Fresh 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 osteochondral allografts that have the highest percentage of viable chondrocytes possible.

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 allografts are size-matched to the individual patient using medical imaging (x-ray, MRI, CT) Non-standard allografts are produced specifically for individual patients
Comprehensive inspection criteria to detect allograft imperfections, tissue and cartilage quality Detailed dissection sheets for each individual graft provide the surgeon an illustration of any denoted imperfections as well as all recorded measurements Preservation methodology developed to optimize chondrocyte viability Preservation solution includes a nutrient medium and an antibiotic Packaging is clearly labeled with expiration dates and storage instructions

Microbiological Testing

Laboratories that perform testing on behalf of the 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 either at the time of recovery or during processing. Swab cultures are obtained from each tissue prior to exposure of the tissue to antibiotics, disinfectants or cleansing agents. Cultures are incubated in two types of media at two temperatures for a minimum of 7 days. Further destructive and fluid extraction cultures may be taken and incubated for up to 14 days. If any of the cultures demonstrate microbial growth, the tissue is sterilized or 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

JRF Ortho utilizes a proprietary preservation media developed to optimize chondrocyte viability
Preservation solution includes a nutrient medium and an antibiotic solution
Fresh grafts may be maintained and stored in preservation solution for up to 28 days at 1-10°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