Mabel Adams Posted May 1, 2011 Share Posted May 1, 2011 I think it is mentioned very briefly in the AABB Perioperative Standards. Link to comment Share on other sites More sharing options...
Liz Posted May 3, 2011 Author Share Posted May 3, 2011 I thought that if I can prepare (manufacture) blood components to be given intravenously and proper Patient ID, I should be capable of preparing and tracing PRP. Still, I welcome your thoughts. Thank you very much. Link to comment Share on other sites More sharing options...
Mabel Adams Posted May 4, 2011 Share Posted May 4, 2011 There is a description in the back of the AABB Perioperative standards book that describes the process. Sorry, I didn't have time to quote it while at work and I didn't bring the Stds book home. Have you done a literature search? Maybe some of the articles would mention instruments used to prepare it. Link to comment Share on other sites More sharing options...
Liz Posted May 4, 2011 Author Share Posted May 4, 2011 There is a description in the back of the AABB Perioperative standards book that describes the process. Sorry, I didn't have time to quote it while at work and I didn't bring the Stds book home. Have you done a literature search? Maybe some of the articles would mention instruments used to prepare it.I do not have the AABB Perioperative standards. I have looked up machines, the thing is I like to see what users think of them and how users proceed. We have all learnt our profession and then corrected things through experience. Thank you. Link to comment Share on other sites More sharing options...
Ellen Zeigler Posted May 4, 2011 Share Posted May 4, 2011 Tendonitis or tendinitis, Osteo-Arthritis, Tennis Elbow, they are now injecting PRP instead of steroids and anti-inflammatory or in conjuction with anti-inflammatory. It seems Tiger Woods and Rafa Nadal the tennis player are treated with it. I was asked today if I would prepare it, I said it needs approval etc... Its a long procedure to get approval. So I am searching to see if it is a Standard of Care before I venture into the approvals, getting a code, writing the SOP and then preparing it. It is autologous prp. and one braws 60mL of whole blood and prepares it on the spot.What do I collect 60mL in?? What do I centrifuge it in?? I have WB and small tube centrifuges..I will read the Technical Manual before I ask more questions.ThanksLizYou may want to search the FDA web site (devices) for Platelet rich plasma. We don't make it but there are some equipment systems that prepare it for the specifics of orthopaedics' practices (some of our sports medicine physicians do) that are FDA approved. They're making autolgous product not intended for coagulation correction, but for materials found in platelet granules Link to comment Share on other sites More sharing options...
Liz Posted May 4, 2011 Author Share Posted May 4, 2011 Absolutely Ellen, that is what I need it for, the platelet granules that carry growth factor (they later degranulate and hasten the healing process). Thank you, I am glad to hear that there are FDA approved machines, I shall look them up.Liz Link to comment Share on other sites More sharing options...
Liz Posted May 4, 2011 Author Share Posted May 4, 2011 Is it still experimental? How can that be if the machine is FDA approved. Or are the actual procedure and the accuracy of the machine separated with reagards to FDA approval. Link to comment Share on other sites More sharing options...
ybunch Posted May 4, 2011 Share Posted May 4, 2011 We use autologous PRP for Tendon repair and in orthopedic surgery. Google Dr. Norman A. Marcus--he is a researcher in Virginia-adjunct professor Johns Hopkins--he had a lot of reference material. We have also used in non-healing diabetic wounds. We use an Angel, which is a total closed system. The manufacturer would have information on validation. Our perfusionists handle this. Hope this helps:) yvette Link to comment Share on other sites More sharing options...
Liz Posted May 5, 2011 Author Share Posted May 5, 2011 Dear Yvette, Thank you for your reply and useful information. I shall look up Dr. Norman A. Marcus and the Angel system. Indeed that is helpful Thank you.Liz Link to comment Share on other sites More sharing options...
bhunterlabguy Posted May 5, 2011 Share Posted May 5, 2011 I hate to be lame, but you could "Google" it. There are a number of vendors who supply kits and equipment for this process. There have been three facilities actually inquiring about licensing for this... Link to comment Share on other sites More sharing options...
ybunch Posted May 6, 2011 Share Posted May 6, 2011 I am sorry. I did not have the researcher's CV handy. He is an orthopedic surgeon and researcher, not a sales rep. Platelet Gel got a bad reputation when banked blood was used. And, then some tried to capitalize on a product. There is a great difference between an autologous fresh product, used at the bedside. Also, Dr. Timothy Hannon with the Society for the Advancement of Blood Management and Strategic Blood Management is an expert on this subject. Liz 1 Link to comment Share on other sites More sharing options...
Liz Posted May 6, 2011 Author Share Posted May 6, 2011 I am sorry. I did not have the researcher's CV handy. He is an orthopedic surgeon and researcher, not a sales rep. Platelet Gel got a bad reputation when banked blood was used. And, then some tried to capitalize on a product. There is a great difference between an autologous fresh product, used at the bedside. Also, Dr. Timothy Hannon with the Society for the Advancement of Blood Management and Strategic Blood Management is an expert on this subject. I contacted Dr. Norman A. Marcus and he replied, he is just charming, thank you for the contact. I shall get in touch with Dr. Timothy Hannon. It is one thing picking up info from “Google” and quite something else getting the opinion of people who have used it and the experts; it becomes a valuable learning experience. That is the benefit of this forum. Thank you very much for your kind help.Liz Link to comment Share on other sites More sharing options...
Avid123 Posted May 6, 2011 Share Posted May 6, 2011 The FDA has approved the medical devices for the purpose of concentrating the platelets. What you use those platelets for is still experimental and not approved therapies. Hence, insurance will not pay for it. I would suggest that the sports medicine clinic purchase the machine and learn to operate it since the procedure should be performed as close to the patient as possible. Janice Link to comment Share on other sites More sharing options...
Mabel Adams Posted May 9, 2011 Share Posted May 9, 2011 Our contractor for perfusion, abi extracorporeal, provides this service in addition to perfusion. Their website is abiextracorporeal.com. They use a SmartPrep 2 model SMPZ(or 2?)-115 by Harvest Technologies. 508-732-7500. There is also something on the technician's business card that says "Autologous Biosolutions" but I am not sure if that is just abi advertising or another middle-man supplier or what. Link to comment Share on other sites More sharing options...
Liz Posted May 10, 2011 Author Share Posted May 10, 2011 Dear Mabel, thank you for the useful information. I am looking it up now, (yes, it is a 2).liz Link to comment Share on other sites More sharing options...
Mabel Adams Posted May 18, 2012 Share Posted May 18, 2012 So, it is a year later and I am now wondering if anyone understands what the AABB & FDA want us to do about PRP use in our ORs. Does anyone have a procedure to share that meets Periop Std 5.4.5.3 on documenting use of PRP products in the patient's medical record (who, what, when)? Or do you know whether FDA considers it a blood product that requires a barcoded label? Link to comment Share on other sites More sharing options...
Ellen Zeigler Posted June 26, 2012 Share Posted June 26, 2012 Does anyone prepare PRP for tendonitis, OA etc..?If so, how do you validate the product?and can you advise a good reference?Thank you This surfaced about 9 months ago here (university center) from a different aspect in that the Orthopaedic Clinical practice is making their own in their office setting. After a bit of heartburn, I wrote their initial SOP so they could track supplies, etc.There are several FDA-approved devices that appear to be very simple (although I'll acknowledge that I have a blood center background). If you don't have any luck with moving the production to the office setting, the AABB Technical manual does have good instructions for making PRP.Good Luck Link to comment Share on other sites More sharing options...
Liz Posted June 27, 2012 Author Share Posted June 27, 2012 I have no news and did not allow it in the Bood Bank ..yet.Something to ask at the AABB meeting to the FDA and Standards meetings. Link to comment Share on other sites More sharing options...
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