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Anonymous
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The panic from these Ethicon drones is quite humorous. Just wait until reprocessing creeps into your other bag of goodies.
This was interesting to read. As a patient I do not care the cost to the hospital or to the reps. I do not care if the hospital uses reprocessed equipment. All I know is I will be telling my doc I want new, clean instruments used on me. My ins is paying for my surgery so the hospital will get paid. If they used reprocessed equiment does my ins have to pay less? They should pay less for second hand equipment and I should legally have the right to know. I hope the news does a story on this because it is scary.
In one simple paragraph, this person single handily summed up the problem with healthcare today. They have no idea what they are paying for and don't bother asking either.
Reprocessed is a huge problem b/c the equipment isn't designed to be reprocessed. It may be clean, but will it work? Maybe. Maybe not. Are you ok taking that chance because the hospital is trying to make a little money after they're being raped by Ethicon from what they charge?
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.
Listen Dum Dum Baby, you must not have got the most basic point from the previous poster. Single Use Devices are labeled that way by the FDA. Period. On a reusable device, the FDA does not say "Ok we think this should be one time use only." No, you just have to show test data that subsequent uses are substantially equivalent to the first use.
The FDA considers the reprocessed device New.
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
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.
What is unsafe?? These are not Space shuttle parts. REVERSE ENGINEERING! Pretty simple procedure that you can you before duplicating all product spec tests. WHo says Ethicon even used correct testing procedures? A lot of time is wasted just so you can have some cool stats to show hospitals.
LOD DEE FREAKING DA!
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?
Very few smart guy. MedSun reported a 13 month study on harmonic scalpel conducted by FDA. 37 failures of Ethicon devices. 3 failures of reprocessed devices.
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.
Can you post a link to this report?
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!
Oh, by the way. . .check out the 2009 FDA MedSun study (13month study of harmonic scalpel). Ethicon had 37 device failures and Reprocessed devices had 3. So you better start having the Mexicans stop batch testing and begin testing each and every device like Ascent does.
Actually there is a huge difference between Ascent ans Sterilmed. Sterilmed only litterly cleans the products. They do not do any reverse engineering to clean all the intricate parts. Ascent breaks the products down to its original components.
Obviously Sterilmed has to prove to the FDA it can clean the products, so no harm no foul.
Let me ask this. Why is it that hospitals STOP reprocessing harmonic? If the savings are so significant and there are no additional problems with the reprocessed harmonic devices, then why do hospitals stop? I can tell you that in my area there have been at least a half dozen hospitals stop reprocessing harmonic. Because of the economic savings, it wouldn't make sense to stop, so why do they?
I can tell you that there are so many unreported failures of reprocessed devices that it is ridiculous. That is the reason these hospitals stop. The physicians are fed up as well as the staff. Do not kid yourself on MedSun data or "Ascent" reported data. The truth is in the fact that hospitals switch back (even though they will be paying more for these instruments) because of problems experienced with reprocessed devices.
I heard that Ethicon is dealing with quality problems at their harmonic plant in Mexico. Is this true?
I heard that Ethicon is dealing with quality problems at their harmonic plant in Mexico. Is this true?
I heard that Ethicon is dealing with quality problems at their harmonic plant in Mexico. Is this true?
This is a huge bubble that's growing bigger and bigger for these reprocessing companies. Once the FDA get's wind of what is actually happening, it's going to blow. A few years from now, you'll come back and read this post and realize that this dude was right.