We switched for the same reason. We found no noticeable difference, except price of course, and we were also able to have custom kitting down. We received no complaints from nursing or radiology. The transition was flawless. Hope yours goes just as well if you decide to make the switch.
I would like to respond to the statement that fentanylius made regarding power injections. I have used Arrow PICC's in the past and will verify that yes, indeed, the location of the PICC should be verifiied prior to injection. Iinitially, I didn't understand why, as not all companies require this, but after our rep informed us of the rationale, it made sense. The statement is one that is taken from the Manual of Contrast Media, version 5.0 from the American College of Radiology, 2004.
The manual states "Power injection of some central venous catheters can be preformed safely, provided that certain percautions are followed. First, either the CT scout scan or a recent chest radiograph shoudld be checked to confirm the proper location of the catheter tip."
I cannot speak for other companies who do not require verification of the tip of the catheter prior to injection, but after reading this, I think tip verification is important to preform. Does it say that a chest XR must be obtained which results in an additional cost? No, this reference says the scout film is OK to use. One is obtained with each CT, thus the guideline can be followed for no additional cost to the patient and hospital.
I would highly recomend tip location verification prior to ANY power injection through ANY ports or PICCs. This is not a product specific recomendation.
The bad things that have happened to patients during powere injectoin through PICCs or Ports have often been related to tip malposition. As you know the tip can migrate after insertion. It is very important to verify that the tip is in the lower third of the SVC before powere injection.
Many CT departments will do a scout scan of the SVC before injecting. Some others repuire a chest X-ray within 24 hours. I'm not sure if there is a standard for the method or type of tip verification but Best Practice would include some form of verification for the safety of the patient.
I totally agree with Mike and Cheryl. It is safer for the patient, and there has not been enough studies done in an actual patient to prove the whole 10 injections thing. I told my xray dept about that when we used the Bard power picc, and they would not go for it. Not enough info, and the power injectable picc's are higher maintenance around here. We do not put them in everyone for that reason. Our patients are evaluated as to what type of picc they need. We had hope for one picc in house when the Solo came out, but that did not work out. Oh well! Maybe we will be luckier with the power injectable that Boston is talking about. We can hope.....
Agree with all that recommend tip confirmation prior to power injection.
As far as the Medcomp catheters go we have been using them for several years and place around 800-900 lines per month, in the past we have used other manufacturers incl. BARD. After switching to the Medcomp line we did not notice any increase in complications associated with line placement. Medcomp has always been willing to customize our product for us to meet our needs, i.e. non-echogenic needle. After an initial learning curve that is present with any new product we do not have any placement associated complaints from our nurses and many actually prefer over the other leading manufacturers. The "cost factors" after switching to Medcomp has also been a tremendous positive!
I will add an additional thought here. When a PICC is placed for power injection it is imperative that the tip is deep in the SVC as the catheter actually moves during the injection. It is best, for a lot of reasons, to place the PICC deep in the SVC, but especaily if pressure injecting thru it. If a catheter, placed high in the SVC, migrates out of the SVC during the injection, one cannot assume that it will pass to it's original placement after the injection. So beware, and get those catheters deep in the SVC, but especially if being injected thru.
First Wow I want to know wh does 800-900 PICC lines a month. That has to be the largest PICC usage in the country.
Short term (<30days) dwell versus long term dwell (>30 days)
Second in my biased manner I have only one statement about any catheter you are looking at. Read the fine print in the instructions for use as I did last night:
Angiodynamics Morpheus: "indicated for short term and long term peripheral access to the central venous system"
Every Bard product but here is the PowerPICC Solo language - "Catheters are packaged in a tray with accessories for reliable long(greater than the 30 days) or short (less than 30 days) term vascular access"
NAMIC (Boston) Xcela power injectable PICC line: "The Xcela Power Injectable PICC line is indicated fo short or long term peripheral access to the central venous system"
Arrow Preesure Injectable: "The pressure injectable PICC is indicated for short and long term peripheral access to the central venous system"
Every manufacturer above has approval to market the indication for short and long term usage (dwell). All language in a manufacturers instructions are approved by the FDA. Short term dwell is under 30 days and long term is over 30 days and indefinite.
MedComp Pro-PICC CT: "The Pro-PICC CT catheter is indicated for short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media." This is the instructions for use currently on their website.
Short term dwell indication = under 30 days
this is the only company I know of that makes a PICC line that is labeled for short term usage of under 30 days, To change language one must get approval for an indications change via a 510K. This may involve testing to prove that claim all of the other manufacturers listed above Angiodynamics, Namic(Boston), Arrow, and Bard have gotten the approval to market the indication for long term dwell of over 30 days.
Does this mean if a catheter is indicated for short term dwell you should not leave it in over 30 days. The acute care catheters are labeled for under 30 days and all peripheral short I.V.'s are so I guess the MedComp Pro PICC is in this same category.
Thank you for the link to the 510K. Actually after reading it, it is clear that this letter is not for Medcomps power injectable PICC line but rather the Pro Line which is a cuffed CVC (tunneled line, generally placed in the IJ) for short term or long term use.
The Medcomp® PRO-LINETM CT Power Injectable CVC's are designed for central
venous catheterization. The PRO-LINETM CT Power Injectable CVC lumen is comprised
of a soft radiopaque polyurethane material. The lumen is connected to the extensions
via a soft pliable hub with suture wing for secure placement. Cuff attachment to the
Please tell us all where you found this 510K. Was it on the tunneled Pro-Line that is cuffed or the Power Injectable Pro-PICC that is not tunneled and cuffred?
This is not on the IFU's for Pro PICC power injectable PICC line on the Medcomp website.
I suggest providing this statement in writing if there is an idication for short and long term dwell for the PRO-PICC (non-tunneled) not PRO-LINE (tunneled).
I have personally done the search on the 510 K and cannot find anything other than short term dwell for the PRO-PICC. We are not talking PRO-LINE tunneled catheters.
Thank you for raising this issue and providing us for an opportunity to respond. I couldn’t have asked for a better lead-in! To address your first comment, are you surprised that we might have a customer that uses 800-900 PICCs per month? The fact is, we have more than one. Surprise!
I appreciate your comments about full disclosure but your bias is beyond obvious. After 12 years in Sales, Marketing and product development in the medical device world (yes, I worked for Bard for nearly 8 years), I am appalled by the unprofessionalism displayed on this forum. The best this forum has to offer is directly related to optimal outcomes and patient care. We all appreciate those comments. I read this forum daily to continuously improve my level of competency. I had no intention of contributing unless I had something to offer that would enhance outcomes. Postings like yours that are filled with speculation and misinformation should have no place on this forum (although I am clearly enjoying it right now). Allow me to clear things up for you. In the future, you may want to stick to clinical issues and stay out of Marketing, Sales and Regulatory issues.
The explanation for the language in our IFU is simple: the indication for such products outside the US is for short-term use. In order to consolidate inventories, we print a single IFU with the indication that would be appropriate for both CE mark and US products. In fact, our approval from the FDA is for long-term- greater than 30 days (Google K072509). The classification on the first page is for a Percutaneous, implanted, long-term, intravascular catheter. The definition of section 880.5970 is as follows:
(a) Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.
The FDA conceded substantial equivalency to guess what...the POWERPICC! As a Business Analyst for Bard, this public information should be at your fingertips. In fact, our products have undergone all of the rigorous testing that others have undergone. To suggest otherwise is naïve, immature and irresponsible. If the folks that actually TREAT patients wish that we make this change in the language of the IFU, consider it done! The fix is on the way. It will require some additional printing, not testing as you wrongly suggest. In the meantime, we’d be happy to provide a copy of our 510K approval letter to anyone who would like it.
Again, thank you for providing us with the perfect opportunity to respond. I look forward to your next attack. You just keep helping us tell our story…perhaps that is why we are the fastest growing PICC supplier!
we switched to medcom several months ago and have had no problems. as a matter of fact, their introducer is awesome. we were having a lot of difficulty with the dilator/introducer with our last picc's. cost was a factor, as medcom came in much lower and with the volumn of lines we place, it ended up being significant. and on top of the extra wire/introducer kit that we were having to open, we are saving the hospital tons of money. we have been very satisfied with the PICC. the reps are more than receptive also, very responsive to our needs/requests and questions.
i agree, the best thing is to contact manufacture reps and do trials. see what works best for your clinicians. we trialled just about every line out there before we decided on the medcom. good luck.
One of the best things about this forum is that it gives manufactures an opportunity to answer questions/concerns about their product.
I’m sure that Medcomp did not want to confuse people by having IFUs stating that the PICC is approved for less than 30 days; with no mention of greater than 30 days.
However, it is confusing.In an attempt to simplify manufacturing (an admirable pursuit) you caused more work for the knowledgeable PICC inserter.They now have to take the extra step in looking up the 510k online and the subsequent step of looking up 880.5970 Class II.
Isn’t it great that someone pointed out this issue and gave Medcomp the opportunity to respond?
To the Medcomp Districkt manager I would point out that the tone of your response did nothing to raise the level of professionalism of this forum.Your response seemed a bit personal.
But thank you for the 510K info. It clears things up.
You are right. I had a chance to raise the bar and did not. The suggestion that we make an inferior product that leaves our clinical partners exposed or is unsafe for our patients is just wrong. It should not be done on a local level let alone on a forum such as this. We will defend ourselves.
The change to the language in the IFU does require working with the FDA. Our customers will see it soon. In the meantime rest assured that no company out there is more committed to product quality and patient saftey than Medcomp.
Wink, wink, nod, nod the fix is on its way from Medcomp in the 510K language
I know the Bard catheter has long and short term dwell for the language in both the domestic and international PICC line IFU's so they obviously only have to print one as well for long and short term dwell. I will have to ask here Mike B. What does Angiodynamics say?
My shock at the 800-900 PICC lines a month had nothing to do with a manufacturer or product usage it had to do with the shock that there are so many accounts doing that volume. I only know of one hospital doing that volume by itself. If you are talking hospital systems with multiple facilities that is different. My shock was a hospital doing 800-900 PICC lines a month must be at least 1,200 beds or a 1,000 beds. There are not many of those out there that are that size in PICC volume. I must have missed alot of those in the 12 years I have doing this.
By the way I forgot to tell you I googled it as suggested so I could learn:
Here is the K072509 read Section E "short term" Thanks for the 510K number. It helps clear up the short term dwell issue under intended usage section E. Is that :short term dwell" for international only and that is what you are speaking of?
I am very confused at this point so I guess you are right I am not in regulatory so I should stick to the clinical issues. The 510K still says short term dwell under intended usage so what does that mean?
I believe the consumer is as confused as I am clinically
Kathy Kokotis Bard Access Systems
510(k) SUMMARY
A. Submitter Information:
Submitter: MEDCOMP®
1499 Delp Drive
Harleysville, PA 19438
Tel: (215) 256-4201
Fax: (215) 256-9191
Contact: Jean Callow
Regulatory Specialist
Date Prepared: 20 2DB7 September 7, 2007
B. Trade Name: Medcomp® PRO-PICC TM CT
Common Name: Peripherally Inserted Central Catheter
I get it now. You would have had me up all night with that 10,000 PICC line a year volume in one hospital. Those must be customers who are independant contractors that use that volume and cover multiple facilities.
Now that makes sense. I only knew of two hospitals in the U.S. with the volume of 10,000 PICC lines a year.
Yep, saving healthcare resources through outsourcing.
Being a consumer I go directly to the manufacturer of the product for clarification of any confusion, as the manufacturer is typically most knowledgeable about their product.
ok, seems to me that the question regarding the 501k has been answered, and once again, we are resortingto sarcasm and nitpicking. this forum has been most helpful to me over the past 4 years, as i am sure it has everyone else. but there are times that it gets totally unprofessional! it should be for sharing information, answering and asking questions, not for acting like kids! this is a great opportunity to raise confusing questions and get professional answers, and that is what we should be sticking to. so lets move on and get back to the origional question.
If this whole 510K issue has not been confusing I don't know what would be.
After the suggestion from ebaxter6 on contacting the FDA directly I thought what a great idea. Therefore that is what I did. My question to them was:
Need clarification on a 510K for the Medcomp PICC (K072509), in the Trade Name: Medcomp? PRO-PICC TM CT Common Name: Peripherally Inserted Central Catheter
Classification: US
Regulation Name: Percutaneous, implanted, long-term intravascular catheter C.F.R. Section: 880.5970 Class II
In the IFU it states that it is a short term dwell catheter.
Seems contradictory, have been told that the regulation name and class are the overiding factors?
It seems that the response from the FDA is consistent as to what I have been told by the reps from Medcomp. As of yet they have not steered me wrong even when I had a question about another manufacturer's catheter. Honesty goes along way!
If the response from the FDA does not clear this up nothing will. They agree with the info. from Mr. Stagg.
We just switched from Bard to Medcomp too. After I read this topic forum, can the Medcomp Power PICCs be used longer than 30 days? I'm confused! I also have another question to ask if anyone has any problem with the Medcomp needles. They are so dull and I need to use extra force to penetrate the skin and the vein wall. I usually stick only one time when I use Bard's needles to access the vein.
The 30 day issue pertains exclusively to what the FDA will allow a manufacturer to claim. It has only been within the past few years, that any catheter came to market with any claim for longer than 30 days. So yes, I do mean that all of those implanted ports, tunneled cuffed catheters and PICCs that have been left in for years were on the market as a 30 day catheter. FDA guidance and regulations has an impact on what the manufacturer can claim about their product, however you can see that healthcare professionals have been using all types of VADs for much longer than 30 days since these devices first came to market. So the difference is what the manufacturer can state vs the professional judgment of healthcare professionals. Now there are catheters that are cleared for market as short term devices (up to 30 days) and there are long term devices (more than 30 days). But this was not always the case. CDC states that the maximum dwell time for all catheters, other than a PIV, is unknown. So we do not have an upper limit as to the dwell time for PICCs, and other CVCs. Lynn
The language in the IFU has been changed as promised some time ago. For those that are interested, the IFU can be downloaded from the Medcomp website. It states that the Pro-PICC is indicated for "short or long-term peripheral access."
I use both the Bard and MedComp PICCs, I find that both products are good and do the job they were designed to do. MedComp is better because you get more components without an up charge. I have had no trouble with the needles in the kit, there are two the cook "like" needle is very sharp and the safety needle is also very sharp. You save your hospital money and have good patient outcomes!
We switched for the same reason. We found no noticeable difference, except price of course, and we were also able to have custom kitting down. We received no complaints from nursing or radiology. The transition was flawless. Hope yours goes just as well if you decide to make the switch.
Heather
Maybe you should read some small prints..... BARD power Picc is approved for 10 power injections without xray prior injection.
Arrow need a xray before you can do the power injection and is approved for 10 as well.
Medcomp need xray as well and is approved for?? Well, depends on who you talking to.
Compare your savings with your chest xray and go from there!
Andre
I would like to respond to the statement that fentanylius made regarding power injections. I have used Arrow PICC's in the past and will verify that yes, indeed, the location of the PICC should be verifiied prior to injection. Iinitially, I didn't understand why, as not all companies require this, but after our rep informed us of the rationale, it made sense. The statement is one that is taken from the Manual of Contrast Media, version 5.0 from the American College of Radiology, 2004.
The manual states "Power injection of some central venous catheters can be preformed safely, provided that certain percautions are followed. First, either the CT scout scan or a recent chest radiograph shoudld be checked to confirm the proper location of the catheter tip."
I cannot speak for other companies who do not require verification of the tip of the catheter prior to injection, but after reading this, I think tip verification is important to preform. Does it say that a chest XR must be obtained which results in an additional cost? No, this reference says the scout film is OK to use. One is obtained with each CT, thus the guideline can be followed for no additional cost to the patient and hospital.
Thanks all,
Cheryl
Cheryl Kelley RN BSN, VA-BC
I would highly recomend tip location verification prior to ANY power injection through ANY ports or PICCs. This is not a product specific recomendation.
The bad things that have happened to patients during powere injectoin through PICCs or Ports have often been related to tip malposition. As you know the tip can migrate after insertion. It is very important to verify that the tip is in the lower third of the SVC before powere injection.
Many CT departments will do a scout scan of the SVC before injecting. Some others repuire a chest X-ray within 24 hours. I'm not sure if there is a standard for the method or type of tip verification but Best Practice would include some form of verification for the safety of the patient.
Thanks,
Mike Brazunas RN
Clinical Specialist
AngioDynamics
Agree with all that recommend tip confirmation prior to power injection.
As far as the Medcomp catheters go we have been using them for several years and place around 800-900 lines per month, in the past we have used other manufacturers incl. BARD. After switching to the Medcomp line we did not notice any increase in complications associated with line placement. Medcomp has always been willing to customize our product for us to meet our needs, i.e. non-echogenic needle. After an initial learning curve that is present with any new product we do not have any placement associated complaints from our nurses and many actually prefer over the other leading manufacturers. The "cost factors" after switching to Medcomp has also been a tremendous positive!
Never hurts to do a trial and see what you think.
I will add an additional thought here. When a PICC is placed for power injection it is imperative that the tip is deep in the SVC as the catheter actually moves during the injection. It is best, for a lot of reasons, to place the PICC deep in the SVC, but especaily if pressure injecting thru it. If a catheter, placed high in the SVC, migrates out of the SVC during the injection, one cannot assume that it will pass to it's original placement after the injection. So beware, and get those catheters deep in the SVC, but especially if being injected thru.
Cheryl Kelley RN BSN, VA-BC
Kathy Kokotis
Bard Access Systems
First Wow I want to know wh does 800-900 PICC lines a month. That has to be the largest PICC usage in the country.
Short term (<30days) dwell versus long term dwell (>30 days)
Second in my biased manner I have only one statement about any catheter you are looking at. Read the fine print in the instructions for use as I did last night:
Angiodynamics Morpheus: "indicated for short term and long term peripheral access to the central venous system"
Every Bard product but here is the PowerPICC Solo language - "Catheters are packaged in a tray with accessories for reliable long(greater than the 30 days) or short (less than 30 days) term vascular access"
NAMIC (Boston) Xcela power injectable PICC line: "The Xcela Power Injectable PICC line is indicated fo short or long term peripheral access to the central venous system"
Arrow Preesure Injectable: "The pressure injectable PICC is indicated for short and long term peripheral access to the central venous system"
Every manufacturer above has approval to market the indication for short and long term usage (dwell). All language in a manufacturers instructions are approved by the FDA. Short term dwell is under 30 days and long term is over 30 days and indefinite.
MedComp Pro-PICC CT: "The Pro-PICC CT catheter is indicated for short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media." This is the instructions for use currently on their website.
Short term dwell indication = under 30 days
this is the only company I know of that makes a PICC line that is labeled for short term usage of under 30 days, To change language one must get approval for an indications change via a 510K. This may involve testing to prove that claim all of the other manufacturers listed above Angiodynamics, Namic(Boston), Arrow, and Bard have gotten the approval to market the indication for long term dwell of over 30 days.
Does this mean if a catheter is indicated for short term dwell you should not leave it in over 30 days. The acute care catheters are labeled for under 30 days and all peripheral short I.V.'s are so I guess the MedComp Pro PICC is in this same category.
Kathy Kokotis
Kathy Kokotis
Bard Access Systems
Thanks for the comment on the volume, what a complement.
Copied from the 510k for the Pro PICC:
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONGTERM GREATER THAN 30 DAYS
May Google K053345, and it will retrieve the actual 510k.
Kathy Kokotis
Bard Access Systems
Kathy Kokotis
Bard Access Systems
Thank you for the link to the 510K. Actually after reading it, it is clear that this letter is not for Medcomps power injectable PICC line but rather the Pro Line which is a cuffed CVC (tunneled line, generally placed in the IJ) for short term or long term use.
The Medcomp® PRO-LINETM CT Power Injectable CVC's are designed for centralvenous catheterization. The PRO-LINETM CT Power Injectable CVC lumen is comprised
of a soft radiopaque polyurethane material. The lumen is connected to the extensions
via a soft pliable hub with suture wing for secure placement. Cuff attachment to the
lumen provides for tissue ingrown.
Kathy Kokotis
Bard Access Systems
Please tell us all where you found this 510K. Was it on the tunneled Pro-Line that is cuffed or the Power Injectable Pro-PICC that is not tunneled and cuffred?
This is not on the IFU's for Pro PICC power injectable PICC line on the Medcomp website.
I suggest providing this statement in writing if there is an idication for short and long term dwell for the PRO-PICC (non-tunneled) not PRO-LINE (tunneled).
I have personally done the search on the 510 K and cannot find anything other than short term dwell for the PRO-PICC. We are not talking PRO-LINE tunneled catheters.
Kathy Kokotis
Kathy Kokotis
Bard Access Systems
Kathy,
Thank you for raising this issue and providing us for an opportunity to respond. I couldn’t have asked for a better lead-in! To address your first comment, are you surprised that we might have a customer that uses 800-900 PICCs per month? The fact is, we have more than one. Surprise!
I appreciate your comments about full disclosure but your bias is beyond obvious. After 12 years in Sales, Marketing and product development in the medical device world (yes, I worked for Bard for nearly 8 years), I am appalled by the unprofessionalism displayed on this forum. The best this forum has to offer is directly related to optimal outcomes and patient care. We all appreciate those comments. I read this forum daily to continuously improve my level of competency. I had no intention of contributing unless I had something to offer that would enhance outcomes. Postings like yours that are filled with speculation and misinformation should have no place on this forum (although I am clearly enjoying it right now). Allow me to clear things up for you. In the future, you may want to stick to clinical issues and stay out of Marketing, Sales and Regulatory issues.
The explanation for the language in our IFU is simple: the indication for such products outside the US is for short-term use. In order to consolidate inventories, we print a single IFU with the indication that would be appropriate for both CE mark and US products. In fact, our approval from the FDA is for long-term- greater than 30 days (Google K072509). The classification on the first page is for a Percutaneous, implanted, long-term, intravascular catheter. The definition of section 880.5970 is as follows:(a) Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.
The FDA conceded substantial equivalency to guess what...the POWERPICC! As a Business Analyst for Bard, this public information should be at your fingertips. In fact, our products have undergone all of the rigorous testing that others have undergone. To suggest otherwise is naïve, immature and irresponsible. If the folks that actually TREAT patients wish that we make this change in the language of the IFU, consider it done! The fix is on the way. It will require some additional printing, not testing as you wrongly suggest. In the meantime, we’d be happy to provide a copy of our 510K approval letter to anyone who would like it.
Again, thank you for providing us with the perfect opportunity to respond. I look forward to your next attack. You just keep helping us tell our story…perhaps that is why we are the fastest growing PICC supplier!
Regards,
Paul Stagg
Regional Director
Medcomp Interventional
we switched to medcom several months ago and have had no problems. as a matter of fact, their introducer is awesome. we were having a lot of difficulty with the dilator/introducer with our last picc's. cost was a factor, as medcom came in much lower and with the volumn of lines we place, it ended up being significant. and on top of the extra wire/introducer kit that we were having to open, we are saving the hospital tons of money. we have been very satisfied with the PICC. the reps are more than receptive also, very responsive to our needs/requests and questions.
i agree, the best thing is to contact manufacture reps and do trials. see what works best for your clinicians. we trialled just about every line out there before we decided on the medcom. good luck.
One of the best things about this forum is that it gives manufactures an opportunity to answer questions/concerns about their product.
I’m sure that Medcomp did not want to confuse people by having IFUs stating that the PICC is approved for less than 30 days; with no mention of greater than 30 days.
However, it is confusing. In an attempt to simplify manufacturing (an admirable pursuit) you caused more work for the knowledgeable PICC inserter. They now have to take the extra step in looking up the 510k online and the subsequent step of looking up 880.5970 Class II.
Isn’t it great that someone pointed out this issue and gave Medcomp the opportunity to respond?
To the Medcomp Districkt manager I would point out that the tone of your response did nothing to raise the level of professionalism of this forum. Your response seemed a bit personal.
But thank you for the 510K info. It clears things up.
Thanks,
Mike Brazunas
Clinical Specialist
Sorry but when I cut and pasted from Word, I lost the last line...
"Angiodynamics."
Wouldn't that be ironic?
Thanks,
Mike Brazunas
Clinical Specialist
AngioDynamics
Mike,
You are right. I had a chance to raise the bar and did not. The suggestion that we make an inferior product that leaves our clinical partners exposed or is unsafe for our patients is just wrong. It should not be done on a local level let alone on a forum such as this. We will defend ourselves.
The change to the language in the IFU does require working with the FDA. Our customers will see it soon. In the meantime rest assured that no company out there is more committed to product quality and patient saftey than Medcomp.
Paul Stagg
Medcomp
Kathy Kokotis
Bard Access Systems
Wink, wink, nod, nod the fix is on its way from Medcomp in the 510K language
I know the Bard catheter has long and short term dwell for the language in both the domestic and international PICC line IFU's so they obviously only have to print one as well for long and short term dwell. I will have to ask here Mike B. What does Angiodynamics say?
My shock at the 800-900 PICC lines a month had nothing to do with a manufacturer or product usage it had to do with the shock that there are so many accounts doing that volume. I only know of one hospital doing that volume by itself. If you are talking hospital systems with multiple facilities that is different. My shock was a hospital doing 800-900 PICC lines a month must be at least 1,200 beds or a 1,000 beds. There are not many of those out there that are that size in PICC volume. I must have missed alot of those in the 12 years I have doing this.
Kathy Kokotis - Bard Access Systems
Kathy Kokotis
Bard Access Systems
Kathy Kokotis
Bard Access Systems
By the way I forgot to tell you I googled it as suggested so I could learn:
Here is the K072509 read Section E "short term" Thanks for the 510K number. It helps clear up the short term dwell issue under intended usage section E. Is that :short term dwell" for international only and that is what you are speaking of?
I am very confused at this point so I guess you are right I am not in regulatory so I should stick to the clinical issues. The 510K still says short term dwell under intended usage so what does that mean?
I believe the consumer is as confused as I am clinically
Kathy Kokotis Bard Access Systems
510(k) SUMMARY
A. Submitter Information:
Submitter: MEDCOMP®
1499 Delp Drive
Harleysville, PA 19438
Tel: (215) 256-4201
Fax: (215) 256-9191
Contact: Jean Callow
Regulatory Specialist
Date Prepared: 20 2DB7 September 7, 2007B. Trade Name: Medcomp® PRO-PICC TM CT
Common Name: Peripherally Inserted Central Catheter
Classification: US
Regulation Name: Percutaneous, implanted, long-term
intravascular catheter
C.F.R. Section: 880.5970 Class II
C. Predicate Device: C.R. Bard, Inc. K053501 6Fr. TLPowerPICCTM Catheter
Medcomp K053345 Pro-LineTM CT Pressure
Injectable CVC.
D. Device Description:
IT
The PRO-PICC catheter is a triple lumen open-ended piec designed for power
injection through one designated lumen. The catheter is an extension of the Medcomp®
Pro-LineTM CT Power Injectable CVC (K053345) and Power Injectable Implantable Port
(K070003) catheter line. The PRO-PICC m CT catheter is comprised of a soft radiopaquepolyurethane material. The lumen has a reverse taper design and is connected to the
extensions via a soft pliable hub with suture wing for secure placement. Clamps are
provided on the extension tubes to prevent air/fluid communication. Female luer
connectors provide the connection for intravenous administration. The designated power
injectable extension line and clamp material are purple in color to differentiate it from the
non-power injectable extensions and the purple lumen identifies it as a power injectable
catheter. The center extension also is printed with the words power injectable. The I.D.
Ring within the clamp on the power extension contains information regarding checking
for blood return and flushing along with rate of infusion for power injection.
The PRO-PICC TM CT catheter is available in 6F triple lumen. The catheter has a usablelength of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are
provided to assist in catheter insertion.
The catheter is packaged sterile in two radiology versions and two nursing configurations
with the necessary accessories to facilitate catheter insertion.
Medcomp PRO-PICC T. CT catheter Summary Page I of 2
1-1
E. Intended Use:
CT The PRO-PICC m catheter is indicated for short term peripheral access to the centralvenous system for intravenous therapy and power injection of contrast media. For blood
sampling, infusion, or therapies, use a 4F or larger catheter. The maximum
recommended infusion rate varies by catheter French size and is printed on the catheter.
F. Performance Data:
In vitro testing was performed on the PRO-PICC TM C catheter to assure reliable design
Kathy Kokotis
Bard Access Systems
Kathy Kokotis
Bard Access Systems
I get it now. You would have had me up all night with that 10,000 PICC line a year volume in one hospital. Those must be customers who are independant contractors that use that volume and cover multiple facilities.
Now that makes sense. I only knew of two hospitals in the U.S. with the volume of 10,000 PICC lines a year.
Kathy
Kathy Kokotis
Bard Access Systems
If this whole 510K issue has not been confusing I don't know what would be.
After the suggestion from ebaxter6 on contacting the FDA directly I thought what a great idea. Therefore that is what I did. My question to them was:
Need clarification on a 510K for the Medcomp PICC (K072509), in the Trade Name: Medcomp? PRO-PICC TM CT Common Name: Peripherally Inserted Central Catheter
Classification: US
Regulation Name: Percutaneous, implanted, long-term intravascular catheter C.F.R. Section: 880.5970 Class II
In the IFU it states that it is a short term dwell catheter.
Seems contradictory, have been told that the regulation name and class are the overiding factors?
It seems that the response from the FDA is consistent as to what I have been told by the reps from Medcomp. As of yet they have not steered me wrong even when I had a question about another manufacturer's catheter. Honesty goes along way!
If the response from the FDA does not clear this up nothing will. They agree with the info. from Mr. Stagg.
We just switched from Bard to Medcomp too. After I read this topic forum, can the Medcomp Power PICCs be used longer than 30 days? I'm confused! I also have another question to ask if anyone has any problem with the Medcomp needles. They are so dull and I need to use extra force to penetrate the skin and the vein wall. I usually stick only one time when I use Bard's needles to access the vein.
The 30 day issue pertains exclusively to what the FDA will allow a manufacturer to claim. It has only been within the past few years, that any catheter came to market with any claim for longer than 30 days. So yes, I do mean that all of those implanted ports, tunneled cuffed catheters and PICCs that have been left in for years were on the market as a 30 day catheter. FDA guidance and regulations has an impact on what the manufacturer can claim about their product, however you can see that healthcare professionals have been using all types of VADs for much longer than 30 days since these devices first came to market. So the difference is what the manufacturer can state vs the professional judgment of healthcare professionals. Now there are catheters that are cleared for market as short term devices (up to 30 days) and there are long term devices (more than 30 days). But this was not always the case. CDC states that the maximum dwell time for all catheters, other than a PIV, is unknown. So we do not have an upper limit as to the dwell time for PICCs, and other CVCs. Lynn
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
The language in the IFU has been changed as promised some time ago. For those that are interested, the IFU can be downloaded from the Medcomp website. It states that the Pro-PICC is indicated for "short or long-term peripheral access."
http://www.medcompnet.com/products/piccs/pro-picc.html#ifu
Please contact your local rep if you have any further questions regarding this issue.