In my hospital the surgeons decided to take an active role in the PICC program, which previous to this development had been the exclusive territory of IV therapy. At my hospital I was shocked to see the relationship between our IV team and a certain vendor that controls most of the PICC market. It was very unprofessional, if not a total violation of medical ethics. We had Rn's working for this company doing classes and yet making decisions about our PICC program. When ever I asked for objective data all I got was a regurgitation of a set response that our IV Rn's got from one of the companies paid Rn's. Many of my fellow surgeons have been reprimanded because of their "close" relationships to the orthopedic companies and this practice has been curtailed. If my hospital is any indication of what is going on with not all, but many IV teams, then the FDA needs to take a serious look at this complete breach of medical ethics. The surgeons were able to put a stop to this at our hospital, but in reading many of the posts on this forum, I can see too many of you are in bed with vendors.
Are you serious? Is not the president elect of AVA working for the leading PICC company in the world. Could you imagine if the president elect of the New England Journal of Medicine worked for J and J? Please! I fought the battle in my hospital because I believe in the ethics of medicine and I also have enough money to make waves. How can you justify an RN working for the market leader in PICC's and also making decisions as to what products to use? In view of the fact that the president elect of AVA (to the best of my knowledge) is employed by the leading PICC company; is like asking the fox to guard the hen-house. Let's be real the relationships between many IV Rn's and device companies, especially the market leader, is out of control. An Rn can't serve two masters the company they work for (if only part time and the hospital and patient). If an RN or doctor leaves the hospital and takes a full time position with a device company that is fine; but you can't work for a hospital and also work for a device company without a conflict of interests. The American patient deserves better than this!!!!!!!!!!!!!!!!!!!!!
Let me speak from a huge amount of first hand experience from working with manufacturers both as an employee and a contractor from nearly 20 years. I can understand your concern when patient care decisions are strongly influenced by nurses who are working as a contractor for one manufacturer. I also see the need for nurses to work for those manufacturers because being trained by a real clinical person is far superior to training provided by a sales rep who has never touched a patient - No offense to all the sales reps out there. You do a great job but should be focused entirely on the business side and leave the clinical and education side to nurses.
One problem is that manufacturers have contracts that include a non-compete clause, prohibiting these nurse educators from working for other companies. So this sets up the nurse to think that they are bound to one company. I have refused to sign contracts with these clauses for more than 11 years now and will continue to do so. I provide services to all manufacturers. So it is possible, but the nurses have to be willing to walk away from the business if the company will not amend this contract.
The FDA is not the one to regulate this aspect of practice. The other message indicated AVA Med but I think you meant to say Advamed - you can find their code of ethics at www.advamed.org. The FDA does strongly regulate what manufacturers say in their product labeling. Everything, including verbal information from anyone working for the company (employee or contractor), is considered to be labeling. All messages from any manufacturer have been through lengthy legal and regulatory review processes to make sure that the product claims being made are well within the statements that are allowable by the manufacturer.
The problem, as I see it, is that nurses must realize the difference between when they are being paid by a manufacturer (and required to follow their statements) and when they are being paid by their healthcare organization employer. They can not allow the former to have undue influence on patient care decisions in the latter. Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
www.hadawayassociates.com
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Cheryl Kelley RN BSN, VA-BC
Lynn: You sound very consensus, but you maybe the exception to the rule. We had 8 RN's and six were actively supporting the device manufacturer's products come hell or high-water. They would not even evaluate other products or consider clinical information contrary to the company they did perdiem work. Money can be a very corrupting force and because not everyone is as consensus as you; as health-care professional we must enforce regulations that demand a separation between money, health-care professionals and device/drug companies. Even an appearance of impropriety can cast a dark shadow upon us. If we lose our integrity, then we lose everything.
I would agree with you on many of these points. The nurses you have seen are performing unethically if they indeed have refused to look at other products. Maybe the actual problem is that nurses working for manufacturers have not been educated about the role, the responsibilities and how to make these distinctions. I have long been concerned that these nurses would actually go to do PICC insertion training and when the learner failed they would take over the procedure. This is way outside the role of what they should be doing.
I strongly agree that nurses who have strong clinical experience is the best person to teach others how to do it. I also know that most PICC insertion education and clinical precepting is now being done by the manufacturers. There has got to be a way to resolve these issues so that everyone wins. Maybe there needs to be some continuing education programs about these issues. Maybe topics on the program at INS or AVA. Just some suggestions.
Speaking of AVA, I would like for you to totally understand the mission and vision of this organization. Many years ago, we set out to change the way things were done. It seemed a tragedy to have the nurses in the presentations and the manufacturers in the exhibit hall and the only way they meet was at exhibit times. There is really so much to be shared and learned from each group. I can not tell you how valuable it has been for me to work with experienced biomedical engineers. So AVA set out to breakdown those barriers. So yes, an AVA officer can be anyone - nurse, sales, marketing person, engineer, researcher, physician, etc. It has been a good thing in many ways. But the people in those roles have to see the big picture. I have always maintained that patients and patient care was the only bottom line for me. I was very fortunate in 1989 to start working for a manufacturer who understood, endorsed and totally supported this approach.
Well, enough of my rambling on about these issues. You have brought up some valid points. Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
www.hadawayassociates.com
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
I totally disagree with you in so many ways but it is futile to continue this discussion because you are not going to change my opinion based on 35 years of experience with numerous employment and contracted situations and I am not going to change yours which is based on a single facility's experience.
Lynn Hadaway, M.Ed., RN, BC, CRNI
www.hadawayassociates.com
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Lynn: Since you have thirty five years of experience with IV therapy and undoubtedly know RN's better than me. Why don't you do a little research? You probably can find out the RN's who are doing per diem work for the drug companies and the leading PICC manufacturer. I would not be surprised that you will find where there is a per diem RN working for a particular vendor, that hospital is using that vendor's product almost exclusively. Who knows maybe this will be my first leap into medical ethics. But, I hold my opinion, that it is at least very plausible that these medical device companies and drug companies are marketing their products under the guise of per diem education to these hospitals. What is more the per diem RN's can then go out to the community and do the drug companies bidding. Because you do have 35 years in IV therapy, it could be your opinion is not as objective as an outsider such as myself. Do the research Lynn and then come back and talk to me. Thank You for your input.
Wow, all this time all i needed to do was work contract for a company to persuade my employer to use said companies products??? Back to reality i do clinical education for cathflo and yes my hospital uses cathlo!! But oops it is the only FDA aprroved drug for declotting. My working contract for cathflo does not influence the purchase of said product in my hospital system, in fact purchasing for the hospital system i work for doesnt take product ultimatums from anyone including surgeons. Please inform me where it is you work because nurses have way more power there. The argument you make comparing nurses and surgeons is so full of holes it hurts. The surgeons you refer to stopped being close to company reps not of their own choosing but by the mandate of the FDA. These doctors were not teaching for said companies and recieving compensation they were taking trips to vail for 4 days with thier families and going to 1 hour presentation on product for trip requirement.
p.s. If this comes across defensive it is. To assume because one works for a vendor and a hospital system must be unethical is as ludicrous as saying all muslims are terrorists!!!
Heath Roye
The point is very simple: If you don't work for a vendor there is no possibility of an appearance of indiscretion. Now that isn't a difficult concept. I can see that some RN's that are having a problem with that very fundamental statement are often associated with or have one of their friends involved with a vendor. When there is a competitive drug to Cathlo and if your hospital was to choose to go with the competitor, I would opine that you would probably be out of a per Diem job. But, I could be wrong. A lot of these relationships seem to be you scratch my back and I will scratch yours. Don't be naive and foolish having an RN in a hospital that also teaches for that vendor is an advantage to the vendor. Now you may well be totally immune from the fact that you are paid by a vendor and that won't have any effect on your loyalty or objectivity, but that is not always the case. Why do you think drug companies take you out to dinner? Why do you think the FDA and other organizations are trying to put a stop to even simple events like this? Are they stupid? Are they naive? No, they understand that where there is an exchange of money/favor there is more of a probability of indiscretion. Let's put two and two together, sir. If the FDA and other organizations are trying to curtail a dinner or golf outing with a vendor; don't you think that a clinician actually working for a vendor and also working at a hospital and using their products is a few degrees above a simple dinner? If you are defensive then it is due to the fact that you probably have a consensus, so there is probably some hope for you. Good Day
I guess I do not get why if this is not a problem for these RN's hospitals, their primary employer, why is it a problem for you?
By the way, there is a competitve drug to Cathflo---the pharmacy can alloquat tPA or alteplase. And many pharmacies do that.
I think you are assuming the floor, staff RNs have any control in choosing products. My experience is that it is a rare thing if a staff RN can give any input whatsoever into product choices. Even if they give input, that does not mean it will be considered. Most product choices are driven by purchasing and upper management, in looking for a cheaper way to accomplish the same thing. In most facilities, it is all about the $$$$$$ and cheaper always wins.
I guess I do not get why if this is not a problem for these RN's hospitals, their primary employer, why is it a problem for you?
By the way, there is a competitve drug to Cathflo---the pharmacy can alloquat tPA or alteplase. And many pharmacies do that.
I think you are assuming the floor, staff RNs have any control in choosing products. My experience is that it is a rare thing if a staff RN can give any input whatsoever into product choices. Even if they give input, that does not mean it will be considered. Most product choices are driven by purchasing and upper management, in looking for a cheaper way to accomplish the same thing. In most facilities, it is all about the $$$$$$ and cheaper always wins.
[/quote]Interesting points.... especially with the drug Cathflo mentioned.
At my hospital, a few weeks ago, the IV therapy department discovered the Nurses were being inserviced by Cathflo reps on the floor as to how to give the drug themselves bypassing the IV department completely. Once they were checked off, they were giving without the IV department even being aware of the situation.
The IV department does not just "hand out" cathflo to anyone requesting it.
There are some patients that do not qualify for cathflo as other methods can often alieviate the issue, such as "was the cather kinked", is it merely positional, and "my favorite"... did you flush it? Floor nurses are often very cautious and do not know how much force can be applied nor do they use push pull or similiar techniques as that is not thier specialty.
I rarely actually have to use a declotting agent when I'm called for a supposed clot.
Cathflo reps knew that by going through the IV department, not "near" as much of thier product would be sold, instead went around us straight to the top.
I guess the real fault is the chain of command that allowed it to happen here.
But still, another example of vendors taking the helm for the sake of their interest.
______________________________
Always remember that you're unique. Just like everyone else.
The second mouse gets the cheese!
I guess I do not get why if this is not a problem for these RN's hospitals, their primary employer, why is it a problem for you?
By the way, there is a competitve drug to Cathflo---the pharmacy can alloquat tPA or alteplase. And many pharmacies do that.
I think you are assuming the floor, staff RNs have any control in choosing products. My experience is that it is a rare thing if a staff RN can give any input whatsoever into product choices. Even if they give input, that does not mean it will be considered. Most product choices are driven by purchasing and upper management, in looking for a cheaper way to accomplish the same thing. In most facilities, it is all about the $$$$$$ and cheaper always wins.
[/quote]Interesting points.... especially with the drug Cathflo mentioned.
At my hospital, a few weeks ago, the IV therapy department discovered the Nurses were being inserviced by Cathflo reps on the floor as to how to give the drug themselves bypassing the IV department completely. Once they were checked off, they were giving without the IV department even being aware of the situation.
The IV department does not just "hand out" cathflo to anyone requesting it.
There are some patients that do not qualify for cathflo as other methods can often alieviate the issue, such as "was the cather kinked", is it merely positional, and "my favorite"... did you flush it? Floor nurses are often very cautious and do not know how much force can be applied nor do they use push pull or similiar techniques as that is not thier specialty.
I rarely actually have to use a declotting agent when I'm called for a supposed clot.
Cathflo reps knew that by going through the IV department, not "near" as much of thier product would be sold, instead went around us straight to the top.
I guess the real fault is the chain of command that allowed it to happen here.
But still, another example of vendors taking the helm for the sake of their interest.
______________________________
Always remember that you're unique. Just like everyone else.
[/quote]
Cathflo=alteplase=activase same drug, so again only fda drug approved for catheter clearance.
Windstrings, i notice that you have kl vascular listed as employer. So if a floor nurse fixes her own line with out calling your service you lose money correct? The competent floor nurse can handle the declotting of lines with education, freeing the "iv team" for their more important work. This works for more than one hospital around the metroplex. This argument again is without merit because really everyone stands to lose one way or another. Heath Roye
The selection of vascular access products are often determined by contract and not by nursing input. Unlike selection of lets say an orthopedic device selected by the physician. That said, successful selling depends on relationship building. Often having experienced nurses doing the teaching results in a much higher quality of education. Success often relies on nuances that is learned from clinical experience. Having been on all sides of this issue I have found the preditory contracts signed by large buying groups or hospitals have much larger impacts on product selection then nurse input. In these contrac dollars are the big issue. It is very naive to think it is only nurses. There are material management idividuals who have serious relationships with specific manufacturers. I do believe that medical manufacturers use clincial nurses more because of their clinical knowledge and their ability to teach their fellow nurses which reslut in positive outcomes rather than the nurses ability to impact the hospitals purchases. Physicians really do have more direct power. If the surgeion will not do surgery in a hospital that does not use his specific product the hospital will provide the product to keep the physician. Many hospitals carry redundant products by different manufacturers just to please the request of a physician. This I can assure you does not happen for the nurse.
Denise Macklin
I have followed this thread with interest, and also as a nurse who has been at the bedside, deciding product and as one who has educated for over 5 years other hospitals on vascular access adn PICC's, the situation that "plsysinc. P" describes as far as product selection DOES indeed exist.
I will simply say that I have seen vascular access teams, PICC nurses, etc. want a product because they feel it is superior to what it presently being used in the facility. That does not mean that the "superior"product will make it thru the door.
If many of you reading this have never been involved in the contract side of product implementation, it gets "hairy" and ther have been several times when the "not on contract" card gets played. Recently, on one account I was involved in, things went as far as the educaiton being scheduled and the purchasing manager called the competition and informed him that "you are going to loose your business if you don't get in here." I know this because the competition rep told the PICC nurse that he was glad the purchasing manager called! The nurse who was defending her decison to evlauate other products was simply told "NO" and that it was because the product was not on contract.
Now with that said, I feel that overall and in general terms, most of us do want to do what is right for the patient, and that all companies feel their product is superior. That's the great thing about America!
Cheryl Kelley RN BSN, VA-BC
Out of curiosity- what device do you use at your hospital spqr?
Jose Delp RN BSN
Clinical coordinator IV Team
Upper Chesapeake Health
Jose Delp RN BSN
CliClinical Nurse Manager IV Team
Upper Chesapeake Health
This whole discussion has been many things, if not interesting, I was the lead of our iv team and did per diem classes for a manufacturer. We had a products committee that nurses sat on to give their input on products, I also sat on that committee. I was one of many! No way would only my opinion count. We had multiple hospitals also. Because I attended INS and AVA conventions and meetings I could speak to a lot of issues and products, not just picc products. The input from this committee was taken in consideration, but contracts played a much bigger role. After many years when a question was raised about my being on the committee and working per diem for a manufacuturer, I resigned from the committee, which was appropriate I suppose, either that or stop the per diem work. The unfortunate thing is that many of us with a lot of expertise wear a number of hats, is it so hard to beleive that we can see many sides of an issue and products and can talk pros and cons without bias??
Hi all. This is Gail Sansivero commenting on the issue of clinicians working with corporations, as employees or consultants. Please note that I am using Mary Tessier's log in as today I am running at work and have no idea what my password on to this site is! (Thanks, Mary!) And I ask all of your for your understanding at the length of this message, but my message is sincere, and I hope fairly straightforward.
1. The IV-Therapy forum should be used for discussion and consultation for vascular access and infusion issues. Personal criticism of individuals is out of line.
2. We should all clearly identify ourselves when posting messages, and own that message.
3. Many, if not all, of AVA presidents, including myself, have been employees of or consultants for corporations. Each of us is responsible for maintaining appropriate standards of professional ethics, and for clearly disclosing our affiliations and potential conflicts of interest. AVA has had a policy on conflict of interest in place for many years. This policy requires AVA leaders to recluse themselves from deliberations and decision making in situations in which a conflict of interest may exist.
4. Consulting agreements are common for expert clinicians in their fields, whether nurses, physicians or others. Many of us hold patents, and have advanced clinical practice through research and development efforts which have come to fruition in new devices and approaches which directly benefit out patients.
5. These same clinicians volunteer in a variety of roles in professional organizations. The time and energy spent in these roles often means that clinicians compromise their own careers to do so. For example, it's hard to have enough time to publish a paper and be AVA president at the same time.
6. I shall assume that the initial criticism of the incoming AVA president is aimed at Nadine Nakasawa. Let me publicly say that Nadine upholds the highest ethical standards in nursing, is a vocal patient advocate, and I have never had cause to question her professional integrity. In fact, I can confidently say that I believe Nadine would give up any consulting arrangement, or even the AVA presidency, if she felt that her ethical standards were being compromised.
Thanks for listening and I'll go home and find my password!
In the medical field our customers are our patients; it is reasonable to conclude that the public would want as little relationship between clinical professionals and the outside influence of money as possible. In fact when it comes to one's health-care, it is even more logical to conclude that the public would demand a separation of money, clinicians and the drug companies, that would far exceed their concern about politicians and lobbyists. Therefore, even if there isn't any impropriety between a drug company and a hospital employee, the most clean relationship is one that does not involve any exchange of money. Be it fair or not the public often thinks that one can't be completely impartial if one is working for a drug company, for example, and also using their product. If one is being paid and or given favors by a drug company, it is easy to say that one will remain totally professional and that maybe the case. On the other hand you can't fault the public, as is the case with lobbyists, to raise questions.
The public is growing very disenchanted with the American health-care system, especially with 47 million of our citizens without insurance. I only think it is a matter of time before the medical profession comes under a tremendous amount of scrutiny, be it fair or otherwise, many relationships as described in this forum will not be looked upon with favor.
Thank you Gail, true words with a clear message. Frustration and anger may lead some people to wild ideas.
I believe what my Grandma said: If you point your finger to a person, three finger will point at you!
This website is for education, related questions and we should help each other.
Privat issues should be not posted, yes you have your freedom of speach but respect the purpose from this website. It is about better patient care and not about you.
Andre Schotte
Kathy Kokotis
Bard Access Systems
What am I missng here.
Past Presidents of AVA:
Carol Renner (93) direct employee of J&J
Kathy McHugh (2007) direct employee of Boston Scientific
Nadine (2009 incoming) soeakers bureau Genentech, preceptor for Bard not sure what others
Darcy (2008 current) speakers bureau Genetech, preceptor Boston, speakers bureau for Biopatch I am pretty sure,
Kathy Kokotis (treasurer direct employee Bard)
I can name more. My opinion volunteer to serve as president or any other function. AVA needs all the help they can get. The reason you see these names over and over is that who is doing the volunteering because they are focused on their practice and expanding it. Don't complain volunteer. No compnay has a lock as you can see on who gets elected and serves at AVA as the individuals come from all over.
enough said
kathy
Kathy Kokotis
Bard Access Systems
Excellent Kathy!!
Again, you've come up with a great reply!! I whole heartedly agree with Kathy here, I'm a member of AVA and seen these Nurses in action and they are FANTASTIC! No one would ever sell out to anyone. They have integrity, professionalism, and intelligence far superior to most!! Jamie
Are you not able to make your own decision which catheter do you want for your patients? Do you need the AVA president or Lynn or Kathy or Nadine to tell you which one do you have to use?
If so, maybe think about changing to bedside nursing. These people are here to help and share the experience with there picc lines. You will use more likely the catheter you grow up with. And, show me a Picc line who can compare with the new SOLO....there is nothing out yet.
We don't need to defend Bard, Bard don't need us for defense.
If you like ARROW or Boston or Medegen, go for it, you are the expert and you have to feel good when you place your line. You consider to the benefits of your patients.
Except experience and opinions, that is the reason we have the website here.
Andre Schotte
What really amuses me about all this whole circus is that SOME people STILL do not admit there is a problem with this whole setup or cannot really differentiate what conflict of interest is all about.
If one is coming here to get an objective opinion and one is expecting to get it from somebody that is working for a given drug company or other manufacturer than that might not be a realistic endeavor. Your point is well taken in that an RN should be able along with the protocol in his/her hospital to make their own decisions. Yet it appears that many take the word of those paid by drug companies as the gospel truth; and somehow bury their heads in the sand to the fact that these people work for the drug companies are paid by the drug companies and therefore it is at least reasonable to believe they are going to give the message of the company they work. That is plain and simple deductive logic and it seems many of you are having a problem with that concept.
Well said. Think we can drop this now?
Jose Delp RN BSN
Clinical coordinator IV Team
Upper Chesapeake Health
Jose Delp RN BSN
CliClinical Nurse Manager IV Team
Upper Chesapeake Health
Kathy Kokotis
Bard Access Systems
Start focusing your anger and conversation on heparin:
I think this point is now mute so I will now give my biased opinion as a Bard Employee. Start focusing on heparin and alternatives to conserve the heparin we have for our patients as that is what it is about.
I recommend going to the American Society of Hospital Pharmacists website and read their recommendations for dialysis, PICC lines, ports and tunneled catheters. I believe the biased Lynn Hadaway who has also worked directly for a manufacturer (Menlo CAre) and served on the AVA board and done consulting work has the info on her blog as well. Lynn is a valuable part of our practice.
Start talking to your pharmacists. Monitor the heparin in stock and heparin needs and substitutes. Baxter is no longer shipping. APP is shipping limited amounts weekly basis only. They are not allowing loading. Start assessing your heparin needs. Save the heparin if you have it for dialysis, than ports, than tunneled lines. Look at off label lock off with Cathflo(R). yes I am on Genentech's speaker bureau think what you want. For acutes and PICC lines look at needless systems, valved catheters, daily saline flushes every 12 hours as part of the MAR (make them mandatory). Train staff on how to recognize an occlusion at stage one with lack of blood return or sliuggish flow to catch it early and save the line.
We need to all share info now and get thru this situation. It has just started as of Monday.
I am sure someone will find a way to say that I biased this discussion to favor a manufacturer of some type. I am sure I invented this recall just to sell Solo or Cathflo.
Kathy
Kathy Kokotis
Bard Access Systems
Thank you Kathy,
at least I don't get blamed for the recall.......
Andre Schotte
There's no issue with the pres. elect of AVA or any other top AVA professionals who may receive compensation from a vendor for work completed. The standard ethics requirement is that when someone in a position to comment or provide information in a professional capacity, comments or presents information that could affect that vendor or their products, to other professionals within the profession, the respondent must disclose that they have a financial relationship with that vendor at the same time the info is presented. If that is not disclosed, then a conflict of interest may occur.
Why Just AVA? Does anyone cares what INS does?
If someone is paid by any company, drug or PICC, it is their job to sponsor that company?
WHO ACTUALLY STARTED THIS IV-THERAPY.NET? AND WHAT WAS THE GOAL?