PICC Line Rejection
Don & Nancy Burrows
Nancy
PrincessVixen29
Sarah*)
Sometimes they get pushed out, but there is something that CAN
stop that. It is called a Statlock and your pharmacist should
be able to order one for you. They are 5 bucks or so. I found
iwth mine that the bottom stickiness left veyr quickly so I tape
it down every few days. It works and hopefully no more coming
out!
-----------------------------------------------------------
Got questions? Get answers over the phone at Keen.com.
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Joel M. Shmukler, Esq
Sarah*) <aramsara...@cs.com.invalid> wrote:
>
>
> Sometimes they get pushed out, but there is something that CAN
> stop that. It is called a Statlock and your pharmacist should
> be able to order one for you. They are 5 bucks or so. I found
> iwth mine that the bottom stickiness left veyr quickly so I tape
> it down every few days. It works and hopefully no more coming
> out!
>
the PICC line is made and know that there are hypoallergenic PICC lines
available.
Also I have seen that PICC lines tend to 'migrate' out over time--the
body tries to force them back out, usually through venous spasm.
PICC lines can be stitched down to prevent that migration!!! My LLMD
CVIR (radiologists who do procedures) now stitches all his patient's
lines in following my suggestion.
Or maybe you could be more specific about what you mean
by 'rejection.'???
Joel M. Shmukler, Esquire, Director LYMECURE
Sent via Deja.com http://www.deja.com/
Before you buy.
KJRU
>Help! Has anyone's body rejected a PICC line?
>
>Nancy
I had a horrible time with PICC lines. Most people have no problem but they had
so much trouble threading my veins. About half way in the vein would collapse
and they had to pull out and start over. There were times we went through 3
kits and still didn't get one in. Once in, I usually did OK for a little
while, but after using all the veins and having so much trouble, I had a
central line inserted and it was MUCH easier.
Is this what you mean by rejection? Or do you mean after they are in?
some helpful tips
next time they try and insert one, drink tons of water, itis much easier if you
are fully hydrated.
about an hour before keep hot compresses on your arms where they will stick
you, you can just get a wash cloth as hot as possible and keep putting it
there.
good luck, if nothing works consider a central line. Many people are afraid at
first but they are so much easier to me.
kj
brite...@hotmail.com
My first picc line lasted 11 1/2 months. It was not stitched in and I
can't imagine my body "spitting out" 23 inches of catheter tubing! lol
The only "rejection" I've ever heard of is of those people who have
allergies to latex, plastics and other.
Mine is on the inside of my elbow. We use a small gauze folded in half
underneath the hub, 3 steri strips and a tegaderm on top. Under the
tegaderm I use an extra packet of the adhesive prep (I call glue!)
No trouble yet. It's like wearing a watch to me these days.
Oh and if you are reading this and going to get one - get a script for
a tube of EMLA cream. It's basically novacaine and you apply it about
1 hour before the insertion -- you won't feel a thing! I
PROMISE! /brite
Bythesunrise
What is a central line? How does it differ from a PICC?
thank you
Lea
Joel M. Shmukler, Esq
Your body doesn't need to spit out the entire length to put you at
risk. Really usually only 8-15 mm of outward migration is necessary to
push the line out of the optimal placement in the SVC (superior vena
cava). For some drugs SVC placement is not as crucial as for others
like doxy or vanco which are caustic and require not only a long term
catheter to avoid repeated heplocks, but also to avoid the irritation
that would occur by having a line short of the SVC terminating in a
smaller vessel without good blood flow as one gets in the SVC. So a
little bit of migration is all that is needed to put one at risk for
phlebitis, DVT, PE etc.
I personally reccomend that the surgeon (and I DO reccomend having PICC
lines surgically implanted and NOT done by home nurses) use lidocaine
to numb the area over a topical cream mostly for sanitary reasons to
guard against infection.
I also reccomend one or more oral valium prior to the insertion. This
relaxes the patient AND their veins and helps guard against venous
spasm during the procedure.
PICC lines implanted in the hospital tend to be a better quality
catheter than that used by home infusion companies. Also an OR or
procedure room tends to be more sterile and sanitary than the home
environment (of course on the other hand hospitals ARE where the most
mutant germs hang out). Also IF anything happens during the procedure
you are where you need to be. (Sometimes PICC insertion can cause
cardiac irritation if done wrong or induce PVC or other heart rythym
abnormalities although relatively rarely). There are some inherent
risks in the procedure such as collapsing a patient's lung (rare) and
better to be in the hospital no matter how rare just in case
(outpatient procedures).
Also, in the hospital an xray can be obtained immediately to confirm
proper line placement--even better they can insert it under the
flouroscope and see where it is going as they insert it.
ALSO: IF your line becomes clogged PLEASE do NOT let any doctor or home
infusion company use abbokinase/urokinase to unclog it! THis product is
VERY unsafe.
See http://www.fda.gov/cber/index.html search for abbokinase:
http://www.verity.fda.gov/search97cgi/s97_cgi.exe?
action=View&VdkVgwKey=http%3A%2F%2Fwww%2Efda%2Egov%2Fcber%2Finfosheets%
2Fabb032299%
2Ehtm&DocOffset=2&DocsFound=28&QueryZip=abbokinase&Collection=all&Search
Url=http%3A%2F%2Fwww%2Everity%2Efda%2Egov%2Fsearch97cgi%2Fs97%5Fcgi%
2Eexe%3Faction%3DSearch%26QueryZip%3Dabbokinase%26ResultTemplate%
3Dstndrslp%252Ehts%26QueryText%3Dabbokinase%26Collection%3Dall%
26ResultStart%3D1%26ResultCount%3D10&hlnavigate=ALL
BELIEVE it or not, this product remains in use even though it is
currently NOT being manufactured. I know of at least one person who
received this drug in the past two months, without ANY warning from
their home infusion company. If your choice is a new PICC line (as
unpleasant as that can be) OR receiving this drug which subjects one to
an UNKNOWN level of risk for HIV, HCV, Reovirus and other infectious
diseases, I personally would opt for the new PICC line every single
time!!!!
Lyme is more than enough for me!
Update on Abbokinase> (Urokinase)
March 22, 1999
------------------------------------------------------------------------
--------
After FDA updated the Information Sheet on <Abbokinase> (Urokinase) on
March 16, 1999, Abbott Laboratories sent a "Dear <Abbokinase> Customer"
message by Western Union Mailgram that evening. FDA has reviewed that
message and issued a Warning Letter to Abbott Laboratories.
We are repeating the information in our March 16 update.
FDA is receiving new inquiries regarding a reported shortage of
<Abbokinase> (Urokinase), a thrombolytic product manufactured by Abbott
Laboratories (Abbott). The agency hopes that the following information
will answer questions about this reported shortage.
In January 1999, Abbott implemented additional testing for finished
lots of <Abbokinase>. Abbott has not yet completed validation of these
additional tests. Additional finished lots of <Abbokinase> will not be
available for use until further testing has been completed. FDA
understands from Abbott that, due to shortage issues, Abbott has been
distributing <Abbokinase> on an allocated basis.
In addition, three lots of in-process product, which were not
manufactured into finished <Abbokinase> or distributed, have been found
to contain reovirus. Reovirus is an adventitious agent that should not
be present at any step in the production of <Abbokinase>. The presence
of reovirus in the in-process product was discovered as a result of
testing begun by Abbott this year at the request of FDA to correct
deficiencies noted during FDA's inspection of Abbott last fall. Most
reovirus infections are asymptomatic or produce minor upper respiratory
or gastrointestinal symptoms. While association of reovirus infection
with other human diseases has been reported, a causal link with other
diseases has not been established.
Abbott is working to determine the extent and the source(s) of the
reovirus contamination. Although a number of studies in the literature
suggest that the heat inactivation step performed during the further
manufacturing of the in-process product into <Abbokinase> should render
reovirus non-infectious, FDA has received assurance from Abbott that
any in-process product that contains reovirus will not be used to
manufacture finished product. Moreover, if any lots of <Abbokinase> are
found to contain reovirus, they will not be subject to distribution.
Finished lots of <Abbokinase> currently on the market have tested
negative for reovirus in Abbott's preliminary test; however, this test
has not yet been validated.
The finding of reovirus contamination of in-process product illustrates
the continuing concerns FDA has regarding the impact of deviations from
Current Good Manufacturing Practice observed during FDA inspections of
Abbott and its supplier of the human neonatal kidney cells used to
manufacture <Abbokinase>. As a result of those inspections, on January
25, 1999, FDA issued an Important Drug Warning to Healthcare Providers
regarding <Abbokinase>, which included the following information and
recommendations:
FDA described Current Good Manufacturing Practice deficiencies noted
during inspections of Abbott and its supplier of the human neonatal
kidney cells that were used in the manufacture of currently available
<Abbokinase>; the agency reported that the deficiencies could increase
the risk of transmitting infectious agents.
FDA recommended that use of <Abbokinase> be reserved for only those
situations where a physician has considered the alternatives and has
determined that the product´s use is critical to the care of a specific
patient in a specific situation.
FDA discussed the risks associated with the use of <Abbokinase> and
encouraged prescribers to consider the appropriateness of other
treatment options for each setting in which the use of <Abbokinase> is
being contemplated.
As set forth in the January 25th letter, FDA is not currently aware of
any cases of infectious diseases that can be attributed to the use of
<Abbokinase>. However, the likelihood that cases of infectious diseases
caused by <Abbokinase>, if any, would have been recognized as such and
reported to FDA is probably very low. Therefore, the actual risk to
patients of developing an infectious disease as a result of using
<Abbokinase> is unknown. FDA recommends that prescribers carefully
consider this new information, as well as the information on
manufacturing deviations set forth in the agency´s January 25th letter,
in assessing the risks associated with the use of <Abbokinase.
------------------------------------------------------------------------
--------
--
Joel M. Shmukler, Esquire, Director LYMECURE
Ruth
(KJRU) wrote:
> >
> >Help! Has anyone's body rejected a PICC line?
> >
> >Nancy
>
> I had a horrible time with PICC lines. Most people have no problem but
they had
> so much trouble threading my veins. About half way in the vein would collapse
> and they had to pull out and start over. There were times we went through 3
> kits and still didn't get one in.
> kj
I had picc line problems..... first one kept filling with blood.....
the thing that worked best for me was a pediatric picc line....I was able
to keep that one in for a couple of months, IIRC.....Of course, that was
nine years ago...there may be improvements by now. I also had a Groshon
Port that failed after only 6 weeks....not sure why.
Sarah*)
I had a picc line and it sprung a LEAK! Then I got a mid line
and it migrated out so far we thought it was another leak but it
was just at the end! So now I have another mid line which is
held in place from migrating out by a Statlock, a little plastic
holder-thingie. I am allergic to that Skin-Prep stuff! We just
use steri-strips, a big clear plastic bandage & change the
dressing once or twice a week.
Like Brite said- it IS like wearing a watch. I was so scared
of it and boy does that seem like wasted energy! If I had known
how easy it was I would've been on it much sooner!!!!!
Next week we see our Doc and it will be the end of my 3
months. But I don't want to stop! I am still improving!!!!!!!!
I am! I am!!!!!
Best Wishes to All*)!)*)*!
-
Sarah*)
BailieBoy
I was on IV rocephin a year ago for 9 weeks.
Thinking in the fall of trying it again with IV zithromax. I'd love to hear
from anyone with severe neuro lyme whos had good results with anything.
Lisa
Ruth
<jmsp...@aol.com> wrote:
(Sometimes PICC insertion can cause
> cardiac irritation if done wrong or induce PVC or other heart rythym
> abnormalities although relatively rarely).
This happened to me...
DEastRDH
I had aPICC line put in last Wed. and by Friday it had to be removed.... I
developed a red line above entry site, my left arm and hand was extremely cold
, and had significant pain in my shoulder, neck area.. I was told I had some
clots develope ,, had to go to the hospital and have scans and xrays.. I am
getting my rocephin by peripheral ivs until I get something else.
Joel M. Shmukler, Esq
>
>
Here are some more links on PICC lines.
A PICC line IS a central line, a perirepherally installed cenral
catheter. There are other types of central lines and a variety of
manufacturers.
Sarah: Please refer to the link on the Intravenous Nursing Society.
Midlines are contraindicated for long term use, and of course you know
that certain drugs REQUIRE a central line.
Cancer Information - Ports and Catheters Photographs
http://ktf.org/dsivphotos.htm
Brown Medical Industries PICC protectors!
http://www.brownmed.com/
Bathguard Home Page
http://www.bathguard.com/
New Welcome to INS (THIS is it and their standards are located there)
http://www.ins1.org/
Nurses
http://www.gettysburghosp.org/nursingt.htm
Here are some other links: http://www.altavista.com/cgi-bin/query?
pg=q&stype=stext&sc=on&q=%22intravenous+nursing+society%22&stq=10
Welcome to many medical associations and organizations with links
to their sites!
http://www.opitsourcebook.com/organi.html
Manual of I.V. Therapeutics, 2nd Edition
http://www.fadavis.com/catalog/nursing/PHARMACOLOGY%20AND%
20MEDICATIONS/0131-X.htm
Medicine / Pharmaceuticals : Risk Management Internet Services Library
(rmis.com)
http://www.rmis.com/sites/medpharm.htm
You can also check about particular devices and brands on the FDA site:
http://www.fda.gov/
Sarah: Please NOTE the section on 'dwell times':
times'
Intravenous Nursing Society Standards
STANDARD II: PERIPHERAL-MIDLINE
A midline catheter shall be removed immediately upon suspected
contamination, complication, or when therapy has been discontinued.
INTERPRETATION
These catheters shall be considered midline only when the catheter is
greater than 3 inches in length with tip residing below the axilla and
insertion site no more than 1½ inches above or below the antecubital
fossa. Removal of midline catheters should be established in
organizational policy and procedure and in accordance with
manufacturer’s guidelines.
The optimal time interval for the removal of a midline catheter is
unknown. However, maximum dwell time should be limited to 2-4 weeks.
Dwell times longer than 4 weeks should be based on the professional
judgment of the nurse after consideration of the following factors:
length of therapy remaining, patient's peripheral venous status,
patient's condition, condition of the vein in which the catheter is
placed, and skin integrity. Removal of these catheters may be
determined by patient condition and diagnosis, type and duration of
therapy administered, determination of infectious or inflammatory
process, and malposition. These catheters should be removed if the tip
location is no longer appropriate for prescribed therapy. Because of
the risk of complications, these catheters should be removed when they
are no longer indicated.
Caution should be utilized in the removal of midline catheters,
particularly when the catheter has remained in place for an extended
period of time. Consideration should be given to abduction of the arm
for removal of these catheters. If resistance is encountered when
attempting to remove the catheter, the physician should be notified.
Upon catheter removal, one should apply pressure, antiseptic ointment,
and sterile gauze dressing to the site. Application of ointment may
occlude the skin tract and prevent air embolism. The dressing should be
changed and site assessed every 24 hours until the site is
epithelialized. The integrity of the catheter should be ascertained
upon removal, nursing interventions implemented as necessary, and
observations and actions documented. If a catheter defect is noted, it
should be reported to the manufacturer and regulatory agencies.
Lyme really sucks!
Mariah's Mommie
real help. Will you be there and speaking to this person -----say, a
month from now?? This person may feel a friendship forming and is so
depressed and in such physical pain and doesn't need any disappointments
from someone they considered a real friend . They may even email
you in private to find you to ask if everything is alright. They may try
2 or 3 other times but you
never do get back to them. Now you have left them wondering why you have
chosen to not be involved in their life anymore. But that is so not
like you. You would never do that to anyone. You are like I said in the
beginning, too sweet and so caring and concerned that you would never
let that happen.-------Helen--------
Empty~Nest~Cape~Cod
Helen~Jim~Mariah
KJRU
I had picc line problems..... first one kept filling with blood.....
>
>the thing that worked best for me was a pediatric picc line....I was able
>to keep that one in for a couple of months, IIRC.....Of course, that was
>nine years ago...there may be improvements by now. I also had a Groshon
>Port that failed after only 6 weeks....not sure why.
glad you remembered that...I had a pediatric one put in too, I had forgotten,
but it lasted longer than any other until I went to the central.
~kj~
if you are going to tread on thin ice
you might as well dance.
Cindi
Well, kinda. My third time around the block on IV's the first line had to
be pulled due to a clot and then they couldn't even get another one in. I
had to go with a central line -- a Hickman, which goes in your chest. I
thought it was a nightmare, but after having 2 PICCs in my arms in the past,
this was actually a lot easier to deal with. Just a lot of pain after
having it put in for a few days.
Cindi
"Don & Nancy Burrows" <bur...@entercomp.com> wrote in message
news:3971a...@newsman.viper.net...
Joel M. Shmukler, Esq
Sarah*) <aramsara...@cs.com.invalid> wrote:
>
> I had a picc line and it sprung a LEAK! Then I got a mid line
> and it migrated out so far we thought it was another leak but it
> was just at the end! So now I have another mid line which is
> held in place from migrating out by a Statlock, a little plastic
> holder-thingie. I am allergic to that Skin-Prep stuff! We just
> use steri-strips, a big clear plastic bandage & change the
> dressing once or twice a week.
>
> Like Brite said- it IS like wearing a watch. I was so scared
> of it and boy does that seem like wasted energy! If I had known
> how easy it was I would've been on it much sooner!!!!!
>
> Next week we see our Doc and it will be the end of my 3
> months. But I don't want to stop! I am still improving!!!!!!!!
> I am! I am!!!!!
>
> Best Wishes to All*)!)*)*!
>
> -
> Sarah*)
>
everyone know. If your PICC line 'springs a leak' (technical term:
becomes 'inflitrated') instead of pulling the PICC line and having to
reinsert in a new vein it is possible to insert a guide wire into
the 'broken' PICC line, pull it out over the end of the guidewire and
insert a new one on the same wire. This preserves the access to that
vein assuming it is a good one and no problems have developed because
of the infiltration or otherwise, and eliminates the need for a whole
new site. This can be especially important for those with difficult
veins or poor access.
Also: the ideas about hydrating prior to PICC insertion AND using a hot
compress (I would suggest a heating pad) are very good ones. THis also
helps if the nurse comes to stick you for blood--makes venous access
easier.
I reccomend using a heating pad for a couple of days following PICC
insertions if the arm is sore. And check with your doctor but in
addition to heparin, one baby asprin a day during IV therapy can be
useful in preventing clots from forming.
Also, although it is tempting to let home nurses pull blood out of the
PICC line when you need blood work done, it can be tough on the line
and can increase the likelihood of clot formation so it is better to
get stuck even with the PICC line.
--
brite...@hotmail.com
which is under the skin. Mine was placed in the outpatient department
at the hospital by a RN. The proceedure was simple and an xray showed
proper placement. (yes rocephin can cook your smaller veins in a dose)
After 11 1/2 months, the line sprung a serious leak at the hub. The RN
had broken her wrist. She opted to let radiology place the new picc
line. It was a horrible experience. EMLA cream was not used. [by the
way, EMLA cream is applied with air tight patch and then removed and
scrubbed before the proceedure - the numbing effect is still 100% for
up to an hour - the cream is not left on the skin during any
proceedure)
There was no lidocaine or other numbing medication used by the
radiologist. It took the him (MD) 2 1/2 hours even with xray, fluro and
ultrasound equipment. The placement was bad and the Cook Brand picc
line was the sorriest equipment I've ever had to work with. It was 6 or
7 inches in length and passed the fold of my elbow. Nuts is what it
was. I waited for the other arm (vein) to heal 1 week and went back to
the outpatient department and we changed back to the small 2" hub
inside of the elbow. Again with the outpatient nurse the process was a
simple one. No pain and no problem! This one is 3 months old now and
doing great.
I have heard of people having home health do a line in the house.
Yikes. And some don't have an xray to cfm correct placement. Now that's
scary!
brite...@hotmail.com
certainly not about picc lines. I came here today to leave you a post.
I hope you find this message. If not, I'm going to post on the open
board.
You are thinking I am not talking to you yes??? Well give me and a few
other people a break around here. We can't always be responsible for
YOUR feelings. Your server has returned THREE (3) emails to me this
week alone. Find out why and you'll then know that I'm still talking
to you.
I have other things to say but I don't think this board is the
appropriate place to address this issue. /brite
brite...@hotmail.com
into my arm - I mean there was a hole in the line near the hub. They
brought in the "PICC line TEAM" to see if it could be repaired. It was
more complicated than dropping super glue on the catheter. The entire
line had to come out - after 11 1/2 months - what can you expect. I
was okay with it.
As for drawing blood, if the RN avoid the pressure by pulling the
syringe out to quickly (causing the end of the catheter to collapse
like a straw) it can work. I always pull labs through the line - no
trouble. If you can't get blood flow, sit straight and turn your head
and neck to the opposite side of the line or stand up with your arm
down... or get stuck.
One time of 3 surgeries they used my picc line for the IV lead. It was
great! I went into O.R. already equipped!
brite...@hotmail.com
Joel M. Shmukler, Esq
brite...@hotmail.com wrote:
> When I said my PICC line sprung a leak... I don't mean infiltrating
> into my arm - I mean there was a hole in the line near the hub. They
> brought in the "PICC line TEAM" to see if it could be repaired. It
was
> more complicated than dropping super glue on the catheter. The entire
> line had to come out - after 11 1/2 months - what can you expect. I
> was okay with it.
Yeah that is what the term 'infiltrated' means in this context--that it
sprung a leak! And they can reinsert a new one into the same vein...
> As for drawing blood, if the RN avoid the pressure by pulling the
> syringe out to quickly (causing the end of the catheter to collapse
> like a straw) it can work. I always pull labs through the line - no
> trouble. If you can't get blood flow, sit straight and turn your head
> and neck to the opposite side of the line or stand up with your arm
> down... or get stuck.
> One time of 3 surgeries they used my picc line for the IV lead. It
was
> great! I went into O.R. already equipped!
>
> Sent via Deja.com http://www.deja.com/
> Before you buy.
>
--
Joel M. Shmukler, Esquire, Director LYMECURE
Joel M. Shmukler, Esq
But I had a radiologist who does CVIR (cardi vascular interventional
radiology) do it.
It is cruel not to use lidocaine IMHO.
I LOVE the Cook catheters!
Maybe you got a Cook brand midline? 7-8 inches sounds awfully short?
brite...@hotmail.com
> Surgeons place central lines all the time! Ever watch ER?
surgeon placing a picc line in response to an earlier post.
> But I had a radiologist who does CVIR (cardi vascular interventional
> radiology) do it.
>
> It is cruel not to use lidocaine IMHO.
I agree with you. They often will use lidocaine after the insertion at
the beginning but nothing topical. It was horrid. I wrote a letter to
patient satisfaction explaining what happened. It may have been his
attitude being called in on a holiday weekend. I wouldn't want this
guy touching my dog!
> I LOVE the Cook catheters!
>
> Maybe you got a Cook brand midline? 7-8 inches sounds awfully short?
the 7-8 inches was the device on the outside of the arm... then the 20"
or so line into the heart. Radiology (here)uses a different line than
does the outpatient center. But outpatient didn't know that. Oh
well.. everybody learns. The one I hated had the "wings" where they
sew it into your arm. He didn't since mine was scheduled to be there
for so long. But I didn't ask him to since I knew I would be changing
back to the other arm and the other brand of picc line.
It's definetly a subject I think everyone should know as much as they
can about before going in for one. I think that takes the fear out of
the process.
brite...@hotmail.com
Joel M. Shmukler, Esq
although I hear that there is a thing that attaches to your arm like
with two sided tape and then the wing attaches to that like with velcro
or some kind of hooks which would be an improvement.
The other thing is how it gets wide and then small again and the
unergonomic big hard plastic clamp. I always had the nurse cushion the
clamp by placing two by twos underneath since the plastic digs into
your arm. Worse if that clip breaks the large part of the catheter
(outside the arm) prevents a new one from sliding over so theoretically
one would need a whole new PICC line although there is a temporary
clamp you can attach but it doesn't work well or for a long time.
My LLMD CVIR radiologist and I are working on a redesign. He told me
Cook is quite open to product improvements.
Also they started using a new catheter downtown in the same health
system but it kept breaking so I have advised many in my area to
request the COok or go to the hospital where my CVIR guy is located--he
has managed to keep the Cooks on order there somehow.
PICCs inserted outpatient by the IV nursing team are NOT as heavy duty.
Same thing with home inserted PICCs--just not as good for possible long
duration use.
I WISH I still had no idea what a PICC line was though!
MaryLuRock
>Yikes. And some don't have an xray to cfm correct placement. Now that's
>scary!
>
hadn't had the x-ray that evening, I suppose I would have had more problems.
The nurse came and pulled it back 2 inches immediately, and the fluttering that
I was having stopped! I think the x-ray should be manditory!
Mary
BratDet
the doctors office while the physician was available for any problems. X-rays
were done within 12 hours to confirm correct placement.
No EMLA cream used, no unusual pain experienced, a simple iv stick
and..... if they insisted on stiching my or my husbands picc line in, I would
have told them to stitch their mouth shut first for suggesting such an
unnecessary thing...and if they suggested Valium, I would have told them to
stuff it....now if I knew of a nervous nellie friend, who cant stand needles,
hated anything medical...and would panic at a dressing falling off,,,,all of
the strategies reccommended would be a blessing.......
it is scarier to have a picc line done in a persons home, because the biggest
danger is an anaphalactic reaction to the intravenous medication.....in terms
of sterility...it is the persons sterile technique
that matters most during insertion and dressing changes...no matter where they
are....Bernadette
Bernadette
BratDet
insertions if the arm is sore. And check with your doctor but in
addition to heparin, one baby asprin a day during IV therapy can be
useful in preventing clots from forming."
pain is due to a clot, a heating pad could dislodge it and help ya shoot an
emboli....and I would also refuse to have blood drawn from my PICC, but it was
never an issue for me....btw Joel using esquire after one's name denotes
someone is a lawyer in possession of a J.D.. Are you??
thanks Bernadette
BratDet
was easy...:) B
Joel M. Shmukler, Esq
insertion for soreness. And actually IF you had a clot(DVT) or a case
of phlebitis one part of the treatment (in addition to heparin and
coumadin/warfarin) IS heating pads.
As to the esquire:
The Merriam Webster Dictionary has the following definition:
es*quire (noun)
[Middle English, from Middle French escuier squire, from Late Latin
scutarius, from Latin scutum shield; akin to Old Irish sciath shield]
First appeared 15th Century
1 : a member of the English gentry ranking below a knight
2 : a candidate for knighthood serving as shield bearer and attendant
to a knight
3 -- used as a title of courtesy usu. placed in its abbreviated form
after the surname <John R. Smith, Esq.>
4 archaic : a landed proprietor
In my case I am NOT a member of the English gentry, nor a candidate for
kingthood serving as a shield bearer and attendant to a knight, nor am
I using it as a title of mere courtesy, nor, finally am I a landed
proprietor (well I do have a couple of roommate/tenants but...)
I AM a graduate of the University Of Pennsylvania School of Law (1990)
and a member of the PA & NJ bars (although in the course of my life I
have visited bars in many others states as well as a saloon or two and
a few english pubs...LOL
Please feel free to check my profile on AOL I have nothing to hide.
Joel M. Shmukler, Esq
without really studying due to other circumstances in my life that
prevented me from studying. I think if I said it was "easy" it was only
easy because I had not overstudied like the rest of the people taking
it so I didn't overthink the questions.
The Jersey bar was actually easier than PA.
lymiechick
going to have it in for any length of time. Having the line
migrate can be very dangerous - doing something relatively easy
and simple to prevent this is a very wise move. As for the
valium, it's not just for nervous people, but relaxes the veins
and muscles, making the insertion easier.
Joel M. Shmukler, Esq
I don't think it is just 'nervous nellies' who might be anxious about a
PICC line insertion--having a catheter threaded up your vein (sometimes
along with the infusion of dye so the doctor can view the procedure
under the fluroscope), and having the end of the line terminate in the
superior vena cava just short of the heart...this is a routine and
minor procedure but has its risks and can be uncomfortable even a bit
painful. And as lymiechick said, the valium prevents venous spasm which
is an involuntary reaction.
God bless you if you didn't need valium. I did the first time but not
thereafter but I still took one to prevent the venous spasm--just not
the four or five I took the first time...
--
Gcldsg
and was never successful. It was painful. In the end I had a broviac cathether
in my chest. It worked well, but I was very allergic to any kind of tape and
had a very sore chest before we were finished with the treatment.
I think it is different with every patient. It depends on a lot of things,
including how receptive and how small or large your veins are.
As with everything else with Lyme disease, there is no one answer for
everybody.
Ann OH
KJRU
>My husband and I were perfectly comfortable with PICC line insertion done
>in
>the doctors office while the physician was available for any problems. X-rays
>were done within 12 hours to confirm correct placement.
>No EMLA cream used, no unusual pain experienced, a simple iv stick
>and..... if they insisted on stiching my or my husbands picc line in, I
>would
>have told them to stitch their mouth shut first for suggesting such an
>unnecessary thing...and if they suggested Valium, I would have told them
>to
>stuff it....now if I knew of a nervous nellie friend, who cant stand needles,
>hated anything medical...and would panic at a dressing falling off,,,,all
>of
>the strategies reccommended would be a blessing.......
>it is scarier to have a picc line done in a persons home, because the biggest
>danger is an anaphalactic reaction to the intravenous medication.....in
>terms
>of sterility...it is the persons sterile technique
>that matters most during insertion and dressing changes...no matter where
>they
>are....Bernadette
>Bernadette
I would have been perfectly comfortable too had it gone that easy for me!! Not
everyone is that easy to stick. I am about as tough as they cone when it comes
to needles and I can tell you some horror stories and not because of bad nurses
or IV specialists.
Apparently you do not know, or have any experience with collapsing veins and
veins that blow, believe me it is no picnic. Then.....once you have the scar
tissue from blown veins it hurts like hell trying to get around it.
I have had more PICC lines than I can count and have sucked it up each time
without valium because I was there myself and driving, but if it helps someone
relax and have an easier time, it is certainly not a cop out .
I have had my arms black and blue all the way up and down trying to get a line
for medication in the hospital too.
You are lucky you are an easy stick.
kj
Chicci
Chicci
Sarah*)
Just a note on picc line Draino-
when I got a clot they didn't use urykinase they
used a new thing called TCP. It made the clot
dissolve in about 10 seconds!!! (after I had to
wait in for the nurse forever*)!*)!
Joel M. Shmukler, Esq
Sarah*) <aramsara...@cs.com.invalid> wrote:
>
> Just a note on picc line Draino-
> when I got a clot they didn't use urykinase they
> used a new thing called TCP. It made the clot
> dissolve in about 10 seconds!!! (after I had to
> wait in for the nurse forever*)!*)!
>
> -----------------------------------------------------------
FYI: Re abbokinase also known as urroikinase: (this is pretty
unbelievable but TRUE:
http://www.fda.gov/cber/index.html
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
January 25, 1999
IMPORTANT DRUG WARNING
Dear Healthcare Provider:
The purpose of this letter is to inform you of important safety
information regarding the use of Abbokinase> (Urokinase). This
information is intended to help physicians and patients understand the
potential risks of transmitting infectious agents associated with the
use of this product. The FDA is recommending that <Abbokinase> be
reserved for only those situations where a physician has considered the
alternatives and has determined that the use of <Abbokinase> is
critical to the care of a specific patient in a specific situation.
During recent inspections of Abbott Laboratories and its supplier of
the human neonatal kidney cells used in the manufacture of
<Abbokinase>, the United States Food and Drug Administration (FDA)
identified numerous significant deviations from the Current Good
Manufacturing Practice regulations designed to help assure product
safety.
<Abbokinase> is produced from primary cultures of kidney cells
harvested post-mortem from human neonates. Products manufactured from
human source materials have the potential to transmit infectious
agents. While some procedures to help control such risks in products of
human source are in place, recent manufacturing inspections revealed
deficiencies in some of the procedures used by Abbott and its supplier
of the human neonatal kidney cells that could increase the risk of
transmitting infectious agents. In considering this risk, the
prescriber should be aware of the following information regarding
currently available lots of <Abbokinase>:
The kidney cells used in the manufacture of this product were harvested
post-mortem from human neonates from a population at high risk for a
variety of infectious diseases, including tropical diseases. The
screening of potential donors did not include the questioning of the
mothers to determine infectious disease status or specific risk factors
for infectious diseases. Although some efforts were made by Abbott´s
supplier to screen and test the mothers, neonate donors, and kidney
cells, Abbott´s testing of the materials it received indicates that
these measures were not consistently or reliably performed.
Neither the mothers nor the neonate donors were tested for hepatitis C
virus (HCV) infection. Abbott has recently instituted a test for HCV in
the kidney cells used in the manufacture of <Abbokinase> and negative
test results have been obtained for currently available lots. However,
Abbott has not validated this test.
Prior to use in the manufacture of <Abbokinase>, the human kidney cells
were harvested, stored and handled in a manner which may have permitted
contamination with infectious agents.
A viral inactivation procedure that substantially inactivates HIV and
HCV in other biological products was used in the production of the
currently available lots of <Abbokinase>. This process has variable
effects on other infectious agents and has not been fully validated for
viral inactivation of <Abbokinase>.
The FDA is not aware of any cases of infectious diseases that can be
attributed to the use of <Abbokinase>. However, the likelihood that
cases of infectious diseases caused by <Abbokinase>, if any, would have
been recognized as such and reported to FDA is probably very low.
Therefore, the actual risk to patients of developing an infectious
disease as a result of using <Abbokinase> is unknown. For each setting
in which the use of <Abbokinase> is being contemplated, we encourage
you to consider the appropriateness of other treatment options. FDA
approved indications for <Abbokinase> are: pulmonary embolism, coronary
artery thrombosis, and i.v. catheter clearance. It should also be noted
that the FDA has not approved the use of <Abbokinase> for clearance of
peripheral venous and arterial obstructions or for clearance of arterio-
venous cannulae.
Other thrombolytic products on the U.S. market with well-described
experience in multiple indications include Streptase« (Streptokinase),
Kabikinase« (Streptokinase), Activase« (Alteplase), Eminase«
(Anistreplase), and Retavase« (Reteplase). We encourage all physicians
to consider the appropriateness of other treatment options. The
following is a list of FDA-approved indications for each of the other
thrombolytic products currently available in the U.S.:
Streptase« (Streptokinase) [Hoechst Marion Roussel]-distributed by
Astra USA
Acute evolving transmural myocardial infarction
Pulmonary embolism
Deep vein thrombosis
Arterial thrombosis or embolism
Occlusion of arteriovenous cannulae
Kabikinase« (Streptokinase) [Pharmacia & Upjohn AB]
Acute evolving transmural myocardial infarction
Pulmonary embolism
Deep vein thrombosis
Arterial thrombosis or embolism
Activase« (Alteplase) [Genentech, Inc.]
Acute myocardial infarction
Acute ischemic stroke
Pulmonary embolism
Eminase« (Anistreplase) [Wulfing Pharma GmbH]-distributed by Roberts
Pharmaceutical Corporation
Acute myocardial infarction
Retavase« (Reteplase) [Centocor, Inc.]
Acute myocardial infarction
Abbott has committed to updating the labeling for <Abbokinase> to
include the information regarding the potential risk for transmission
of infectious diseases and to expeditiously correcting the deviations
from Current Good Manufacturing Practice.
It is important that adverse experiences involving suspect infections
following the administration of <Abbokinase be included among those
adverse events reported to Abbott Laboratories, Pharmaceutical Products
Division, North Chicago, IL 60064, at 1-800-633-9110, or to the Agency
via the MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-
FDA-0178, via the MedWatch website at www.fda.gov/medwatch/, or by mail
(using postage-paid form) at MedWatch, HF-2, FDA, 5600 Fishers Lane,
Rockville, MD 20852-9787. Health professionals and consumers should use
the Form 3500 for adverse event/product problem reporting.
FDA will provide updated information on this product, as appropriate,
via the Internet at http://www.fda.gov/cber. Information also will be
available from the CBER voice information system at 1-800-835-4709, the
CBER FAX information system at 1-888-CBER-FAX, and to subscribers of
CBER´s automated mailing system, CBERINFO. Prescribers are encouraged
to consult these resources.
-- Signature --
Kathryn C. Zoon, Ph.D.
Director
Center for Biologics Evaluation
and Research
FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Services 5600 Fishers Lane Rockville, MD 20857
------------------------------------------------------------------------
--------
FDA Talk Papers are prepared by the Press Office to guide FDA personnel
in responding with consistency and accuracy to questions from the
public on subjects of current interest. Talk Papers are subject to
change as more information becomes available.
------------------------------------------------------------------------
--------
T99-32 Print Media: 301-827-6242
July 16, 1999 Broadcast Media: 301-827-3434
Consumer Inquiries: 888-INFO-FDA
SERIOUS MANUFACTURING DEFICIENCIES WITH ABBOKINASE> PROMPT FDA LETTER
TO ABBOTT LABS
FDA has informed Abbott Laboratories of additional concerns related to
manufacturing deficiencies for urokinase (<Abbokinase>). Until these
problems are corrected, further distribution of <Abbokinase> would
violate federal laws designed to assure the safety of drugs for patient
use. FDA's concerns about the product relate to serious deficiencies in
the manufacturing processes, the testing of the product, and the
screening and testing of the donors of the kidney cells used to make
<Abbokinase>.
<Abbokinase> is derived from cultures of human kidney cells from
newborns who have died of natural causes, and is approved in the United
States to dissolve blood clots in the lungs and heart arteries. It is
also approved to help clear intravenous catheters.
During inspections of Abbott Laboratories and of BioWittaker, Inc.,
Abbott's supplier of human kidney cells, FDA identified numerous
significant deviations from current good manufacturing practice (CGMP)
regulations designed to assure product safety.
Compliance with CGMP is important because products manufactured from
human sources have the potential to transmit infectious agents. CGMP
for products such as <Abbokinase> requires important, overlapping
safeguards in the production process, including adequate
screening of donors and testing of the cells,
controls for proper harvesting, storage, and handling of materials used
in all stages of manufacturing, and
processes to remove or inactivate infectious agents from the product.
Over the past several months, the firm has reported to FDA that a
number of in-process lots of <Abbokinase> were contaminated with
microorganisms. Six such lots were found to contain various strains of
reovirus, a virus that usually results in no symptoms or causes minor
respiratory or gastrointestinal symptoms. Association of reovirus
infection with other human diseases has been reported, although a
causal link has not been established. Another in-process lot was
contaminated with mycoplasma, a microorganism that can cause
respiratory infections, and, on rare occasions, other infections that
may be serious. Abbott has assured FDA that none of these in-process
lots were manufactured into final product or distributed.
These recent findings of contamination and Abbott's inability to locate
the source of the problem have raised further concerns at FDA about
Abbott's entire manufacturing process for <Abbokinase>. Abbott's
deviations from CGMP could significantly impact the safety of the
product. One FDA concern is that deficiencies in manufacturing
practices could also lead to the product being contaminated with
microorganisms that have not yet been detected.
In January 1999, FDA issued a letter to health care providers in order
to alert them to important safety information regarding the use of
<Abbokinase>. The letter included information about the potential risks
of the product for transmitting infectious agents. It also recommended
that <Abbokinase> be reserved for only those situations where a
physician has considered the other available treatment alternatives and
has determined that the use of <Abbokinase> is critical to the care of
a specific patient in a specific situation. In addition, at FDA's
request, Abbott changed the labeling of the product to include
additional information to reflect these safety concerns so that
physicians would have a clear understanding of the risks of using
<Abbokinase>.
However, since the January letter to health care providers, FDA
obtained additional information regarding the inadequacy of the
screening and testing of the mothers and donors of the human kidney
cells used to produce <Abbokinase>. Information was also obtained
regarding the seven instances of in-process lots of product being
contaminated with reovirus and mycoplasma.
In the letter to Abbott, the agency has detailed the steps Abbott needs
to take to correct the serious and significant manufacturing
deviations. These include:
completing a thorough and adequate investigation of the reovirus and
mycoplasma contamination, including the source of the contamination,
manufacturing <Abbokinase> using human kidney cells that have been
obtained, processed, and tested through adequate methods, and
assuring that fully validated methods are used in the manufacturing
process to test for infectious agents and remove them.
The limited number of lots of <Abbokinase> shipped early this year were
distributed only after they were tested for certain infectious agents
and found negative by Abbott Laboratories and FDA. Abbott Laboratories
has not distributed any new lots of the product since then.
The actual risk to patients of developing an infectious disease as a
result of using <Abbokinase> is unknown.
Patients should discuss any concerns they may have about prior use of
<Abbokinase> with their physicians.
Physicians should continue to report any adverse events, including
infections that may be attributable to <Abbokinase. These reports can
be made to Abbott Laboratories, Pharmaceutical Products Division, North
Chicago, Il. at 1-800-633-9110 or the FDA via the Medwatch program by
phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or via the Medwatch
website at www.fda.gov/medwatch/.
####
Update on Abbokinase> (Urokinase)
March 16, 1999
------------------------------------------------------------------------
--------
FDA is receiving new inquiries regarding a reported shortage of
<Abbokinase> (Urokinase), a thrombolytic product manufactured by Abbott
Laboratories (Abbott). The agency hopes that the following information
will answer questions about this reported shortage.
In January 1999, Abbott implemented additional testing for finished
lots of <Abbokinase>. Abbott has not yet completed validation of these
additional tests. Additional finished lots of <Abbokinase> will not be
available for use until further testing has been completed. FDA
understands from Abbott that, due to shortage issues, Abbott has been
distributing <Abbokinase> on an allocated basis.
In addition, three lots of in-process product, which were not
manufactured into finished <Abbokinase> or distributed, have been found
to contain reovirus. Reovirus is an adventitious agent that should not
be present at any step in the production of <Abbokinase>. The presence
of reovirus in the in-process product was discovered as a result of
testing begun by Abbott this year at the request of FDA to correct
deficiencies noted during FDA's inspection of Abbott last fall. Most
reovirus infections are asymptomatic or produce minor upper respiratory
or gastrointestinal symptoms. While association of reovirus infection
with other human diseases has been reported, a causal link with other
diseases has not been established.
Abbott is working to determine the extent and the source(s) of the
reovirus contamination. Although a number of studies in the literature
suggest that the heat inactivation step performed during the further
manufacturing of the in-process product into <Abbokinase> should render
reovirus non-infectious, FDA has received assurance from Abbott that
any in-process product that contains reovirus will not be used to
manufacture finished product. Moreover, if any lots of <Abbokinase> are
found to contain reovirus, they will not be subject to distribution.
Finished lots of <Abbokinase> currently on the market have tested
negative for reovirus in Abbott's preliminary test; however, this test
has not yet been validated.
The finding of reovirus contamination of in-process product illustrates
the continuing concerns FDA has regarding the impact of deviations from
Current Good Manufacturing Practice observed during FDA inspections of
Abbott and its supplier of the human neonatal kidney cells used to
manufacture <Abbokinase>. As a result of those inspections, on January
25, 1999, FDA issued an Important Drug Warning to Healthcare Providers
regarding <Abbokinase>, which included the following information and
recommendations:
FDA described Current Good Manufacturing Practice deficiencies noted
during inspections of Abbott and its supplier of the human neonatal
kidney cells that were used in the manufacture of currently available
<Abbokinase>; the agency reported that the deficiencies could increase
the risk of transmitting infectious agents.
FDA recommended that use of <Abbokinase> be reserved for only those
situations where a physician has considered the alternatives and has
determined that the product´s use is critical to the care of a specific
patient in a specific situation.
FDA discussed the risks associated with the use of <Abbokinase> and
encouraged prescribers to consider the appropriateness of other
treatment options for each setting in which the use of <Abbokinase> is
being contemplated.
As set forth in the January 25th letter, FDA is not currently aware of
any cases of infectious diseases that can be attributed to the use of
<Abbokinase>. However, the likelihood that cases of infectious diseases
caused by <Abbokinase>, if any, would have been recognized as such and
reported to FDA is probably very low. Therefore, the actual risk to
patients of developing an infectious disease as a result of using
<Abbokinase> is unknown. FDA recommends that prescribers carefully
consider this new information, as well as the information on
manufacturing deviations set forth in the agency´s January 25th letter,
in assessing the risks associated with the use of <Abbokinase.
>
--
Joel M. Shmukler, Esquire, Director LYMECURE
Sarah*)
Joel-
What's TCP>? Do you know>?
-
Sarah*)
BratDet
time...but EVERY person is DIFFERENT in their needs, and the MAJORITY of people
are absolutely FINE without added drugs....or stitching a PICC line in place
and I know many people who have never had a picc line migrate a
centimeter...yes there are horror stories...but I also disagree with the use of
Valium unless needed..and to me needed is for patients comfort.not to prevent
venous spasms that can happen at anytime AFTER a picc line insertion.....let's
think logically here...when do you get your PICC line instructions??? Errr
after the PICC line is in...I prefer as clear a mind as possible to understand
directions and most people are smart enough to have a friend/significant other
also listen to instructions.....
if your dressing is properly done it is VERY secure...
The simpler a procedure can be ...the better tolerated by the "patient"....
Yes, I am a minimalist...but when ill, I prefer the least amount of drugs so I
can figure out what the hell is really causing what problem......the real point
of my post is just to point out that for the majority of PICC line persons,
Valium is not needed nor is stitching...and if someone feels they need it....by
all means go for it...but I want those who might get one that there ARE choices
to make....Bernadette
Jonathan R. Strong
> Yes, I am a minimalist...but when ill, I prefer the least amount of drugs
so I
> can figure out what the hell is really causing what problem......the real
point
> of my post is just to point out that for the majority of PICC line
persons,
> Valium is not needed nor is stitching...and if someone feels they need
it....by
> all means go for it...but I want those who might get one that there ARE
choices
> to make....Bernadette
OK - one more experience to add to this:
I had a PICC line inserted back in 1992 that I kept in for three weeks, and
I've had another one in this year for quite a while. In both cases, the
actual
insertion only took a few minutes and was actually less uncomfortable than
a typical injection - just a small "stick" when the introducer was put in,
and
then I literally didn't feel the line go in. In both cases, a portion of the
line
outside the insertion point was looped and held down with steri-strips. The
connection to the larger tube and a portion of that larger tube rests on a
small
gauze pad and the whole thing is held in place by a 3" x 5" piece of
Tegaderm. The rest of the larger tube and the valve that allows for a quick
hookup to a syringe (sans needle) extends beyond the Tegaderm.
Between the steri-strips and Tegaderm, there's pretty much no way the
line is going *anywhere*. The whole dressing including steri-strips and
Tegaderm and the external section of tubing is replaced weekly.
I have no doubt that some folks have had a rough time with this and I don't
mean to minimze their experiences, but I wanted to share the fact that it's
often an essentially painless and problem-free setup.
- Jon
lymiechick
to me needed is for patients comfort.not to prevent venous
spasms that can happen at anytime AFTER a picc line
insertion.....let's think logically here>>
Well, thinking logically, having a venous spasm after picc line
insertion is not going to make it difficult or even impossible
for the line to be inserted, because the line is already in.
As for stitching, I guess we'll just have to agree to disagree,
although I do think it's very unlikely for people who have lines
in for any length of time not to have migration without
stitching. This migration may not be enough to be dangerous, but
considering the risks of migration I still feel it shouldn't be
chanced when stitching is so simple to do. My feeling is always
to err on the side of caution, especially when the negative
outcomes can be so extremely negative, but of course others may
disagree.
One added note: I've had picc lines installed both by a nurse at
home and in the hospital by a radiologist. The picc line
installed at home was a constant source of discomfort,
constantly filled with blood, and had to be removed after about
10 days due to clotting. Also, the insertion was very painful.
However, the only problem I had with the other line was that the
first line had a hole, but it was easily replaced over a guide
wire. The procedure itself was painless and I never had any
problems with the second line.
KJRU
The bottom line is, do what is right for you, the good far out weighs the bad
as far as getting the treatment needed.
For anyone that is worried, even though I had some problems......if I need more
IV therapy and they wanted to try another picc line, I would be fine with
trying.
Probably on the scale of things that have been tough with this disease...it
ranks pretty low.
kj
zebra
unable to thread the line past a kinky vein. I was a very sick chick at the
time and I couldn't tolerate anything, much less a painful invasive
procedure. The pain and stress released chemical mediators in my system
which made me very ill (mast cell attack, secondary to severe Lyme). I
scared the nurse to pieces, and appropriately so.
Later, a piicc line was inserted by a radiologist under fluroscopy. I
insisted IV narcotic analgesia (low dose) and antihistamines (pepcid). What
a difference! I felt fine afterward.
Do not underestimate the harmful effects of pain and anxiety on the body.
Now, as a somewhat healthier sick Lyme chick, I could probably tolerate that
which I couldn't tolerate when desperately ill.
Every case, every patient, every circumstance is different.
People know if they are tolerant or not / tough or not / feel pain or not /
and their knowledge should be respected.
Z