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Re: Legal development: FDA's discretion to declare a product candidate a drug vs a device is limitedcan't say for sure but i would suspect anything used as a lock solution that can get into the body would now be considered a drug==esp since neutrolin would set a precedent i believe---no telling with our government though-- still very little of the lock solution would get into the body as it would mostly be a saline or perhaps a heparin flush if need be. they wouldn't be using Neutrolin as a flush good info in this article--interesting to see that low strength heparin increases formation of staph aureus biofilm and higher strength heparin makes it worse...hmmm https://c.ymcdn.com/sites/www.asdin.org/resource/resmgr/imported/SDI 466 Locking Solutions.pdf i think if a clot forms it will be removed using TPA (or similar) Or the catheter will be replaced see this: Problems Specific to Dialysis Catheters Dialysis catheters are the least preferred way of doing hemodialysis for good reasons. They carry the highest risk of infection, and unless there is a good reason not to (or if it is an emergency), no patient should be starting dialysis via a catheter. Once inserted, catheters might not work right from the get-go, something called early catheter malfunction, and that is usually because of malpositioning of the catheter in a vein. The catheter in this situation can sometimes be manipulated and repositioned to make it work, or it needs to be exchanged. In some instances, a catheter that has been functioning well for weeks to months can stop working, and this could be indicative of blood clot formation inside or around the catheter. This thrombus will require treatment, either using "clot-busting" thrombolytic medications, or the catheter needs to be changed. It is because of this risk that dialysis catheters are "locked" with anticoagulant medications after use to prevent blood clot formation. NOW THIS from another article about using tenecteplase to bust up clots in/around catheters-- interesing to note the study had 192 patients and 5 infections---hmmmm About 20% of hemodialysis patients use catheters for dialysis and there is a large amount of dysfunction with them,” said Dr. Fishbane, who presented study findings here at the Society of Interventional Radiology annual meeting. “They are very, very prone to blood clots that form in and around the catheter.” Tenecteplase literally lyses these clots, he added, noting that tenecteplase could decrease morbidity and improve patient satisfaction. “It certainly may improve the efficiency of dialysis and it could mean a considerable cost savings by eliminating these complications.” Five catheter-related bloodstream infections and one thrombus occurred in the study population. All of these problems resolved with treatment. The researchers observed no episodes of intracranial hemorrhage, major bleeding, or embolic events. |
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Msg # | Subject | Author | Recs | Date Posted |
37373 | Re: Legal development: FDA's discretion to declare a product candidate a drug vs a device is limited | hayfarmer | 2 | 12/11/2019 9:17:13 PM |