Clean Collaboration: Putting the pieces of the puzzle together on difficult to clean medical devices a Collaboration approach. Jahan Azizi BS, CBET

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3 Clean Collaboration: Putting the pieces of the puzzle together on difficult to clean medical devices a Collaboration approach. Jahan Azizi BS, CBET

4 Ongoing Safety Review of Arthroscopic Shavers The FDA has become aware of events in which tissue has remained within certain arthroscopic shavers, even after the cleaning process was believed to have been completed according to the manufacturer's instructions. Reports submitted to the FDA suggested that the tissue retained was not evident to the naked eye. Multiple manufacturers of these devices recently informed their customers of this situation and reiterated the importance of proper cleaning procedures.

5 We will cover: What are difficult/impossible to clean surgical instruments. What is the matter with impossible to clean surgical instrument? Are the user facilities using manufacturers Instruction For Use (IFU) Why current IFUs may not be effective? A Collaborative Case Study. Tools and Technology used in the study.

6 Arthroscopic Shaver

7 CDC investigation into cross-contamination The CDC found two probable sources deep inside a hand-held arthroscopic shaver, used to shave away bone and tissue during orthopedic surgery; and inside a long, metal tube called an inflow/outflow cannula, used both to irrigate and suction the surgical site. During the investigation, surgical tools were inspected with a tiny video camera revealing human tissue and bone stuck in both devices. The camera also found a bristle from a cleaning brush left in an arthroscopic shaver.

8 Stryker Formula Core Shavers Moving parts, couplings, on-board suction and the need to protect electronic components present cleaning challenges.

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10 Video Tower with light source, camera, monitor, storage and printing devices/the new 3 mm cameras can be attached to a PC/laptop USB port Flexible Inspection Scope Close up inspecting a lumen Video tower with light source, camera, monitor, storage and printing devices.

11 Shaver IFU

12 High volume, complexity, design, lack effective IFUs,..

13 Samples of Problematic Instrumentation Septorrhinoplasty set due to all the cannulas Coronary suctions due to the strange shape of the cannula All ear trays, suctions and the very fine, delicate instruments. Gastroscopes, Bronchoscopes, etc... Defribrillator Paddles Lenses Trivex System Drills & saws Gamma nail sets Extract-All set Kerrison Rongeurs Spring-loaded drill guides Flexible scopes (ERCP) Bipolar forceps with delicate tips Tympanomastoid set Orthopedic reamers Arthroscopic Shaver

14 Bioburden: Blood, Bone, Tissue Examples (include but not limited to) ANSI/AAMI/ISO TIR11139:2006 as "population of viable microorganisms on or in product and/or sterile barrier system" Foreign Bodies (Debris ): Bone cement, artificial nails, Gelfoam and like products, ink pens/pencils, insects, Ioban, jewelry, knife blades, coins, rust, suture, unidentified material, bone wax

15 Endoscopic Retrograde Cholangiopancreatography (ERCP)

16 Investigators were able to remove this surface residue with a swab. What lies farther in?

17 Damaged lenses on the ports indicate this scope is in need of repair or replacement.

18 Examples of Debris and Damage Found in Endoscopes.

19 Distal End of Endoscope

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21 The Core Testing Visual checks ATP testing Hemoglobin/Protein/carbohydrate Total Organic Carbon Protein assay (Micro BCA)

22 A fully-assembled minor neuro tray

23 Suction tips displaying laser-etched identification numbers. Each tray is supplied with two each: Adson CVD 15FR, and Frazier suctions sizes 8, 10, and 12.

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25 Wear, rust, and corrosion.

26 Testing set-up with MediCount, Channel Check, rack for TOC, spectrophotometer. Confidential Quality Improvement/peer review document of UMHHC. Unauthorized disclosure or duplication prohibited. Document protected from disclosure pursuant to MCL ; MCL ; MCL ; MCL

27 Pipetter and tips for distributing samples.

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29 The Sievers 900 Laboratory Total Organic Carbon (TOC) Analyzer This technology evolved under a NASA contract to develop an instrument to monitor drinking water quality in space. Analytical Instruments is simplifying how pharmaceutical companies implement TOC for cleaning validation and cleaning verification applications. Detection range of 0.5 to 50 ppb.

30 Manufacturing defects

31 represent a cleaning challenge.

32 Rust, residue, or staining on the interior.

33 Manufacturing defect a gouge opposite the thumb hole

34 Large metal shavings along the shaft.

35 Debris remaining in the lumen.

36 Another example of debris

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39 Photos using Flexible Inspection Scope

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42 Wonder why it is difficult to clean?

43 Next Step Arthroscopic Shaver

44 Shaver 12D January 3, 2013

45 Shaver 12D January 24, 2013

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47 AAMI ST 79 IFU Inspection using magnification might identify residues more readily than the unaided eye. Visual inspection alone may not be sufficient for assessing the efficacy of cleaning processes; the use of methods that are able to measure organic residues that are not detectable using visual inspection should be considered in facility cleaning policy and procedures (see Annex D for available methods).

48 Simple survey at the 2014 IAHCSMM annual meeting, work shop on site and surface inspection Do you presently test/check/swab any of your instruments after cleaning for residual organic soil? Do you presently visually inspect the housing/barrel of your art. shavers with any type of scope? Presently do you think you are following the IFU for cleaning & inspecting art. shavers properly? N/A NO YES Before this workshop did you know of the issues associated with visual inspection of art. shavers? Do you presently clean arthroscopic shavers in your dept?

49 IFU Support for using a Flexible Inspection Scope Arthrex - Adapteur Power System II (APS II) Shaver Hand pieces -DFU- 0154r10* INSPECTION AND MAINTENANCE Step 4 in the DFU (IFU) Check device for visible soil. It is recommended that the cannulation be inspected with an illuminated, magnifying scope. Clean the device using the guidelines for manual cleaning if any soil is visible. * STRYKER Shaver HandPiece R-2012/10 * INSPECTION EN 21 Step 9 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 *

50 Arthroscopic Shaver

51 Flexible Inspection Scope

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54 Debris accumulation as instruments ages Data indicate that levels of detectable organic residue are increasing over time. Manufacturing flaws were unexpectedly common even in the new instruments; unfinished interiors in suction tips will inevitably collect debris

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56 Physics of Brushing Assessment and Prediction Courtesy of: Dr. Mohamed E. Labib NovaFlux

57 Physics and Mechanics of Brushing

58 Only two particles (1 micron) in the vicinity of Bristle Contact Point A may touch it. R bristle = 100 micron Bristle Tip 1 micron A 1 micron Tube Wall Sub-micron Particles Cleaning strip width (b) for 1 micron particles

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60 Inside an Arthroscopic Shaver, with Visible Debris and the Bristles of a Cleaning Brush

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62 Conventional Lap instrument and one-piece Kerrison Rongeurs

63 Tempest Surgical Device Washer High fluidheat agitated submersion Low flow, high pressure fluid stream Varying frequencies from digital ultrasonics

64 CleanStart Sprint High fluidheat agitated submersion Low flow, high pressure fluid stream Varying frequencies from digital ultrasonics

65 Video Tower with light source, camera, monitor, storage and printing devices/the new 3 mm cameras can be attached to a PC/laptop USB port Flexible Inspection Scope Close up inspecting a lumen Video tower with light source, camera, monitor, storage and printing devices.

66 Case Study on collaboration among the device, washing instrument, and validation and verification producs manufacturers. 6 Clear Flush Kerrison Rongeurs 8 length, 40 degree up, coated: A FP (1mm) A FP (2mm) A FP (3mm) A FP (4mm) A FP (5mm After receiving the above instruments, pictures were taken of each one prior to any inoculation or cleaning in order to establish a baseline for posttesting comparison.

67 Case Study Continue All instruments were then seeded both inside and out with Healthmark s Artificial Test Soil (ATS) containing hemoglobin, protein and carbohydrate to simulate the types of bioburden most frequently encountered in surgical cases. Following the guidelines outlined in AAMI TIR#12, the ATS serves as the inorganic/organic challenge for this test protocol. The instruments were then left for twenty-four (24) hours to allow the Test Soil to dry and harden on the outsides and insides of the instruments to simulate a worst case reprocessing scenario. After the twenty-four (24) hour mark, more pictures were taken of the instruments in order to show that the Test Soil was present and had thoroughly dried and hardened on the instruments

68 Case Study Continue After the Clear Flush Kerrisons were photographed with the dried and hardened Test Soil, they were reassembled for decontamination and cleaning (again, these instruments are not take-apart style instruments and they were only disassembled for the purpose of this test). The instruments were then put into the Tempest Washer and were connected to the Tempest Washer s pressure infusion hoses using Midbrook s exclusive infusion fixation devices.

69 Case Study Continue Once all of the Clear Flush Kerrison infusion ports were connected to the pressure infusion hoses, the Tempest Washer was run through the standard, automatic cannulated cycle (please see the Additional Information, Pictures and Test Results section for a full cycle breakdown). The jaws of the flushable Kerrisons were in the open, normal position during the entire cleaning cycle. Upon completion of the standard cleaning cycle inside the Tempest, the instruments were air-dried, inspected, and postcleaning pictures were taken to document the results.

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74 Case Study Test Results: The Tempest Washer removed one-hundred percent (100%) of the inoculated Artificial Test Soil (ATS) containing hemoglobin, protein, and carbohydrate after drying for twenty-four (24) hours from all six Clear Flush Kerrisons. The twenty-four (24) hour inoculation period was designed to replicate a worst case scenario from the start of a surgical procedure, the duration of a procedure (which can be up to 14 hours for a liver transplant), transport to decontamination, and the eventual start of the cleaning process.

75 Questions? Jahan Azizi