FAQ
The post-operative evacuation or removal of air, fluid and devitalised tissues from the operating site after surgery.
to drain the exudate or wound fluid to promote the wound flaps to join together to prevent infections
Promotion of a faster wound healing Reduction of haematoma Reduction of possible infections Reduction of scar tissue formation
Haematoma formation - haematomas produce elevation and discoloration of the wound edges, discomfort, and swelling.
Patellar dislocation following haematoma - A large hematoma can cause a disruption of the medial retinaculum. This may cause patellar dislocation after primary total knee replacement.
Neck haematoma - Neck hematomas following operations on the thyroid, parathyroid, or carotid artery are particularly dangerous, because they may expand rapidly and compromise the airway.
Wound infection with small haematoma - Small hematomas may resorb, but they increase the incidence of wound infection.
Fullness, pain, bruising and psychological fear of bleeding - Feeling of fullness and pain in the area which is affected. The skin may turn into deep purple blue colour and may have an effect on patients and their psychological fear of bleeding.
Leaking - accumulated blood increase pressure and blood sometimes leaks through skin sutures.
Compression and lack of oxygen- Proper oxygen or if the tissues in the affected area get compressed.
Necrosis - Necrosis which occurs due to the death of the blood cells, wound separation and infection can also be observed.
Seroma formation - Seromas often follow operations that involve elevation of skin flaps and transection of numerous lymphatic channels (eg, mastectomy, operations in the groin).
Abscess: risk of infection - Seroma formation may develop into an abscess and begin the symptoms of an infection and requires medical treatment for that.
Abscess: uncomfortable and cause of sickness - An abscess is unlikely to disappear on its own, it may grow in size and become very uncomfortable, and the associated infection may cause high level of sickness.
Detect a bleeder early - When a drain is used, a large bleeder can be detected (if this occurs) early in the recovery room and measures can be taken immediately.
Wound healing - Remove accumulative wound fluid, reduce internal pressure, draw wound clefts together, reduce scar tissue.
following surgeries
General surgery 50 – 400 ml
Orthopedics - total knee replacement 600 – 800 ml
Orthopedics - total hip replacement 300 – 600 ml
Orthopedics - Spinal surgery 200 – 300 ml
Abdominal - Hepatectomy 200 – 400 ml
Abdominal - Pancreatectomy 200 – 400 ml
Abdominal - Abdominoperineal resect. 200 – 400 ml
Breast surgery - Mastectomy 80 – 600 ml
Breast surgery - Axillary lymphadenectomy 80 – 600 ml
Plastic surgery - Breast reduction 150 – 250 ml
Plastic surgery - Face lift (rhytidectomy) 50 – 150 ml
Plastic surgery - Hand 50 – 150 ml
Gynaecology - Ceasarean section 60 – 400 ml
ORL surgery – Parotidectomy 40 – 300 ml
ORL surgery - Laryngectomy 40 – 300 ml
Urology 100 – 450 ml
to prevent that the patient - by accident - pulls the drain out of the wound to ensure that the drain remains “put” into the patient
We offer you the choice of premium vacuum wound systems with constant suction to accommodate optimal possible wound drainage either with high vacuum or low vacuum devices.
LVS – Low Vacuum Wound Drainage System 600 ml
LVS NG – Low Vacuum Wound Drainage System NG 600 ml, 400 ml and 200 ml
HVS - High Vacuum Wound Drainage System 600 ml, 400 ml and 200 ml
All systems can be used for general surgeries where postoperative surgical wound drainage using vacuum suction is indicated. The portfolio is quite broad; however, we suggest limiting the portfolio size and use the following systems per application.
LVS 600 ml
For orthopedic surgeries. The LVS 600 ml system is very ideal for orthopaedic surgeries where average 400 – 600 ml of wound drainage is collected, such as total knee replacement (TKR), total hip replacement.
Dislocation of the patella following haematoma has been reported after TKR. A large hematoma can cause a disruption of the medial retinaculum. This may cause patellar dislocation after primary total knee replacement.
LVS NG 400 and 200 ml
For breast surgeries, incl mastectomy, axillary lymph and general surgeries
The LVS NG is indicated for general surgeries and ideal for breast surgery incl, mastectomy, axillary lymph, and general surgeries. Generally these surgeries require drainage of 80 – 600 ml. The LVS NG most popular sizes come with a 200- or 400-ml bottle.
Low vacuum is created by means of a low vacuum valve situated in the connecting tube.
HVS 600 or 200 ml
For total hip replacement and mastectomy. It can be ideal for total hip replacement where drains are placed deep inside the surgical wound and proper wound approximation is essential. For mastectomy it can be ideal to remove seroma fast and provide maximal drainage
The constant vacuum in combination with a high suction force provides active adhesion formation between healing surfaces, removes large volumes of fluid quickly and improves proper flap apposition.
The 200 ml replacement bottle can also be used in combination with LVS. In case an LVS 600 ml is full and only little drainage is expected, it would be worthwhile to collect to lower volume HVS 200 ml bottle.
Constant vacuum suction is where wound fluid is continuously collected in a pre-evacuated or pre-vacuumed bottle. The Medinorm® LVS, LVS NG and HVS systems are pre-evacuated or pre-vacuumed.
All the Medinorm production bottles are created with vacuum using a specialised vacuum machine. The level of vacuum is controlled.
Continuously drain wound fluid until the bottle is full To continue to draw wound clefts together Tissue layers remain closed during drainage process There is no interference, so minimise disturbance of the wound Promote optimal wound healing Self-contained, the product does the work for you “One” handling to activate system
Due to physical limitation, bellows type devices have a limited negative pressure. It is too low to promote a faster wound healing. As a result, Bellows type devices require emptying and re-activating on numerous occasions during the wound healing process (i.e. every 8 hours, or just before a change in hospital shift).
Yes, you may find it here.
https://pubmed.ncbi.nlm.nih.gov/3354278/
https://pubmed.ncbi.nlm.nih.gov/2179912/
https://pubmed.ncbi.nlm.nih.gov/7502086/
Scientific reviews on our download centre, click here.
When the negative pressure indicator is on minimum or when there is no vacuum present anymore inside the system.
By measuring and calculating using the calibrations on the bottle
No, because of safety and avoid cross-contamination, you don’t open nor empty the Medinorm system
The bottle is already prevacuumed, in other words one just has to switch the lever from off to on, or open the sliding clamp, after connecting the wound tube
A constant at 150 mmHg
A constant at 100 mmHg
A constant at 600 mmHg
Yes, if the patient is sent home but drainage has to continue.
Yes, it is a closed system.
A CH/FG 10 or 1/8” round wound drain with plenty but small perforations
Medifix is the brand name for the connection between drain and needle. It is part of the end part of a drain and merely is a screw connection. The needle has a screw fitting. So to remove the needle, one simply unscrew the needle from the drain.
Commonly a Medifix connection can be found on a middle-perforated drain. This drain is extra long with a perforation in the middle part. Cut drain equally in 2 pieces to create 2 drains. After placing one drain, the needle can be unscrewed and placed to the other drain. Thus, to insert 2 drains in the wound site.
Yes, the Medifix connection is closed. So the procedure is to cut the drain in 45 degree angle for easier insertion into Y-drain connector, according to the IFU.
facilitate the disconnection and connection of the drain and the needle ensure that drain and needle will be of a same size guarantee a smooth connection between needle and drain
Prevents backflow to the patient of wound fluid
A small drain system with drain CH/FG 6 or CH/FG 8 with atraumatic trocar. It is used particularly for smaller surgeries. Ideal for small cases such as hand surgery, and for cases where low suction force is required.
Having your own blood is more beneficial than having someone else’s blood. Having your own blood back minimises the risk of side effects and post-operative infection. The use of antibiotics and the number of days you spend in hospital may also be reduced. Having your own blood back will reduce your need for blood from the Blood Bank. Of course, this will also help to relieve the pressure on the Blood Transfusion Service!
Simply put, this is when the blood you lost immediately after your operation (post-operative) is collected, filtered and given back to you.
This is particularly useful in knee, hip & spinal surgery, since most blood is lost in the hours immediately after surgery.
With joint replacement or spinal surgery it is common for blood to collect at the site of the surgery and slow the healing process. This blood is removed by a surgical drain and later discarded. Blood may also be lost during the operation.
There are several factors why wound drainage is important:
to eliminate the rate of haematoma
to decrease the wound infection rate
to promote faster wound healing
to reduce scar tissue formation
Constant suction is important, because it promotes faster wound healing by continuously pulling the wound flaps together.
Your own blood will be given back to you sooner than a normal blood transfusion could, putting you on the road to recovery quicker. Your own blood contains blood cells not present in someone else’s blood. These may help to boost your immune system and help to protect you against infection.
Yes, it is important that the surgeon uses a sufficient part of the perforated area inside the wound site. The DONOR™ system uses a continuous suction, so blood will have limited chance to clot, since blood is drained on a continuous bases. The drain has different and plenty perforations (tiny holes) in order to reduce clotting of the drain. A smaller diameter drain is also more comfortable for the patient, especially when the drain is removed after wound drainage has finished. Even though, we recommend 10 CH/FG drains, we have bigger drain diameters available, which are sold separately. The Y connector of the DONOR™ system can be connected with 10, 14 and 16 CH/FG drains.
There are several advantageous to use 10 CH/FG drains:
less dead space in wound area after removing drains
less obstruction of wound tissue
less painful for patient while removing drains
easier to remove drain from patient
The drain is made of Polyurethane (PUR). A PUR drain exceeds polyvinyl chloride (PVC) in material characteristics. PUR drains lead to smoother insertion and removal of drains in the wound sites. The material is safer to use with patients. The risk of breakage, collapsing or blockage is minimized and finally, it is more environmental friendly.
The drains are guaranteed DEHP free.
Softer, more elastic and more gentle than PVC.
No softening agent is used with PUR.
The drain will not harden in the body as compared to PVC.
PUR has anti thrombogenous characteristics resulting in less tissue in growth in the drain holes.
Less clogging and blockage of the drain.
To ensure that the holes of the wound tube are situated far enough into the wound area (to prevent leakage). It is recommended that the wound drain should not be pulled out of the wound further than the black marker.
The system is operated by gravity and through the self-levelling drip chamber. The DONOR™ system will stop automatically and blood will be left in the giving set. There is no risk of air going into the patient once the flow of blood has finished, however, it is recommended to monitor the patient when reinfusion is almost finished. It is not necessary to reinfuse the last part of blood, which is still in the giving set. Just before the reinfusion process ends, disconnect the complete system according to your hospital policy (e.g. blood transfusion policy/ protocol).
The canister has a capacity of 800 ml. In practice, a canister will fill up to approximately 700 ml, since air/dead space from the patient’s wound site and connecting tubes will be in the system as well. The advice is that you need to collect at least 150 ml of blood to make it worthwhile to start re-infusion, however you should follow the guidance of your protocol.
For users and quality reasons blood reinfusion may fail. Read the instructions for use and see if every step has been followed correctly. Complete an incident form and report any errors to your company representative. Separate trocars, wound drains and giving sets can be purchased separately for use in case these items are the failure point. A second DONOR™ or DONOR replacement bottle can be used if necessary. Follow your protocol for advice on what to do.
The guidelines are there to protect the patient and you, the users. Always follow your protocol guidelines and please also check the aaBB guidelines. Blood that has been collected after 6 hours needs to be discarded.
A maximum of 2 DONOR units (e.g. 1400 ml) should be the maximum. If the patient bleeds more than 2 DONOR units in the first 6 hours, please consult the specialist surgeon.
No, the system can only be used once. The LipiGuard filter has been validated up to 1 unit of blood. With every DONOR™ system there is always 1 filter available, which is included in the bottom tray. So 1 unit of collection equals 1 unit of filtration. It is not recommended to compromise the effectiveness of the filter by using the same filter with multiple units of blood.
In case it is necessary to reinfuse more blood, it is important to take a second system, which comes with a new filter. This allows for maximum safety when filtering the blood .
Using DONOR™ only 1 time will also avoid to mix old blood with new blood. So, you collect only on time, filter and reinfuse the blood and then dispose the system. Mixing old blood with new blood may reactivate leukocytes and release multiple cytokines and C3a. This reduces the quality of blood. In addition, fat will stay on the bottom of the system. If you start to recollect, you are also going to mix again old fat with the re-collected blood.
No, the DONOR™ does not need a battery. The system is pre-evacuated during the production process. This means that the systems already comes with a vacuum. Battery operated systems can make a noise and every time when a battery is disposed, it will have a bad influence on the environment.
Blood reinfusion needs to start within 6 hours after activation. A DONOR™ replacement system is available to continue the wound drainage for the remaining 18 hours (normally wound drainage is used for 24 hours).
The DONOR™ replacement system cannot reinfuse, so it is just for wound drainage only. This helps the nurse to know that the reinfusion is not necessary anymore. It is better to have 2 different systems, each serving their own purpose:
1. The DONOR™ reinfusion system is to collect and reinfuse patient’s own blood within the first 6 hours.
2. The DONOR™ replacement system is to only collect the wound drainage after 6 hours.
Follow the advice of your hospital protocol on volume of reinfused fluids, however it may need to be discussed for each hospital in line with their policy. Other users have changed their practice and fitted patients with a 3 way venflon port when autologous blood transfusion is expected. Caution, never flush the DONOR™ system or the filter and giving set with saline.
Autologous blood is still blood and should be treated with the same precautions as homologous blood. Follow your trust policy and discard in accordance with it.
There is DONOR training manual available and includes the official instructions for use, the instructions for use with visual pictures, protocol and trouble shoot.
Separate instructions with pictures
A instruction video showing a step by step instruction
Pocket books with instruction
Scientific literature is available
Please contact us for more information, click here
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Before removing the drain from the patient’s side, ensure that the pressure difference inside and outside the patient will be eliminated by letting the wound relax for 10 to 20 minutes. Always consult the procedure with a specialist or surgeon.
If the product and sterility is compromised, do not use the product and contact your local supplier. Please quarantine the product and give to your supplier in case further inspection may be needed.
In case of vacuum loss, the product will not function anymore, and you need to use another product. Quarantine the product, leave it in its original packaging, and give to your supplier in case further inspection may be needed.
With all vacuum systems quality can be assured most of the time, however very occasionally some systems lose their vacuum before use.
Another possibility is storage and logistics. Please ensure room temperature conditions for both storage and transport.
Check before opening the packaging and ensure if the white bellow on top of the system is in the max. position
In situations where bellow is at the min. position, please put the product to one side, complete an incident form and record product code and batch number of the affected product and an explanation. Contact your representative who will arrange for collection and a replacement or credit to be sent out to the hospital. In this case take another system, check again, open package and follow the normal procedure.
Please note that vacuum may get lost when stored or logistically has been transported under high temperature conditions. It may also have been that the product has been put into direct sunlight, which also may cause vacuum loss.
Store products at a temperature between 5°C (41°F) and 35°C (95°F).
Peak temperatures above 35°C (95°F) should never be exceeded.
Protect product from direct sunlight.
Please check if the perforated section of the wound drain is outside the patient’s skin therefore pulling in air.
Please check it the Luer-Lock connection has been cross thread or not tightened.
In case of DONOR, in either situation, non-sterile air has entered the system. Since unsterile air has entered the system, it cannot be used for reinfusion and needs to be discarded.
If the perforated area of the drain is outside the wound skin, call the attention of the surgeon for assistance to remove the drain as you cannot attach a new vacuum system, since it will not hold and drawing new air into the system from outside the wound site.
Attention should be made that the patient has been in contact with unsterile conditions. Therefore, it is better to continue wound drainage with a normal wound drainage system.
We need the following information:
Product in its original packaging, unused
Article number
Batch number
Make a notification what exactly happened.
No, because of danger of cross-contamination we cannot accept used products. Please make pictures and try to locate the default, write down batch number, article number and a clear notification of the complaint.
Click here for table different sizes. (uit catalogus, pagina uploaden met CH/ mm tabel)
Yes, we have a download centre and includes all items handled in the FAQ.
Please contact us via our contact form.