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Increasing Scrutiny on Endoscopes. Increasing Scrutiny on Endoscopes. Increasing Scrutiny on Endoscopes.
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1. Meeting (and Exceeding) JCAHO Requirements on Endoscopes Dennis Leiner
Lighthouse Imaging LLC (Portland, ME)
Michael R. Erwine
MRE Dynatech NV LLC (Carson City, NV)
2. Increasing Scrutiny on Endoscopes
4. Increasing Scrutiny on Endoscopes
5. Increasing Scrutiny on Endoscopes
6. Increasing Scrutiny on Endoscopes
7. Increasing Scrutiny on Endoscopes
8. Increasing Scrutiny on Endoscopes
9. Clinical Engineering Requirements Must include endoscopes in medical equipment inventory
Flexible scopes
Rigid Scopes
PM frequency under your control
Decide what to do and how often to do it
Be able to defend your decisions
Some responsibilities may fall under other departments
GI Lab
Central Sterile Supply
Etc.
10. Clinical Engineering Requirements JCAHO servicing requirements
May be in-house or out of house
“Whether it is the responsibility of clinical engineering or the GI lab, someone has to stand up, and say, ‘I am watching this process.’”
Organizations have a methodology for tracking inventory and service history of endoscopes
“All we are requiring is that endoscopes are included on the medical equipment inventory to ensure that proper management of them is occurring.”
11. Endoscope Vigilance Program Recognize what you must do
Satisfy JCAHO requirements for tracking
Make decisions on an Endoscope PM program
Make decisions on what you can do
Shift some “responsibility” to other departments
What you should do… investigate what opportunities exist for advancing your department and making a more defined organizational impact
Quality of care
Financial savings
12. Endoscope Vigilance Program Decide on a level of testing
“Screen” scopes before sending out for repair
Manage endoscope contracts
Teach endoscope processors how to spot trouble
Investigate test equipment options
Rigid endoscope “test tools”
Flexible endoscope “test tools”
Light source “test tools”
13. Opportunity Knocking
14. Opportunity Knocking
15. Opportunity Knocking Step #1:
Understanding flexible and rigid endoscopes and the technology behind them
16. The Science of Endoscopy
17. “Where does the Biomedical Engineer Fit In?” Virtually all complex hospital equipment has associated equipment to validate and/or test for correct operation.
EXCEPT OPTICS Companies do an excellent job in providing you with tools to validate and perform preventive maintenance on virtually all of your hospital equipment. Unfortunately, the same can’t be said for optics. Biomeds have sometimes adapted various generalized optical test equipment like photometers to try to get some quantitative data but scopes are quite unique optical devices and its very difficult to get meaningful data with what is available commercially.
How many people here get involved in endoscope repair? Do scopes go through your department before going out for repair?Companies do an excellent job in providing you with tools to validate and perform preventive maintenance on virtually all of your hospital equipment. Unfortunately, the same can’t be said for optics. Biomeds have sometimes adapted various generalized optical test equipment like photometers to try to get some quantitative data but scopes are quite unique optical devices and its very difficult to get meaningful data with what is available commercially.
How many people here get involved in endoscope repair? Do scopes go through your department before going out for repair?
18. “What is important to the physician?” Is there enough light?
Is the image sharp?
Does the focus control operate smoothly?
Is there a leak?
Does the articulation work? Can you think of anything else that is important?Can you think of anything else that is important?
19. Most problems with scopes are created at the repair facility. When you’re called down to the OR because the endoscope system isn’t operating well, it’s very important to quickly isolate the failure mode so the right component can be fixed. Similarly during preventive maintenance, you need to know what’s working right and what’s not, so that the proper device can be sent out and the repairs done in a cost-effective manner.
There really aren’t many different things that can go wrong as a result of hospital personnel and procedures. Unfortunately, what can go wrong is often catastrophic.
You’ll notice that the bulk of failure modes are the result of incorrect actions during repair, when the lens systems and fiberoptics may be worked on. This is more common than you may suspect. There are at least 150 third-party endoscope repair companies in the United States alone. The quality of work ranges from excellent to well… less than excellent.
That’s why we don’t want to wait until the scope is in a patient to check the device quality.
When you’re called down to the OR because the endoscope system isn’t operating well, it’s very important to quickly isolate the failure mode so the right component can be fixed. Similarly during preventive maintenance, you need to know what’s working right and what’s not, so that the proper device can be sent out and the repairs done in a cost-effective manner.
There really aren’t many different things that can go wrong as a result of hospital personnel and procedures. Unfortunately, what can go wrong is often catastrophic.
You’ll notice that the bulk of failure modes are the result of incorrect actions during repair, when the lens systems and fiberoptics may be worked on. This is more common than you may suspect. There are at least 150 third-party endoscope repair companies in the United States alone. The quality of work ranges from excellent to well… less than excellent.
That’s why we don’t want to wait until the scope is in a patient to check the device quality.
20. Most endoscope problems require specialized equipment in order to diagnose. Problems include: Leakage/Broken Lenses
Light Source and Cable Transmission
Endoscope Fiberoptics
Resolution (Image Sharpness)
Image optics transmission
Vignetting (whiteout)
Distortion
I’d like to discuss some more difficult measurements that are no less important to the surgeon. The first test is system leakage or a broken optical component.I’d like to discuss some more difficult measurements that are no less important to the surgeon. The first test is system leakage or a broken optical component.
21. Endoscope Leak Testers give hospitals the most value in reducing repair costs. Most hospitals have a leak tester for identifying mechanical leakage in their flexible scopes. This is a really good investment because if the leak is identified before the scope is flooded with sterilization liquids, the cost of repair may be thousands of dollars less expensive.Most hospitals have a leak tester for identifying mechanical leakage in their flexible scopes. This is a really good investment because if the leak is identified before the scope is flooded with sterilization liquids, the cost of repair may be thousands of dollars less expensive.
22. An automatic endoscope leak tester allows evaluation of a dry scope. Most hospitals have a leak tester for identifying mechanical leakage in their flexible scopes. This is a really good investment because if the leak is identified before the scope is flooded with sterilization liquids, the cost of repair may be thousands of dollars less expensive.Most hospitals have a leak tester for identifying mechanical leakage in their flexible scopes. This is a really good investment because if the leak is identified before the scope is flooded with sterilization liquids, the cost of repair may be thousands of dollars less expensive.
23. Rigid endoscope lens testers check for moisture and broken lenses, a cause of blurry images. Rigid scopes can also leak but aren’t able to be checked with a mechanical leak tester. Fortunately, there are simple devices that can be used for looking inside the scope on each of the lens surfaces in the shaft. Here’s a device that Lighthouse has developed, the ELT-1. It’s an inexpensive and simple endoscope testing device which lets you see if there is any moisture inside the scope or if a lens is broken or the adhesive separated.Rigid scopes can also leak but aren’t able to be checked with a mechanical leak tester. Fortunately, there are simple devices that can be used for looking inside the scope on each of the lens surfaces in the shaft. Here’s a device that Lighthouse has developed, the ELT-1. It’s an inexpensive and simple endoscope testing device which lets you see if there is any moisture inside the scope or if a lens is broken or the adhesive separated.
24. Tests Requiring Special Equipment: Leakage/Broken Lenses
Light Source and Cable Transmission
Endoscope Fiberoptics
Resolution (Image Sharpness)
Image optics transmission
Vignetting (whiteout)
Distortion
There is a simple device for measuring the light throughput in endoscope systems.There is a simple device for measuring the light throughput in endoscope systems.
25. Lighthouse Imaging worked closely with Sonora Medical Systems to design a product that biomeds can use for testing the optics and fiberoptics used in your hospital. Sonora recently introduced this product, called The Firefly, to test the light levels throughout endoscope systems. So, basically, the biomed measures the output of the lightsource, then measures both the lightsource and the light guide, and then finally the lightsource, light guide, and endoscope. In this way, you have a way of isolating which portion of the system has a problem and quickly and cost-effectively troubleshooting it.
Ideally, you would measure your equipment when its operating correctly and perform regular preventive maintenance to track equipment degradation before it becomes unusable. We also have typical data that is provided with the Firefly in case the “as-new” measurements are not available for a particular device.Lighthouse Imaging worked closely with Sonora Medical Systems to design a product that biomeds can use for testing the optics and fiberoptics used in your hospital. Sonora recently introduced this product, called The Firefly, to test the light levels throughout endoscope systems. So, basically, the biomed measures the output of the lightsource, then measures both the lightsource and the light guide, and then finally the lightsource, light guide, and endoscope. In this way, you have a way of isolating which portion of the system has a problem and quickly and cost-effectively troubleshooting it.
Ideally, you would measure your equipment when its operating correctly and perform regular preventive maintenance to track equipment degradation before it becomes unusable. We also have typical data that is provided with the Firefly in case the “as-new” measurements are not available for a particular device.
26. Lighthouse Imaging worked closely with Sonora Medical Systems to design a product that biomeds can use for testing the optics and fiberoptics used in your hospital. Sonora recently introduced this product, called The Firefly, to test the light levels throughout endoscope systems. So, basically, the biomed measures the output of the lightsource, then measures both the lightsource and the light guide, and then finally the lightsource, light guide, and endoscope. In this way, you have a way of isolating which portion of the system has a problem and quickly and cost-effectively troubleshooting it.
Ideally, you would measure your equipment when its operating correctly and perform regular preventive maintenance to track equipment degradation before it becomes unusable. We also have typical data that is provided with the Firefly in case the “as-new” measurements are not available for a particular device.Lighthouse Imaging worked closely with Sonora Medical Systems to design a product that biomeds can use for testing the optics and fiberoptics used in your hospital. Sonora recently introduced this product, called The Firefly, to test the light levels throughout endoscope systems. So, basically, the biomed measures the output of the lightsource, then measures both the lightsource and the light guide, and then finally the lightsource, light guide, and endoscope. In this way, you have a way of isolating which portion of the system has a problem and quickly and cost-effectively troubleshooting it.
Ideally, you would measure your equipment when its operating correctly and perform regular preventive maintenance to track equipment degradation before it becomes unusable. We also have typical data that is provided with the Firefly in case the “as-new” measurements are not available for a particular device.
27. Lighthouse Imaging worked closely with Sonora Medical Systems to design a product that biomeds can use for testing the optics and fiberoptics used in your hospital. Sonora recently introduced this product, called The Firefly, to test the light levels throughout endoscope systems. So, basically, the biomed measures the output of the lightsource, then measures both the lightsource and the light guide, and then finally the lightsource, light guide, and endoscope. In this way, you have a way of isolating which portion of the system has a problem and quickly and cost-effectively troubleshooting it.
Ideally, you would measure your equipment when its operating correctly and perform regular preventive maintenance to track equipment degradation before it becomes unusable. We also have typical data that is provided with the Firefly in case the “as-new” measurements are not available for a particular device.Lighthouse Imaging worked closely with Sonora Medical Systems to design a product that biomeds can use for testing the optics and fiberoptics used in your hospital. Sonora recently introduced this product, called The Firefly, to test the light levels throughout endoscope systems. So, basically, the biomed measures the output of the lightsource, then measures both the lightsource and the light guide, and then finally the lightsource, light guide, and endoscope. In this way, you have a way of isolating which portion of the system has a problem and quickly and cost-effectively troubleshooting it.
Ideally, you would measure your equipment when its operating correctly and perform regular preventive maintenance to track equipment degradation before it becomes unusable. We also have typical data that is provided with the Firefly in case the “as-new” measurements are not available for a particular device.
28. Tests Requiring Special Equipment: Leakage/Broken Lenses
Light Source and Cable Transmission
Endoscope Fiberoptics
Resolution (Image Sharpness)
Image optics transmission
Vignetting (whiteout)
Distortion
The rest of the measurements we’ll be discussing all are about the imaging system itself. We’ll start with the image optics transmission and uniformity.The rest of the measurements we’ll be discussing all are about the imaging system itself. We’ll start with the image optics transmission and uniformity.
29. This is the standard MIL resolution chart that many of you are familiar with. You look at the target and decide what the finest bar spacing is that can be clearly identified.
Unfortunately both of this chart is of limited value in measuring the image quality through an endoscope.
Why? Let me show you an example…
This is the standard MIL resolution chart that many of you are familiar with. You look at the target and decide what the finest bar spacing is that can be clearly identified.
Unfortunately both of this chart is of limited value in measuring the image quality through an endoscope.
Why? Let me show you an example…
30. The photos below each car are enlargements of the charts on the car above. In the left picture we can resolve to maybe -4, 5. However, in the right hand picture we can see all the way down to -3,3.
Not a good metric. We see that its more important to get nice blacks at lower bar spacings then it is to separate higher bar spacings. This is where the concept of modulation transfer function, or MTF, comes into play. This parameter, which must be measured with a computer, can quantify the contrast of an image. The photos below each car are enlargements of the charts on the car above. In the left picture we can resolve to maybe -4, 5. However, in the right hand picture we can see all the way down to -3,3.
Not a good metric. We see that its more important to get nice blacks at lower bar spacings then it is to separate higher bar spacings. This is where the concept of modulation transfer function, or MTF, comes into play. This parameter, which must be measured with a computer, can quantify the contrast of an image.
31. So, I wouldn’t tell you about this technique if I didn’t have a piece of equipment that would measure MTF. The EndoBench has been in production for more than 10 years and has proven very useful in performing rigorous quality measurements on endoscopes. Most of the EndoBenches sold have gone to manufacturing facilities and this is what its been optimized for. In fact, most of the rigid endoscopes sold in this country are manufactured at facilities that have at least 1 EndoBench. As you would expect, this product tend to be quite complicated and expensive.
I want to give you a sneak preview of a new product that will be introduced next month that is geared to the biomed.So, I wouldn’t tell you about this technique if I didn’t have a piece of equipment that would measure MTF. The EndoBench has been in production for more than 10 years and has proven very useful in performing rigorous quality measurements on endoscopes. Most of the EndoBenches sold have gone to manufacturing facilities and this is what its been optimized for. In fact, most of the rigid endoscopes sold in this country are manufactured at facilities that have at least 1 EndoBench. As you would expect, this product tend to be quite complicated and expensive.
I want to give you a sneak preview of a new product that will be introduced next month that is geared to the biomed.
32. So, I wouldn’t tell you about this technique if I didn’t have a piece of equipment that would measure MTF. The EndoBench has been in production for more than 10 years and has proven very useful in performing rigorous quality measurements on endoscopes. Most of the EndoBenches sold have gone to manufacturing facilities and this is what its been optimized for. In fact, most of the rigid endoscopes sold in this country are manufactured at facilities that have at least 1 EndoBench. As you would expect, this product tend to be quite complicated and expensive.
I want to give you a sneak preview of a new product that will be introduced next month that is geared to the biomed.So, I wouldn’t tell you about this technique if I didn’t have a piece of equipment that would measure MTF. The EndoBench has been in production for more than 10 years and has proven very useful in performing rigorous quality measurements on endoscopes. Most of the EndoBenches sold have gone to manufacturing facilities and this is what its been optimized for. In fact, most of the rigid endoscopes sold in this country are manufactured at facilities that have at least 1 EndoBench. As you would expect, this product tend to be quite complicated and expensive.
I want to give you a sneak preview of a new product that will be introduced next month that is geared to the biomed.
33. So, I wouldn’t tell you about this technique if I didn’t have a piece of equipment that would measure MTF. The EndoBench has been in production for more than 10 years and has proven very useful in performing rigorous quality measurements on endoscopes. Most of the EndoBenches sold have gone to manufacturing facilities and this is what its been optimized for. In fact, most of the rigid endoscopes sold in this country are manufactured at facilities that have at least 1 EndoBench. As you would expect, this product tend to be quite complicated and expensive.
I want to give you a sneak preview of a new product that will be introduced next month that is geared to the biomed.So, I wouldn’t tell you about this technique if I didn’t have a piece of equipment that would measure MTF. The EndoBench has been in production for more than 10 years and has proven very useful in performing rigorous quality measurements on endoscopes. Most of the EndoBenches sold have gone to manufacturing facilities and this is what its been optimized for. In fact, most of the rigid endoscopes sold in this country are manufactured at facilities that have at least 1 EndoBench. As you would expect, this product tend to be quite complicated and expensive.
I want to give you a sneak preview of a new product that will be introduced next month that is geared to the biomed.