Marburg Bonebank-System

Scope of application

The Marburg Bonebank-System can be used for the thermal disinfection of allogeneic femoral heads from surgical living donors with a head diameter of up to 56 mm.

Characteristics

• Approved by the 'Paul-Ehrlich-Institut', the German federal institute for vaccines and biomedicines
• Simple intraoperative application
• No quarantine storage necessary
• No second testing of donor necessary
• Easy extraction of transplant as 'waste tissue' during primary hip endoprosthesis
• Manufacturing, processing and storage of transplant in hospital-internal (local) bonebanks
• Safe and cost-efficient transplantat
• Worldwide dissemination, approx. 200,000 femoral heads have been thermally inactivated with the system until today

Indications

• Change of prosthesis
• Correction of misalignments
• Multiple fragment - and comminuted fractures
• Loss of substance due to infections
• Pseudarthrosis
• Interbody fusions
• Endoprosthesis surgery
• Spine surgery
• Tumor surgery
• Posttraumatic reconstructive surgery

Effects

• Virus inactivation: HIV 1, HIV 1/0, HIV 2, HTLV, CMV, CPV (model virus for HPV B 19 / Hepatitis B), BVDV (model virus for Hepatitis C)
• Inactivation of Syphilis
• Inactivation of the Zika-Virus
• Inactivation of bacterial infectious agents
• Reduction of the fat content of the tranplant
• Extensive preservation of the biomechanical and the biological valence of the transplant

Lobator sd-2

Microcontroller regulated control unit for heating and cooling of the heating section with documentation of every process cycle.

Lobator sd-3

Computer monitored control unit with touchscreen for the controlled heating and cooling of the heating section with dual documentation of every process cycle. Web-enabled for remote maintenance and storing of all processes on a central server. The storage capacity is aligned with the legal documentation obligation.

The Disinfection-Set consists of an outer packaging and the Disinfection container. The two-piece outer packaging consists of polystyrene and is sealed sterile by means of a thread mechanism with an Evoprene seal. The Disinfection container consists of Macrolon and has a 2-chamber-system. Thereby it fulfills the conditions of clean room class A. The lower part (container) is used for the insertion of the femoral head and the filling with Ringer's Solution until the level reaches the minimum level mark. The top, also referred to as transfer container, is used for the sterile sealing of the lower chamber and after process ending for taking up the disinfection liquid.

• Material: Calibre (Polykarbonat)
• 2-chamber-system
• Fulfilment of the conditions of cleanroom class A
• Components: Outer packaging and Disinfection container

Indication

The Disinfection container is used for the thermodisinfection in the control unit Lobator sd-2 and the subsequent sterile deep-freeze storage of allogeneic femoral heads from surgical living donors.

Contraindication/ side effects

Not applicable

Manufacturers guarantee

The Disinfection-Sets are produced batchwise. Each producted batch will not be offered on the market until a laboratory, accredited by the ZLG, has performed a hygiene control regarding the conditions of production, the bacterial exposure on the Disinfection-Sets before sterilization (bioburden) ranges below the prespecified limit and the certificate of sterility of a certified sterilizer is present.

The Transport- and Storage Container-Set consists of a double rigid packaging and is designed for the contamination-free transport and storage of tissue.

• Sterile delivery
• Storage at up to -80°C
• Material of inner container: high-quality plastic Macrolon
• Material of outer container: Polystyrene
• Sealing of container with safety threads in three differnet colors accoring to the traffic light system