Monitoring the Sterilization Process

Monitoring the Sterilization Process
Types of sterilization processes used in health care facilities are steam, ethylene oxide, dry-heat, gas plasma and chemical sterilization. In this session today, we will discuss monitoring of the steam and EO sterilization process. THETA CHAPTER May 09

Quality Assurance Each Health Care Facility should have a system in place to provide quality patient care through the provision of sterile equipment and medical devices. Read the Slide – Definition of quality. All patients have the right to be protected from harm. More that one million patients are injured annually in health care facilities. Included are 120,000 preventable deaths. 2 million nosocomial infections per year in the US; ~250,000 in Canada. This leads to increase length of stay, increase in SSI. Effective component of infection control that can help reduce the incidence and cost is an effective sterilization process.

Quality Assurance Program
Should include: Administrative Controls Chemical Indicator Monitoring Biological Indicator Monitoring Mechanical Indicators Continuing Education Quality, consistency and accuracy are the hallmarks of a successful sterilization program. Standards are developed to help you achieve this goal. Read slide. Each health care facility should have system in place to provide quality patient care through the provision of sterile instruments and medical devices.

Quality Assurance CPD - Administrative Controls
policies and procedures continuous education, training and observation of employees maintain updated knowledge about guidelines, current research and recommended practices CPD designed to facilitate efficient processing of patient care items Administrative controls are general and relate to the overall functioning of the department. These controls provide consistency in work practice to assure quality in service, practices and patient care and safety. To achieve quality outcomes and best standards of practice, departmental quality assurance programs should be based on recognized standards and guidelines. Policies and procedures must be in writing and reviewed and updated as required. Read Slide. Policies and procedures should include methods for cleaning, decontaminating, assembling and packaging and sterilizing, dress codes, personnel hygiene, handwashing, etc. Supervision and consultation in the work area to ensure continuous training of staff to minimize or eliminate human errors and to ensure policies and procedures are being followed. Continuous education to ensure that staff stay up to date with changing standards and guidelines. With regionalization, construction and renovation, it is important that CSR departments are designed to minimize contamination of sterilized items and maximizes efficiency in the work area.

Accepted Practice Guidelines
CSA Canadian Standards Association International AAMI Association for the Advancement of Medical Instrumentation ASHCSP American Society for Healthcare Central Service Professionals AORN Association of Operating Room Nurses ORNAC Operating Room Nurses Association of Canada CDC Centers for Disease Control and Prevention LCDC Laboratory Centre for Disease Control Read slide. These organizations influence the practices in the CPD. The practices in Canada are especially influenced by CSA, AORN and ORNAC.

Objectives of Monitoring the Sterilization Process
Assure high probability of absence of microbes on processed items Detect failures as soon as possible Remove medical devices involved in failures before patient use Improve patient outcomes Control costs Peace of mind The objective of a sterilization process monitoring program is finding marginal sterilization processes or failures in the system rather than telling you that there is not a problem. Sterilization process monitoring program is used to detect sterilization process failures and test equipment after failures so it can be put back into routine use. Objectives of the Sterilization Process: -Assure high probability of absence of microbes on medical devices being processed -Detect failures as soon as possible -Remove medical devices involved in failures before patient use -Improve patient outcomes -Control costs -Peace of mind

Methods of Monitoring Mechanical Indicators Chemical Indicators
Equipment control Chemical Indicators Exposure/Process control Pack control Biological Indicators Load control Read Slide. Each of the methods will be discussed in the following slides.

Sterilization Process Monitors
MECHANICAL STERILITY ASSURANCE COMBINED RESULTS CHEMICAL When monitoring any sterilization process, there are several indicators we rely on to assure that sterile products will be delivered to the operating room. Mechanical indicators are the digital readings on the sterilizer, print-out, alarms, etc.. that provide the first indication that everything is cool or that there is a problem. Chemical indicators are used to verify the presence of sterilant in the chamber. External chemical indicators such as gas indicator tape are used as process indicators to differentiate processed from non-processed goods. Internal chemical indicators are used inside bundles or containers to verify sterilant penetration. Biological indicators are used to verify the microbial killing power of the sterilization process. An organism resistant to that type of sterilization is used. Does anyone remember the name of the bug used to monitor the ethylene oxide sterilization process? That's right! The CSA specifies the use of a BI containing a minimum of 1 million Bacillus subtilis spores. This spore population is much higher than the bioburden remaining on cleaned instruments. So, if you can kill this large population of a resistant spore, one can be confident the rest of the load is sterile. BIOLOGICAL

Equipment Control Mechanical Indicators show: what is happening in the chamber whether conditions are being met cycle, time, temperature and pressure Equipment control consists of monitoring sterilizers prior to and during daily use to determine if the sterilizer is operating to the set conditions of time, temperature, pressure, air removal, moisture conditioning and sterilant exposure. These are your mechanical indicators and are a permanent part of the sterilizer. They indicate what is happening in the sterilizer from moment to moment. They do not tell you what is happening in the load only that the sterilization equipment is functioning or not. They tell you whether or not the conditions for sterilization are being met.

Mechanical Indicators Recording thermometer – circle graph Computer printouts – paper strip Gauges – jacket and chamber pressure If conditions were not met: Consider load un-sterile and do not use sterilizer until the problem is identified Equipment control consists of monitoring sterilizers prior to and during daily use to determine if the sterilizer is operating to the set conditions of time, temperature, pressure, air removal, moisture conditioning and sterilant exposure. These are your mechanical indicators and are a permanent part of the sterilizer. They indicate what is happening in the sterilizer from moment to moment. They do not tell you what is happening in the load only that the sterilization equipment is functioning or not.

Examples of recorders and gauges
Examples of recorders and gauges. Gauges are usually mounted on the front of the sterilizer. These register the pressure in the jacket and temperature (top picture). Automated devices, check to make sure that cycle parameters were maintained and initial the recording at the end of every cycle. For older sterilizers without an automated device, the operator must look at the gauges at critical points in the cycle to verify that the parameters are being met and then record the readings on a record sheet/chart.

Equipment Control Mechanical Indicators monitor one location in sterilizer do not monitor each pack or tray do not indicate sterility Read slide.

Exposure control / Pack control Chemical Indicators (CI) monitor one or more of requirements -time, temp, and sterilant can be external and Internal give instant results indicate proper conditions for sterilization were present

Exposure Control External Chemical Indicator process indicator - autoclave tape distinguishes processed from unprocessed medical devices secures pack labels pack If indicator did not change, do not use Provides a way to distinguish processed from unprocessed medical devices without opening the packages. For example, steam autoclave tape placed on the outside of a package. All recommended practices state that an external chemical indicator should be printed or affixed on each package except if the internal CI is visible from the outside. Peel pouches usually have the external indicator built in to the packaging. Double pouching does not make the external indicator an internal indicator. External indicators is a safeguard against distribution of items that have not been sterilized.

Pack Control Internal Chemical Indicator inside each package, tray or container paper strips or cards validates sterilant penetration colour change strip or moving front format can measure all process parameters (Integrators) Pack control is the monitoring and issuing of packs for use based on the readout of the chemical indicator inside the package. Chemical indicator can be multi-parameter or integrating. The CSA standards indicate that an internal indicator be placed inside all packages.

Chemical Indicators Samples of colour change chemical indicators and moving front integrating chemical indicator.

Pack Control Internal Chemical Indicator Pack Control CI - advantages detects incorrect packaging incorrect loading malfunction of sterilizer easy to retrieve and read The chemical indicator is placed in the location previously determined to be least accessible to the sterilant (EO or Steam). The CI does not tell you if pack is sterile but does allow detection sterilization failures due to factors such as incorrect packaging, incorrect loading (human errors) or equipment malfunction.

Chemical Indicators Do not tell you that spores are killed Do not tell you that item is sterile

Chemical Indicators Chemical Indicators cannot
replace Biological Indicators based on accepted practice guidelines and current scientific knowledge

Sterilization Process Monitoring
All recommended practices state that both biological and chemical indicators shall be used to monitor the sterilization process. Read Slide.

Load Control Biological Indicators Confirm the ability of the sterilization process to kill microbial spores Load control or biological indicator monitoring is the foundation of a successful sterilization process monitoring program. Load is processed and released based on the result of the BI in a test pack. At present, the BI is the best means at our disposal to confirm the sterility of an article or to determine the efficiency of a sterilization process. True sterility testing is destructive and would require opening in the package, culturing onto growth medium and then waiting for microorganisms to grow.

Load Control Biological Indicators large number of spores Integrate all the parameters of the sterilization process Most critical test of the sterilization process CSA requires routine monitoring daily Biological indicators may be self contained or be of the spore strips. Self contained - ~25 years ago. Rapid Readout - ~7 years ago Readout time varies from 1 hour up to 7 days depending on the product used. Spores are designed to provide a safety margin. Spores are more resistant than the bioburden on the device. Spore count far exceeds the bioburden on medical devices that have undergone a properly controlled cleaning process. Sterilization cycle has been designed by the sterilizer manufacturer to provide overkill. Biological Indicators: -Large number of resistant spores -Spore count gives a margin of safety -Integrate all the parameters of the sterilization process -Most critical test of the sterilization process -CSA requires monitoring daily and each load containing an implantable True sterility testing is destructive and would require opening in the package, culturing onto growth medium and then waiting for microorganisms to grow.

Biological Indicators
Examples of self contained biological indicators. There are other biological indicators that are paper strips impregnated with spores. Once sterilized they are then aseptically transferred to a growth medium in the microbiology lab. This can take up from 3-7 days for results. These types are mainly used in dry heat sterilizers.

Vial Ampoule Cap Spore Strip Filter
Components of the self contained biological indicator. Steam enters the cap and contacts the spore strip. Following sterilization, the vial is cooled and then crushed and incubated for hours. Products with rapid read out capabilities give results in 1-3 hours.

Steam Sterilizers Routine Monitoring - Steam
Test pack – includes BI containing Bacillus stearothermophilus Performed daily and in every load containing implantable device Placement - near drain in fully loaded sterilizer Routine Testing ensures the ongoing performance and quality of the sterilization process. Routine challenge test pack must be done each day the sterilizer is used and should be placed in each type of cycle (vacuum assisted or gravity) to be used that day. Every load with an implantable devices should also be monitored. The FDA refers to an implantable any item that will remain in the body longer than 30 days. Test pack can be commercially or in-house prepared. Test packs must be consistent from pack to pack. The components, arrangement of items, placement of the BI and size of the pack must be the same each time the pack is made. Not many facilities make their own test packs. Towels are freshly laundered and not ironed. Each is approx. 410mm x 660mm (16 x 26 ins). Towels placed on top of each other to form a stack 230mm (9 ins) long, 230mm (9 ins) wide and 150mm (6 ins) high Steam biological indicator with Bacillus stearothermophilus and a chemical indicator is placed between the 8th and 9th towels in the geometric centre of the pack. Should weigh 1.4 kg (3 lb). The test pack is placed near the drain in a normally loaded sterilizer. In house prepared test packs shall be positioned horizontally. This is usually the cold spot. Follow manufacturers of commercially prepared test pack for instructions on placement. Run a normal cycle. Let pack cool then remove BI and incubate according to manufacturers instruction.

Routine Test Pack Placement
Routine test pack for steam sterilizers is places in a fully loaded sterilizer over the drain.

Ethylene Oxide Sterilizers
Routine Monitoring – EO EO Test pack – includes BI containing Bacillus Subtilis Performed every load Placement - centre of normally loaded sterilizer A routine biological indicator test pack shall be placed in each load to be sterilized. Prior to assembly, test pack components should be held until processed at room temperature (18-24C) and at a relative humidity of at least 40% for a minimum of 2 hours. Test packs must be consistent from pack to pack. The components, arrangement of items, placement of the BI and size of the pack must be the same each time the pack is made. Not many facilities make their own test packs. Place the biological indicator in a plastic syringe. The plunger diaphragm should not touch the BI when the plunger is inserted into the barrel of the syringe. Place the syringe in the folds of the surgical towel and insert the towel into the peel pouch or contained in a wrapper. The routine test pack shall be placed in the centre of a normally loaded sterilizer. In-house prepared test pack shall be positioned horizontally. This represents the cold spot. Follow the manufacturers direction for the placement of commercially prepared test packs. Run a normal cycle. BI should be removed from the sterilizer to minimize worker exposure to EO. Remove the BI and incubate according to manufacturers direction.

Biological Indicator Test Packs
Samples of commercially available biological indicator test packs. Biological indicator monitoring is usually done with a biological indicator test pack. The test packs represent worse case loads and is done in an empty sterilizer during qualification (after installation/repairs) and a loaded sterilizer during routine testing.

Bowie Dick Type Tests Detects entrapped air in Vacuum-assisted sterilizers, not for Gravity Measures steam penetration Run daily Test packs – can be in-house or commercially prepared The Bowie Dick test is not a sterility assurance test. The Bowie Dick test is not used in gravity and steam-flush pressure-pulse sterilizers. Why is air removal critical? Steam and air do not mix well, air is repelled by steam, similar to oil and H2O. Air insulates instruments hence rendering the sterilizer a hot air oven as steam in not able to contact instruments. Test packs - Commercially prepared Test Pack or In-House Prepared Test Pack Absorbent surgical towels are used. The towels must not be ironed as this causes excessive dryness and will affect the test. Fabric softeners must not be used as the chemical residues interferes with steam penetration. Towels should be folded to size 250mm x 300mm (9 x 12 ins) and placed one above the other. Height of the test pack shall be 250mm x 280mm (10 x 11ins). The height will be dependent on the thickness of the towels used. The mass of the pack shall be 4 kg 8.8 lb.) The BD sheet is placed in the centre of the pack and loosely wrapped with a single wrapper.

Bowie Dick Test Pack Composition (left) and placement (right) of the Bowie Dick Test Pack. Placement of in-house prepared test pack is horizontally over the drain.

Bowie Dick Test Run a warm-up cycle first Place test pack in an empty sterilizer over the drain 132C (270F) for minutes Uniform colour change Retain in records The Bowie Dick test must be performed for vacuum assisted sterilizers each day the sterilizer is used. The Bowie Dick test is performed before the first processed load of the day. A shortened cycle (omit the drying phase) must be run first to heat the sterilizer properly if has been turned off. If the sterilizer is run continuously or if the jacket heat is not turned off, the test may be made at any time but preferably the same time each day. The shall be placed in the lower portion of the sterilizer nearest the chamber drain opening in an empty sterilizer. Follow manufacturers instruction for commercially prepared test packs. In-house prepared test packs shall be positioned horizontally. Temperature shall not be higher than 134C(273F) for maximum of 4 minutes, or 135C (275F) for maximum of 3.5 minutes. Higher temperatures or longer holding times, the ink sensitivity may be exceeded and invalidate the test.

Bowie Dick Test results If colour change not uniform Repeat test Shut down Call repair person Retest If uniform colour change Use sterilizer Colour change is dependent on factors such as brand or storage conditions, but uniformity of the colour change is the most important consideration. Accept – Uniform colour change; no white blotches. Unacceptable – Non-uniform colour change indicates an air pocket was present during the cycle. You cannot increase time and temperature to make the BD test pass. Sterilizer must be removed from service and repaired.

Bowie Dick Test Unprocessed Processed

Bowie Dick Test Packs Examples of commercially available Bowie Dick test packs.

“It is a dangerous practice simply to conclude, without investigation, that indicator giving warning is incorrect.” AAMI TIR Read Slide. Do not ignore the results but follow up to determine cause of failure.

Sterilization Process Routine Monitoring
Chemical Indicator Bowie Dick Type Test External Internal CSA Recommends Daily Each package, tray, container If you can see the internal indicator from outside of the package then no external indicator is required.

Sterilization Process Routine Monitoring
Biological Indicator Steam Flash Ethylene Oxide CSA Recommends Daily; every load with an implantable device Daily; every load with an implantable device Every Load

Installation & Repair Testing
Performed: before sterilizer released for use after major repairs or relocation after unexplained sterility failures after changes in sterilant supply annually 3 cycles using BI test pack – yielding 3 negative results If vacuum – 3 cycles with Bowie-Dick test pack Read Slide. Biological indicator monitoring is usually done with a biological indicator test pack. The test packs represent worse case loads and is done in an empty sterilizer during qualification (after installation/repairs) and a loaded sterilizer during routine testing. Installation Testing of Sterilizer (EO or Steam) Capability – 3 cycles yielding 3 negative results -before a sterilizer is released for use -after major repairs, construction, relocation -after unexplained sterility failures -after changes in sterilant supply or delivery -annually Vacuum-assisted sterilizers – also run 3 consecutive Bowie-Dick tests yielding 3 negative results.

Record Keeping Document all materials that have been processed and the results of the sterilization process monitoring The goal should be to create a system that provides a complete picture of each load, including how, where, when it was sterilized and its specific quality assurance results. This system must include specific documentation for every item sterilized. (Using labels, envelopes and forms.) Failure to do so will make it impossible to guarantee patient safety in the event of a recall.

Record Keeping Product Labeling lot or load control number
processing date sterilizer number cycle number Expiration statement event-related time-related Record keeping control documents that materials have been processed and includes monitoring control evidence. Use labels, envelopes, forms, and computer tracking systems. Good records will help trace each package backward through the levels of monitoring control and diagnose problems if there is a sterilization process failure. Each sterilizer load should be documented.

Record Keeping Load Records date and time of all cycles
exposure time and temperature load contents initials of operator BI results, CI results Records of sterilizer maintenance, calibration, and repair

Product Recall Recall Procedure If positive BI:
review record, quarantine load notify maintenance personnel identify microorganism on + BI If contamination occurred, and record is OK, release load Product recalls are expensive and time consuming and inconvenient, the risk of litigation, patient harm and nosocomial infections. Whether you re monitoring steam or EO the recall procedure is identical. CSA standard is clear that each facility shall establish a written recall procedure. The procedure should outline the circumstances for issuing a recall, designated the personnel authorized to issue a recall order, outlines the procedure to be followed when a recall is necessary and designates the personnel responsible for writing the final report. Recall policies should be developed with infection control and risk management. Develop a cheat sheet/flow chart and mount in area of sterilization so in a recall you are not looking for the policy. Speed is the most important factor when dealing with a recall so medical devices do not get used on a patient. It is important to assume that a positive BI is the result of a sterilization process failure and recall the load. A record keeping system must be in place to allow for recall when needed. Recall Order – in writing, identify all products to be recalled, identify persons or departments to whom the order is addressed, record kind and quantity of product obtained, specify action to be taken, retain record according to facility policies. Recall Report - in writing, reason for the recall, corrective action to prevent recurrence, numbers of intended recall and number of actual recall, maintain records according to facility policies.

Product Recall If microorganism is the spore, do further testing
Follow hospital policy Initiate recall and request sterilizer service as needed Written recall order Written report There are a variety of causes for BI failure – sterilizer malfunction and/or operator error. False positives sometimes occur as a result of external contamination during removal from test pack and transferring to a culture medium or during the incubation procedure. Whenever there is a positive BI, the load must be recalled. Recall of all medical devices processed in the sterilizer in question since the last negative BI. If you monitor once per week, then all loads processed during the last week must be recalled. If you monitor daily, every load run that day must be recalled. If you monitor every load, only one load needs to be recalled. The more frequent monitoring reduces the number of loads to be recalled. Recall should also be done when any indicators or monitors suggest a sterilization process failure. If microorganism is the test organism (spores), do further testing, example: 2nd test positive - initiate recall and request sterilizer service 2nd test negative - conduct a third test 3rd test negative, do not initiate a recall 3rd test is positive, initiate a recall and request service

Continuing Education Quality patient care Review CSA standards
Know your hospital policies Ask questions; Keep learning Apply what you learn into practice

Read cartoon. Learning is continuous or you lose it.

Reference CSA Standards
CAN/CSA-Z Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements (Adopted ISO :1995) CAN/CSA-Z Effective Sterilization in Health Care Facilities by the Ethylene Oxide Process CAN/CSA-Z Effective Sterilization in Health Care Facilities by the Steam Process

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