Important Patient Information
Patient information on Joline Long Term Dialysis Catheters
Your doctor has ordered long-term access to your central blood circulation system for your medical treatment. This is performed with a vascular catheter (referred to as a catheter in the text below). This leaflet contains information about your catheter and the implant card (International Implant Card). This information is intended to supplement the instructions from your doctor or nurse. If you have any questions or concerns about your catheter, always discuss these with your doctor or nurse.
Implant Card
Patient Information
You can download the current version of the patient information here.
General Information About The Catheter
The catheter is essentially a long plastic tube that is impermeable to X-rays. Its tip is located in the right atrium of your heart. Implanting the catheter provides long-term access to your central blood circulatory system. Within a few weeks, the catheter grows into the tissue under the skin via a small plastic felt. The catheter is attached to the skin with sutures until the felt has grown in completely and securely.
During dialysis the ends of the catheter that are located outside the body are connected to the tubes of the dialysis machine. This allows the blood to be pumped out of your body, cleaned in the dialysis machine and pumped back again.
After each dialysis session the catheter is flushed with saline solution. Then it is filled with a special fluid, the “lock solution”, to prevent blood clots clogging the tube. Nevertheless, blood may still run back into the catheter and clot there. Such blocked catheters usually have to be surgically removed and replaced.
Safety clamps and small caps at the ends of the catheter prevent blood loss between the dialyses.
The exit site of the catheter and the parts of the catheter outside the body are covered with protective dressing while the catheter is not being used for dialysis. The main purpose of this protective dressing is to prevent infections by protecting the exit site from contamination and pathogens.
The catheter is intended for long-term implantation of more than 30 days. Permanent implantation is not intended. The indwelling period of the catheter is determined by your treating doctor or the dialysis centre. If necessary, it will be replaced by a shunt (also called a fistula) or a port system according to the treating doctor’s instructions. The catheter can also be surgically removed after a kidney transplant.
More information on the type and quantity of the most important materials that you as a patient may come into contact with can be found in the patient information.
Behaviour in the Event of Complications
Please always follow the doctor’s orders.
You must be aware of the following signs and symptoms that may indicate a possible problem. In the cases below, please contact your dialysis centre or doctor immediately:
Bleeding, swelling, pain, redness of the skin or a local feeling of heat at the surgical site or at the exit site of the catheter
Chest pain or other heart complaints after surgery
If you have a fever (over 38 °C) or chills, inform the treating doctor that you have a catheter
Swelling of the arms or legs
A feeling of cold or numbness in the affected leg if the catheter was inserted from the groin
Blood or other fluids leaking from your dressing
Detachment or soaking of the protective dressing
Warnings and Precautions
All catheters must be carefully cared for to ensure that they remain functional. Therefore, please observe the following warnings and precautions for everyday use of your catheter:
Do not manipulate the catheter. For example, you must not pull on it or hold it under tension. Opening the clamps and unscrewing the closure caps is strictly forbidden to avoid blood loss! Otherwise there is a risk to life!
Never use scissors or other sharp and pointed objects (e.g. needles or razor blades) near the catheter! If the catheter is punctured or cut, there is a risk to life!
The protective dressing may only be removed and renewed by trained specialists! The exit site is carefully cleaned and sterilely re-bandaged by trained specialists at each dialysis.
Showering is recommended instead of bathing or swimming to avoid contamination. Before showering, cover the protective dressing with an additional waterproof dressing. Remove the waterproof dressing after the shower.
Using a sauna is not recommended to avoid contamination. The extremely high temperature and high humidity in the sauna can cause the protective dressing over the catheter to detach.
For dialysis treatment, the catheter must be easily accessible and visible in order to keep the situation under control at all times and to respond quickly if complications arise. Please keep this in mind when selecting your clothing for dialysis treatment. We recommend blouses, shirts or cardigans.
Summary of Safety and Clinical Performance
The summary of safety and clinical performance in accordance with Article 32 of Regulation (EU) 2017/745 can be found via the European Database on Medical Devices (EUDAMED) using the Basic UDI-DI (see below), as soon as it becomes available at https://ec.europa.eu/tools/eudamed. Alternatively, the summary of safety and clinical performance can be requested.
Short Term Dialysis Catheter (ST)
Basic-UDI-DI: 425020391010000YX
Long Term Dialysis Catheter (PU-LT)
Basic-UDI-DI: 425020391022000ZQ