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hemodialysis definition: therapy for the insufficient cleansing of the blood by the kidneys based on dialysis.
Hemodialysis definition: Removal of certain elements from the blood based on the difference in their rates of diffusion through a semipermeable membrane.
Hemodialysis Solutions definition: Solutions prepared for hemodialysis. The composition of the pre-dialysis solution may be varied in order to determine the effect of solvated metabolites on anoxia, malnutrition, acid-base balance, etc. Of principal interest are the effect of the choice of buffers (e.g., acetate or carbonate), the addition of cations (Na+, K+, Ca2+), and addition of carbohydrates (glucose).
Dialysate, Hemodialysis definition: Solutions prepared for use in hemodialysis for exchange of solutes below a certain molecular size (determined by the cutoff threshold of the membrane material) across a semipermeable membrane.
Hemodialysis Units, Hospital definition: Hospital units in which care is provided the hemodialysis patient. This includes hemodialysis centers in hospitals.
Hemodialysis, Home definition: Long-term maintenance hemodialysis in the home.
Cannulae, Hemodialysis definition: Cannulae inserted into an arteriovenous fistula for placement of an arteriovenous shunt.
Catheters, Vascular, Hemodialysis definition: Vascular catheters designed for extracorporeal dialysis of the blood. These catheters are used for withdrawal and infusion of blood to the patient; the blood is circulated via an extracorporeal blood circuit through the dialyzer and returned to the patient following a closed loop.
Catheters, Vascular, Hemodialysis, Central Venous, Single-Lumen definition: Central venous hemodialysis catheters that consist of a single-lumen silastic tube that may be used only with single-needle hemodialysis systems. These catheters are usually inserted via the external (or, less frequently, the internal) jugular vein or the subclavian vein and advanced to the superior vena cava; insertion through the femoral vein to the inferior vena cava is a less frequently used alternative.
Dialyzers, Hemodialysis definition: Dialyzers used in the process of removing a patient's blood from metabolic waste, ions, and organic salts caused by malfunction or failure of the kidneys. These dialyzers consist of three basic components: the blood container, the dialysate container, and a semipermeable membrane separating the two. Hemodialysis dialyzers are typically an integral part of hemodialysis units. Dialyzers are manufactured in three basic configurations known as coil, parallel plate, and hollow fiber.
Dialyzers, Hemodialysis, Coil definition: Hemodialysis dialyzers consisting of dialysis membrane tubing wound in a circular manner around a central axle, with a supporting mesh separating the coils. The blood flows inside the tubing, and the dialysate flows through the space created by the supporting plastic mesh.
DIALYZER, CAPILLARY, HOLLOW FIBER definition: A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer. (1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (Sec. 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (Sec. 876.5830) or dialyzers of high permeability (Sec. 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (Sec. 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (Sec. 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system (Sec. 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
Dialyzers, Hemodialysis, Hollow-Fiber definition: Hemodialysis dialyzers consisting of cylindrical containers with thousands of longitudinally arranged hollow-fiber capillary tubes. Blood enters and exits through the lumen of the hollow fiber while the dialysate flows through the container on the outside of the fibers.
Dialyzers, Hemodialysis, Parallel-Plate definition: Hemodialysis dialyzers in which sheets of dialysis membrane are placed in the device between support plates to form parallel layers. The blood and dialysate circulate in separate alternating compartments.
CLAMP, LINE definition: A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.
Clamps, Tubing, Hemodialysis Unit Blood Line definition: Tubing clamps designed to manually grasp and compress the arterial and/or venous blood line of a hemodialysis machine without damaging it. These clamps are usually available in several sizes and configurations as integral components or according to the hemodialysis line to be clamped and the hemodialysis machine characteristics; some clamps include identification (e.g., color coding) to differentiate between venous and arterial clamps. Hemodialysis line clamps are used to close the blood flow from and/or to the patient at the beginning or end of the hemodialysis procedure or when it is necessary to stop the procedure; the hemodialysis unit also includes as an integral part an additional venous line clamp that is used for automated closing of blood infusion to the patient when a problem in the hemodialysis procedure (e.g., air bubbles, blood leaks) is detected.
ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS definition: A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer. (1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (Sec. 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (Sec. 876.5830) or dialyzers of high permeability (Sec. 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (Sec. 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (Sec. 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system (Sec. 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES definition: A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer. (1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (Sec. 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (Sec. 876.5830) or dialyzers of high permeability (Sec. 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (Sec. 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (Sec. 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system (Sec. 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
CATHETER, HEMODIALYSIS, IMPLANTED definition: A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices. (1) The implanted blood access device consists of various flexible or rigid tubes, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various shunts and connectors specifically designed to provide access to blood, such as the arteriovenous (A - V) shunt cannula and vessel tip. (2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (Secs. 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
Hemodialysis Needle Sets definition: Needle sets that include a large-bore (typically 16 G) winged needle. During use, the Luer fitting is attached to a hemodialysis pheresis set. Usually, two needle sets are used simultaneously per dialysis patient, with one needle inserted in a vein and the other inserted in an artery. Both needles are kept in the patient until the hemodialysis procedure is completed.
Hemodialysis Needle Sets, Protective definition: Hemodialysis needle sets that allow the needle to be retracted into or covered by a protective sheath. These needle sets are used for prevention of accidental needlesticks during hemodialysis.
CATHETER, HEMODIALYSIS, NON-IMPLANTED definition: A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices. (1) The implanted blood access device consists of various flexible or rigid tubes, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various shunts and connectors specifically designed to provide access to blood, such as the arteriovenous (A - V) shunt cannula and vessel tip. (2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (Secs. 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
Catheters, Vascular, Hemodialysis, Central Venous definition: Hemodialysis catheters designed for direct insertion into a central vein, using surgical procedures. These catheters usually consist of a silicone rubber (silastic) tube with several lateral holes; they are inserted and advanced to locate the distal tip in a central vein, typically the superior vena cava or the right atrium (through the subclavian or internal jugular vein punctures), or less frequently in the inferior vena cava (through femoral insertion). Central venous catheters are used temporarily in the case of temporary but reversible access difficulties, acute renal failure, plasmapheresis, ultrafiltration, or dialysis treatment for acute poisoning. They are also permanently implanted for regular hemodialysis treatment in patients, when the peripheral vasculature may be or become unsuitable, or when the arteriovenous fistula is not indicated (e.g., preexisting cardiovascular diseases).
Catheters, Vascular, Hemodialysis, Central Venous, Double-Lumen definition: Central venous hemodialysis catheters that consist of two (usually parallel) lumen tubes. These catheters are commonly inserted via the subclavian route and advanced to the superior vena cava, but sometimes the jugular vein insertion is used as an alternative.
KIT, REPAIR, CATHETER, HEMODIALYSIS definition: A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices. (1) The implanted blood access device consists of various flexible or rigid tubes, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various shunts and connectors specifically designed to provide access to blood, such as the arteriovenous (A - V) shunt cannula and vessel tip. (2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (Secs. 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
Testers, Hemodialysis Dialysate definition: Testers designed to measure and display the main parameters of the dialysate used to remove metabolic products from the blood during hemodialysis procedures. These testers typically consist of an electronic unit that includes measuring devices for conductivity, temperature, and pH; some testers have an extended range of temperature and conductivity measurements to check heat disinfection temperature and/or acid and bicarbonate solution conductivity. Hemodialysis dialysate testers are used to check the dialysate in hemodialysis machines before patient treatment.
Needles, Hemodialysis definition: Needles designed for withdrawal and reinfusion of blood from the peripheral circulatory system after processing in an external hemodialysis machine. These devices typically consist of thin-walled needles of appropriate diameter (typically 14 to 19 gauge) and length to be introduced in arteries and veins and connected to the blood line of a dialysis machine. Hemodialysis needles are available either with a single lumen for alternating flow procedures or with two coaxial lumens for simultaneous withdrawal/infusion procedures; they may be used for periodical long-term treatments or for one-time emergency procedures.
Needles, Hemodialysis, Arteriovenous Fistula definition: Hemodialysis needles designed for withdrawal and reinfusion of blood from an arteriovenous (AV) fistula during dialysis procedures. These needles typically consist of a thin-walled, small-length (e.g., 25 to 32 mm [1 to 1.25 inch]) stainless steel cannula (typically 14 to 17 gauge) for introduction into the AV fistula and fixed or rotational wings that help with the insertion and add protection to inadvertent pull-out; they usually also include a tube (e.g., 15 to 30 cm length) to be connected to the blood line of a dialysis machine.
CATHETER, HEMODIALYSIS, TRIPLE LUMEN, IMPLANTED definition: Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion.
DETECTOR, LEAK, BLOOD definition: A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer. (1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (Sec. 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (Sec. 876.5830) or dialyzers of high permeability (Sec. 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (Sec. 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (Sec. 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system (Sec. 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
Detectors, Blood Leakage, Hemodialysis Unit definition: Detectors designed to sense blood leaks in the dialyzer of hemodialysis machines. These detectors typically use optical devices that sense the presence of hemoglobin in the spent dialysate, usually indicating a leak in the dialyzer. Detection of leaks in the dialyzer not only prevent from blood losses but also the pass of toxins from the dialysate into the blood. Blood leakage detectors are used mainly in the dialysate path or dialyzer of hemodialysis units; they usually trigger alarms, stop blood pumps, shut arterial and venous clamps, and set ultrafiltration rate to a minimum.
HEMODIALYSIS definition: Administration through hemodialysate fluid. (FDA)
Administration via Hemodialysis definition: Method of administering the drug through hemodialysate fluid.
Diffusion, hemodialysis definition: Diffusion, hemodialysis
Injection, hemodialysis port definition: Injection, hemodialysis port
Workstations, Hemodialysis definition: Workstations designed to acquire, process, and store digital data related to hemodialysis treatments and equipment. These workstations typically store and process patient and treatment data, send treatment parameters to the hemodialysis machines, and provide complete patient prescription, treatment, and related data. Hemodialysis workstations typically include a high-capacity digital computer, printers, input and output devices, and processors; they usually follow the instructions of specialized software intended for management of hemodialysis procedures. They are frequently installed as a component of or interact with hemodialysis machines and/or hospital information systems; some workstations include capabilities for management of peritoneal dialysis procedures.