Nipro and the FDA

You commented. We listened. Many of you were concerned about being switched to the new Nipro needle, so HDU has sent a letter to the FDA enumerating those concerns, and asking for a meeting with them while we are in Washington DC later this month, attending the Kidney Health Initiative. Below is a copy of the letter we sent to the FDA:

Jeffrey Shuren, M.D., J.D.

Director, Center for Devices and Radiological Health

United States Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Dr. Shuren:

Home Dialyzors United (HDU) requests that the Food and Drug Administration (FDA) revoke its approval of the NIPRO® BioHole Needle with CAPICK Scab Remover (NIPRO Needle with CAPICK) premarket notification under Section 510(k) of the Medical Device Amendments of 1976. For the reasons stated below, we believe that this device is not “substantially equivalent” to the predicate devices cited in the approval letter of March 17, 2010, and that the differences pose significant risks to the health and safety of patients receiving dialysis for End-Stage Renal Disease (ESRD), We are requesting full review of the safety of this device.

HDU, a 501(c)(3) nonprofit, is the only dialysis patient organization dedicated to home dialysis. Our membership includes home dialyzors, care partners, nurses, nephrologists, renal professionals and others. Our mission is to educate, support and advocate for home dialysis. We support broader use of home dialysis not just because it offers dialyzors and their care partners more flexibility in choosing when to dialyze, but also because outcomes data show that home dialyzors have fewer infections, spend fewer days in inpatient hospital stays related to dialysis and its complications, have longer survival rates, and have better survival-to-transplant rates.

Specifically, based on complaints HDU has received from both home dialyzors, and health care professionals, we are concerned that the NIPRO Needle with CAPICK poses increased risks of infection, damage to the fistula, and adequate scab removal, and, for many patients, is more painful to use than the predicate devices. In some cases, patients have been able to persuade their physicians to specify that an alternate AVF needle be supplied to the patient; in others, patients are choosing to pay out-of-pocket for alternate devices rather than use the NIPRO Needle with CAPICK that is supplied by the dialysis center.

The NIPRO Needle is an arteriovenous fistula (AVF) device designed for use with the “buttonhole” (or constant-site cannulation) technique for dialysis access. Under this technique, the arterial and venous needles are always inserted into the fistula at the same sites and the same angles. Overtime, scar tissue is formed at each site, creating two tunnels to guide the needle placement. When beginning each treatment, the scabs from the previous treatment are removed from the buttonholes before the AVF needles are inserted.

It is important to note that Medicare payment to the dialysis supplier includes payment for AVF needles which are then used either by technical staff in the dialysis center, or, in the case of home hemodialysis, supplied to the patient or patient’s care partner. Therefore, substantial equivalence must be viewed in terms not only of safety, but also ease of proper use, and the patient’s subjective experience of pain.

Turning to the specific concerns:

Infection Risks – The CAPICK, which resembles the removable cap of a ballpoint pen, is included in the same package as the needle, rather than being packaged separately. This means that as soon as the package for the needle is opened, the CAPICK can be exposed to non-sterile conditions, risking infection in the access site.

Air Embolism Risks – Prior to inserting the needle into the fistula, the needle should be examined for any bubbles in the dialysate. Although a few small bubbles are acceptable, the dialysate should be nearly bubble-free to prevent the formulation of an air embolism that could create a blockage in the blood stream. The NIPRO needles with CAPICK are frosted, rather than clear, making it more difficult to determine if the line has been adequately cleared of bubbles before use.

Damage to fistula –The needle is ¼-inch longer the needle on predicate devices, making it easier for the user to puncture the fistula rather than having the needle stop in the fistula before hitting the fistula wall

Ease of Use – The tube is ½-inch shorter than other buttonhole needles. The scab picker is not shaped to remove the scab easily and completely for access to the fistula, and may, in fact, push pieces of the scab back into the fistula.

We would appreciate the opportunity to discuss our concerns further with you at a mutually convenient time.

Sincerely yours,

 

Tina Harrison,Board President

Home Dialyzors United