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

2. Presented by SPSmedical Largest sterilizer testing Lab in North America with over 50 sterilizers Corporate member of OSAP Develop and market sterility assurance products Provide variety of educational programs to assist with compliance in best practices to medical and dental facilities worldwide Woman owned business, certified by the state of NY

3. Continuing Education Program Following established protocols for instrument processing is an important aspect of modern dental care as it helps to minimize the patient’s risk for infection. This program is intended to provide an “overview” of current recommended CDC guidelines and is approved for 1.0 CDE credit by DANB. Approved for 1 hour by the Dental Assisting National Board, Inc. Category 4.

4. INSTRUMENT PROCESSING There are six (6) recommended steps for Instrument Processing: 1.Cleaning 2.Inspection 3.Packaging 4.Sterilization 5.Storage & Delivery 6.Quality Assurance

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

6. 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.

7. 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.

8. 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..

9. 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 2 - INSPECTION

10. 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

11. 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.

12. 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

13. 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.

14. STEP 3 - PACKAGING Sterilization wrap may be used for packaging dental 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 and FDA clearance.

15. STEP 3 - PACKAGING Wrap in a way that allows sterile presentation of the dental 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..

16. 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. Chemical Indicator Chemical Integrator

17. 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

18. STEP 4 - STERILIZATION Sterilizers are Class II medical devices subject to FDA approval per a 510(k) clearance letter. They are available in a variety of sizes with the following processes most common to dental: Steam Chemical vapor Dry heat / Rapid heat transfer

19. STEP 4 - STERILIZATION Saturated steam under pressure is one of the oldest methods used to sterilize dental instruments. The CDC recommends steam sterilization as the process of choice, because it is efficient, fast, and inexpensive. Chamberland autoclave built in 1880

20. STEP 4 - STERILIZATION By heating distilled water under pressure, moist heat is created and rapidly kills microorganisms. Some common steam 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

21. Chemical vapor sterilizers are available with a pre-set cycle of 270°F/132°C for 20 minutes exposure. This proprietary process uses a chemical solution, instead of water, that rapidly kills microorganisms. STEP 4 - STERILIZATION OSHA requires a Material Safety Data Sheet on the chemical solution used for this proprietary sterilization process

22. STEP 4 - STERILIZATION Dry heat sterilizers are also used in dentistry for instruments and materials that can withstand very high temperatures. Static air dry heat sterilizers are similar to an oven, as they utilize heating coils to transfer heat to the instruments over long exposure times. Static air dry heat sterilizers typically operate at 320°F/160°C for 1 to 2 hours exposure time

23. STEP 4 - STERILIZATION Forced air dry heat sterilizers are also called “rapid heat transfer” sterilizers and they circulate hot air during the cycle reducing the time needed for sterilization. This type of dry heat sterilizer is capable of sterilizing unwrapped instruments in as little as 6 mins. Forced air dry heat sterilizers operate at a range of 375°F to 420°F depending on the manufacturer

24. 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.

25. 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.

26. STEP 5 – Storage & Delivery Special Note: Opening sterile packages at point of use, increases patients’ confidence.

27. 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

28. 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.

29. STEP 6 – Quality Assurance 2) Chemical indicators should be on the outside and inside of all packages to visibly show they have been processed. Some internal chemical indicators are FDA cleared as Class 5 “integrators” which can measure all parameters of sterilization inside the package.

30. 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. The CDC says sterilizers should be spore tested at least weekly, and every load that contains an implant.

31. STEP 6 – Quality Assurance Biological Indicators are processed along with a normal load. After processing, self- contained BI vials are activated by crushing the side of the plastic vial and then incubated. 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.

32. STEP 6 – Quality Assurance Biological Indicators can also be sent to an outside Lab for 3 rd party verification. After processing the BI strip along with a normal load, the BI is sent to a lab for incubation. Test results are returned via mail or fax, with some services offering internet record keeping via password. If a failure is recorded, the Laboratory calls the user with recommendations and instructions to retest

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

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

35. SPSmedical thanks you for taking the time to review… The six (6) recommended steps for Instrument Processing: 1.Cleaning 2.Inspection 3.Packaging 4.Sterilization 5.Storage & Delivery 6.Quality Assurance

36. 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. How often should you use a spore test? 9. Mail-in services offer _______ verification? 10. What can cause a sterilizer to fail?

37. 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 DANB (Dental Assisting National Board)

38. ! 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.comwww.spsmedical.com For technical questions or to receive your Certificate, call: 800-722-1529 or E-mail: education@spsmedical.com © 2008, SPSmedical Supply Corp.

39. Reference Center for Disease Control and Prevention. Guidelines for infection control in dental health- care settings, 2003. MMWR Recomm Rep, 52 (RR-17): 1-76.