Principles & Design Considerations for Sterile Processes

© Ron Blank and Associates, Inc. 2008 ®

Please note: you will need to complete the conclusion quiz online at ronblank.com to receive credit

Principles & Design Considerations for Sterile Processes GETINGE INFECTION CONTROL IS ONE OF THE THREE BUSINESS AREAS WITHIN GETINGE AB, A PUBLICLY-LISTED, SWEDISH-BASED GROUP OF COMPANIES. THE GETINGE INFECTION CONTROL (IC) BUSINESS AREA CONSISTS OF TWO DIVISIONS: HEALTHCARE AND LIFE SCIENCES. TOGETHE R WITH THE TWO OTHER BUSINESS AREAS, EXTENDED CARE (ARJO & HUNTLEIGH) AND MEDICAL SYSTEMS (MAQUET), THE ENTIRE GETINGE GROU P OF COMPANIES FOCUSES ON STATE-OF-THE-ART MEDICAL TECHNOLOGY.

An AIA Continuing Education Program Credit For This Course Is 1 AIA HSW CE Hour Getinge USA Inc. 1777 East Henrietta Rd. Rochester, NY 14623-9040 Phone: 800-475-9040

www.getingeusa.com

Course Number: get11a

An American Institute of Architects (AIA) Continuing Education program Approved Promotional Statement: Ron Blank & Associates, Inc. is a registered provider with The American Institute of Architects Continuing Education System. Credit earned upon completion of this program will be reported to CES Records for AIA members. Certificates of Completion are available for all course participants upon completion of the course conclusion quiz with +80%. Please view the following slide for more information on Certificates of Completion through RBA

This program is registered with the AIA/CES for continuing professional education. As such, it does not include content that may be deemed or construed to be an approval or endorsement by the AIA or Ron Blank & Associates, Inc. of any material of construction or any method or manner of handling, using, distributing, or dealing in any material or product.

An American Institute of Architects (AIA) Continuing Education program Course Format: This is a structured, web-based, self study course with a final exam. Course Credit: 1 AIA Health Safety & Welfare (HSW) CE Hour Completion Certificate: A confirmation is sent to you by email and you can print one upon successful completion of a course or from your RonBlank.com transcript. If you have any difficulties printing or receiving your Certificate please send requests to [email protected]

Design professionals, please remember to print or save your certificate of completion after successfully completing a course conclusion quiz. Email confirmations will be sent to the email address you have provided in your RonBlank.com account. Please note: you will need to complete the conclusion quiz online at ronblank.com to receive credit

Course Description Be able to describe why the sterile processing department is important, and the concepts of decontamination and sterilization. Identify the type of equipment found in the SPD, and understand the workflow and factors to consider when designing a SPD.

Course Objectives Upon Completion of this course the participants will be able to:  Explain why the Sterile Processing Department (SPD) is such an  

 

important and integral part of a facility where sterility is paramount Comprehend the basic concepts of decontamination and sterilization Identify the type of equipment found in the SPD Be familiar with the workflow of SPD List factors to consider when designing a SPD

The Sterile Processing Department (SPD) WHAT IS THE VALUE OF THE SPD IN A FACILITY? WORKFLOW OF THE STERILE PROCESSING DEPARTMENT DECONTAMINATION: CLEANING & DRYING WHAT IS: THE DECONTAMINATION PROCESS? PREP & PACK? STERILIZATION? STERILE STORAGE?

Introduction What are some of the differences between a hospital and a hotel?  They both want a nice entrance, friendly and calming

environments, and return visits.  They also have individual guest rooms with attached bathrooms.  Hospitals typically do not have pools, but many have whirlpools for expectant mothers in the LDRP.  The biggest difference is the role that sterile processing plays in the health of patients, employees, and the building. Without it, surgeries would be much more dangerous, with lasting debilitating results and effects.

The Sterile Processing Department

What is the Value of the SPD in the Facility?  The SPD plays an integral role within a healthcare facility by providing

sterile surgical instrumentation to the OR as well as all other areas that require sterile goods.  The infection control practices within the department prevent the onset

and spread of infectious diseases such as HIV, Hepatitis A & B, TB, etc.  The SPD is the department within a healthcare facility that processes

and controls medical supplies, devices, and equipment, sterile and nonsterile, for patient care areas of the facility. (Per AAMI, Association for the Advancement of Medical Instrumentation)


Workflow of the Sterile Processing Department The shown 3-D diagram on the following slide is a representation of a sterile processing department. This example is a new trend in the U.S. market that has become a standard in Europe. They divide each of the cleaning stages into separate zones. Typically in the United States we see the packing department in the same area as the sterilization room. A fourth area that in shown in this diagram is the sterile storage and staging area. Here materials and instruments are pulled, packed, and organized onto carts for specific scheduled operations.


Workflow of the Sterile Processing Department

Sterile Storage

Sterilization Prep and Pack

Soiled Return

Decontamination


Workflow of the Sterile Processing Department  Note the separating walls for each of the above areas.  During the course of this presentation: A red floor will designate the

decontamination/dirty area. Blue will represent the prep/pack area and green will be for sterilization and sterile storage.  In some of the larger hospitals in the U.S. a 3 zone department is being established because of its uni-directional flow, cutting down on the possibility of crosscontamination.  We are going to step through the SPD starting in the Disinfection area.


What is the Decontamination Process? So what is decontamination? Here is the definition as provided by OSHA: “The use of physical or chemical means to remove, inactivate or destroy blood borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is safe for handling, use or disposal.” (OSHA CFR 1910.1030)


What is the Decontamination Process?  In the surgical environment hospitals must be very cognizant of all

types of contamination. This does not only include dust, lint, paint chips, metal shavings, hair, but also microscopic soils that are invisible to the eye that can and will cause infection in the surgical incision.  Therefore, what types of soils on surgical instrumentation are we

removing? First are the organics, mainly comprised of blood, tissue, fats, feces, grease, and proteins. Second are the inorganics such as water deposits – lime, rust and types of scale. Each of these can cause and infection in a surgical wound leading to more serious complications.


Decontamination Cleaning & Drying Automated Cleaning

Manual Cleaning

 The washer disinfector renders its

 No automated disinfection of

load (i.e. washed goods, surgical instruments, etc.) safe to handle  Disinfection and cleaning of noncritical goods prevents hospital acquired infections  Staff safety-cleaning process takes place in a closed chamber which means no risk for splashes and thereby contamination  Correct drying after cleaning can easily be arranged and integrated into the process

instruments and utensils, increases the risk of contaminations and infections.  Contamination risk for staff due to exposure to soil and liquids.  Wet goods may cause re-contamination


What is Prep & Pack?  Today most sterilizers can be found in the prep/pack room, but as

mentioned before, this trend is changing. You can think of this area as being the ‘clean room’.  During a typical site visit, you as the visitor would ‘gown-up’ and enter the prep/pack area first. Why would this be?


What is Prep & Pack?  The main reason is to eliminate the possibility of cross contamination.

If you were to enter via the ‘dirty’ decontamination door then into the prep/pack the hospital runs the risk of you carrying a potential ‘bug’ with you that could invade, attach, or contaminate a disinfected or sterilized instrument.  The professionals in prep and pack must pay close attention to details. Each instrument must be visually examined for quality. They must check surfaces for remaining soils, determine if the instrument is functioning properly – does it need sharpening? is it bent? is it worn and needs to be replaced? insure that instrument sets and trays are assembled, wrapped and placed into the sterilizers correctly, catalogue and pull instruments, track and trace instruments and sets, and verify the sterilizers performed their cycles correctly each and every time.


What is Sterilization? Let’s ask these questions of ourselves: 1. If I have a splinter in my finger that needs to be removed and I light

a match and hold a needle in its flame for 10 seconds, is the needle sterilized?  No, the needle would contain trace amounts of soot. 2. If I had a paring knife and used it to cut a cucumber, would the knife be sterilized if I dipped it in rubbing alcohol for 30 second?  No, there would be bio-burden on the blade. – It must be clean to be sterilized 3. If I am standing in line at the local buffet and I pick up a clean hot plate from the plate cart, is the plate sterilized?  No, and it may not be completely disinfected if you find food particles on it – like melted cheese.


What is Sterilization? So what is sterilization  Sterilization is the process used to render a product free from all

forms of viable micro-organisms (bacteria, spores, fungi, and viruses)  Sterilization is required because not all micro-organisms have been completely destroyed during the decontamination process.  Within the SPD, the sterilization area is where sterilizers (steam, and/or low temperature processes), are located including the space for loading, unloading, and cooling. This can be accommodated by a two or three zone system.


What is Sterile Storage?  Sterile storage is the OR instrumentation and equipment warehouse

typically for the entire hospital. If a product is disinfected and/or sterilized it will have a home in this department or in another sterile storage location. Like a warehouse, orders are packed and sent to other locations for use on specific patients undergoing specific procedures.


Equipment, Design Layout and Workflow for Decontamination GOOD WORK FLOW FOR DECONTAMINATION WHY DO WE HAVE A STAINLESS STEEL SINK MODULE? WHAT IS THE PURPOSE OF AN ULTRASONIC CLEANER? WHAT DOES A WASHER-DISINFECTOR

ACCOMPLISH?

WHAT ARE THE TYPES OF AUTOMATION FOR WASHER DISINFECTORS?

On the Following Slide…  You will see a layout of the full SPD area for a large facility  Shown at a glance is a typical plan for a 200 bed hospital. Note the

dirty and clean elevator locations. Notice the three zone layout: red, blue and green zones. We are going to take a closer look at each of these areas, describing the equipment that is found, how and why it is used, and the department workflow.

Equipment, Design Layout and Workflow for Decontamination

Good Work Flow for Decontamination


On the Following Slide…  There is a quick diagram of a typical decontamination department with

equipment in place  Notice the work flow path including the cart washers, the 3 bay wash sinks, ultrasonic washer, auto load tables for the air glide system, environmental/janitor closet, detergent storage room, and manual equipment wash room.  Note: The blue Clean Disinfected area to the right of the image


Good Work Flow for Decontamination 4 Bay Washer/Disinfector

Cart Washer

Soiled Goods Elevator

Utility Table

3-Bay Sink

Sonic Washer

Return Conveyor


Why Do We Have a Stainless Steel Sink Module?  Sink modules are used for manual soaking, hand washing, and rinsing

of instrumentation.  The sink may include a main and treated water faucet, a spray rinser, air gun, and tubular manifold.  Material comes to the SPD decontamination room via a “Dirty Elevator” or doorway.  First area for processing is the SSS. Usually there are three sinks. The first sink is filled with water and an enzymatic cleaner. Here the surgical items are allowed to soak. The second sink is used for washing and scrubbing of the surgical devices and instruments. Close attention is paid to joints, cracks, crevices, lumens, and dimpled surfaces.


What is the Purpose of an Ultrasonic Cleaner? The next basin is the rinse sink… Ultrasonic  For instruments that are heavily covered

in bio burden or have hard to clean surfaces an ultrasonic cleaner is used. This machine creates vibration or cavitation waves that shear soils from instruments. An example of a hard to clean instrument would be a reamer, due to its sharp fluted surfaces.


What is the Purpose of an Ultrasonic Cleaner?  Ultrasonic is a type of specialized unit that is used to remove debris

  



from difficult to reach areas of surgical instruments such as box locks, and serrations. Instruments are submersed in a liquid detergent bath. The passage of Ultrasonic waves cause cavitations (vibration). The vibrations create mechanical energy which removes debris from the surfaces. The detergent traps the loose debris from settling on the instruments.


What Does a Washer-Disinfector Accomplish?  The washer-disinfectors effectively cleans,

thermally disinfects, and dries moisture from temperature stable utensils, surgical instruments, anesthesia materials and glassware prior to any necessary sterilization.  What do we mean when we say thermal disinfection? What is the boiling point of water?  We know that water boils at 212 degrees F at sea level. We also know that when we say boil it also means water is turning into steam. At these extreme temperatures most organic organism will meet their demise. So when we say thermal disinfection we are speaking about the temperature and exposure time these organisms have in the water. Equipment, Design Layout and Workflow for Decontamination

What Does a Washer-Disinfector Accomplish?  What about drying? What does ‘bone dry’ mean in the SPD

environment?  Death Valley is a very hot place. Almost all forms of life would have an extremely hard time surviving there for any long duration of time. Just as an oak tree transplanted from North Carolina to the desert would not survive, the same can be said of a micro organism in a high temperature dryer. Heat and high temperatures kill them off.  One way to determine the effectiveness of a washer disinfector is to submit it to a TOSI (Test Object Surgical Instrument) test. A description of the test sample is described below.  A ‘test soil’ is engineered to have the same attributes as human blood. Blood has many properties that make it adhere to surfaces. This makes it a good test media for determining the washers effectiveness. cont… Equipment, Design Layout and Workflow for Decontamination

What Does a Washer-Disinfector Accomplish? The test soil is placed under a small window cover on a slotted or grooved metal plate that represents the multiple surfaces of a surgical instrument. The plate is then placed at an angle that makes it difficult for the washer to clean. Once complete, the operator looks through a window on the plate to determine the amount of soil removed.  The bottom line is we must wash and disinfect all instrumentation effectively. If we do not, any excess bio burden remaining will be ‘cooked’ onto those items in the sterilizer.  The washer-disinfector is the piece of equipment that destroys infectious micro-organisms (HIV, TB, Hepatitis, etc.)  Facilities are required periodically to verify the effectiveness of the washer-disinfector. The TOSI test is one way to accomplish this. Best practices allow for utilization of high volume and low pressure to effectively pass TOSI tests. Equipment, Design Layout and Workflow for Decontamination

On the Following Slide…  Shown is a typical plan for a 200 bed hospital. Note the dirty and clean

elevator locations. Also notice the three zone layout: the red, blue and green zones.  We are going to take a closer look at the Prep, Pack, and Sterilization areas, describing the equipment that is found, how and why it is used, and the department workflow.

Equipment, Design Layout and Workflow for Prep, Pack and Sterilization

Equipment, Design Layout, and Workflow


Good Work Flow for Prep, Pack, and Sterilization Steam Sterilizers

RO Water System

Return Conveyor

Pass Thru Window

Prep and Pack Tables Equipment, Design Layout and Workflow for Prep, Pack and Sterilization

What is the Use and What Would I Find on a Prep and Pack Table?  Used for the sorting, inspection, and packaging of decontaminated

goods prior to sterilization.  Task lights, monitors, instrument tracking system, sterile wrap, heat shrink units, etc.


What is a Pass Through Window Used For?  A pass through window is used to move

clean items into prep and pack area and items that need to be reprocessed back to decontaminated area.


What Does a Sterilizer Achieve?  Sterilization is the process used to destroy all remaining microbial life.  The sterilizing agent can be steam, plasma, ozone, EO Gas, or other low

temperature solutions.  Steam is the most widely used and cost effective solution, and typical applications include wrapped and unwrapped, porous and non-porous hard goods, towel packs, and liquids.  Low temperature sterilizers are used with temperature sensitive goods.


What Does a Sterilizer Achieve?  Sterilizers kill the remaining microbial life left on surgical instruments.  How do we know if the sterilizer is working properly? 

Sterilizers are tested using a Bowie-Dick test. A Bowie-Dick tests for air leaks, inadequate air removal and steam penetration for vacuum-assisted steam sterilizers.

 How do we know if the sterilizer is killing microbial life? 

Biological indicators monitor the effectiveness of the steam sterilization process.

 How do we know if a pack has been sterilized? 

Chemical indicator tape gives the sterilizer operator assurance that each pack or item has been exposed to the sterilization process. Hatch marks on the tape turn black when exposed at the correct temperature and time in a sterilizer.

 Once an item has been sterilized it is considered 100% free of organics

and inorganics.  Remember, it must be clean first to be sterilized! An unclean item can not be sterilized.


What Should I Consider When Planning For Sterilization?  Two zone or three zone (single or double door sterilizers) 

Capacity

 Appropriate floor space 

 

Loading / unloading areas Service Access Cooling Area


What Should I Consider When Planning For Sterilization?  When planning for sterilization you need to present the two and three

zone options to the hospital. Depending on design the architect and equipment planner will need to specify either a single door sterilizer or a double door sterilizer.  Remember - a single door sterilizer will be used in a department that is combining prep/pack and sterilization. This is the typical model found in the U.S. The European trend of a 3 room department is becoming more accepted in the U.S. This layout includes a decontamination room, a prep and pack room, then a sterilization room.


What Should I Consider When Planning For Sterilization? Secondly, what are the capacity requirements of the facility? Will they need large floor mounted units which can sterilize hundreds of instruments at one time or will they need to do only a few sets, such as in a surgery center? Most hospitals like to combine both large sterilizers and smaller units allowing the facility to run a small ‘quick turn’ load if a emergency set is needed.


What Should I Consider When Planning For Sterilization?  Appropriate Floor Space  Sterilizers generate intense heat. Extreme caution should always be

used when in their area. You will find hot pads and gloves next to the units and rods used for pulling the hot instrument trays out of the units. Due to these conditions architects and hospitals must make sure the adequate space is giving for cooling of the cart and wrapped instrument trays. A lot of heat will be dispersed into the sterilization area.


What Should I Consider When Planning For Sterilization? Sterilizers work by using steam that is forced through valves, channels, chambers, and drains. Like most mechanical and electronic devices (i.e.: cars, computers, A/C units), heat is the enemy. Manufactures must have a service access area next to the sterilizer to perform preventive maintenance activities twice a year. Most of the time, the sterilizers are not shut down long enough to cool to comfortable working conditions for engineers and workmen. The possibility of getting burned is even greater if the service area is made to small.


What Should I Consider When Planning For Sterilization?  Utilities (including steam and water quality)  What types of resources do I need to run a sterilizer?  You must have electricity, steam, and water.  What are my clearances? Do I have enough drainage? Where are my

drains located? Where are my steam lines located? Is the steam the appropriate temperature? What are my lighting requirements? What direction do my doors open?


What Are the Benefits of Automation?  Improved ergonomics  Improved throughput  

Efficient staging of loads to be processed Reduction of labor time

 Less handling of heavy and hot (temperature) loads  Reduction of amount of loading equipment required


Recap - Good Work Flow for Sterilization Here is a quick diagram of a typical department with equipment in place.

Steam Sterilizers

RO Water System Return Conveyor

Pass Thru Window

Prep and Pack Tables


Equipment, Design Layout, and Workflow for Sterile Storage WHAT IS STERILE STORAGE? WHAT DO I NEED TO KNOW ABOUT STERILE STORAGE?

WHAT ARE THE BENEFITS OF AUTOMATION?

What is Sterile Storage?  The area of the healthcare facility

designed to store clean and sterile items before their selection and distribution for use in procedures (AAMI).  Includes items supplied from SPD as well as pre-packed clean/sterile items from outside vendors.  You would find instrument tracking, sterile storage carts, racks, case carts, and shelving systems in this area.  Many hospitals require a positive airflow from sterile storage out into other areas. This provides more assurance that the temperature and humidity stay constant within the sterile storage room. Equipment, Design Layout and Workflow for Sterile Storage

What Do I Need to Know About Sterile Storage?  It should be located near a dock for the receiving of materials.  Consideration of elevator placement for best material flow efficiency.  Proper square footage must be allocated for storage and

material break-out.  Sufficient space allocation for instrument tracking system.

Equipment, Design Layout and Workflow for Sterile Storage

What Are the Benefits of Automation?  When designing a sterile storage area automation is becoming an

important factor. With the number of specialized instruments, containers, screws, and implants, high density storage units are becoming a common trend. Many larger facilities are investing money in both vertical density systems, as shown, and rotating carousel systems. With these units an operator would read their pick list and program the unit to bring the desired item to them, instead of walking to specific shelf location.  These systems greatly improve ergonomics and decrease muscle and skeletal injuries.  Larger items would still be housed on standard wire shelving.


What Are the Benefits of Automation?  High density storage  Ease of finding\picking location of

equipment  Less injuries due to improved ergonomics  Elimination of manual counting results in improved inventory accuracy  Increased staff efficiency


Department Design and Layout WHAT TO CONSIDER WHEN RENOVATING WHAT TO CONSIDER IN NEW CONSTRUCTION

What to Consider When Renovating  Renovation can be a huge undertaking but also a huge opportunity.

When considering a renovation much pre work or up front work needs to be conducted. Most IC companies can help with this activity. Pay close attention to structural details including piping, columns, drains, and electrical services and beware of hidden pipes and services located in walls. It is amazing the places you will find sewage lines.  An exhaustive review of the following questions needs to be undertaken

when planning a renovation project…

Department Design and Layout

What to Consider When Renovating  What is the current baseline of department functionality and capacity?  What is the current square footage, equipment location, and utility 

  

hook-ups. What is your processing capacity of existing equipment? What type of inefficiencies currently exist? What are the departmental objectives (i.e. staff reduction, quick turn, etc.) What types of cases will the facility be adding?  

Evaluate number of cases Evaluate types of cases

 Should I be planning for future expansion?

Department Design and Layout

What to Consider in New Construction Starting with a clean sheet of paper is like holding a new born baby. There is so much potential, but where do you start? Based on experience these are initial questions that should be considered.  What types of cases the facility is conducting? 

Define number of OR's   

Evaluate number of cases Evaluate types of cases Define materials to be processed

 What are the departmental objectives

(i.e. staff reduction, quick turn, etc.)?  Identify proper equipment to handle projected caseloads.  

Automation considerations Instrument Tracking

 Should I be planning for future expansion? 

Plan for shelled space Department Design and Layout

Summary THE STERILE PROCESSING DEPARTMENT (SPD) IS AN IMPORTANT DEPARTMENT IN THE FACILITY BASIC CONCEPT OF DECONTAMINATION

THE BASIC CONCEPT OF STERILIZATION EQUIPMENT FOUND IN THE SPD UNDERSTAND THE WORKFLOW OF SPD FACTORS TO CONSIDER WHEN DESIGNING A SPD

Summary The Sterile Processing Department (SPD) is an important department in a healthcare facility 

The SPD plays an integral role within the facility by providing sterile surgical instrumentation to the OR as well as all other areas that require sterile goods.

Basic concept of decontamination 

The use of physical or chemical means to remove, inactivate, or destroy blood borne pathogens to render items safe to handle.

The basic concept of sterilization 

Sterilization is the process used to render a product free from all forms of viable micro-organisms, (bacteria, spores, fungi, and viruses).

Summary Equipment found in the SPD Decontamination – stainless steel sink, Ultrasonic cleaner, WasherDisinfector, Instrument tracking system  Prep & Pack – Pass through window, work tables, instrument tracking system, instrument storage, etc.  Sterilization – Sterilizers (steam and low temperature), transfer carts, instrument tracking system  Sterile Storage – shelves, carts, instrument tracking, etc. 

Understand the Workflow of SPD   

Define two zone or three zone SPD floor plan Proper equipment needs Automation considerations

Factors to consider when designing a SPD   

Objectives of Department Proper equipment location Expansion

Course Summary By now you should be able to:  Explain why the Sterile Processing Department (SPD) is such an 

  

important and integral part of a facility where sterility is paramount Comprehend the basic concepts of decontamination and sterilization Identify the type of equipment found in the SPD Be familiar with the workflow of SPD List factors to consider when designing a SPD

© Ron Blank and Associates, Inc. 2008 ®

Please note: you will need to complete the conclusion quiz online at ronblank.com to receive credit

Principles & Design Considerations for Sterile Processes GETINGE INFECTION CONTROL IS ONE OF THE THREE BUSINESS AREAS WITHIN GETINGE AB, A PUBLICLY-LISTED, SWEDISH-BASED GROUP OF COMPANIES. THE GETINGE INFECTION CONTROL (IC) BUSINESS AREA CONSISTS OF TWO DIVISIONS: HEALTHCARE AND LIFE SCIENCES. TOGETHE R WITH THE TWO OTHER BUSINESS AREAS, EXTENDED CARE (ARJO & HUNTLEIGH) AND MEDICAL SYSTEMS (MAQUET), THE ENTIRE GETINGE GROU P OF COMPANIES FOCUSES ON STATE-OF-THE-ART MEDICAL TECHNOLOGY.

An AIA Continuing Education Program Credit For This Course Is 1 AIA HSW CE Hour Getinge USA Inc. 1777 East Henrietta Rd. Rochester, NY 14623-9040 Phone: 800-475-9040

www.getingeusa.com

Course Number: get11a

Principles & Design Considerations for Sterile Processes

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