1. Procedures for Cleaning, Disinfecting and Sterilization Of Medical Instruments

2. Introduction One of the most important responsibilities of the medical assistant is to process contaminated instruments for reuse. Instrument processing involves much more than sterilization. Sterilization is a process intended to kill all microorganisms and is the highest level of microbial destruction. Proper technique is required to prevent the spread of infection and is crucial in your role as a health care worker.

3. In the News 2015: The Bellevue Clinic and Surgery Center of Seattle Children's Hospital notified some 10,000 patients this summer that they could be at risk for infection because of improperly cleaned surgical instruments going back to 2010. A community health center in Tucson, Arizona, earlier this year contacted dental patients about testing them for possible infection after discovering that dental equipment had not been sterilized. Last year, Pennsylvania authorities found that physicians at a surgery center failed to perform high-level disinfection of sigmoidoscope biopsy ports and to sterilize various forceps. Improper reprocessing of some of these instruments has been linked to outbreaks of multidrug resistant infections, some lethal, in hospitals across the country. http://www.medscape.com/viewarticle/850894

4. Classification of Instruments Instruments and equipment are divided into three classifications: Critical Semicritical Noncritical The classifications are used to determine the minimal type of posttreatment processing. All instruments and equipment classified as semi-critical or critical must be cleaned before they are sterilized. Processing instruments should proceed in a single loop, from dirty through clean to sterile, without ever doubling back.

5. Classification, cont. Critical instruments must be heat sterilized before reuse. Critical items are surgical and other instruments used to penetrate soft tissue or bone, enter vasculature or contact patient’s blood. Semicritical instruments are those that come in contact with mucous membranes or non-intact skin, but do not penetrate soft tissue or bone. Semicritical instruments should be heat sterilized before reuse. If this is not possible (because the instrument will be damaged by heat), the instrument should receive, at a minimum, high-level disinfection. Noncritical items should be processed with an intermediate or low- level disinfectant after each patient use.

6. Personal Protective Equipment You must always use personal protective equipment, including utility gloves, mask, and protective eyewear and clothing, when processing instruments.

7. Biological Indicators Rapid biological indicators (RBI) provide a test to monitor proper functioning of the sterilizer and to ensure that spore producing bacteria are destroyed during the sterilization process.

8. Biological Indicators, cont. Must be processed at least once daily when the sterilizer is in use. Sterilized items processed prior to performing RBI and control testing will be held and not placed into circulation until results of RBI and control have been confirmed to be acceptable. PPE is to be used when handling RBI according to procedure. Used and unused RBIs must be disposed of in red, puncture proof, medical waste/ sharps containers. RBIs will be processed for color readout when there is possible sterilization failure, installation of new sterilization unit, or service/repair of sterilizer is performed. ALL POSITIVE RESULTS OF PROCESSED RBIs WILL BE ACTED ON IMMEDIATELY.

9. RBI Procedure Clean and wrap instruments per policy and procedure. Put aside one pack or pouch as a “test”. This will be the test pack that contains the RBI. The pack or pouch should be representative of equipment to be processed in the load. Select the appropriate RBI. 1292 (BROWN CAP) RBI is used for STAT IM and packs processed at 250°C; 1291 RBI (BLUE CAP) is used for pouches processed at 270°C. Ensure that RBI has not expired. Place the test pack (with RBI) in the most challenging area of the sterilizer- the lowest shelf, near the drawer and over the drain. Process load according to policy & procedure. Remove the test pack at the end of sterilization after allowing to cool with sterilizer door open for 5 min. and unwrap, allowing to cool at least an additional 5 min prior to removing RBI. Allow RBI to cool additional 10 min outside test pack prior to crushing.

10. RBI Procedure, cont. Check chemical indicator on RBI to ensure color changed from rose to brown (if unchanged, check sterilization process and placement and repeat sterilization load). Don gloves and goggles. Press cap of the RBI down. Crush the glass ampule in the crusher well of the 290 incubator. Hold the RBI by the cap and tap bottom of vial against a hard surface until media wets the spore strip at bottom of vial. Open cover of 290 incubator and place RBI into appropriate port. Record information on the RBI log. Close cover and wait for results. The yellow light should illuminate.

11. RBI Procedure, cont. Results of the RBI should be as follows: 1292= 3 hours 1291= 1 hour When red or green light appears, the RBI may be read. Interpret results as follows: Negative results (green light -): indicates an acceptable sterilization process. Place load items in holding area until control RBI is processed. Positive results (red light +): indicates an unacceptable sterilization process. When results are +, all items in load must be quarantined. Follow policy & procedure when proceeding. Record all results and actions taken on RBI log.

12. Control RBI Incubate an unprocessed, control RBI at least once daily. The control must be from the same lot as the RBIs used to monitor the loads. Interpret the control as follows: Positive results (red light +): Indicates an acceptable control. The results should be documented on the log and all items sterilized earlier may be released from holding. Negative results (green light -): Indicates an unacceptable control. Immediately notify CMO/COO or designee for action plan.

13. Pre-Cleaning Procedure All instruments used on patients must be transferred to the “dirty” utility room. Don utility gloves, goggles and gown. Remove any visible debris by scrubbing brush and running water over slop sink. Mix 1 tsp of Klenzyme with 1 pint water and soak instruments in solution for 5 min in a stainless steel container. Remove instruments and discard solution in slop sink. Rinse instruments and remove gloves.

14. Pre-Cleaning Procedure, cont. Don gloves and mix 1 tbsp. Ascend with 1 gallon water in bucket and soak for 10 min. Wash each instrument individually with stiff brush and Ascend solution. All surfaces should be scrubbed to remove all debris left after use and remaining after being soaked in enzymatic solution. Remove instruments from Ascend solution. Discard solution in slop sink and rinse container & instruments with distilled water. Mix ½ cup Buell Lubricant with 3 cups distilled water in stainless steel bowl and soak instruments for 1 min. Remove instruments from Lubricant solution. Discard solution in slop sink and rinse container. Place instruments on clean towel and air dry.

15. Pre-Cleaning Procedure, cont. Place instruments in sterilization bags with chemical indicators and label with date cleaned (ensure that instruments are placed in bags so that provider can remove by handle when opened for use so as not to contaminate). a)Unfold flap of bag. b)Insert item, handles in first. c)Peel off liner. d)Refold along crease- press down from center outward. e)Initial and date flap- items should show date processed.

16. Pre-Cleaning Procedure, cont. Hinged instruments, such as hemostats and extraction forceps, should be packaged in the open position to ensure adequate steam contact with all surfaces. Storage practices for wrapped sterilized instruments will be event- related. This approach recognizes that the product should remain sterile indefinitely, unless an event causes it to become contaminated (i.e. torn or wet packaging). Sterile items will be inspected weekly and before use for signs of contamination (tears, rips, spots of discoloration).

17. Before You Proceed… Only staffed who have been trained and completed Sterilization competency testing may perform procedure. Cleaning, disinfecting, lubricating and wrapping instruments as previously described must be performed prior to placing instruments in autoclave for sterilization. Biological testing must be conducted on every load of supplies that is sterilized. Sterilization must be conducted in the “clean” utility room only. NEVER USE TAP WATER. ONLY DISTILLED WATER IS TO BE USED.

18. Sterilization Procedure Place wrapped, clean instruments in sterilizer. Every item must have a chemical indicator impregnated into the wrapper. Place biological indicator in the most challenging area of autoclave- the lowest shelf, near the door and over the drain. Close drain on sterilizer. Pour 1 gallon distilled water into autoclave. Firmly close sterilizer door and select exhaust speed. Ensure that sterilizer is locked before beginning cycle. Set time for 30 minutes. After load has run, let autoclave cool for at least 30 min.

19. Sterilization Procedure, cont. Open valve and drain. Dispose of distilled water in bucket. Use forceps or other tools to remove sharp instruments from sterilizer. Be sure to check for appropriate color change on steam strip indicator. Hold all items until biological indicators are acceptable.

20. What Questions Do You Have? See Infection Control Policy & Procedure manual for full procedure instructions. Do not proceed with the sterilization process until you have been signed off by a trainer at WellOne.