Why does Ethicon allow companies to reprocess their devices?

Ethicon spent $$ on the R&D, regulatory, patents...doesn't seem right that a reprocessor can just clean the trash and take their profits.

 

What doesn't seem right is charging hospitals full price for devices that can be used again.

STFU.

 

What doesn't seem right is hospitals using reprocessed medical devices on patients without their consent.

 

Where the hell have you been over the last 6-7 years? Reprocessing is here to stay, whether you like it or not. When smarter companies, like Stryker, buy the reprocessing company to ensure they rake in their original price and product but then re-sell yours, they beat everyone to the punch.

The government (FDA) has approved reprocessing making it legal. I think the bigger battle won't come from us but from the insurance companies when they are charged for reprocessed products as if they were new. That's fraud and a big legal no-no.

 

There is a simple way to fix this. Think about what drove hospitals to look at reprocessing in the first place. There's your answer.

 

Do your homework before popping off the mouth. Of course Insurance companies pay out the same price for both OEM and Reprocessed devices because the FDA says they are the same device. Their is no difference from the predicate. It is perfectly legal and Medicare has the same payout.

I love when someone goes on a board and shows their ignorance.

 

What doesn't seam right is the patient can't choose a reprocessed device pver an OEM. The FDA study which is reported in the MedSun (Medical Device Safety Network) says reprocessed fail at a much lower rate. I would rather one used on me.

 

What doesn't seem right is a patient has to have a device from EES that was made from junk in Juarez Mexico.

 

Good point. This topic is much bigger than consent or cost at this point. Hospitals are laying off staff members in groups of more than 100 at a time, cutting back on their educational budgets and closing entire departments due to reimbursement cutbacks and guess what....this is just the first wave. There is more to come. That being said, by directly impacting the spend on supply costs; those funds are immediately available to divert back into staffing, education, technology which all result in sustainable patient care. This is not a safety or legal issue anymore. Those points have been investigated many times over the years and all government and regulatory agencies have deemed this to be a safe and legal practice. I challenge you to do some research on the profit margins reported by the OEMs the first 3 quarters of 2010, then go find out how many people in healthcare lost their jobs due to reimbursement cutbacks, you might feel differently.

 

What really doesn't seem right is the FDA clearing devices which are to be permanently implanted in one's body under the 510K CLEARANCE process, meaning no clinical trials are required.

Worse that that is the fact that the FDA will clear further devices for market based on the "substantial equivalency" to a device which had used a predicate device that had been pulled from the market.

On August 12, 1996, Boston Scientific submitted documents to the FDA under the 510K clearance process for their new device, the ProteGen Sling. As the predicate for this new device, Boston Scientific used a device that had been approved under the Pre-Market Approval process, Ethicon’s Mersilene Mesh, approval #K851086. On November 15, 1996, Boston Scientific was cleared to proceed to market with the ProteGen Sling, under clearance number K963226. Just two years and two months after receiving clearance, Boston Scientific on January 22, 1999 submitted a letter to the FDA initiating a recall of this product. The reason as stated in the FDA’s enforcement report of March 17, 1999 stated “Use of the ProteGen in the treatment of female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”

The FDA waited nearly 6 weeks to formally recall the ProteGen Sling after receiving the letter from Boston Scientific. Prior to this recall being initiated, I found three surgical mesh devices for urinary incontinence that were cleared by the FDA that had directly used the ProteGen Sling as their predicate device; one device was cleared that had used it indirectly.

To date, I have found more that 65 devices for which their clearance can be traced either directly or indirectly back the the recalled Protegen Device. When I say "indirectly", I mean that the predicate device used, though not directly identified as the predicate, can be tied back to the ProteGen via a clearance chain of all the mesh devices used as predicates.

see articles http://ireport.cnn.com/docs/DOC-416625 and http://ireport.cnn.com/docs/DOC-422675
(I researched them and wrote them both, and they are on CNN iReport's webpage)

I spent two years researching surgical mesh, and I can prove every word that I say to be the truth.

I even found one device, the IN-SLING manufactured by Influence INC. where the FDA Clearance Document Number K972651 states "“No performance standards applicable to surgical mesh have been established by the FDA” yet the FDA approved this device and has subsequently cleared many more surgical mesh devices over the last decade. If, as this document states, no performance standards had been established, neither this device or its predecessor the ProteGen Sling should have received FDA clearance.

And lastly, what is really pathetic is the fact that Women worldwide are being used a guinea pigs, whether the implant is a single use device or a reprocessed device by the FDA, The Pharmaceutical Companies and their Reps.

In case anyone has any doubt, I am one of the thousands that was injured by a bladder mesh device, and it has destroyed my life!

 

that's all she wrote....

 

I get a kick out of Ethicon reps and the revolving door...there is always a new rep right around the corner. My understanding is that Ethicon has been beaten badly by company's that are just flat out more creative than they are...

Ethicon has the same right to reprocess their own equipment, but are not that advanced. Thanks to reprocessors for manufacturing devices in the US, not in Juarez, Mexico.

 

BLOOMBERG...JNJ is garbage. Did everyone see the front cover of Bloomberg BusinessWeek where they quoted JNJ Ethicon as having 50 recalls in over 15 months. I did some research and there was a trocar recall from Ethicon a few months ago. By comparison, I did not see any reprocessors that had recalls.

 

Its a shame that Ethicon was not smarted enough to reuse their own devices...for anyone thinking about going to work for Ethicon, you better have a back up plan, their is a mass exodus including Bill Wilson, Jarrod Bowers, Mike Sevetich, and hundreds more. These guys were DM's and product managers.

 

Believe me, after two years of research, like the energizer bunny I could keep going, and going, and going!

 

It's real simple. I dont have a problem with reprocessing as long as:

1) The patient is informed there will be a single use device re-used on them
2) The patient is informed they will pay the same price for both the new and used device
3) The patient is allowed to share in some of the savings the hospital realizes
4) The insurance companies reimburse at a lesser rate for the used device

To say "its the same device" and should be charged and reimbursed the same as new is like saying because a car is not a single use device you should be able to sell a used car w/ a re-built engine as "new" and charge new car prices.

As a hospital administrator, reprocessing is great for "patients" but not one of them would opt to have a device used to removes their mother's uterus that was used last month to remove another patient's colon. To say otherwise is living in a f'ing fantasy world.

 

1) United States Government has declared reprocessed devices are the same or better than the OEM.
2) Patients DO NOT pay for the devices used, it comes out of the DRG because it is a PROCEDURE that is billed not the products genius.
3) It is called keeping the lights on and staff available when there are no cases going on. Patients get the added benefit of that as well as hospitals being able to afford the latest and greatest in technology because of their savings. Don't forget hospitals lose a lot of money due to indigent care and from people who just don't pay.
4) Once again genius, devices are not reimbursed, it comes out of the DRG. It is obvious you do not understand your book of business and how the OR works.

In addition, hospitals have been reprocessing for over 50 years. They are simply outsourcing the reprocessing of their single use devices that you claim can only be used once. Also, reprocessed items have less failures than the OEM. Don't take my word for it, look it up on MedSun and Maude reports.

Ever look on that back table and see all of the metal babcocks, scissors, etc? Do you think those are brand new? This is 1 reason why you should not be at Ethicon, you are an idiot. So much good talent has left, and those that are very good at what they do and have remained are on the way out because it is obvious Ethicon stop taking care of the tenured reps with a lot of knowledge.

Good Luck!

 

1) The US Gov't once declared African American's were 3/5's of a human being, so sorry if I'm not blown the fuck away. I disagree with the position of the gov't. I am sure you wouldn't mind the patient being informed, correct? You're company doesn't lobby the shit out of Washington to prevent that, do they? "Medical Devices" is a broad term. Want to say a Sharp's container is the same or better? Fine. A disposable for a Divinci or a Ligasure? Debatable.

2) Have you ever looked at a hospital bill? Have you ever asked for a detailed, line item receipt? You know, so you can see they charge $16 for a band aide and $35 for an Advil? Do you follow? So the question is how do they charge for a reprocessed supply or device? Discount, or same price as if it came out of the box from the OEM? Simple question.

3) I am all for the hospital lights being on and all of that happy horseshit. Because I know this is why you are so passionate about reprocessing. Its all about being green and making sure people are able to get good care. You are a real philanthropic son of a gun. I simply believe a patient deserves to know and I think its wrong to charge full price for a used item. There isn't another market example you can give me where someone argues a used car, clothes, TV,condom,plane,easy chair, or toilet paper is equivilant to new and should be worth the same amount.

4)I think we've already covered this one.

I don't work for Ethicon. I don't give a fuck about your failure rate. I simply think a patient should be consented, and there should be price concessions for reprocessed equipment. If you can't tell the difference between a multi use, stainless steel hemostat and a single use, handheld or other single use device that has electronic components then you aren't very smart. You probably couldn't handle a job much more challenging than garbage collection. Hey, congrats, you found your calling.

 

Well since you don't work for us, then why don't you both get your own fu*king board you schmucks!

 

I find people that use "emocons" like to suck cock. Are you a chick?