Fresh Frozen Osteochondral Allograft Criteria

JRF Ortho makes every effort to ensure the quality and safety of our grafts. Our cleansing, processing and preservation procedures are designed to produce safe, high quality fresh frozen allografts.

Cleaning and Processing

To minimize potential contamination from the donor, environment, personnel or equipment, all tissue is processed in ISO Class 5 clean rooms. Processing is performed under aseptic conditions within 48 hours of tissue recovery.

Aseptic processing environment and techniques
Highly trained processing technicians
As needed, fresh frozen allografts are size-matched to the individual patient using medical imaging (x-ray, MRI, CT)
Comprehensive inspection criteria to detect allograft imperfections, tissue and quality
Detailed dissection sheets for each individual graft provide the surgeon an allograft photo as well as all recorded measurements.

Microbiological Testing

Laboratories that perform testing on behalf of JRF Ortho are CLIA-certified. Testing includes microbiological evaluations during processing and final packaging, as well as environmental and water quality monitoring.

Donated bone and tissue are cultured both at the time of recovery and during processing. Swab cultures are obtained from each graft prior to exposure of the tissue to antibiotics and disinfectants. Cultures are incubated in two types of media at two temperatures for a minimum of 7 days. Further destructive and fluid extraction cultures are taken and incubated for up to 14 days. If any of the cultures demonstrate microbial growth, the tissue is not released for transplant. Any aerobic or anaerobic bacteria detected are identified to the Genus level.

Environmental Monitoring

Environmental monitoring utilizes a combination of RODAC touch plates, viable air particle counts, non-viable air particle counts and settle plates.

Preservation and Storage

Fresh Frozen grafts may be maintained and stored for up to 5 years at or below -40°C

JRF Ortho Allograft Service Coordinators

Our Allograft Services Coordinators (ASC) are highly trained to size match, assess and verify the sizing suitability of the allografts provided for each individual patient. They also coordinate with technicians, physicians and customer service personnel to ensure the proper allograft is delivered for each surgical case. Our ASC’s are available to provide superior customer care 24/7 to handle all technical support needs and emergencies.

Updated on: 16/03/2021