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Reprocessing Reusable Medical DevicesCleaning and Moist Heat Steam SterilizationValidation Processes Jozef Mastej, M.S.
Vice President of OperationGibraltar Laboratories, Inc.
Proprietary and Confidential © Gibraltar Laboratories, Inc.
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Relevant Standards
• AAMI TIR 30:2011 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
• FDA Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff Document issued on: March 17, 2015 [This document supersedes: “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance” (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080268.pdf)]
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Relevant Standards
• ANSI/AAMI ST79:2010/A4:2013 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• AAMI TIR12: 2010 – Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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Relevant Standards
• ISO 17665-1: 2006 – Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
• ISO 17665-2: 2009 – Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
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Overview of Reusable Medical DeviceReprocessingReprocessing is defined as validated processes used to render a medical device, which has been previously used or contaminated. Reprocessing of reusable devices involves the following three steps in sequence:
USE
Point-of-Use Processing[prompt, initial treatment to remove and/or prevent drying of soil and contaminants]
Cleaning [and return to use, or]
Disinfection Sterilization[Low, Intermediate or High Level]
Note: Cleaning, Disinfection, and sterilization are distinctly different processes.
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1) Point-of-Use Processing
Reusable devices are segregated from waste. Devices are typically wiped clean of visible soil, kept moist, properly contained and transported to a dedicated cleaning work area.
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2) Cleaning – is the physical removal of contaminants; the methods and agents used for cleaning should be designated to remove such soil (e.g., blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares the items for safe handling and/or further decontamination.Effective cleaning should:• minimize the soil transfer from one patient to another or between
uses in a single patient;• prevent accumulation of residual soil throughout the product’s use
life; and• allow for successful, subsequent disinfection/sterilization step if
necessary.
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Validation of the Cleaning Process Using Worst‐Case Testing.a. Artificial Soil clinically relevant.b. Medical Devices represent the worst case [most
challenging to cleaning process and the most inaccessible locations on your device]
c. Number of devices or replicates shall be justifiabled. Documentation of test methodse. At least two quantitative test methods and acceptance
criteria
2) Cleaning ‐ continued
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a. Artificial Soil The artificial test soil, shall be selected based on the composition of which accurately represents materials that the device would likely be exposed to during an actual clinical use, and would create the greatest (worst-case) challenge to the cleaning process.
2) Cleaning ‐ continued
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b. Inoculation Sites Soil inoculations should mimic worst-case clinical use conditions. We recommend you use the artificial soil to inoculate the device in all locations likely to contact patient materials, including all locations that are difficult to clean[lumens, internal moving parts, etc.]
2) Cleaning ‐ continued
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c. Simulated Use ConditionsSimulated use conditions for the validation studies should be considered, especially for devices with features at risk for the accumulation of soil with repeated use. In such cases, your validation studies should use devices that have undergone some simulated use. Your validation studies should incorporate multiple full use cycles and should be designed to assess the accumulation of soil over time. The number of simulated use cycles that you use should be scientifically justified.The control devices should be prepared and processed in exactly the same manner as the test devices; positive control devices should be soiled and negative control devices should not be soiled.
2) Cleaning ‐ continued
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d. Documentation of Methods Designed to Test the Cleaning Process Validation protocols should support the cleaning instructions provided in your device labeling. Examples of worst-case processing conditions:• If the cleaning instructions recommend a 10 to 20 minute pre-soak, the validation protocols should specify 10 minutes.• If the cleaning instructions advise the user to manually clean at 45ºC ± 5ºC, the validation protocols should specify
cleaning at 40ºC. • Enzymatic Detergents: In general, “worst-case” implies shortest times, lowest temperatures, etc. An exception to
validation at lowest temperature would be enzymatic detergents, which typically have “optimally effective” temperature ranges. Validation protocols should adequately address the temperature range specified in the cleaning instructions for enzymatic detergents.
• Medical Washers/Disinfectors: If your process validation uses automated medical washers/washer disinfectors or ultrasonic cleaners, your worst-case should include the extremes of the intended cycle parameters for the available medical washer/washer disinfector cycles or ultrasonic cleaners.
• If a device consists of lumens, ports, or channels that must be flushed during cleaning, the validation protocol should include minimal flushing specifications, such as time, flush volume or flow rate, and number of repetitions (e.g., 10 mL flush, performed 3 times).
2) Cleaning ‐ continued
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e. The artificial test soil chosen should allow at least two clinically relevant soil components to be quantified for validation testing (e.g., total organic carbon, protein, carbohydrates, endotoxin, hemoglobin, detergent residuals (cytotoxicity)).
Total organic carbon (TOC) analysis is an analytical technique to measure the amount of carbon bound on organic compounds; acceptance criteria: < 3.4 µg/cm2 [based on Carbon content of common proteins when Artificial Soil is mostly protein based].Protein analysis quantitatively assessed the presence of residual protein; acceptance criteria: < 6.4 µg/cm2.Carbohydrates are a significant constituent of cell structure, particularly bacterial biofilm; acceptance criteria: < 1.8 µg/cm2.Endotoxin can cause pyrogenic reactions and is particularly problematic if left on reusable medical devices that are considered “critical” and enter sterile body cavities; acceptance criteria: < 2.2 EU/cm2.Blood cells contain hemoglobin, and adequate cleaning should remove it; acceptance criteria: < 2.2 µg/cm2.
Note: The above acceptance criteria are based on published data for flexible endoscopes (Alfa et al., 2002) – AAMI TIR30
2) Cleaning ‐ continued
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Methods Validation You should validate the test methods you choose to measure residual soil. Your documentation of the method should include analytical sensitivity and specificity information, as well as predetermined cleaning endpoints, and should describe appropriate controls.
2) Cleaning ‐ continued
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Extraction Method
Devices should be subjected to a validated method of extraction for recovery of residual soil.
The extraction methods should be completely described for each device and its recovery efficiency should be determined as part of its validation.
Exhaustive extraction and extraction using a known quantity of soil are commonly used methods for determining recovery efficiency.
Extraction should sample all surfaces, including internal surfaces (such as lumens) and mated surfaces.
The worst case challenge (most difficult to remove) components of the soil should be addressed in the determination of recovery efficiency testing.
2) Cleaning ‐ continued
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3) SterilizationMoist Heat Steam Sterilization ‐process that uses saturated steam under pressure, for a specified exposure time and at a specified temperature, as the sterilizing agent. Sterilization is the validated process used to render a product free from viable microorganisms.
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3) Sterilization – ContinuedPart I – Temperature mapping [full-cycles for each sterilization condition and load configuration]Part II – Microbiological challenge - Sterilization efficacy study to demonstrate SAL 10-6 using overkill method [half-cycles for each for each sterilization condition and load configuration]
Sterility Assurance Level [SAL]: Probability of a single viable microorganisms occurring on an item after sterilization. SAL 10-6 means that there is less than or equal to one chance in a million that a single viable microorganism is present on a sterilized item. It is generally accepted that a SAL 10-6 is appropriate for items intended to come into contact with compromised tissue.
Part III - Verification of drying time [full-cycles for each sterilization condition and maximum load configuration, any additional instructions; such as door “cracked” open, additional cooling outside the autoclave, etc. shall be performed]
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3) Sterilization - Continued
Examples of medical trays being prepared for moist heat steam sterilization process
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Purpose: To verify acceptable temperature distribution within containment device during a sterilization process. Internal mapping profiles of temperature distribution inside the containment device, with thermocouples
placed in strategic areas, shall be conducted on full-cycles. Areas that may be considered for monitoring are the containment device corners [lid and bottom], on the sides, at the center, and on the inner side of any filter.
At a minimum, a probe shall be placed in a lower corner, the diagonally opposite corner, and the center of the containment device. If filters are used in the containment device, fourth thermocouple shall be placed on the inner side of the filter.
For thermal sterilization processes, calibrated thermocouples shall be used to map the temperature profiles of the containment devices.
For containment devices that require a filter, testing shall be performed with commercially available filter material that is compatible with the sterilization method and recommended by the containment device manufacture. Compatible filter material/commercial grades shall be clearly indicated in the product labeling.
Simultaneously containment devices should be double wrapped with Convertors Bio-Shield Sterilization Wraps or placed in a Rigid Container.
3) Sterilization Validation Part I – Temperature Mapping
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Examples of thermocouple placements3) Sterilization - Continued
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Purpose: To demonstrate sterilization assurance level 10‐6 using overkill method Determination of using either liquid spore suspension or inoculated carrier Geobacillus stearothermophilus. Biological Indicator or liquid spore suspension requirements. D121value ≥ 1.0 minute [AAMI TIR 12] or ≥ 1.5 minutes [ANSI/AAMI/ISO 11138‐3] – based on the
Manufacturer’s Certificate. The BI’s or Geobacillus stearothermophilus spore suspension will be enumerated to verify its
population and confirm identity.
Biological indicator (BI): Inoculated carrier contained within its primary pack ready for use and that provides a defined resistance to the specified sterilization process.
Spore Suspension: Spore Suspensions contain bacterial spores in an aqueous solution and contain no extraneous contamination that could affect performance. Providing a defined resistance to the specified sterilization process.
3) Sterilization Validation Part II – Microbiological Challenge
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1.Convertors Bio‐Shield Sterilization Wraps, FDA‐cleared 510K
2.Rigid Containers, FDA‐cleared 510K
3.Calibrated Steam Sterilizer, FDA‐cleared 510K
3) Sterilization Validation Part II – Microbiological Challenge -continued
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Determination of placement of BI’s or inoculation placement and rationale. Sterilization processes.
Gravity-displacement steam sterilization: Type of sterilization process in which incoming steam displaces residual air through a port or drain usually in or near the bottom of the sterilizer chamber.
Pre-vacuum steam sterilization: Also known as dynamic air removal steam sterilization. One of two types of sterilization cycles in which air is removed from the chamber and the load by means of a series of pressure and vacuum excursions [pre-vacuum cycle] or by means of a series of steam flushes or pressure pulses above atmospheric pressure [steam-flush-pressure-pulse (SFPP) cycle].
3) Sterilization Validation Part II – Microbiological Challenge -continued
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Conservative determination of lethal rate of the sterilization process – Overkill approach
The BI's shall be distributed on every level of the tray to provide coverage of the interior space of the tray and are positioned in potentially difficult areas to sterilize with respect to lumen, surface of the instrument and to provide geometric coverage as worst case position.
Three half-cycles of each sterilization process using maximum load configuration. Pulsed pre-vacuum half-cycle – 2 minutes at 132°C exposure time Gravity-displacement half-cycle – 7.5 minutes at 132°C exposure time
In addition three pulsed pre-vacuum half-cycle – 2 minutes at 132°C exposure time using minimum load configuration.
In summary, it will be determined if a ≥ six log reduction of the indicator microorganism is achieved in the half-cycles. If all the BI’s are negative upon sterility testing after exposure to the half-cycle, the full-cycle will equal twice the exposure time used in the half-cycle. In the future, when a full-cycle is run, a reduction of >12 logs is expected and a SAL of 10-6 will be attained.
3) Sterilization Validation Part II – Microbiological Challenge continued
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Time and temperature parameters for gravity-displacement steam sterilization cycles in health care facilities. (Reference ST79 Table 4)
Item Exposure Time at 121°C (250°F)
Exposure Time at 132°C (270°F)
Exposure Time at 135°C (275°F) Drying Times
Wrapped instrument 30 minutes 15 minutes 15-30 minutes
10 minutes 30 minutes
Textile packs 30 minutes 25 minutes 15 minutes
10 minutes 30 minutes
Wrapped utensils 30 minutes 15 minutes 15-30 minutes
10 minutes 30 minutes
Unwrapped nonporous items (e.g., instruments) NA 3 minutes 3 minutes 0-1 minute
Unwrapped nonporous and porous items in mixed load NA 10 minutes 10 minutes 0-1 minute
3) Sterilization - Continued
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Minimum cycle times for dynamic-air-removal steam sterilization cycles (Reference ST79 Table 5)
Item Exposure Time at 132°C (270°F)
Exposure Time at 135°C (275°F) Drying Times
Wrapped instrument 4 minutes 20-30 minutes
3 minutes 16 minutes
Textile packs 4 minutes 5-20 minutes
3 minutes 3 minutes
Wrapped utensils 4 minutes 20 minutes
3 minutes 16 minutes
Unwrapped nonporous items (e.g., instruments) 3 minutes 3 minutes NA
Unwrapped nonporous and porous items in mixed load 4 minutes 3 minutes NA
3) Sterilization - Continued
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The dryness of the trays fully loaded with its associated implants and reusable instruments shall be included in the validation process because dryness following sterilization is critical in maintaining the sterility of the trays and its components. The weight of the double Convertors Bio‐Shield Sterilization Wraps shall be recorded. The surgical tray shall be simultaneously double wrapped with Convertors Bio‐Shield
Sterilization Wraps or placed inside the rigid container. The surgical tray shall be placed in the steam sterilizer for the three full‐cycles. Note: The fully loaded chamber is the worst case condition with respect to drying time for a given sterilization process. Following sterilization the surgical tray shall be visually inspected for the presence of
moisture by removing the wrapping, and examining the tray and its components. The tray’s Convertors Bio‐Shield Sterilization Wraps shall be removed and their weight
recorded. In addition, with respect to moisture retention following sterilization, the wrap weight shall not increase by more than 3% relative to its weight before sterilization.
3) Sterilization Validation Part III – Drying Time
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Examples of residual moisture3) Sterilization - Continued
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QUESTION AND ANSWER SESSIONCan we answer any questions?
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CONTACT USGibraltar Laboratories is conveniently located
GIBRALTAR LABORATORIES
122 Fairfield Road 16 Montesano Road
(Shipping/Receiving)Fairfield, New Jersey 07004
122 Fairfield Road 16 Montesano Road
(Shipping/Receiving)Fairfield, New Jersey 07004(973) 227-6882(973) 227-6882
[email protected]@gibraltarlabsinc.com
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Proprietary and Confidential © Gibraltar Laboratories, Inc.
www.gibraltarlabsinc.com / (973) 227-6882www.gibraltarlabsinc.com / (973) 227-6882
