Cleaning, Packaging & Sterilization of Surgical Instruments

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

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 both 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: Decontamination Inspection Packaging Sterilization Storage & Delivery 6. Quality Assurance

DECONTAMINATION Soiled instruments should be cleaned and disinfected in a designated area, immediately after the surgical procedure. Quick cleaning removes blood or debris much easier and can minimize staining, corrosion or pitting of instruments. If there is a delay in cleaning, keep the blood from drying by placing a wet towel over the instruments or soak with an enzymatic solution.

DECONTAMINATION Mechanical cleaning is a safer practice for staff and a more effective process over manual cleaning. Therefore, whenever possible, mechanically clean instruments, using warm water and a neutral pH detergent.

DECONTAMINATION 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.

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

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.

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

PACKAGING Sterilization pouches are recommended 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.

PACKAGING When pouching instruments, select an appropriate and be sure to remove any excess air before sealing. For quality assurance, include a multi-variable indicator or an integrator, inside to verify the sterilization parameters were met. Indicator Integrator

PACKAGING To assist sterilization and aid drying, place pouches facing each other and on edge using a pouch divider. Double pouching instruments is okay if desired, but be sure to select the correct size pouches.

PACKAGING Sterilization wrap is recommended to be used for packaging instrument trays or cassettes. 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 (IFU) and FDA clearance.

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.

PACKAGING Wrapped instruments should be sealed with a color change indicator tape. Latex/Lead free indicator tape is now available. For quality assurance, include a multi-variable indicator or an integrator inside, to verify sterilization parameters were met. Indicator Integrator

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 removing from the sterilizer

PACKAGING Sterilization containers are also available to package instrument trays. 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

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.

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

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.

STERILIZATION Always process instruments according to the sterilizer or instrument manufacturer’s validated cycle parameters. Some common sterilizer cycle exposure times are: 250°F/121°C for 30 minutes 270°F/132°C for 10 minutes 273°F/135°C for 4 minutes Dry times are additional and can be from 20 to 40 minutes, depending on load type.

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.

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.

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.

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

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.

Quality Assurance 2) Chemical indicators change color or show movement during processing, to verify sterilization parameters were met. Chemical indicators should be used with every package on the outside and inside.

Quality Assurance If your facility has a large steam sterilizer, it is typically a pre-vacuum type sterilizer that requires an air removal check before using. This daily check is done with a Bowie-Dick test pack, usually before the first load of the day. Most table top sterilizers are gravity displacement and do not require this special test; however, recently table top prevacuum sterilizers (Class B) have been introduced.

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 exposure time. 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

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 an implant.

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 BI, along with a Class 5 integrator for immediate release of load, and is FDA cleared for use with standard or extended sterilization cycles.

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. If a rigid container is used, then a BI should be run inside the container without a load. AORN standards now recommends using a sealed container when flashing, that is FDA cleared for use with flash sterilization.

Quality Assurance Biological Indicators can also be sent to an outside Lab for 3rd party verification. This system is most popular with private offices and uses paper BI strips and pre-paid mailer. After processing, the BIs are mailed to the Lab for incubation and a Test Report is returned. If a failure is recorded, SPSmedical calls the user with recommendations and instructions to retest

Quality Assurance While sterilizers can and do mechanically fail, human error is the leading cause of sterilizer failure, e.g. Cold start Wrong cycle Overloading Improper packaging According to the CDC, sterilizers that fail the routine BI 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: Decontamination Inspection Packaging Sterilization Storage & Delivery Quality Assurance

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 www.SPSmedical.com

Purchasing AAMI Standards If your organization is not a member of AAMI, you may want to purchase the Standards directly from SPSmedical at our member discount. We can save you 40-50% depending on the document. For example: ORDER CODE: AAMI ST:79 List Price: $240 Member Price: $120

Cleaning, Packaging and Sterilization of Surgical Instruments THANK YOU! SPSmedical Supply Corp. Sterilization Products & Services 6789 W. Henrietta Road Rush, NY 14543 USA Fax: (585) 359-0167 Ph: (800) 722-1529 Website: www.spsmedical.com © 2004-2010, SPSmedical Supply Corp. Cleaning, Packaging and Sterilization of Surgical Instruments Certificate is available after viewing by calling SPSmedical or e-mailing education@spsmedical.com