§876.5540. Blood access device and accessories. — Inbound Citations

(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 (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.

(a) A pediatric continuous renal replacement therapy hemodialysis system is a device intended for use as an artificial kidney system for the management of pediatric patients with acute kidney injury and/or fluid overload by performing such therapies as hemodialysis, hemofiltration, hemodiafiltration, and isolated ultrafiltration. Using a hemodialyzer with a semipermeable membrane, the hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via ultrafiltration) and/or diffusion (via a concentration gradient in dialysate). The hemodialysis delivery machine, with an automated ultrafiltration controller, controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. During treatment, a patient's blood is circulated through the blood tubing set connected to the hemodialyzer's blood compartment. Blood access devices and accessories for hemodialysis required for the prescribed treatment are regulated under § 876.5540.

(a) A hemodialyzer with expanded solute removal profile is a device intended for use a part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (§ 876.5860), including solutes at the upper end of the “middle” molecular weight range (0.5 kDa to 60 kDa). This device is intended to be used with the extracorporeal hemodialysis delivery systems, blood tubing sets, blood access devices, and accessories regulated under §§ 876.5820, 876.5860, 876.5540, and/or 876.5600.

(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:

(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.

(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.

(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.

(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:

(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.

(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.

(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.

(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:

(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.

(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.

(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.

(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:

(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.

(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.

(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.

(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:

(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.

(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.

(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.