Cleaning, Packaging & Sterilization of Instruments Presented by: SPSmedical Supply Corp. 6789 W. Henrietta Road ∙ Rush, NY 14543 USA

Presented by SPSmedical Largest sterilizer testing Lab in North America with over 50 sterilizers Develop and market sterility assurance products that offer advanced technologies Provide full day sterilization Seminars and Facility audits for compliance with standards and recommended practices Corporate member: CSA and AAMI, serving on numerous sterilization committees Woman owned business, certified by the state of NY

Continuing Education Program Following established protocols for instrument processing is an important aspect of modern health care as it helps to minimize the patient’s risk for infection of the surgical site. This program is intended to provide an “overview” of current recommended practices and is accredited by two national sterile processing organizations. Approved for 1.5 contact hours through IAHCSMM and 1.0 contact hour through CBSPD

Meets in Washington, DC throughout each year and Association for the Advancement of Medical Instrumentation Meets in Washington, DC throughout each year and establishes best practices for sterilization which become the American national standards. Membership includes: Health care facilities Health care organizations Government agencies Medical device manufacturers Testing labs and Consultants

Association of periOperative Registered Nurses Recommended Practices are developed by the AORN Recommended Practices Committee and approved by the AORN Board of Directors. The Joint Commission inspects facilities for compliance with best practices.

INSTRUMENT PROCESSING There are six (6) recommended steps for Instrument Processing: Cleaning Inspection Packaging Sterilization Storage & Delivery 6. Quality Assurance

STEP 1 - CLEANING Cleaning of instruments (manual or mechanical) should be performed in a designated area, immediately after the surgical procedure. Quick cleaning removes blood or debris much easier and can minimize instrument staining, corrosion or pitting.

STEP 1 - CLEANING Mechanical cleaning is a safer practice for staff and has been proven to be up to 16 times more effective over manual cleaning. Therefore, whenever possible, mechanically clean instruments, using warm water and a neutral pH detergent.

STEP 1 - CLEANING After cleaning, thoroughly rinse instruments with tap water to ensure loosened debris and detergents are removed. If the tap water is of poor quality, consider using treated water as a final rinse to avoid instrument staining.

STEP 2 - INSPECTION Each instrument should be critically inspected after each cleaning for residual debris or damage. Replace instruments as needed and never sterilize a “dirty” instrument.

STEP 2 - INSPECTION In addition, check each instrument for proper function and lubricate those that have “metal to metal” action. Instruments with stiff joints may be a sign of inadequate cleaning.

STEP 3 - PACKAGING Instrument packaging should be done in a clean and low contamination area, using FDA approved products: Sterilization pouches Sterilization wrappers Sterilization containers

STEP 3 - PACKAGING Sterilization pouches are for packaging single instruments and small, light weight items. Paper/plastic pouches allow you to see the contents and are available in heat seal and self seal design and a wide selection of sizes.

STEP 3 - PACKAGING When pouching instruments, be sure to select an appropriate size pouch and to remove any excess air before sealing. For quality assurance, include a chemical indicator/integrator, inside to verify the sterilization parameters were met. Chemical indicators verify some parameters have been met Chemical integrators verify all parameters have been met

STEP 3 - PACKAGING To assist sterilization and aid drying, place pouches facing each other and on edge using a pouch divider. SPSmedical has inexpensive pouch dividers available for small and large sterilizers.

STEP 3 - PACKAGING Sterilization wrap may be used for packaging instrument sets. For an effective barrier and to maintain sterility until point of use, be sure to double wrap per the wrap mfg’s instructions for use and FDA clearance.

STEP 3 - PACKAGING Wrap in a way that allows sterile presentation of the processed tray or cassette. Select the appropriate size wrap and be careful not to wrap too tight or too loose as this can compromise sterility by creating air pockets or allowing strike through.

STEP 3 - PACKAGING Wrapped instruments should be sealed with a color change indicator tape. For quality assurance, include a chemical indicator or integrator inside, to verify sterilization parameters were met. Indicator Integrator

STEP 3 - PACKAGING Wrapped trays (being heavier) should be placed on the lower shelf of the sterilizer. Loading heavier items on the bottom shelf and lighter items on the top, enables condensate to drain out without wetting other items in the load. To maintain sterility, packages should be visibly dry before transporting to a sterile storage area

STEP 3 - PACKAGING Sterilization containers can be used to process instrument sets. Made of rigid metal or plastic, filters allow the sterilant to enter the case and sterilize the items. Posts or instrument stringers should be used to separate and keep hinged instruments in their open position. For quality assurance, be sure to include a chemical indicator or integrator inside every case prior to processing

STEP 3 - PACKAGING Packaging systems (pouches, wrapped sets or rigid containers) can be mixed in the same load providing they are approved for use with the sterilization process. Rigid containers offer excellent protection during storage and can be stacked without compromising sterility.

STEP 4 - STERILIZATION Steam sterilization is CDC recommended as the process of choice whenever possible. Steam under pressure is considered safe, fast and the most cost effective sterilization method for health care facilities. Gravity displacement and pre-vacuum are the two most common types of steam sterilizers

STEP 4 - STERILIZATION Steam sterilizers are Class II medical devices subject to FDA approval per a 510(k) clearance letter. They are available in a wide variety of shapes and sizes for sterilization of heat-stable instruments.

STEP 4 - STERILIZATION Always process according to the sterilizer or instrument manufacturer’s validated cycle parameters. Some common sterilizer cycle parameters are: 250°F/121°C for 30 minutes 270°F/132°C for 10 minutes 273°F/135°C for 4 minutes

STEP 4 - STERILIZATION Not all instruments can be processed at common or “normal” cycle times. For example, SYNTHES General graphic cases: Gravity sterilizer: 270°F/132°C for 22 minutes Pre-vacuum sterilizer: 270°F/132°C for 8 minutes

STEP 5 – Storage & Delivery Sterile items should be stored in a manner that reduces the potential for contamination. The shelf-life of sterile packages is event related and depends on the quality of the packaging material, storage conditions and amount of handling.

STEP 5 – Storage & Delivery Sterile packages should always be handled with care. Avoid dragging, crushing, bending, compressing or puncturing, as this can compromise sterility. Be sure to inspect sterile packages before distributing. Do not use any package that is damaged, wet or opened.

STEP 5 – Storage & Delivery Sterility maintenance bags (dust covers) may be used to provide additional protection to wrapped instruments that could be subjected to adverse environmental conditions or multiple handling before use. Dust covers should be 2-3 mils thick and applied ASAP after sterilization, once the package has cooled.

STEP 6 – Quality Assurance Sterility assurance of processed instruments should be routinely verified using three (3) types of indicators: 1) Physical 2) Chemical 3) Biological

STEP 6 – Quality Assurance 1) Physical indicators are the time, temperature and pressure gauges built into sterilizers. These readings should be recorded for every cycle and verified prior to unloading the sterilizer. Hospital sterilizers are required to have a chart or printout, whereas this is optional for sterilizers located in private offices or clinics.

STEP 6 – Quality Assurance 2) Chemical Indicators change color or show movement during processing, to verify sterilization parameters were met. These devices are available in tape, card and strip formats for use with all processes.

STEP 6 – Quality Assurance Chemical indicators should be on the outside and inside of all packages to visibly show they have been processed. Some chemical indicators are FDA cleared as “integrators” which can measure all parameters of sterilization inside the package.

STEP 6 – Quality Assurance Most large steam sterilizers are pre-vacuum and require an air removal check before using. This daily test is done with a Bowie-Dick test pack, before the first load of the day. Most table top sterilizers are gravity displacement and do not require this special test.

STEP 6 – Quality Assurance Test Procedure: Place a Bowie-Dick test pack on the lowest shelf, over the drain in an empty chamber at 273°F for 3.5 or 4 minutes. After processing, the color change indicator inside the test pack should show a uniform color to pass. Retain the indicator as part of your Infection Control records. PASS FAIL

STEP 6 – Quality Assurance 3) Biological indicators provide users the highest level of sterility assurance and contain bacterial spores available in plastic vial or paper strip format. Steam sterilizers should be biological tested at least weekly, preferably daily and every load that contains a medical implant.

STEP 6 – Quality Assurance Biological Indicators are processed along with a load for all sterilizers, except flash. After processing, SPSmedical BI vials are activated by crushing and then incubated at 60°C for 24 hrs. Sterilizer failure is noted if the spores in the vial grow during incubation. Growth is observed by a color change in the media from purple to yellow.

STEP 6 – Quality Assurance A BI inside a Test Pack should be used to monitor large sterilizers when processing packaged instruments. Steam - place on the bottom shelf, directly above the drain with a load. The SPSmedical Steam BI test pack includes a 24 hr BI, along with a Class 5 integrator for immediate release of load and is FDA cleared for use with standard or extended sterilization cycles.

STEP 6 – Quality Assurance Flash sterilizers are different in that the BI is not placed inside a test pack or with a load, but rather in an empty tray over the drain. SPSmedical recommends adding a Class 5 integrator, as it will tell you immediately what the BI will tell you after incubation.

STEP 6 – Quality Assurance Biological Indicators can also be sent to an outside Lab for 3rd party verification. The SPSmedical mail-in systems use BI strips and pre-paid mailer envelopes. After processing, the BI strip is mailed to the SPS lab for 24 hr incubation and a Test Report is returned. If a failure is recorded, SPSmedical calls the user with recommendations and instructions to retest

STEP 6 – Quality Assurance Mail-in spore testing of sterilizers is very popular with medical device mfg’s and private offices. SPSmedical provides this 3rd party service to thousands of customers each day. For user convenience, test reports are also posted online @ www.checkyourtest.com. * Password protected

STEP 6 – Quality Assurance While sterilizers can and do mechanically fail, human error is the leading cause of sterilizer failure. Cold start Wrong cycle Overloading Improper packaging Sterilizers that fail the biological test, should not be used until a passed test is recorded

SPSmedical thanks you for taking the time to review… The six (6) recommended steps for Instrument Processing: Cleaning Inspection Packaging Sterilization Storage & Delivery Quality Assurance

TEST - What did you just learn? 1. Name the 6 recommended steps? 2. What is considered the best way to clean? 3. Why should you inspect instruments? 4. Name 3 types of sterile packaging? 5. Which sterilization process is preferred? 6. How long do packages remain sterile? 7. Is autoclave tape a reliable sterility indicator? 8. Chemical indicators have how many classes? 9. Steam sterilizers should be BI tested how often? 10. EO gas sterilizers should be BI tested how often?

CE Certificate Available This continuing education program was developed and produced by SPSmedical Supply Corp. Participants who view this program may request a Certificate with CE contact hours at no charge directly from SPSmedical. 1.0 hr Certification Board for Sterile Processing & Distribution 1.5 hrs International Association of Central Service Material Managers

THANK YOU! SPSmedical Supply Corp. Sterilization Products & Services 6789 W. Henrietta Road Rush, NY 14543 USA Fax: (585) 359-0167 Ph: (585) 359-0130 website: www.spsmedical.com For technical questions or to receive your Certificate, call: 800-722-1529 or E-mail: education@spsmedical.com © 2008, SPSmedical Supply Corp.

References & Resources Association for the Advancement of Medical Instrumentation (AAMI) 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795 703-525-4890 Fax: 703-276-0793 Website: www.aami.org Association of periOperative Registered Nurses (AORN) 2170 South Parker Road, Suite 300 Denver, CO 80231-5711 800-755-2676 Fax: 303-750-3212 Website: www.aorn.org American Society for Healthcare Central Service Professionals (ASHCSP) One N. Franklin Avenue, Suite 2800 Chicago, IL  60606 312-422-3700 Fax: 312-422-4577 Website: www.ashcsp.org International Association of Healthcare Central Service Material Management (IAHCSMM) 213 W. Institute Place, Suite 307 Chicago, IL 60610 312-440-0078 Fax: 312-440-9474 Website: www.iahcsmm.org

Monthly Audio Seminars Continuing Education Additional Self-Study CD-ROMS available Hazard Communication Decontamination, You & Biofilms Personal Protective Equipment Cleaning Surgical Instruments Selection & Use of Packaging Systems Steam Sterilization: Process of Choice Flash Sterilization in the OR Safe & Effective Use of ETO Sterilization Quality Assurance Eliminating Sterile Outdates CJD: A Sentinel Event Monthly Audio Seminars Audio Seminars are presented each month for 1.0 CE credit to sterile processing personnel certified through CBSPD and IAHCSMM

AAMI Standards on CD Get all 50+ AAMI standards and guidance documents for sterilization on a CD-ROM! CD-ROM is searchable, printable, portable, and economical. Every AAMI document covering sterilization in health care facilities, sterilization equipment, and industrial sterilization process control is included. In addition, are important FDA and CDC guidance documents, Code of Federal Regulations sections pertaining to sterilization, and sterilization articles from the AAMI peer-reviewed journal Biomedical Instrumentation & Technology. ORDER CODE: STBKCD List Price: $655 Member Price: $475