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HOW TO GET TO VISUALLY CLEAN | SITE & SURFACE INSPECTION BACKGROUND Visual inspec�on is the most o�en specified technique for inspec�ng medical devices. Standards, guidelines and ar�cles all support the use of visual aids and tests for stain iden�fica�on to ensure medical devices are clean and func�onal before they are high level disinfected or sterilized and then ul�mately used on a pa�ent. “…inspec�on should be done just prior to steriliza�on. Inspect all instrument surfaces and individual parts for: Cleanliness of instruments, i.e. no debris, blood, �ssue, etc. If not fully clean, repeat previous cleaning steps or properly dispose of the instruments…”1 “…A�er cleaning, visually inspect all surfaces, ratchets, box locks, holes, channels and lumens for complete removal of soil and fluids. If ANY soil or fluid is s�ll visible, return the instrument for repeat decontamina- �on…”2 “Visual inspec�on is defined as the process of using the unaided eye, alone or in conjunc�on with various aids, as the sensing mechanism from which judgments may be made about the condi�on of a unit to be in- spected.”3 “…visually inspect the hand piece, including all internal surfaces, for remaining soil. Use an endoscopic camera and endoscope if necessary to see the inner surface of the lumen. If soil remains, repeat the manual cleaning procedure, focusing on those areas…”4 “…If areas are difficult to inspect visually, check for blood by immersing or flushing the device in a 3% hydro- gen peroxide solu�on. If bubbling is observed, blood is present. Rinse devices thoroughly a�er using hydro- gen peroxide solu�on. If soil is s�ll present, re-clean the device…”5 “… A stain is a discolora�on on an instrument’s surface. Rust is a red or orange colora�on on the surface of surgical instruments resul�ng from oxida�on. Note: Ensure that a “stain” observed is not dried blood… Use the eraser test to check for rust by rubbing an eraser over the stain/rust. If the spot is easily removed, it is a simple stain. If you discover pi�ng under the stain, it cannot be repaired…”6 “Inspec�on using enhanced visualiza�on tools such as lighted magnifica�on and video borescopes might iden�fy residues not observable by the unaided eye”7 “…Inspec�on using magnifica�on and addi�onal illumina�on might iden�fy residues more readily than the unaided eye… tools such as video borescopes of an appropriate dimension (length and diameter) may be used to visually inspect the internal channels of some medical devices…”8 “…protein is a marker commonly used to evaluate cleaning efficacy… health care personnel inspect every device for visible organic soil and contamina�on in a simple func�onality check, usually as part of the inspec- �on, prepara�on, and packaging procedure…”9 So, what is visually clean and what are the steps a medical device reprocessing professional should take to ensure a medical device is visually clean? It is a simple process of site and surface inspec�on that must be performed each �me a medical device is handled. Visual inspec�on is a process of using the unaided eye, alone or in conjunc�on with various aids (borescope, magnifier, stain iden�fica�on) to inspect medical devices for defects in func�onality, pi�ng, stains, and im- perfec�ons during its processing cycle and rejec�ng the medical device according to the medical devices IFU if any imperfec�ons are found. Stain iden�fica�on is a process of using various methods to detect what the makeup of that stain is, and correct it from appearing again. The standard, “is the medical device visually clean?” and understanding the type and source of the stain helps you reduce the chance of it reoccurring again in your process. First, if it is visually dirty, you must re-clean it (unaided eye detec�on). Second, visually inspect with the use of a magnifying glass. Third, use enhanced visual inspec�on (Borescope, Flexible Inspec�on Scope, USB microscope); consider hard to see areas of a medical device, like a lumen. Fourth, stain iden�fica�on. You want to know what the stain is composed of (rust, organic soil, blood, pro- tein, or another bioburden). Then, work towards resolving the issue to prevent it from appearing again. STEPHEN M. KOVACH, BS, CFER DIRECTOR OF EDUCATION | HEALTHMARK INDUSTRIES FRASER, MICHIGAN, USA | [email protected] STAINS OF PROTEIN ON STAINLESS STEEL 0.1μg 1μg 10μg 100μg EXAMPLES OF DEBRIS FOUND IN SHAVERS AFTER CLEANING Upon inspec�on of the lumen step area of an orthopedic shaver with a flexible inspec�on scope, a piece of bioburden was recovered for tes�ng. The sample from this shaver was tested for protein with a commercially avail- able protein test that is sensi�ve to 1.0µg. The sample tested posi�ve for protein. Actual scraping/peeling of the inner lumen of an endoscope found during inspec�on a�er the cleaning process. This needs to be sent back for repair. This could dislodge and go into a pa�ent during examina�on. DISCUSSION Who is telling medical device reprocessing professionals to visually inspect instruments? The manufacturer of the instruments with their IFU (Instruc�ons For Use) then the standards, guide- lines, ar�cles and studies, and lastly, the customer, who is the pa�ent. They want a clean and func�onal medical device. The facility must decide what medical devices should be inspected, how o�en, and with what. Deciding how to reach “visually clean” can only be accomplished with research (risk or gap analysis) into the specific issues of that facility. Researching these solu�ons should be done as a team made up of medical device reprocessing professionals, risk manage- ment, infec�on control and other key members of the facility. SOLUTIONS Who is telling medical device reprocessing professionals to visually inspect instruments? The manufacturer of the instruments with their IFU (Instruc�ons For Use) then the standards, guidelines, ar�cles and studies, and lastly, the customer, who is the pa�ent. They want a clean and func�onal medical device. The fa- cility must decide what medical devices should be inspected, how o�en, and with what. Deciding how to reach “visually clean” can only be accomplished with research (risk or gap analysis) into the specific issues of that facility. Researching these solu�ons should be done as a team made up of medical device repro- cessing professionals, risk management, infec�on control and other key members of the facility. Identify medical device to be visually inspected - post cleaning. i.e. Orthopedic Shaver Inspect device according to IFU Are the internal and external surfaces of the device visibly clean? Use of optical inspection tools is suggested. For example, magnifiers for surfaces or a Flexible Inspection Scope for internal channels. Prep Pack Do you want to identify the stain (soil)? Sterilize Yes No Yes No Reclean Repeat, begin at step 1. Type of test needed Flush Swab Test Device What type of soil? (blood, protein, ATP, other) Read results, evaluate process, make changes if necessary. Reclean Repeat, begin at step 1. Test Device What type of soil? (blood, protein, ATP, other) Read results, evaluate process, make changes if necessary. Reclean Repeat, begin at step 1. 1 Aesculap; SOP-AIC-5000239 Rev. 7 02/17 2 www.bossinst.com 3 Federal Aviation Administration (1997). Visual Inspection for Aircraft. Advisory Circular ACNO. 43-204. 4 www.stryker.com 5 DePuy Spine, Inc.; 0902-90-013 - Rev. E 6 https://www.iahcsmm.org/images/Lesson_Plans/Nursing_Plans/Nursing610.pdf 7 © 2017 Association for the Advancement of Medical Instrumentation ; ANSI/AAMI ST79:2017 8 ANSI/AAMI ST91:2015. Flexible and semi-rigid endoscope processing in health care facilities 9 © 2017 Association for the Advancement of Medical Instrumentation ; ANSI/AAMI ST79:2017 10 Healthmark White Paper; Use of the Flexible Inspection Scope (FIS) for Inspection of Flexible Endoscopes and Other Medical Devices; M. Drosnock : 2017 EXAMPLES OF ENHANCED OPTICAL INSPECTION TOOLS EXAMPLES OF SURFACE TEST METHODS Surface hemoglobin test: This swab method produces a colorimetric result that is easy to interpret. Sensi�ve down to 0.1µg hemoglobin. Surface protein test: This swab method produces a colorimetric result that is easy to interpret. Works for both soluble and insoluble proteins; detec�on limit of 1.0µg within minutes. DRIVE FORK AREA LUMEN STEP AREA KEY AREAS TO EXAMINE WITH A FLEXIBLE INSPECTION SCOPE THAT THE UNAIDED EYE CANNOT SEE 10 DISTAL TIP & UP INTO THE BENDING SECTION INSTRUMENT/SUCTION CHANNEL BIOPSY PORT & BIFURACTION A SAMPLE FLOW CHART FOR A MEDICAL DEVICE REPROCESSING DEPARTMENT DEBRIS FOUND IN DOPPLER PROBE TIPS USING A USB MICROSCOPE STAINS THAT COULD BE MISTAKEN FOR HARD WATER SPOTS, TESTED POSITIVE FOR HEMOGLOBIN STAIN COLOR POSSIBLE CAUSE BROWN/ORANGE HIGH pH OF CLEANING SOLUTION GRAY EXCESSIVE USE OF RUST REMOVER BLACK/PURPLISH CONTACT WITH AMMONIA LIGHT/DARK COLORED SPOTS WATER DROPLETS DRYING ON THE SURFACE Thank you to Ralph Basile, Amanda Dupure, Jen Gubin, Shirley Thomas and Alisha Lowe for their help in making this poster possible.
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