Sterility Maintenance  Shelf life Management
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Sterility Maintenance Shelf life Management

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Sterility Maintenance  Shelf life Management Sterility Maintenance Shelf life Management Presentation Transcript

  • ROYAL COMMISSION MEDICAL CENTER YANBU AL SINAIYAH STERILITY MAINTENANCE SHELF LIFE MANAGEMENTPRESENTED BY : HATHROUBI MUNEER RCMC CSSD OFFICER
  • OBJECTIVES  To understand how contamination can occur and when microorganisms can be introduced into a sterile package.  To realize the importance of the selection of the pack and the correct technique of packaging that can protect the sterile goods.  To confirm the importance of using Cellulose fibers instead of linen.  To understand the importance of packaging, and the storage condition for sterility maintenance and Shelf life method and the responsibility of the user.
  • HISTORY  The SMITHSONIAN INSTITUTE has flasks that were sterilized in 1863 by LOUIS PASTEUR; these flasks are still sterile after more than 140 years.
  • DEFINITION Shelf life is the period of time during which a sterile item is considered safe to use. Shelf life is considered to be event –related not time related. That is while the probability of contamination increases with time, it is more influenced by handling and storage methods. Sterile items that are protected from the environment have been proven to remain sterile indefinitely. Shelf life is not matter of sterility maintenance. Many products from outside manufacturers carry out expiration dates that relate to product and packaging degradation, not to product sterility per se. It is important that sterile items be properly stored so that the packaging is not compromised.
  • RISK MANAGEMENT RE-USABLEINSTRUMENT Cleaned / Wrapped / Disinfected S Packed RISK MANAGEMENT Sterilized FOR HEALTH OF PEOPLE Sterile until use - Select correct material. - Validation of the concept. - Validation of processes for packaging. -Sterility maintenance. 5
  • TOPICS 1- MATERIAL REQUIREMENT 2- PACKAGING SYSTEM DESIGN REQUIREMENTS 3- PROCESSES VALIDATION 4- STERILITY MAITENANCE SHELF LIFE
  • Topics 1- MATERIAL REQUIREMENT 2- PACKAGING SYSTEM DESIGN REQUIREMENTS 3- PROCESSES VALIDATION 4- STERILITY MAITENANCE SHELF LIFE
  • Key Characteristics of Sterilization WrapsMost experts and organizations agree on several key characteristics of wrapping and packaging: • Barrier effectiveness prevents contamination and maintain sterility. • Permeability/penetrability allows for the effective penetration of sterilants (steam, ethylene oxide, plasmas, irradiation, ozone and moisture). • Aeration allows for the post-sterilization dissipation of moisture and the sterilants used. • Efficiency of use means the product can be easily inserted, maintains "seal integrity," has the ability to conform to the contents and has ease of presentation to the sterile field maintaining aseptic technique. • Drapability means the wrap conforms to the contents and contours of the product/instrument and can opened on a flat surface or held out of the sterile field during presentation • Flexibility accommodates any size or shape article.
  • Key Characteristics of Sterilization Wraps • Durable package integrity means the wrap resists punctures, tears and abrasions. Conforms to measurement standards for tensile strength, porosity and moisture vapor transmission rates. • Toxin free means non-toxic and non-fast dyes prevent adverse physical reaction of handler or change/coloration of the contents or wrapper. • Odor free characteristics prevent any allergic reactions from inhalation of chemical processes used in manufacturing or laundering. • Lint free/minimal linting means the wrap is devoid of or contains minimal linting properties (Gelbo Lint INDA Standard testing method 160-1-92) . • Cost effectiveness ensures the wrap is economical, saves time and reduces waste without compromising aseptic technique. • Content verification means the ability to identify the internal contents of the product produced visually or by labeling.
  • How to consider the choice ofpackaging? Question: How to be sure that the medical device placed in the wrap packaging is still sterile when introduced in operating room ? Problematic: There is no destructive and routine test able to determine if the barrier integrity of the pack is still valid Answer: Compliance to EN ISO 11607 part 1 & 2 Part 1 : Requirements for material and Packaging System Design Part 2 : Validation requirements of processes for packaging 3 requested conditions: 1- Have the adequate material 2- Have a validated packaging system design 3- Follow a protocol from packaging to operating room with regular check of the integrity of the packaging
  • Different options of packaging… Wraps Cellulosique paper Linen Wet laid non-woven SMS (PP) ContainersPouches Cellulosic paper PEHD (flash spun bond) 11
  • Sharp instrument tip protection
  • Topics  1- MATERIAL REQUIREMENT  2- PACKAGING SYSTEM DESIGN REQUIREMENTS  3- PROCESSES VALIDATION  4- STERILITY MAITENANCE SHELF LIFE
  • Role of packagingAllow sterilization AND provide a high bacterial barrier performance during the storage of the sterilized packs Sterilizing agent Micro-organisms ____________Bacterial barrier against contamination coming from: - Air (airborne, micro particles, dust) - Fluids (drops, aerosols) 14
  • Microbial barrier The principle of bacterial barrier is that bacteria die / burn their energy before crossing barrier material  Tortuous path Part of the non-compliant materials are the ones which are not barrier enough to stop bacteria on their way Film to paper pouches poorly manufactured (no sealing in some areas) Materials with holes or with insufficient tortuous path 15
  • Microbial barrier : Focus on linen LINEN CELLULOSE MATERIALS Easy pénétration of Dense and matted layers of micro organisme cellulosique fibres blocking micro organisme 16
  • Microbial barrier : Focus on linen CELLULOSE LINEN MATERIALS Water drop Fluide droplet in contact with linen and with Cellulose Sterisheet® material . Due to the natural absorbancy of linen, the droplet passes straight through. With the repellent qualities of Sterisheet® the passage is inhibited. 17
  • Microbial barrier : Focus on linen DRY STATE WET STATE Germ Bacterial Germ Water Proofness Filtration Proofness resitance Efficiency EN 868-2 Annex BNon wovenCellulose fibers- PASS 96% to 99% PASS 30screpe paper pulp,plastic polymersNon wovenCellulose fibers- PASS 85% PASS 25sWet laidWoven Textiles FAILED 48% FAILED 2s(new Linen)Woven Textiles (re- FAILED 17% FAILED 0susedLinen) 18
  • How to validate that the design of yourpackaging system is adapted ? :Validation of the packaging system design by real test & good practices Several wrapping methods- Envelope folding- Square folding- Pasteur folding- Roll method The most common and recommended folding is envelope folding Why? - To create the more tortuous path which means a better barrier against penetration of micro-organism Design validated by Event-Related Sterility Maintenance Study - Reduce handling during opening 19
  • How to validate that the design of your packaging system is adapted ? Double sequential wrap is recommended Why? -Bacterial filtration efficiency & germproof ness test (DIN 58953-6 2.14 & 2.15) is improved. - Guarantee aseptic opening - Possibility to combine different generation wraps. -Can offer a combination of the best characteristics and benefits of each generation of products. -Provide the most adapted wrapping solution and a tailored made wrapping system. -Possibility to have a colour coding :Security : Superposition of two colours allows to visualise any defect & prevent dust cover entering the operation rooms 20
  • Validation of the double wrapping Vssingle wrapping double sequential wrapping
  • Validation of the double wrapping Vs single wrappingBacterial Filtration Efficiency test (ASTM F2101) Double Wrapping BFE Single Wrapping (interleaved) Cellulose fibers, paper 85% to 99% 95% to 100% New Linen 48% 75% Re-used linen 17% 59% 22
  • Notes The three Cellulose Materials wraper sheet generations offer high bacterial barrier performances, making Cellulose Materials a true sterilization wrap. The Bacterial Filtration Efficiency test (BFE) which measures the ability of any given material to withstand penetrations by bacterias, show readings of up to 98% for Cellulose Materials crepe papers. Furthermore, all Cellulose Materials wraps pass the DIN Bacterial barrier Test considered one of the most severe and realistic test designed up to date. Linen, on the contrary, show poor Bacterial Filtration Efficiency readings (17% for reused linen), do not pass the DIN test and therefore do not offer any protection to penetration of bacterias.
  • Topics  1- MATERIAL REQUIREMENT  2- PACKAGING SYSTEM DESIGN REQUIREMENTS  3- PROCESSES VALIDATION  4- STERILITY MAITENANCE SHELF LIFE
  • How to validate that the design of yourpackaging system is adapted ?Validation of the packaging system design by real test & good practices  Efficiency of sterilization : Steam penetration testing thru activating sterilization indicators  Integrity of the packege / Maintenance of sterility integrity over time : Event-Related Sterility Maintenance Study (Nelson laboratories) This test is performed on double-layer packaging after sterilization, and simulates shelf storage – inside a room whose humidity and temperature are regularly recorded – along with weekly handling of the packaged packs. The packs are inspected after period of 180 days and the results is given as the percentage of uncontaminated packs. Microbial aerosol challenge test (Nelson laboratories) aerosolizing high number of Bacillus atrophaeus spores and then testing the contents of the package for ingression of that organism. 25
  • Validation of the maintenance of sterility over timeEvent-Related Sterility Maintenance Study 30 days 180 days Cellulose fibers, paper 100% 100% New Linen 76% 66% Re-used linen Not tested Tested on double sequential wrapping 26
  • Topics  1- MATERIAL REQUIREMENT  2- PACKAGING SYSTEM DESIGN REQUIREMENTS  3- PROCESSES VALIDATION  4- STERILITY MAITENANCE SHELF LIFE
  • GUIDELINE FOR PACKAGIN All the items must be carefully checked before packing Medical devices • check the medical devices are clean • check the medical devices are not damaged - no stain / no corrosion • check there is no residual water • check all items for a given procedure are there Sterilization sheets • check if packaging product is clean, without any holes & tears & secure its tracking number trace ability feature Packing area • prepare a clear & clean area 28
  • PROTOCOL FOR VALIDATION OFPACKAGING PROCESSCondition A written protocol and visual aids for each step:1- Packing preparation2- Sterilization (Loading)3- Transportation4- Storage5- OpeningOnly a visual inspection, will guarantee the integrity of thepackagingAt the end of each stage, a visual inspection must beperformed thru a documented quality system includingrecords, training & qualifying any actor of the chain Following guideline is based on these 3 conditions and the results of in situ testing, experience & good practices 29
  • Topics  1- MATERIAL REQUIREMENT  2- PACKAGING SYSTEM DESIGN REQUIREMENTS  3- PROCESSES VALIDATION  4- STERILITY MAITENANCE SHELF LIFE
  • STERILITY MAITENANCE SHELFLIFE Shelf life refers to the period of time any disinfected or sterilized item is safe to use. The time an item remains safe for use is more event-related than time-related.(Actual sterility may be indefinite depending on the package materials, the item itself and the handling and storage). Some manufactured items have a label claim of “Sterility guaranteed unless packaged is punctured or broken.” This labeling claims indefinite shelf life under the condition of proper handling and storage.
  • ROTATION OF THE STOCK Rotation of stock entails a system of adding newer sterilized items to an inventory to enable the use of the oldest first to prevent stale dating. When we go to the supermarket we always do the opposite: we look for and select the items that are freshest. In contrast, in dispensing we should select the oldest dated sterile items and use them first.
  • COMPROMISET CONDITIONS Any package with puncture, or dropped on the floor, rough handled, bended, creased, getting wet or damp, writing on the paper portion, pressurized and impacted. Packages that are found to be bent, damp etc. are considered no longer fit for service and require re-processing. puncture
  • GUIDE LINE FOR STORAGE  shelf life of a package sterile is event related not time-relatedSterile items should be stored in a manner that reduces the potential forcontamination• Storage area dedicated to sterile supplies• Temperature and humidity controlled (Room temperature between 22 & 24 C & Humidity does notexceed 70%)• Away from direct sunlight• Traffic should be controlled to limit access to sterile items.• Sterile items stored far enough away from the floor, the ceiling, and outside wallsto allow for adequate air circulation• Avoid friction of packs against the shelves during handling• first in / first out policy•Written policies and procedures should be developed for the storage, handling and rotation. 34
  • WHERE ARE WE ? COMPARISON BETWEEN OUR RCMC CSSD & OTHER FACILITY CSSD
  • OTHER CSSD FACILITY
  • RCMC CSSD
  • RCMC CSSD
  • OTHER FACILITYDECOTAMINATION AREA
  • RCMC CSSDDECONTAMINATION
  • OTHER FACILITY CSSDPROCESSING AREA
  • OUR PROCESSING AREA
  • OTHER FACILITY PACKAGINGAREA
  • PACKAGING AREA
  • OTHER FACILITY STERILESTORAGE ROOM
  • RCMC CSSD STERILE STORAGEROOM
  • MESSAGE The following guidelines should be observed when opening sterile packages:•Remove the outer wrap before entering the OR, not tointroduce exterior micro-organisms.• Enter the OR with the inner wrap only Aseptic technique presentationIf the material is a non woven resistant todisinfectants, it can be used as sterile field• Internal indicators should be checked to confirm before theappropriate end point response
  • MESSAGEOpening sterile packages• Before it is opened, the package should be inspected for theappropriate appearance of the external sterilization indicator andthe physical integrity of the packaging  Last and more crucial inspection  Place visual aids of final packaging inspection & refused package in this area if compromised. 48
  • ISO 11607-1 : Material Requirements  Example of what RCMC CSSD done to be in compliance with ISO 11607-1 for material requirements ( during the period of preparation for the JCI survey).  Documentation provided by the supplierKey properties Requirements Compliance demonstrating Tools:to be evaluated Standards & appropriate Test methodsMicrobial barrier Porous material shall provide an Tests listed in EN 868-2 adequate microbial barrier Bacterial Filtration Efficiency (ASTM F2101) Germ Proofness (DIN 58953-6 § 2.14 & § 2.15)Biocompatibility & toxicological Biocompatibility ISO 10993attributes Sensitisation / Irritation / Cyto- ISO 10993 toxicity EN 11737 Bio-burden control EN 868-2 Chemical propertiesPhysical & chemical properties Physical & chemical properties Tests listed in EN 868-2 follow-upCompatibility with respect to Folding EN 868-2forming and sealing processes Drape ability EN 868-2Compatibility with respect to Suitability for use in sterilization EN 868-2 after sterilizationthe intended sterilization processes and cycle parametersprocessesAcceptable shelf-life Any shelf-life limitations for pre- EN 868-2 sterilization and post-sterilization storage Bacterial Filtration Efficiency (ASTM F2101) Germ Proofness (DIN 58953-6 § 2.14 & § 2.15) on 5 years aged paper, before and after sterilization 53
  • What can be done against nosocomialdiseases?  Good practices: - Hand washing - PPE (gloves, gowns..) - Medical and surgical equipment care: - Cleaning - Disinfection - Packaging - Sterilization of reusable medical devices - Traceability - Preference of single use devices - Good sterilization method. - Good storage technique.