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Hospital medical equipment - general information Apheresis units UMDNS 16405, 23134, 23135, 23136, 23137, 23139 Apheresis units GMDN 16405 Other common names: Blood cell processors, blood component separators, plasma blood donor apheresis units, platelet blood donor apheresis units, therapeutic apheresis units Health problem addressed Apheresis systems collect and separate blood components for donation; they can also remove or exchange substances in therapeutic procedures. Therapeutic apheresis is used on patients with Goodpasture syndrome, preeclampsia and eclampsia in pregnancy, leukostasis cause by elevated white blood count in leukemia, systemic lupus, vasculitis, polymyositis or dermatomyositis, severe rheumatoid arthritis, or to reduce risk of antibody-mediated rejection of organ transplants. Product description Apheresis units incorporate polyvinyl tubing that draws blood from the patient and moves it through centrifuges and/or filters to separate blood products. The blood is then returned to the patient via tubing or is collected in bags, often suspended from a pole, for donation or disposal. A display and control panel allow the operator to program the unit and view progress and/ or alerts. Safety features include pressure sensors, ultrasonic air-bubble detectors, optical fluid-level detectors, and dry-heat fluid warmers. The warmers help prevent hypothermia caused by infusing low-temperature fluids. The unit may have wheels or it may be placed on a cart. The operator programs the unit to run the desired separation protocol; the unit automatically controls the centrifuge, pump, and other settings. Rotary peristaltic pumps draw blood from the patient or donor and pump blood through filters or centrifuges. Filters separate blood components based on size; centrifuges separate by density. Optical sensors detect plasma-cell interfaces to minimize contamination from other components. Centrifuges have inlet and outlet ports and compartments to keep components separated. Pumps move the blood products into collection bags, add anticoagulant, and reinfuse fluids. Replacement fluids (e.g., saline, serum albumin, plasma protein fraction, fresh frozen plasma) are infused into the patient to maintain appropriate intravascular volume and pressure. Operating steps • Apheresis machines are wheeled to the bedside or donor chair. • Operator connects the sterile tubing sets, also called pheresis sets, to the patient or donor. • As the patient’s blood is pumped into the machine, an anticoagulant is automatically added and the blood enters the chamber. • Blood components are separated using centrifugation and/ or filtration; the method of separation depends on the product that is to be removed or collected from the blood. Reported problems Air embolism is a risk despite the presence of air-bubble detectors in most apheresis units. Complications related to double-lumen venous catheter placement, such as vascular erosion and http://www.who.int/medical_devices perforation, have been reported. Hemolysis is associated with kinked tubing or poorly connected sets. Decreased ionized calcium in the plasma could lead to cardiac arrhythmia. Blood or blood component transfusions pose a risk of infection such as hepatitis and AIDS. Use and maintenance User(s): Nurse or technician Principles of operation 2012 Apheresis unit Maintenance: Biomedical engineering staff and/or service contract with the manufacturer or third-party organization Training: Manufacturer-provided training, manual Environment of use Settings of use: Hospital; clinic; outpatient clinic Requirements: Line power, biohazard disposal Product specifications Approx. dimensions (mm): 920 x 550 x 700 Approx. weight (kg): 95 Consumables: Sets, tubing, anticoagulant & replacement fluids Price range (USD): 20,000-157,000; (50,000 typical); price covers all types and variations Typical product life time: 8 years Shelf life (consumables): 1-2 months for anticoagulant; 2-5 days for platelets Types and variations • Units designed only for donor collection, therapeutic exchange, therapeutic removal, or a combination of these • Continuous units that enable simultaneous blood removal and return (requires two access sites; contraindicated in some patients) © Copyright ECRI Institute 2012 (not including GMDN codes and device names). UMDNS codes and devices names: © Copyright ECRI Institute 2012. Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System. GMDN Codes and Term Names: © Copyright and database rights: GMDN Agency Ltd 2005-2012. All rights reserved.