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Thanks for the rundown Paul. I also believe
that the entire length of the taper doesn’t have to be inserted below the
skin. If you have a concern about the diameter of the vein being too small for
the taper, make your scapel knick small. The narrower, distal part of the taper
performs the tamponade quite well, keeping the larger, proximal part of the
taper outside the vein. I don’t think it is even an issue to consider in
our 500lb folks. Regards,
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I will start by making a
disclaimer that my opinions may be a little biased as I work for Bard Access
Systems, however, I will try to present what I know in an unbiased manner and
let you draw your own conclusions. Also, there really isn't any good data
out there to support claims one way or the other. The paper everyone
keeps citing is old and is really not applicable any longer. So here goes. First, I think we need to
look at this type of device objectively. Why was it created in the first
place? The answer to that question is pretty simple. Clinicians identified
a concern. That concern was that clinicians were seeing many PICC
lines that kinked at the insertion site and prevented medication
infusion. Manufacturer's response to that concern was to create the
reverse taper PICC. This design virtually eliminates the kinking issue,
and by the way has several other advantages that I'm sure you are all aware
of. A couple of those advantages are tamponading of bleeding
at the insertion site, and of course extra strength to the portion of the
catheter that is most likely to be stressed and strained. I think it is also
important that we look at some of the other benefits this style of device can
bring, namely minimized exposure to blood at the insertion site. We all
have to be wary of blood exposure as the consequences can be very
hazardous. Also, I think it is important to remember that skin flora love
the nutrients that blood and blood products can provide to them. We are
just asking for PICC track infections and BSIs when we allow blood to remain on
the catheter and skin at the insertion site. I know that these
infections can be propogated merely by the fact that we can't remove all layers
of skin containing normal microbes when doing a skin prep, but we can minimize
the environment they have to grow in by taking away nutrients that are provided
in blood. In addition, I think it
is important to think about how and where PICCs are being inserted these
days. While not everyone has made the transition to upper arm placement,
many have. You know as well as I do that the upper arm basilic vessel is
rarely close to the surface. Additionally, some clinicians actually
tunnel their PICC into the vessel. In many cases the tapered portion
of the PICC is either not in the vessel or just begins to enter the vessel.
I do think it is important to ensure that the PICC you are inserting is
adequately sized for the vessel you are accessing. As you know, INS has
long been a proponent of placing the smallest access device possible for the
ordered therapy. I have been all over the country asking clinicians what
their PICC practices are. How do they know the PICC they are inserting is
appropriate for the vessel they have chosen to access? Ultimately many
are using the unwritten rule of ensuring that the PICC does not occupy any more
than 1/3 of the vessel's internal diameter. In my opinion, this is a very
good practice because most clinicians only have ultrasound to evaluate vessels,
and unless that vessel is damaged or partially occlued, it is difficult if not
impossible to see the true inner diameter of the vessel. With all of that being
said, let's also look at some history here, because reverse tapered PICCs are
not new to the market. In fact, one radiology vendor has had a
reverse tapered PICC on the market for more than 7 years. If you
look at the market today, 80% of all PICCs being sold in the Okay, here's where I try
to remain objective, and understand that there will be differing opinions out
there, but perhaps some data will be helpful. I can tell you
that Bard tracks all Bard PICC catheter sales very closely. We
have a Field Assurance department that receives all complaints about Bard
products. In the five years these products have been available, we
have not seen increased reports of thrombosis related to the PICC or the
reverse taper design. Additionally, I have reviewed the FDA MAUDE
data base, and do not seen increased numbers of reports there either. As
you may be aware, Bard can not control the information that is submitted to the
MAUDE data base. I also understand that all of us are too busy to
submit reports to regulatory authorities every time an incident arises,
however, if it becomes a recurring issue, we are ethically compelled
to inform the manufacturer and/or the FDA. Finally, I have the
opportunity to travel all over the country and interact with many 100's of
clinicians each year. Frankly, I have had many questions asked about
thrombosis related to reverse taper designs, but have not had anyone tell me
that they are seeing this as a recurring problem. Of the few that I
have discovered, I have also had discussions with them regarding the size
vessel they are placing the PICC into in the first place--and have found
that the PICC was too large for the vessel they were accessing. In
conclusion, we don't have evidence to support the claim that
reverse tapered PICCs increase thrombosis rates. Before we believe
any manufacturer's claims on this subject, we each need to conduct our own
research so we can base our opinions on hard and fast research rather
than hearsay or innuendo. I apologize for making
this so long, but felt it necessary to really lay out the entire
issue. Thanks for giving me some of your time today.
Paul
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copies of the original message and any attachments.[v1.0] |
- FW: reverse taper Blackburn, Paul
- RE: reverse taper Dianne Sim
