Reprocessing Study

[Anonymous]

While you spent 3 hours writing all this, I was in the OR taking away yet another one of your accounts.

That's pretty funny. Why do I feel like you are from EES. While you were counting your product on the shelf in the OR pretending to be important I was just across the street meeting with the CFO and laying out the plans for implementation at yet another one of the Hospitals you serve. Instead of hanging out in the OR all day pretending perhaps you should consider who has the purse strings. Puff Puff Pass.

 

[Anonymous]

So eloquently written.

But, I call your b.s. I'm not saying that what you stated about your job has no truth.

I worked for Ascent. You are not selling to c-suite administrators or execs daily. Your dm and rsm does that. You may sit in and adlib on those meetings, but don't juice yourself here.

Not saying what "Ethicon" jokers are doing is grand in any fashion.

One poster was correct Ascent treats you guys like garbage, but the experience is an awesome steppping stone if spun correctly.

I was able to make the jump to olympus from ascent.

No offense, but we are talking about two entirely different companies and sales forces. Ascent use to have a few high caliber reps and were making decent cash but they replaced them with entry level reps with no previous OR or device experience and pay them $40-$75K and are basically a glorified UPS delivery rep. I know that Ascent has their Corp come in to do presentations, etc. I position myself (as every rep should) to sell to the C-suite. You cut your sales cycle in half if not by thirds. So, no I dont sit in on these meetings, I conduct them as a consultant. You have to create equal stature and a business need. So yes, I sell to the C-Suite on a regular basis. Not saying I get in everywhere but that is where I start, not in Mat Mgt. I regulary conduct business review meetings and presentations within C-suite on a monthly basis. Probably 30% in C-Suite and the remainder with Materials and Directors. Just yesterday, I presented (alone) to CEO, CFO, CNO, Dir Mat Mgt, OR Dir, Risk Mgr, and Inf Control. Starting implemetation in 3 weeks. Nothing against Ascent, both put out a safe and clean product but we have two different approaches and sales forces. One of the reasons we make 3X more, are growing faster, and deliver 3X savings to our customers. If you dont have C-suite onboard and involved, a Hospital's program will crumble the first time Ethicon starts gunslinging false and misleading information.

 

[Anonymous]

By the way, the patient is already having devices that have been reused from other patients. It is no different reusing a reprocessed device than a reusable device that has been cleaned at the facility. No difference from a reusable lap grasper that has been cleaned by the facility or a reprocessed grasper that was once a SUD but now has the 510K to be used as a multiuse device under FDA guidelines.

You're missing the point. Reusables are designed to be resued. That's why they're mostly metal. Reprocessed are disposables, designed to work once, but b/c some company says they can effectively clean them, hospitals assume they're like new and will function like new. They're not! Soaking a plastic device in cidex for an hour degrades the material so it ends up failing during use. I've seen it happen a number of times and then the doc gets pissed.

 

[Anonymous]

You're missing the point. Reusables are designed to be resued. That's why they're mostly metal. Reprocessed are disposables, designed to work once, but b/c some company says they can effectively clean them, hospitals assume they're like new and will function like new. They're not! Soaking a plastic device in cidex for an hour degrades the material so it ends up failing during use. I've seen it happen a number of times and then the doc gets pissed.

I'm very aware about the point you are misinformed on. Who says these devices are made to be used once? Right, the OEM, so they can sell more devices and so the Hospital themselves will not attempt to reprocess it in-house. The reprocessed market of SUD's is a rather small market of devices, we are talking about about 3% of devices that can be safely reprocessed.

The FDA does not issue 510K clearance on the sole reason that these devices can be cleaned. They also have to be functionally equivalent. Meaning there is much scientific research involved for material stability to determine if the materials used are stable enough and compatible with reprocessing chemicals. Using the Fourier Transform Infrared Spectrometry for plastics, elastomers, and thermoplastics will determine what were the materials used in a device. This same technique will tell us if a device's material has undergone any changes after it has been reprocessed. Energy dispersive X-ray spectroscopy will confirm durability and functionality after usage and reprocessing and measure tensile strength, stiffness, torque, etc. With the proprietary cleaning agents and techniques which we use these compoents remain the same. We also back this with both simulated procedure studies which fatique testing is performed and blind studies with Surgeons to confirm their is no difference with new or reprocessed.

You are also correct in your statement about some SUD's that are designed to only be used once. There are many devices we test that cannot be returned functionally equivalent to the predicate device. This is done with scientific research which typically takes about a year per device.

 

[Anonymous]

I'm very aware about the point you are misinformed on. Who says these devices are made to be used once? Right, the OEM, so they can sell more devices and so the Hospital themselves will not attempt to reprocess it in-house. The reprocessed market of SUD's is a rather small market of devices, we are talking about about 3% of devices that can be safely reprocessed.

The FDA does not issue 510K clearance on the sole reason that these devices can be cleaned. They also have to be functionally equivalent. Meaning there is much scientific research involved for material stability to determine if the materials used are stable enough and compatible with reprocessing chemicals. Using the Fourier Transform Infrared Spectrometry for plastics, elastomers, and thermoplastics will determine what were the materials used in a device. This same technique will tell us if a device's material has undergone any changes after it has been reprocessed. Energy dispersive X-ray spectroscopy will confirm durability and functionality after usage and reprocessing and measure tensile strength, stiffness, torque, etc. With the proprietary cleaning agents and techniques which we use these compoents remain the same. We also back this with both simulated procedure studies which fatique testing is performed and blind studies with Surgeons to confirm their is no difference with new or reprocessed.

You are also correct in your statement about some SUD's that are designed to only be used once. There are many devices we test that cannot be returned functionally equivalent to the predicate device. This is done with scientific research which typically takes about a year per device.

SUD (Single Use Devices) are for SINGLE use. That means once. Not "some" SUD's. All SUD's. You clearly do not know anything about the FDA or the 510k process. When devices are submitted to the FDA, not only is test data required, but also product labeling indicating if it is multi use or sinlgle use. Again, Single Use means one time.

Using your Fourier and X-Ray Spectrometry tells you nothing about the device other than the chemical structure of the plastic. Did you happen to design the product? No you didn't. Do you know how and what tests were performed on it so you can duplicate it and verify that it meets the original specs? No you don't. Do you even know the original specs? No you don't.

I could take a device by another company, clean it as you do, test it and based off my test data, I could show that functionally, it is as effective as a new one. I could also do tests that show that it doesn't match a new one. What the hell does that show? Nothing b/c I don't know how it was originally tested.

The bottom line is the reason this whole industry came about was b/c hospitals are getting raped in the cost of their devices. A need was clearly identified, however, there is a unsafe element behind it.

 

[Anonymous]

its a shame when products get bent on the mayo stand or the cords get cut .... which then prevents the reprocessing . Any good Ethicon rep would make sure that would never happen

 

[Anonymous]

its a shame when products get bent on the mayo stand or the cords get cut .... which then prevents the reprocessing . Any good Ethicon rep would make sure that would never happen

That's pretty funny too. This happened once and the ESS rep was kicked out of the Hospital. Hospitals have Vendor Interference Policies which prevents this from happening and staff reports it to their Directors if they see this happening. Good luck with that one.

 

[Anonymous]

SUD (Single Use Devices) are for SINGLE use. That means once. Not "some" SUD's. All SUD's. You clearly do not know anything about the FDA or the 510k process. When devices are submitted to the FDA, not only is test data required, but also product labeling indicating if it is multi use or sinlgle use. Again, Single Use means one time.

Using your Fourier and X-Ray Spectrometry tells you nothing about the device other than the chemical structure of the plastic. Did you happen to design the product? No you didn't. Do you know how and what tests were performed on it so you can duplicate it and verify that it meets the original specs? No you don't. Do you even know the original specs? No you don't.

I could take a device by another company, clean it as you do, test it and based off my test data, I could show that functionally, it is as effective as a new one. I could also do tests that show that it doesn't match a new one. What the hell does that show? Nothing b/c I don't know how it was originally tested.

The bottom line is the reason this whole industry came about was b/c hospitals are getting raped in the cost of their devices. A need was clearly identified, however, there is a unsafe element behind it.

You are correct. Single Use Devices are required to be submitted to the FDA labled SUD so the Hospital does not reprocess it themselves. That is where the reprocessor picks up the ball and gets the 510K so we can market the device once we can show it can be cleaned, functionally tested, and sterilzed to meet FDA standards. So explain a little further for me, an endo shear might be used for a single cut only or can it be used for 5 or 10 or 20 cuts??? Or a multi clip applier. It has twenty staples, so the Doc should only squeeze the trigger once??? My point is that these device are re-used multiple times during a case. Now the device is cleaned and enabled for more uses without changing the device. The SUD label is simply submitted by the manufacturer so the Hospital does not try to reuse it.

Exactly, functionality test data must be submitted for a 510K from the reprocessor as well. If you disagree, you should report all these "issues" to the FDA. They are the SAME governing body that issued you the 510K and issued us our 510K.

As far as knowing the specs of the product? Yes we do have them, it is called reverse engineering. Pretty simple actually. We know every single component measurements, make up and strength of the materials and NOTHING changes these components during or after reprocessing.

You are incorrect again as far as (tests???) are concerned that it doesnt match a new one?? You make no sense here man. Do you think we are fabricating our own devices?? It's the SAME device, no better- no worse. We simply cleaned the crud off of it- Period!

When we resharpen-yes it is in manufacturer specs. Do you think that everyone of your devices is exactly the same as the next? WRONG- there are manufacturer tolerances or specs. There is a range. When we resharpen a shaver, we have a CNC (computerized numerical control) machine that sharpens it to OEM specs. We then place it in an optical comparitor. We are talking abour 1/1000's of a inch within manufacturer specs. Dont talk about what you dont know. You are throwing shit around hoping something sticks.

According to the FDA, reprocessed devices are as safe and effective as a new device. End quote. If you have issue- show me the scientific data behind your claims. There is NONE. And if there were you would be required to submit it to the FDA. Again, there is NONE. On the other hand, we have overwhelming scientific data that the FDA is in full agreement with.

I respect your opinion but there is NO data whatsoever that suggests there is any increased safety to the patient. No increase in infections rates and no decrease in clinical outcomes. Look at the MAUDE data, and the GAO reports in 2000 and 2008. Nothing.

 

[Anonymous]

When we resharpen-yes it is in manufacturer specs. Do you think that everyone of your devices is exactly the same as the next? WRONG- there are manufacturer tolerances or specs. There is a range. When we resharpen a shaver, we have a CNC (computerized numerical control) machine that sharpens it to OEM specs. We then place it in an optical comparitor. We are talking abour 1/1000's of a inch within manufacturer specs. Dont talk about what you dont know. You are throwing shit around hoping something sticks.

Jesus, I don't even know where to start. So I'm going to pick one element of you're argument that you're the most wrong about.

If you, a secondary middleman between the manufacturer and the hospital, resharpen something, (or test it for that matter), how in the hell do you know what the original manufacturing specs are? Do you call up the manufacturer and say "hi, we're going to reprocess a device you manufacture and to validate it's effectivness, we need all your original specifications"? Do you think you're going to get them? No. What you know is what you can measure. And measuring something, gives you one measurement. Not a range, as would be on a manufactured device, because, just as you said, not all are the same.

Here's where you sound really stupid too: If you don't know what the original specs are, because, trust me, you DON'T KNOW, then how can you sharpen them to the specs? And if you know jack about manufacturing, you'll know that some of these specs are +/- .001" (some are even smaller!)....which means, that if you do sharpen something, wouldn't you now be out of spec?

All you're telling me is you can figure out what the material is. I can pull a device from any one and "reverse engineer" it too. Doesn't tell me much though. Do you want me to tell you how many times I have to send product back in to HQ because it failed...only to find out that the engineering team determined it to be reused? Don't even try to tell me about the "safety" of the device. Safety is not just about cleanliness.

Your fancy talk about Spectrometry and CNC equipment is not impressing me.

 

[Anonymous]

I respect your opinion but there is NO data whatsoever that suggests there is any increased safety to the patient. No increase in infections rates and no decrease in clinical outcomes. Look at the MAUDE data, and the GAO reports in 2000 and 2008. Nothing.

sorry to burst your bubble here, but MAUDE doesn't report if the device was reused. They only report failures that affect the patient. Any guess as to how many of these devices were reused?

 

[Anonymous]

If you, a secondary middleman between the manufacturer and the hospital, resharpen something, (or test it for that matter), how in the hell do you know what the original manufacturing specs are? Do you call up the manufacturer and say "hi, we're going to reprocess a device you manufacture and to validate it's effectivness, we need all your original specifications"? Do you think you're going to get them? No. What you know is what you can measure. And measuring something, gives you one measurement. Not a range, as would be on a manufactured device, because, just as you said, not all are the same.

Here's where you sound really stupid too: If you don't know what the original specs are, because, trust me, you DON'T KNOW, then how can you sharpen them to the specs? And if you know jack about manufacturing, you'll know that some of these specs are +/- .001" (some are even smaller!)....which means, that if you do sharpen something, wouldn't you now be out of spec?

Actually, we do have the specs. It's pretty simple... it's called statistics. You take 100 new devices and measure to get the range of specs of new. For example, CNC technology uses a carbide-diamond tip to resharpen devices to within +/- 0.0005" of original design specifications - this is less than half the width of a human hair. Such precise sharpening allows users to expect the same product performance and clinical outcomes from a reprocessed device. Each blade and shaver has been reverse engineered to create the precise specifications that are equivalent to the original device. It is then de-burred to remove any microscopic burrs that may effect product performance and then placed in an optical comparator at 20X manification to assure it is within OEM specs.

I will not argue with the fact that reprocessed devices dont fail. New devices also fail. I have also had devices come back to me reported to have failed and it ends up being a new device. All devices fail- new or reprocessed and neither of them fail at a higher frequency than the other. Sometimes it is user error and other times it fails because of a manufacturing defect. Bottom line is that whether a device is new or reprocessed they all fail for the same reasons.

 

[Anonymous]

sorry to burst your bubble here, but MAUDE doesn't report if the device was reused. They only report failures that affect the patient. Any guess as to how many of these devices were reused?

Get your facts straight. Maude data does report whether the device is reprocessed or if it was with its initial use? The FDA requires reprocessors to label the device as we now become the device manufacturer. The most recent study analyzed data from 2000-2006 and shows that reprocessed devices have a 99.9997% adverse event free. 22,232 reported adverse events for new and 65 for same brand/model reprocessed devices. The entire reprocessing industry has ZERO MDR's as compared to hundreds of events associated with OEM devices.

The FDA has stated that 65,325 reports have been filed since October 2003 for the malfunction or injury associated with the first use of devices labeled for "single use". Of these reports, only 176 cases of apparent malfunction or injury were associated with reprocessed devices, and the FDA determined that ALL 176 cases were not attributable to the reprocessing of the device. Moreover, the FDA stated that its analysis "did not identify any adverse events that were actually related to the reprocessing of the SUD".

Case in point- The reults from the MAUDE data analysis shows that 1) Reprocessed devices typically perform as intended, and 2) the low rate of reported failures for these devices is consistant with that performance. In a nut shell, single use devices can be effectively reprocessed using FDA validated procedures with no increased reports of patient adverse events.

 

[Anonymous]

SONOSURG!

 

[Anonymous]

The FDA has stated that 65,325 reports have been filed since October 2003 for the malfunction or injury associated with the first use of devices labeled for "single use". Of these reports, only 176 cases of apparent malfunction or injury were associated with reprocessed devices, and the FDA determined that ALL 176 cases were not attributable to the reprocessing of the device. Moreover, the FDA stated that its analysis "did not identify any adverse events that were actually related to the reprocessing of the SUD".

So 176 is an acceptable failure rate for reused product? What is not an acceptable failure rate? Where do you draw the line? Do your statistics tell you that?

Dude, you're throwing around stats and facts that you can't back up. Use some common sense. Why do you think product is labeled single use only? It's not that hard.

 

[Anonymous]

I'm very aware about the point you are misinformed on. Who says these devices are made to be used once? Right, the OEM, so they can sell more devices and so the Hospital themselves will not attempt to reprocess it in-house. The reprocessed market of SUD's is a rather small market of devices, we are talking about about 3% of devices that can be safely reprocessed.

This whole back and forth conversation has been a very interesting read. While I was reading it, I had a few questions for the Ascent reps who are involved in this conversation.

1. One of the arguments that I read was that the OEM is responsible for stating that the device can only be used once. However, if you read the IFU for the Ascent Harmonic, it also states that it is a single use device. Why is it that Ascent can state that their device is only a single use instrument but if EES states it for their instrument, it is because they want the hospitals to purchase more instruments?

2. If Ascent is so confident in their products, why are there still Ethicon Endo Surgery labels on these instruments? If you look at the shaft of the ACE, it still has "Ethicon Endo Surgery" written on it. Why not "Ascent Healthcare"? Is Ascent trying to create confusion in the marketplace? The same can be said for the handle. There is still a "Harmonic ACE" on the handle.

3. Why did it take litigation from EES for Ascent to actually put their label on the devices? Prior to litigation a couple of years ago, a surgeon wouldn't know if it was reprocessed device because unless they saw it removed from the packaging, you didn't see any type of "Ascent Healthcare" on the actual device, just Ethicon Endo Surgery.

If Ascent is so confident in their products, why not remove all EES labels and eliminate any confusion for the surgeons/staff members as to what device they are using on their patients?

 

[Anonymous]

I'm very aware about the point you are misinformed on. Who says these devices are made to be used once? Right, the OEM, so they can sell more devices and so the Hospital themselves will not attempt to reprocess it in-house. The reprocessed market of SUD's is a rather small market of devices, we are talking about about 3% of devices that can be safely reprocessed.

This whole back and forth conversation has been a very interesting read. While I was reading it, I had a few questions for the Ascent reps who are involved in this conversation.

1. One of the arguments that I read was that the OEM is responsible for stating that the device can only be used once. However, if you read the IFU for the Ascent Harmonic, it also states that it is a single use device. Why is it that Ascent can state that their device is only a single use instrument but if EES states it for their instrument, it is because they want the hospitals to purchase more instruments?

2. If Ascent is so confident in their products, why are there still Ethicon Endo Surgery labels on these instruments? If you look at the shaft of the ACE, it still has "Ethicon Endo Surgery" written on it. Why not "Ascent Healthcare"? Is Ascent trying to create confusion in the marketplace? The same can be said for the handle. There is still a "Harmonic ACE" on the handle.

3. Why did it take litigation from EES for Ascent to actually put their label on the devices? Prior to litigation a couple of years ago, a surgeon wouldn't know if it was reprocessed device because unless they saw it removed from the packaging, you didn't see any type of "Ascent Healthcare" on the actual device, just Ethicon Endo Surgery.

If Ascent is so confident in their products, why not remove all EES labels and eliminate any confusion for the surgeons/staff members as to what device they are using on their patients?

The back and forth discussion has been from a SterilMed rep.

1) Single Use Device only pertains to the Hospital's reprocessing department that they cannot attempt to clean the device- does not pertain to a third party reprocessor with a 510K clearance for the device. It is Ethicon that states to the customer that their device cannot be reprocessed by a third party. Obviously the FDA disagrees and has issued 510K's to both SterilMed and Ascent.

2) The reprocessors are not changing the device...we are cleaning it, function testing, and sterilizing the device for reuse. We are providing a service to the Hospital. Does the Hospital buff off the V-mueller manufacturer label on their reusable products after they reprocess it themselves in house?? Nope. Why would we rename the device? The Hospital has given us their device and requested us to clean it and return back to them as subtanially equivalent. If you take your suit to a dry cleaners do you ask them to change the label of the manufacturer??? No, they perform a service for you and return the same suit to you.

3) The FDA requires all reprocessors to mark a device they have reprocessed and track how many times the device has been reprocessed. The reprocessor now becomes the device manufacturer in the eyes of the FDA and assumes all liability.

Hopefully, this has helped to answer your questions. And by the way. Stryker, much like Ethicon, was one of the most hostile towards the reprocessing industry printing many so called "white papers" that said reprocessing was not safe, the instruments were contaminated, etc. Of course all of these "studies" were biased studies paid for by Stryker done in 3rd world countries where reprocessing is not regulated as it is here by the FDA. SURPRISE- All of a sudden, last December Stryker found 535 million reasons that reprocessing is safe and effective when they purchased Ascent. Now SterilMed remains the only independent full service reprocessor in the nation. I don't see that lasting long as we will also be purchased by a major medical manufacturer sometime this year. My guess is Covidian. I'd wouldn't want to be working for Ethicon in a year.

 

[Anonymous]

So 176 is an acceptable failure rate for reused product? What is not an acceptable failure rate? Where do you draw the line? Do your statistics tell you that?

Dude, you're throwing around stats and facts that you can't back up. Use some common sense. Why do you think product is labeled single use only? It's not that hard.

Not trying to be rude but you are not comprehending what you read? There are over 9 million devices reprocessed a year. We have never been involved in a lawsuit and there is no evidence of increased infection rates or a decline in clinical outcomes. The MAUDE data simply reports that over a 6 year period, reprocessed devices has a 99.9997% adverse free rate. And out of the 176 reported events, the FDA determined that ALL 176 cases were not attributable to the reprocessing of the device. Moreover, the FDA stated that its analysis "did not identify any adverse events that were actually related to the reprocessing of the SUD".

In summary, reprocessed devices and new devices clearly fail at the same rate as evidenced in the MAUDE data. They fail no fewer or no more than a new device. They are substanially equivalent. New devices and reprocessed devices all fail for the same reason and at the same rate.

It's pretty simple reason why the device is labeled as single use device. During the FDA 510K process, the original manufacturer did not submit the required data for the reuse of these devices by the Hospital. So the reprocesor submitted the required data and received their own 510K for reuse under strict FDA regulations that can only be done by the submitting party.

You say I am throwing around stats and facts that I cant back up??? These are not my facts, these are the FDA's facts/stats. Your ignorance is a little suprising to be honest. The FDA is the same governing body that states your product is OK to go on the market which states our product is OK to go on the market. Your right, it's not that hard to comprehend.

 

[Anonymous]

While you spent 3 hours writing all this, I was in the OR taking away yet another one of your accounts.

CAFEPHRAMA To a "T" ...hahaha classic

 

[Anonymous]

How often are you SterilMed guys going up against Ascent in your accounts - and fighting to defend? Do you see Ascent leveraging their Styker portfolio to get into accounts? I often times wonder just how far this business can really go...

 

[Anonymous]

The bigger question is how long until these guys get into a price war....and the bottom falls out. They have no IP protection and are fairly interchangeable...sooo... THE OEM's WILL PREVAIL!