If you type “best-selling PRP tube” into your search engine, the yellow top vacuum centrifuge tube is likely one of the top results that you’ll see. Contrary to what you may think based on its popularity, the yellow top PRP tubes are NOT meant to be used in patient procedures. Although your clinic may be able to save some money using these tubes and other non-FDA approved PRP kits, they could end up costing you much more in the long run.
Yellow top tubes, or SST Tubes (serum separator tubes), are intended for lab use only. They contain silica as a preservative and separate the plasma from whole blood in a manner that causes division and not aggregation. Therefore, these tubes to do not produce any Platelet Rich Plasma (PRP) but rather a plasma sample devoid of platelets all together! As a result, using these tubes therapeutically is not only a dangerous and irresponsible off-label use, but also clinically infective. Platelets are the clotting factor of blood; and SST tubes exclude them. There is no clinical value to these tubes, other than testing of hormone levels and exogenous substances.
In addition, incidents caused by using yellow top tubes are not covered by malpractice either as FDA approved ONLY for in vitro use – outside of a living organism! For example, let’s say 123 Med Spa has been using a their own, homemade PRP product for years with no issues. One day, a patient comes in for an appointment and undergoes a simple PRP procedure. It is performed properly, and so the patient leaves the office with no complications. Later, however, the patient has a bad reaction, and their skin becomes inflamed and infected. As a result of this, they hire a lawyer and sue 123 Med Spa. During the trial, the attorneys go through every part of the procedure and ask about the PRP products that the spa utilized. In doing this, the lawyers would be able to demonstrate that cutting corners on the production of the PRP product demonstrates a willingness to cut corners on all aspects of the med spa. The patient’s issue may have little to do with PRP, but the practice’s disregard of the basics may impact its legal position. All that is left for the opposing council to prove is that 123 Med Spa utilized a non-FDA cleared product on a patient, even though FDA-cleared versions of that product exist, to potentially win the court case and financial compensation.
*The above case is fictional, and any similarities to existing practices or pending litigation are purely coincidental.
What does this mean for your practice and its utilization of PRP? Make sure that whichever company you purchase from has a valid FDA 510(k) clearance in order to protect your practice. The cost of goods difference between making it yourself and purchasing from a reputable company is minimal compared to the litigation cost and potential patient harm.
Juventix Regenerative Medical is proud to offer FDA 510(k) Cleared and ISO 13485 and CE certified (Class IIb) products as a representation of our company’s commitment to the highest industry standards possible. Juventix Regenerative Medical is the leading provider in autologous Platelet Rich Plasma (PRP) and other related Cell Therapy technologies. We work with scientists and practitioners to develop, launch, and supply a wide range of medical devices and regenerative products for numerous medical disciplines including aesthetics, orthopedics, neurology, pain management, sports medicine, wound care, dentistry, veterinary, and more.
To purchase or learn more about our FDA cleared PRP products and medical supplies, please visit our website www.juventix.com or call us at (866) 693- 4777.
Legal Disclaimer: The information contained in this article is provided for informational purposes only and should not be construed as medical or legal advice on any subject matter. You should not act or refrain from acting on the basis of any content included in this site without seeking medical, legal or other professional advice. The contents of this site contain general information and may not reflect current legal developments or address your situation. We disclaim all liability for actions you take or fail to take based on any content of this article.
Sources
· https://www.americanmedspa.org/blogpost/1633466/359758/How-to-Maintain-PRP-Equipment-Compliance
· https://www.hindawi.com/journals/sci/2016/7414036/
