Rigid Fragility. Bill Hoff Regional Product Manager IMS-Integrated Medical Systems, Inc.

Transcription

1 Rigid Fragility Bill Hoff Regional Product Manager IMS-Integrated Medical Systems, Inc.

2 Rigid Endoscopes Are

3 Objective Describe design considerations related to rigid endoscopes that impact safety, operation, maintenance, repair and budgetary requirements by consideration for: Construction Environment for safe use Maintenance Misuse Chemical and fluid impact Financial issues

4 Anatomy

5 Glass Rod Lenses a.k.a Image Relay System

6 Debris Field Brass spacer shavings Inspecting the ORS

7 Silver Solder vs. Gold Solder Sterrad damage Silver Solder Scope Gold Solder Scope

8 Care and Handling Most Rigid Damage is not Procedure Related

9 Opportunities for Damages Bending the endoscope shaft Dropping the endoscope Repeated use of immediate use steam sterilization Contact with other devices when scope is not in use on the table/mayo stand Stacking items on top of scope during storage and transportation Contact with another device in surgical field Not disengaging camera coupler from scope during room turn

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11 Touch Point: Transportation

12 Touch Point: Operating Room Shaved Scope Tip Lasered Scope Tip

13 Distal Tip Damage Using magnification, inspect distal end for: Cracks or chips to objective window Ensure distal end tubing (bevel) is uniform, smooth and not dented or bent

14 Light fibers degrade with age and Spotting broken fibers at lightpost reduce light output Light fibers badly eroded at light post from heat from light source Broken light fibers

15 Spotting damaged light fibers

16 Touch Point: Operating Room Adequate Table Space for Scope Placement Stacked Items on Scope During Procedural Utilization

17 Proper Removal from Case is Essential

18 Touch Point: Operating Room Multiple Scopes in Scope Warmer Stacked Items on Scope During Procedural Utilization

19 Touch Point: Transportation Basin Placed on Scope Shaft Stacked Items on Scope During Transportation Scope Placed Back in Dedicated Tray for Transport

20 Touch Point: Cleaning & Decontamination Cleaning and Decontamination Important to assess how much time passes after procedure, before pre-cleaning occurs; soil hardens with time Pre-Cleaning and Decontamination: Is enzymatic cleaner used for decontamination? Is concentration of enzymatic cleaner correct? Are distal window and eyepiece window wiped clean with alcohol?

21 Touch Point: Cleaning & Decontamination Tape to Mark Proper Water Level for Enzymatic Cleaner Concentration Scopes Resting on Sink Ledge After Decontamination

22 Touch Point: Cleaning & Decontamination Alcohol Rinse Following Manual Cleaning Failure to Clean Window Results in Build-up of Anti-fog Compound

23 Cleaning Process Problems: Dirty Lenses Most film or debris can be cleaned off with an alcohol pad For stubborn film or water spots, an abrasive paste may be necessary to thoroughly clean the lens

24 Isolate and Immobilize

25 Proactive vs. Reactive Track your repairs to determine repair trends Risk assessments Review vulnerable activities and environments that impact rigid endoscopy health and safety. Target in-services to specific user groups and device care and handling issues Verify competency for use and be/hold accountable to patterns of behavior Preventative maintenance inspections Catch smaller issues before they become major higher costing issues

26 Touch Point: Inspection Check distal tip for shaves or burns Check shaft for dents, metal burs Check illumination at distal tip Check for clear image Check straightness of shaft

27 Set Goals ~ Implement Strategy Reduce the number of rigid endoscopes needing repair and overall expenditures related to rigid scopes by 20% annually. Inventory utilization analysis Reliability centered maintenance Risk assessments for cause, effect, prevention Targeted education and competency evaluations Repair history review and trend analysis Quarterly and annual reviews

28 Rigid Endoscope Restoration Considerations Repair is not regulated by the FDA Ensure proper steps are thoroughly taken to restore your devices back to manufacturer s standards Visit research and development labs of any parties involved Ask Identifying questions to ensure credibility

29 Repair Variances OEM High NA Fibers (120 ) $$$$ Low NA Fibers (80 ) $ Assembly Tool + Correct Mechanical Components + Fiber = Correct Illumination & Image Why should this matter? Proper illumination of total field of view within OEM standards Patient safety (can surgeon see?)

30 Solderable Window/Negative Lens Solder Negative Lenses Metalized $$$ Glued $ Windows $$$ Non- Metalized $ Autoclavable scope models require a solderable window or negative lens Not all windows are made withstand the autoclave process and perform correctly You may have seen glued lenses or the use low-quality generic lens options

31 OEM $$$ Custom Lenses Custom Lenses G O O D Resectoscope & rigid scope image during prostate surgery (Simulated case, loop size is actual) Generic Lenses $ Why this Matters.. The good resectoscope image shows the loop at mid extension - the loop is in the center of the image, this is because the field of view & direction of view are correct Compare to bad image; it has the wrong direction & field of view - the loop is not in the center of the image B A D Relative scale of objective lens

32 Objective Lens Assemblies Clinical Implications: Image Quality ~ Field of View ~ Angle of View

33 Autoclavable Endoscopes Laser Weld Soldered Simple Repairs Glue Autoclavable Endoscopes Heat and pressure tolerant adhesives Gold/Silver soldering of distal tip Laser Welding of all exposed joints Result: Scope goes from autoclavable to non-autoclavable!

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