Misinformation in Medical Device Sales: A Case Study featuring Platelet-Rich-Plasma (PRP)

Misinformation isn't just a problem on the news, or social media, but can be encountered offline and in business as well. I was speaking with a client today who had been misinformed by a competitor's sales agent and I want to share the interaction as an example of deceptive sales tactics in healthcare/medical devices and how to counter them with factual data.

"When you were told that our vacuum?tubes contain endotoxins by our competitor's sales representative,?they were purposefully misrepresenting the facts in an effort to confuse you and steal your business away. Juventix PRP tubes are FDA-cleared 510(k) class II medical devices that are labeled "pyrogen-free". Pyrogen-free?means free of pyrogens, which are bacterial endotoxins that can cause fever in humans and test animals. We are labeled in this fashion because our PRP tubes are a sterile medical devices. The entire contents of the packaging/tray have been steam (autoclave), UV, and ionizing radiation sterilized. Until the moment you open the packaging and the contents touch?outside air, you are handling a fully sterile medical device.

Juventix PRP is also designed as a closed system, meaning that after you draw the patient's?blood into the collection tube, centrifuge to separate?the plasma, platelets, and growth factors from the red blood cells, and harvest those components utilizing?the included 18ga draw needle and 10cc syringe you are still handling a sterile sample. This is why it is important not to remove the sealed top from the tube when extracting the PRP and to follow the preparation instructions (please reference the first instructional video on the following webpage):?https://juventix.com/training-videos/).

That being said, many people try to save money by using various forms of serum separator?tubes (SST tubes) to produce PRP. These tubes are disposable laboratory?testing supplies that are designed to separate?the blood serum (plasma) from the whole blood sample. These tubes are not sterile and are labeled for in vitro use only. In vitro means performed or taking place in a test tube, culture dish, or elsewhere outside a living organism. In other words, you are not supposed to put the sample back into a living being after using an SST tube. There are various?other reasons why it is inappropriate?and dangerous to use SST tubes as a medical device and not as intended (for laboratory?use only).

???????????? ?????? ???????????contain the anticoagulant sodium polyanetholesulfonate (SPS). Sodium polyanethole sulfonate (SPS) is an anticoagulant and a component of blood culture media that helps grow bacteria from blood samples. SPS prevents the killing of bacteria by the body's innate cellular and humoral factors.?It's used to enhance the recovery of microorganisms in blood culture media. This means that Yellow Top Tubes actually induce bacterial growth, so not only would a serum (plasma) sample produced with a Yellow Top Tube not be sterile, but any bacteria present would be enhanced increasing the risk of infection and other adverse events. You can read more about the dangers and miss-use of Yellow Top Tubes here:?https://juventix.com/myth-busting-the-yellow-top-prp-tube/

?????? ?????? ???????????do not contain an anticoagulant. This tube is used for collecting serum or clotted whole blood specimens. This means when centrifuged the red blood cells (RBCs) for a clot at the bottom of the tube along with the platelets (as it is the platelets?that are the clotting factor that?produce clots). The serum (plasma) that you are left with is therefore devoid of all/virtually all platelets.?This is not PRP, but rather Plasma devoid of any platelets?and has no clinical therapeutic use in addition to being potentially unsafe. You can read more about the dangers and miss-use of Red Top Tubes here:?https://juventix.com/inappropriate-use-of-pet-tubes-for-prp-and-prf/

?????????? ?????????????????? ???????? (??????) (?????????? ??????)?do not contain an anticoagulant but contain a clot activator and serum separator gel. Much like the Red Top Tube, this format results in producing a serum (plasma) sample devoid of all/virtually all platelets. Additionally, these tubes have a coating of silicone and micronized silica particles, that if injected might trigger serious and potentially fatal repercussions, such as stroke and other cerebrovascular events. You can read more about the dangers and miss-use of Tiger Top Tubes here:?https://juventix.com/dangers-of-the-tiger-top-prp-tube-non-fda-approved-prp-kits/"

After correcting the record both in writing, so that the client could have the hard evidence to fact-check the misinformation, and by phone to demonstrate that we took their concerns and our customer relationship with them very seriously, we maintained the account and did not lose a customer to the deceptive behavior of a competitor in the field.

If you are currently working with a medical device company that engages in misinformation, deceptive sales practices, and other bad behavior I welcome you to disavow the dark side of the medical device industry and instead consider coming to work with a reputable company that operates on a factual basis and conducts themselves with integrity.

Juventix Regenerative Medical is an industry leader in the regenerative medical field. Our Platelet Rich Plasma (PRP) Kits are 510K cleared by the FDA and designed for safety, sterility, and effectiveness. Juventix Regenerative Medical has never received any warning letters from the FDA and any claims that are made for the use or applications of our PRP or PRF products are based on current published scientific studies, of which there are presently more than 22,686 available on PubMed and other scientific sites readily available on the web.

Avoid working with "bad actors" and instead choose a company that is trusted by professionals in the regenerative community.

For more information about Juventix Regenerative Medical and its offerings, visit www.Juventix.com or call (866) 693-4PRP.

#MedicalDevice #FDARegulations #PRP #RegenerativeMedicine #Biologics #HealthcareInnovation #FDA #Juventixormation isn't just a problem on the news, or social media, but can be encountered offline and in business as well. I was speaking with a client today who had been misinformed by a competitor's sales agent and I want to share the interaction as an example of deceptive sales tactics in healthcare/medical devices and how to counter them with factual data.

"When you were told that our vacuum?tubes contain endotoxins by our competitor's sales representative,?they were purposefully misrepresenting the facts in an effort to confuse you and steal your business away. Juventix PRP tubes are FDA-cleared 510(k) class II medical devices that are labeled "pyrogen-free". Pyrogen-free?means free of pyrogens, which are bacterial endotoxins that can cause fever in humans and test animals. We are labeled in this fashion because our PRP tubes are a sterile medical devices. The entire contents of the packaging/tray have been steam (autoclave), UV, and ionizing radiation sterilized. Until the moment you open the packaging and the contents touch?outside air, you are handling a fully sterile medical device.

Juventix PRP is also designed as a closed system, meaning that after you draw the patient's?blood into the collection tube, centrifuge to separate?the plasma, platelets, and growth factors from the red blood cells, and harvest those components utilizing?the included 18ga draw needle and 10cc syringe you are still handling a sterile sample. This is why it is important not to remove the sealed top from the tube when extracting the PRP and to follow the preparation instructions (please reference the first instructional video on the following webpage):?https://juventix.com/training-videos/).

That being said, many people try to save money by using various forms of serum separator?tubes (SST tubes) to produce PRP. These tubes are disposable laboratory?testing supplies that are designed to separate?the blood serum (plasma) from the whole blood sample. These tubes are not sterile and are labeled for in vitro use only. In vitro means performed or taking place in a test tube, culture dish, or elsewhere outside a living organism. In other words, you are not supposed to put the sample back into a living being after using an SST tube. There are various?other reasons why it is inappropriate?and dangerous to use SST tubes as a medical device and not as intended (for laboratory?use only).

???????????? ?????? ???????????contain the anticoagulant sodium polyanetholesulfonate (SPS). Sodium polyanethole sulfonate (SPS) is an anticoagulant and a component of blood culture media that helps grow bacteria from blood samples. SPS prevents the killing of bacteria by the body's innate cellular and humoral factors.?It's used to enhance the recovery of microorganisms in blood culture media. This means that Yellow Top Tubes actually induce bacterial growth, so not only would a serum (plasma) sample produced with a Yellow Top Tube not be sterile, but any bacteria present would be enhanced increasing the risk of infection and other adverse events. You can read more about the dangers and miss-use of Yellow Top Tubes here:?https://juventix.com/myth-busting-the-yellow-top-prp-tube/

?????? ?????? ???????????do not contain an anticoagulant. This tube is used for collecting serum or clotted whole blood specimens. This means when centrifuged the red blood cells (RBCs) for a clot at the bottom of the tube along with the platelets (as it is the platelets?that are the clotting factor that?produce clots). The serum (plasma) that you are left with is therefore devoid of all/virtually all platelets.?This is not PRP, but rather Plasma devoid of any platelets?and has no clinical therapeutic use in addition to being potentially unsafe. You can read more about the dangers and miss-use of Red Top Tubes here:?https://juventix.com/inappropriate-use-of-pet-tubes-for-prp-and-prf/

?????????? ?????????????????? ???????? (??????) (?????????? ??????)?do not contain an anticoagulant but contain a clot activator and serum separator gel. Much like the Red Top Tube, this format results in producing a serum (plasma) sample devoid of all/virtually all platelets. Additionally, these tubes have a coating of silicone and micronized silica particles, that if injected might trigger serious and potentially fatal repercussions, such as stroke and other cerebrovascular events. You can read more about the dangers and miss-use of Tiger Top Tubes here:?https://juventix.com/dangers-of-the-tiger-top-prp-tube-non-fda-approved-prp-kits/"

After correcting the record both in writing, so that the client could have the hard evidence to fact-check the misinformation, and by phone to demonstrate that we took their concerns and our customer relationship with them very seriously, we maintained the account and did not lose a customer to the deceptive behavior of a competitor in the field.

If you are currently working with a medical device company that engages in misinformation, deceptive sales practices, and other bad behavior I welcome you to disavow the dark side of the medical device industry and instead consider coming to work with a reputable company that operates on a factual basis and conducts themselves with integrity.

Juventix Regenerative Medical is an industry leader in the regenerative medical field. Our Platelet Rich Plasma (PRP) Kits are 510K cleared by the FDA and designed for safety, sterility, and effectiveness. Juventix Regenerative Medical has never received any warning letters from the FDA and any claims that are made for the use or applications of our PRP or PRF products are based on current published scientific studies, of which there are presently more than 22,686 available on PubMed and other scientific sites readily available on the web.

Avoid working with "bad actors" and instead choose a company that is trusted by professionals in the regenerative community.

For more information about Juventix Regenerative Medical and its offerings, visit www.Juventix.com or call (866) 693-4PRP.

#MedicalDevice #FDARegulations #PRP #RegenerativeMedicine #Biologics #HealthcareInnovation #FDA #Juventix #MedicalMisinformation #PRPBestPractices #HealthcareEthics #PRPSafety

About the Author: Lance Liberti is a nationally recognized healthcare consultant and new patient marketing professional with more than two decades of practical experience in the field. His experience spans multiple areas of practice including non-surgical spinal decompression, medically supervised weight loss, aesthetic medicine, and non-operative extremity pain management. The president and CEO of Integrative Practice Solutions and Juventix Regenerative Medical Mr. Liberti specializes in assisting health and wellness professionals to integrate boutique medical services into their practices to offer non-surgical solutions to those suffering from various degenerative musculoskeletal conditions. To learn more about Mr. Liberti’s extensive experience and see examples of his work products view his LinkedIn profile here: https://www.dhirubhai.net/in/lanceliberti

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