prevent tearing during movement or storage. Items should be packaged to ensure that sterilant can contact all surfaces.

Peel Packs Double peel-packs are used as indicated by the manufacturer instructions for use, with evidence- based guidelines being followed. No folding over of the inner paper/plastic peel pack, as this may prevent the sterilant from contacting the contents of the package Use the proper size pouch for the proper instruments

Peel Pouches Pouches should be sized to prevent tearing during movement or storage. Items should be packaged to ensure that sterilant can contact all surfaces.

What Is Wrong With This Picture? . Photo by Sylvia Garcia-Houchins, RN, MBA, CIC

What is Wrong With This Picture? If double pouching is performed, it must be validated by the manufacturer. Photo by Sylvia Garcia-Houchins, RN, MBA, CIC

Labeling Sterile Products Label should Not compromise the barrier Include Contents Date sterilized Identifier that allows the item to be tracked back to the sterilization load © Sylvia Garcia-Houchins © Sylvia Garcia-Houchins © Sylvia Garcia-Houchins © Sylvia Garcia-Houchins

Reprocessing Single Use Devices IC.02.02.01, EP 5: When reprocessing single- use devices, the organization implements infection prevention and control activities that are consistent with regulatory requirements and professional standards. In other words, before a device intended for one use or use on a single patient during a single procedure can be reprocessed and reused, a third party or a health care facility must comply with the same requirements that apply to original equipment manufacturers.

Reprocessing Single Use Devices Because most health care organizations cannot meet these rigorous requirements, the majority should either use a third party reprocessor that can meet the requirements or choose not to reprocess and reuse SUDs. The organization would benefit from a clearly written policy and the infection preventionist can be a valuable collaborator in developing the policy.

Points to assess Storage of Sterile Trays Segregation of Sterile and Unsterile Visual cues Workflow, Traffic, and Access Control Temperature & Humidity Airflow Alternate storage sites OB ‘Sterile’ Core Hallways

Storage of Sterile Items Protect sterility until ready to use Store to protect packages from dust, moisture, falling on floor Transport only covered, dry packages Handle to protect package integrity Rotate sterile items first in, first out Store and label for effective recall system Expiration date vs. event-related sterilization

Storage Dust covers may be used to protect sterilized items that could be subjected to environmental challenges or excessive handling before use

Storage AAMI recommends sterile items be stored at least 8 inches off the floor 18 inches below ceiling or sprinkler 2 inches from outside wall away from any location where they could become wet

Storage of Critical Devices If open shelves are used, traffic control, ventilation, and housekeeping should be monitored Bottom shelves should be solid to prevent soiling when floors are cleaned Covered or closed cabinets limit dust and are preferred for seldom-used items

Storage of supplies Supplies, including those in rigid containers, should not be stored next to or under sinks, under exposed or open water or sewer pipes, or in any location where they could become wet. All items in clean storage rooms should be clean (no soiled items), and clean items should not be stored in soiled rooms.

Storage of supplies Clean and sterile items should be removed from their external shipping containers before they enter storage areas, because the containers may have been exposed to unknown and potentially high microbial contamination during shipping, and may serve as generators of and reservoirs for dust and vermin Outside shipping containers and corrugated boxes should not be used as containers in sterile storage areas.

IC.02.02.01 EP4 Common Findings With Storage No barrier on bottom shelf Peel pack issues Hang time of scopes outside of policy Instruments outside of or opened peel pack with no clear process

Compliance Tips Review your current processes (tracers) Revise protocols that cover equipment reprocessing effort, including Transporting items to be cleaned Cleaning and decontamination Sterilization Storing or immediate use Review manufacturers recommendations Provide training and ongoing observation

Sterile Processing is a Team Sport Work with Engineering/ Facilities Who monitors temp/humidity/pressure? Do you follow AAMI, AORN, ASHRE, FGI? Is it documented consistently? Can staff speak about it? Do they know who to contact if there is a problem?

Sterile Processing is a Team Sport Can maintenance documents be produced promptly? Who is responsible for checking eye wash stations? What is the condition of the surfaces? (counters, floors, walls)

Sterile Processing is a Team Sport Work with EVS Do they have access areas to clean daily? Who is responsible for cleaning what? (vents) If there is a consistent EVS employee, what about when they are out? Is there a checklist or sign off? Audit process?

Emergency Situations for Early Release Emergency situations should be defined in written guidance, developed in consultation with infection prevention and control, the surgeon, the OR manager, and risk management. Steps should be taken to reduce the frequency of emergency releases of implantable items.

Additional Risks for Reprocessing Immediate Use Steam Sterilization (IUSS) Vendor Trays Emergent and Add-on Cases

Contracted Services Contracted services for equipment / loaner instrumentation How are these services tracked and monitored? Does equipment / loaner instruments arrive in sufficient time to reprocess?

Standardize Work Practices Determine process/best practice – standardize to it Involve frontline staff Develop P&P Train/re-educate Follow-up to assure sustainability and provide feedback

Education and Competencies Upon hire Recommend at least annually Whenever new item or equipment borrowed leased purchased Whenever new policies and procedures are implemented

Education and Competencies Determine frequency of competency and training based on staff turnover, purchasing new equipment or products, or a breach in the process has been identified Random observations Who signs off on competencies? Who signed them off?

Education Training should include: Principles of cleaning, disinfection and sterilization Inspection, preparation, and packaging of instruments Worker safety and use of personal protective equipment (PPE) Manufacturer’s instructions for use Quality control of processes Endoscope model-specific cleaning and disinfection, if applicable

Training and Competency Training is NOT equivalent to demonstrated competency Competency is ability of the individual to perform specific tasks in accordance to the standards that are required

HLD & Sterilization BoosterPak® Available for accredited organizations on the organizations extranet site, including Guest Access Applicable to hospitals, critical access hospitals, ambulatory, and office-based surgery settings Excellent source for teaching and policy development

HLD & Sterilization BoosterPak® Targeted audience: Frontline staff conducting HLD and sterilization Supervisor/manager of HLD and sterilization Infection Preventionists Goal: To ensure HLD and sterilization practices are conducted according to regulatory standards and evidence-based guidelines, to minimize the potential risk of infection to patients

Questions or Comments? Thank you! mcole@jcrinc.com