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Copyright © 2012

People, Places, Processes & Products that Influence the Supply Chain

 

INSIDE THE CURRENT ISSUE

November 2011

2011 Endoscope Care Guide

INSIDE THE GUIDE...


Choosing between OEMs and ISOs for repair services


Five primary cost saving tips


Handling reprocessing breakdowns before they happen


Instrument inspections made easier

Quick Reference Tools

·  Flexible GI Endoscopes

·  Small Diameter Flexible

    Endoscopes

·  Rigid Endoscopes


Maintenance and repair secrets that will save you money


Maintenance and repair services


Myths debunked about scope processing


The inherent dangers of reprocessed residue


Understanding manufacturer reprocessing instructions


Warning signs your endoscopes may need service


When the FDA halts the use of your processing technology

 

Five primary cost
saving tips

Here are five primary cost saving tips for endoscopes that every facility should know.

Routine maintenance is extremely important to catch those minor repairs before they become very expensive major endocsope refurbishments. To use an analogy, much like our cars, most people change engine oil every 3,500 miles to prevent damage. Using this same approach with preventive maintenance for your endoscopes, big dollars will be saved in the long run.

Constantly auditing your reprocessing methods and personnel is key. Over 50 percent of endoscope failures can be directly linked to the cleaning process. Improving and perfecting these practices can only help to reduce this percentage. Thoroughly rinsing the endoscope before placing into a scope washer is an example of a simple, yet proactive measure to reduce chemical damage.

Hold your current repair vendors feet to the fire. Providing CEU credits, educational programs, care and handling recommendations, and hands on training are a must. Repair vendors need to be more like "service partners." Allow your vendor to provide the expertise needed to implement cost saving ideas and programs at no charge to the facility in lieu of consultants.

Don’t be afraid to challenge the original equipment manufacturers (OEMs) when they attempt to void warranties just because you utilized other repair options. This is a strong-arm tactic to charge you more. Most independent service organizations (ISOs) employ technicians originally trained by the OEM.

Avoid popular OEM "repair/exchange" programs. While providing excellent options for reducing down time, unfortunately these programs do carry premium charges. When it comes to cost savings, these programs don’t fit the bill.

Jim Rygiel is scope repair manager, Spectrum Surgical Instruments Corp.

Revealing endoscope repair secrets

Repairing, let alone cosmetically maintaining, your organization’s endoscopic devices requires accurate decision making as well as precision service.

Healthcare Purchasing News asked experts from Integrated Medical Systems International Inc., Karl Storz Endoscopy Inc. and Spectrum Surgical Instruments Corp., to share some maintenance and repair insights to assist in keeping your endoscopic products in use for a long time. Following is what they recommended.


Hospital personnel often don’t have the capacity to "look under the hood" of their recently serviced endoscopes. So how can you ensure the quality of work performed inside the scope? Here are a few pointers:

  • Your service provider’s representative should assist you with inspecting your newly repaired scope. The work that was performed, and the reason repair was required, should be clearly explained. In addition, your representative should offer preventive steps you can take to decrease the frequency and severity of future problems.

  • Angulation – A flexible scope should angulate according to the manufacturer’s performance standards, with allowable tolerances. Angulation knobs should be free of play with working free engage systems. Check for tightness of knobs while scope is coiled and knobs turned.

  • Internal Working Channels – Channels can be tested by passing a correctly sized cleaning brush through the biopsy channel and suction channel, brush should pass smoothly through with no restrictions or resistance.

  • Illumination – Project light through the light prong to observe and test the amount of light dispersed by light guide lenses in distal tip. Reverse process to observe light output in light prong.

  • Air/Water Function – While attached to light source and processor, test both the air and water functions of your flexible scope. Place tip of scope into water, enact air by placing finger on air/water button to cover hole, and air should blow out of the tip of scope creating bubbles. Take tip of scope out of water, fully depress air/water button, and water should project across the objective lens of scope.

  • Image – When internal components are replaced within the scope’s insertion tube, it is vital these components are aligned properly for full functionality and to reduce friction and interference. The image of the scope can be affected by misalignment. To test, simply check image on tower and gently coil scope’s insertion tube while monitoring image. Look for flickering, color change, stains, missing pixels, shadows or a complete blackout of image.

  • The most expensive damage to a flexible endoscope is caused by fluid invasion. The good news is fluid invasion is also the most preventable damage. A proper leak test process can help you dramatically reduce the incidence of costly repairs resulting from fluid invasion.

  • What pricing program best fits your facility’s budget? Service agreements, capitated agreements, time-plus-materials? Every facility is different. Do your homework and research to find the best program for you.

  • Proactive maintenance iInspections work. They provide insightful information about your inventory, its current condition, and needed maintenance. And now it’s a requirement to have these inspections documented and available for review.

  • In-services, risk assessments, and validations are all critical processes that should be scheduled regularly to raise awareness of existing and potential issues affecting scope maintenance and repair.

  • Communication is key in addressing issues for a fast and effective preventive solution. All parties involved should work together to create streamlined processes.

Jonathan Hart is product manager,
Integrated Medical Systems International Inc.


In reference to flexible endoscopes, five areas are commonly overlooked. They focus on the endoscope’s distal tip and extensive leak testing.

  • Damage to the c-cover, the little black cap that covers the distal end, easily goes unnoticed because it does not necessarily affect functionality. C-cover damage may occur during a procedure, during transport, or even in storage due to impact from other devices or cabinet doors. Cracks, scratches, or burns can harbor bio-burden because they are not easily cleaned. They can also become sharp and injure the patient or staff.

  • Illumination and objective lenses are the glass lenses at the end of the light bundles and image bundle (fiberscopes) or CCD chip (videoscopes). These lenses are easily cracked or chipped when the distal end is dropped or crushed during transport or storage. As with the c-cover, damage to these lenses may not necessarily affect the scope’s functionality. But it can make the tip of the scope sharp or allow moisture to enter the scope, causing more extensive and expensive damage.

  • During a wet leak test, a videoscope’s electrical connector is often left out of the sink to minimize risk of fluid invasion. To thoroughly sterilize or disinfect the scope, however, it must be fully submerged. Before every wet leak test, the integrity of the seal between the endoscope and the water resistant cap must be inspected.

  • During a leak test, the angulation knobs and control switches must also be completely submerged. But the inspection should not stop there. Angulation knobs should be manipulated to identify possible leaks between the knobs. The best way to perform this is to turn each knob, one at a time, in each direction. The control switches should be massaged in a circular motion to check for possible holes, both in the button itself and in the seal between the control body and the switch.

  • By inspecting these five areas more closely a hospital can increase patient safety and reduce the frequency of major repairs.

Leticia Zirkle, is product manager,
Integrated Medical Systems International Inc.


Instrument inspection for form, fit and function are all critical for a sterile processing and distribution technician to consider when performing inspections. Generally, SPD technicians do a good job of ensuring that the items are clean and in good working order, but there are some common areas where a more thorough inspection will pay big dividends in the operating room.

  • Any instruments that require assembly or work with another accessory instrument should be assembled and disassembled by the SPD technician to ensure proper fit and that the locking mechanisms are working properly. For instance, bridges and sheaths for resection or cysto should be assembled and disassembled.

  • For bridges and sheaths, the two components should be assembled and an endoscope inserted to ensure that the scope slides smoothly through the sheath. If the scope requires any force to insert it then either the bridge/sheath or scope are bent or dented and should be repaired before going into the set. Damaged accessory instruments, like bridges/sheaths and optical forceps, can cause damage to the endoscope.

  • Routine checks of reusable scissors and trocars for sharpness will help the hospital avoid the high cost of disposable items. This must be done each time the set is sent for reprocessing. If the surgeons find dull scissors or trocars in a set they will likely want to change to disposable alternatives as they do not want to waste time in the OR or compromise their patients’ safety by using an instrument that is not in good working order. The use of Theraband scissors test material to confirm sharpness and proper training by a qualified technician can help SPD professionals learn the testing procedures.

  • Inspection of rigid endoscopes. Often we see staff look through an endoscope across the room to see if the endoscope is damaged. Rigid endoscopes are designed to be used from 2 centimeters to 5 centimeters from the target object. Looking through an endoscope across the room will cause the SPD technician to miss many of the flaws caused by damage or improper cleaning. The best way to inspect the endoscope after decontamination is to do the following:

  1. Clean the proximal and distal lenses with isopropyl alcohol.

  2. Inspect the proximal and distal lenses with a magnifying lens to ensure that no film or bioburden is present.

  3. Remove all light guide adaptors and clean the light guide post with isopropyl alcohol.

  4. Inspect the light fibers by pointing the distal end of the endoscope toward an overhead room light and observe the light guide post. Note that, due to the angle of view (0, 12.5, 30, 70, or 120), the endoscope will need to be angled so that the light hits the distal end of the endoscope directly. The light guide post fibers should present as bright and round. Black spots indicate broken light fibers. Yellow spots indicate aged fibers or that a film has built up on the distal end of the endoscope or over the light guide post as a result of improper cleaning. Generally, for rigid endoscopes, if 20 percent or more of the fibers are black or yellowed, the endoscope should be sent for exchange or repair.

  5. Inspect the image by looking at typewritten letters at a distance of 2 centimeters to 5 centimeters. Be sure to focus on the center of the image and also around the outside edge. Look for any areas where the image is not sharp as this indicates damage to the internal rod-lens system.

  6. By following these simple steps with a rigid endoscope, the SPD technician can be assured that the endoscope is in proper working condition for the next surgery.

  • Lubrication is extremely important for all moving parts on handheld surgical instruments. The proper lubricant should be applied upon each inspection to help ensure proper function.

Karl Storz always recommends to our customers that they send their damaged devices back to the OEM or an authorized repair facility to ensure the quality and sterilization integrity of the device. Upon receiving a repaired or exchanged endoscope back from the OEM or an authorized repair facility, the device should be thoroughly inspected for any possible damage that could have been incurred during shipping. If the device was sent to a third party for repair, the customer should have done their due diligence to ensure that the third party used only manufacturer’s components in the repair process. If the third party uses non-OEM parts then, the customer must do a much more thorough inspection to determine if the endoscope meets the form and functions of an original from the OEM.

We have witnessed fiberoptic flexible endoscopes being returned to a customer by third parties where another OEM’s flexible shaft was used in place of an original Karl Storz shaft. To the untrained eye, this would appear acceptable; however, the shaft was oversized and the working channel undersized for the model of endoscope. In the OR, this prevented the anesthesiologists from inserting the shaft to the point where it was needed for the placement of a double lumen tube.

We have also seen oversized threadwraps on the distal end of flexible endoscopes, which could present a patient hazard. Incorrect materials used on bending sections or other areas of a repaired endoscope could compromise sterilization, according to ASP. For rigid endoscopes, if the shaft was replaced, it should be compared to the length of an original endoscope of the same model number. For cysto and resectoscopes, a change in the length of the shaft by a third-party repair can result in potential patient harm during resection procedures (for example, arcing can occur if the endoscope is not of the proper length), or it can cause OR delays if the equipment fails to function as intended by the manufacturer.