May 5, 2015
Nieltje Gedney, Executive Board
Home Dialyzors United
Re: Draft Letter to FDA re Issues With NIPRO Needles
Dear Nieltje Gedney,
This letter is in response to the draft letter to FDA re Issues with NIPRO Needles. You have stated in this letter that the FDA should revoke our substantial equivalence determination due to what you believe are significant risks posed by the NIPRO BioHole Needle with CAPICK. We would like to address each of your concerns individually.
- 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.
- The CAPICK is an accessory to the BioHole Needle – packaged together for ease of use to the patient or clinician, just as the predicate device (Medisystems ButtonHole Needle with Steripick) is packaged. Packaging the CAPICK independently of the BioHole Needle would increase the manufacture cost, in turn increasing patient treatment costs as well as waste due to unnecessary packaging materials. The device would still be exposed to non-sterile conditions as soon as the package is opened, which is common for many medical devices, including the predicate. The device label advises not to use the device if the packaging is damaged (which would compromise the sterility), and the Instructions for Use (IFU) state to remove the CAPICK from the needle cap using aseptic technique. It is also stated in the IFU that a second skin disinfection is recommended, after the scab pick has been used, before cannulation.
- 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.
- The risk of micro air bubbles has many factors including needle entry angle cannulation and depth of the patients tunnel track. An AVF needle with a back-eye can also contribute to the micro air condition. These elements are independent of the tubing materials and coloring. The clarity of the Needle tubing is comparable to the predicate tubing which is also slightly frosted in color.
- Damage to fistula –The needle is ¼-inch longer than 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
- The BioHole Needle has an exposed needle length of 1” or 1 ¼” as indicated on the device label and meets all Kidney Disease Outcomes Quality Initiative (KDOQI) and Fistula- first guidelines. The depth of cannulation is dependent on the cannulator and the patient’s access as written per clinic protocol as well as how the tunnel track was physically developed. This process is defined by national standards, not device manufacturers.
- 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.
- The BioHole Needle tubing is 12″ long, as indicated on the device label. The CAPICK was designed as a dull plastic needle with large finger grips to prevent the skin from being cut during use and with a bevel on each side of its point. It is for skin contact only and not to be used inside the tunnel track.
We believe our device has proven substantial equivalence to the predicate device. The issues that you have outlined in your letter can be significantly reduced with training provided by the Nipro Clinical team through the Nipro Connect Educational Program. More details of this program can be found on our website: http://www.nipro.com/nipro-connect-educational-program/. Please contact us to arrange a mutually convenient time for Nipro products in-service. I have attached a copy of the BioHole Needle with CAPICK step-by-step user guide for your reference.
We will continue to investigate these issues. If you have additional or more detailed information that you would like us to consider please pass this information along for us to review and respond to.
We appreciate you bringing these issues to our attention. At Nipro Medical we take customer complaints very seriously and continue to work hard in developing and manufacturing quality medical devices. We strive for high levels of customer satisfaction. Your input will assist us in achieving this goal.
Director of Quality Assurance and Regulatory Affairs