Emergence of Covid-19 Leads to Emergency Use Authorization for Apheresis Systems in US

 

Apheresis refers to a medical treatment that involves removal of whole blood from the patient, separation of blood into various components and then removing an element from the patient's blood. Apheresis can be done in one of two ways: Intravenous infusion, or Extracorporeal Shock Therapy. Intravenous infusion is done by giving nutrients intravenously, while Extracorporeal Shock Therapy is done by placing needles on the affected area and delivering electric shocks to it.

This technique is often used as a treatment for shock or deep vein thrombosis. It can also be used in treatment of Covid-19, which has prompted regulatory bodies to issue emergency use authorization for apheresis systems. For instance, in April 2020, The U.S. FDA issued emergency use authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.

 

Plasmapheresis, photopheresis, leukapheresis, plateletpheresis, low-density lipoproteins (LDL) apheresis, erythrocytapheresis, lymphapheresis, and lipidpheresis are some of the types of apheresis. Some methods of apheresis also include direct transfer of platelet-rich plasma from the diseased platelet to an uninfected donor. In this case, the donor's blood does not contain platelet particles and/or clots. If there is a problem with direct plateletpheresis, it may cause bleeding. Some doctors use an autologous serum as a replacement, which is made from the patient's own blood and contains platelet-rich plasma. Although this treatment is not used as often as it was in the past, it can be effective if the patient is scheduled properly.

Plasmapheresis involves taking platelet from the diseased platelet to a donor. The platelet is then taken and introduced into the recipient's blood stream, where it is used to generate platelet production. The platelet will help the transplanted blood develop properly, resulting in the needed blood to save the life of the patient. Apheresis has been used for patients with chronic diseases such as leukemia, as well as bone marrow or stem cell transplants. It is currently being studied for its effect on people with multiple sclerosis and possibly other chronic health disorders.

Apheresis requires the mixing of some specially prepared components and is usually carried out on an outpatient basis. The donor site is chosen beforehand, and a venipuncture point is prepared before the procedure begins. This point is marked by a small needle, and the blood from the donor is mixed with the platelets from the recipient. The platelet-rich plasma is then passed through the cannula, into the syringe, and collected into a special collection bag.

Apheresis has been a subject of controversy since the first days of its application. Originally, the procedure was criticized because it seemed to produce a greater number of adverse effects in patients that were undergoing it, and because it seemed to work better for people suffering from leukemia, rather than patients with all other kinds of diseases. Since then, the controversy has died down, especially with the release of the long-term reports from the clinical trials of apheresis. While some researchers have raised questions about the safety of whole blood and other Apheresis therapies in light of the controversy, most agree that the benefits of this therapy far outweigh any reservations.