RegenKit^® Extracell BMC

Warnings and precautions

This kit is intended only for bone reconstruction, orthopedic and traumatological surgeries.

A strict aseptic technique must be followed during bone marrow aspirate. Use proper safety precautions to avoid contact with patient blood or cross-contamination. Use proper safety precautions to guard against needles or broken tubes. Do not use sterile component of this kit if package is opened or damaged. Do not use components of this kit if they are broken or present a defect. Do not use the tube if it lost vacuum. Do not use the sodium citrate solution or other tube components alone. Store between 5ºC and 30ºC; bring kit to ambient temperature before using the tubes. Do not re-sterilise, do not use after the expiry date. Single use device, do not reuse any part of the kit. Reuse may lead to infection or other illness / injury. Transfer needle must be used to transfer liquids only and should not be used for injection. The preparation of the bone marrow concentrate must be performed by a physician trained on the equipment and procedure, or under the supervision of the physician. The treatment with bone marrow concentrate must be performed by a qualified physician. Do not inject bone marrow cell concentrate intravascularly. The patient must be informed of the general risks associated with the treatment and of the possible adverse effects. The safety and effectiveness of combination of bone marrow cell concentrate with other therapies should be assessed by the physician. The safety and effectiveness have not been evaluated in children and in pregnant or lactating women.

The bone marrow cell concentrate must be prepared from fresh blood and must be used within four hours (extemporaneous use only). All tubes and components of the kit are to be entirely discarded by elimination method after each use to avoid potential contamination with blood products. Use a 45° fixed angle rotor centrifuge or a horizontal head swinging bucket centrifuge (ex. RegenPRP Centri provided by Regen Lab). Follow the manufacturer’s instructions when using the centrifuge. Tubes should be centrifuged, as recommended in the instructions for use, at a relative centrifugation force (RCF) of 1500 g. Excessive RCF (over 2200 g) may lead to tube breakage resulting in blood exposure, and possible injury. RCF below 1500 g may lead to incorrect blood separation and red blood cell contamination of bone marrow cell concentrate. Centrifuge carriers and inserts size should be adapted to the tubes. Use of carriers too large or too small may result in breakage of the tubes. Caution should be taken to ensure that tubes are properly seated in the centrifuge carriers. Tubes must be balanced in the centrifuge.

Possible adverse effects

Haemorrhage, hematoma, delayed wound healing. Early or late operative infection. Persistent pain, seromas. Allergic reaction to anaesthesia.