Products and Services Catalogue

Transcription

1 Products and Services Catalogue Solid and Flexible Bio-Processed Allograft Implants Advancing Tissue Innovations Since 1972

2 A History of Providing Highest Quality and Innovation Mount Sinai Allograft Technologies, a department of Mount Sinai Hospital formerly known as The Rubinoff Bone Bank, has been a leader in advanced tissue innovations since We are committed to providing the highest quality bone and tissue allograft products as well as continued innovation in the development of allograft implants for transplantation. We are dedicated to meeting all surgical needs and to exceeding all client expectations. We work closely with the Trillium Gift of Life Network to promote their mission of increasing donor awareness and to ensure that the wishes of Ontario donor families are carried out with the utmost care and respect. Our allograft implants are 100% Ontario produced, human allograft tissues. Industry Leading Processing Techniques To produce the safest and highest quality Canadian produced allograft implants, Mount Sinai Allograft Technologies leverages the expertise of a variety of medical experts, state-of-the art laboratory testing, proven bio-processing techniques, tested irradiation methods and preferred packaging systems. Our dedicated, highly experienced and trained staff are always ready to support your needs. Large tissue sample of clean bone Ground bone sample Products and Services Catalogue

3 Product Excellence Overview Governance & Standards Quality Systems Donor Testing DDHeath Canada Registered DDCanadian Standards Association Certified DDAmerican Association of Tissue Banks Accredited DDOntario Laboratory Accredited DDCollege of American Pathologist Accredited DDClinical Laboratory Improvement Amendments Accredited DDFDA Good Manufacturing Practices DDFDA Good Tissue Practices DDISO 9001 Adopted Practices Nucleic Acid Tests DDWest Nile virus Nucleic Acid Test (WNV RNA) DDHepatitis B Nucleic Acid Test (HBV DNA) DDHepatitis C Nucleic Acid Test (HCV RNA) DDHIV Nucleic Acid Test (HIV RNA) Serology Tests DDHepatitis B surface antigen (HBsAg) DDHepatitis B core Antibody (HBcAb) DDHepatitis C Antibody (HCV Ab) DDHTLV 1&2 Ab (HTLV Ab) DDHIV 1& 2 Ab (HIV Ab) DDSyphilis (RPR) DDCMV IgG Ab Donor Recovery & Processing Sterilization Techniques Packaging Materials Lyophilized Tissues Distribution Customer Service DDAseptic Zone & Sequential Recovery Techniques DDAseptic Processing Techniques DDClass B, C Processing Environment DDValidated Methods to Eliminate Cross-contamination DDGamma-Irradiation DDCertified 25kGy Dose to Effectively Eliminate Bacteria DDMoisture Barrier DDProduct Visibility DDMedical Device Approved to Prevent Cytotoxicity DDFreeze-dried to a Moisture Level of Less Than 6% DDRoom Temperature Storage DDProduct Specification and Measurements DDRecipient Tracking Fax-back Form DDSecure and On-time Delivery DDConsignment Services available DD24/7/365 Ordering and Inquiries DDEmergency Requests & Delivery DDProduct returns accepted Products and Services Catalogue

4 Product Type Overview Types Storage Large Traditional Implants Frozen Cortical Strut Impants Frozen Fresh Osteochondral Implants Refrigerated Cancellous Ground Bone Frozen and Freeze-dried Cortico-Cancellous Ground Bone Frozen and Freeze-dried Tendons and Soft Tissues Frozen Spinal Implants Frozen and Freeze-dried DDFreeze-dried tissue may be stored at ambient (room) temperature for up to five (5) years. DDFrozen musculoskeletal tissue may be stored at -40 degrees C or colder for five (5) years or -20 degrees C for temporary storage of up to six months. Packaging Mount Sinai Allograft Technologies supplies packaging systems of superior quality to surgeons and operating room staff. Our packaging system ensures that each packaged tissue maintains integrity and sterility. Each tissue is packaged and heat sealed in a class-c or higher clean room environment. The materials we use are certified to be non-toxic and made up of pure High Density Polyethylene polymer which is one of the more biocompatible and hypoallergenic materials available. In addition, each package is easy to open using a flexible peel-back closure. Standard packaging. Box containing Bone and tissue. Products and Services Catalogue

5 Ordering Allograft Implants and Services Healthcare facilities and surgeons are approved to order allograft tissues from Mount Sinai Allograft Technologies. Only licensed surgeons and clinical professionals are permitted to transplant allograft implants. Phone Orders: Fax Orders: On-line orders: Special Orders Allograft tissues can be ordered 24 hours a day, 7 days a week and 365 days a year. Emergency orders can be fulfilled on short notice. In many cases, orders can be shipped for same day or next day delivery. Please call us for more information on rush orders. Consignment Services We are pleased to offer a bulk supply of allograft products on a consignment services basis to our higher volume, pre-approved users. This unique service will permit users to always have an adequate supply of high quality tissues on hand, preventing stock-outs, and allow ordering of customized grafts. Additional benefits of our consignment services include more effective surgery scheduling and operating room efficiency gains. Please contact us for additional details regarding consignment services. Return Policy We are pleased to accept returns of unused items subject to our return policy. Please see our return policy for more details on the last page of this catalogue. Payment Account statements are sent on a monthly basis and are due within 30 days from the issue date, unless stated otherwise. Payments can be made via corporate cheque. Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex 600 University Avenue, 6th floor, Room 209 Toronto, Ontario, Canada, M5G 1X5 General Inquiries t f allograft@mtsinai.on.ca Visit us at Products and Services Catalogue

6 Allograft Implants for Orthopaedic Applications Products Centre Large Traditional (LT) Grafts Items Canal Diameter Length (Min.) Catalogue Number Femur Whole Femur Half Proximal with Head Varies 200mm LT2 Femur Half Proximal minus Head Varies 200mm LT3 Femur Half Distal with Head Varies 200mm LT4 Tibia Whole Tibia Half Proximal 200mm LT6 Tibia Half Distal 200mm LT7 Humerus Whole Humerus Half Proximal with Head 150mm LT9 Fibula Whole LT10 Radius Whole Ulna Whole Acetabulum Full Iliac Crest Full Hemi-Pelvis Full LT1 LT5 LT8 LT11 LT12 LT13 LT14 LT15 Cortical Strut (CS) Grafts Items Diameter (Min) Width (Min.) Length (Min.) Catalogue Number Fibula/Ulna/Radius Shaft mm CS1 Femur Shaft 25mm 150mm CS2 Femur Plate 20mm 150mm CS3 Femur Head 40mm CS4 Tibia Shaft 150mm CS5 Tibia Plate 20mm 150mm CS6 Humeral Shaft /Distal 15mm 100mm CS7 Humeral Head 40mm CS8 Products and Services Catalogue

7 Fresh Osteochondral (FO) Grafts Items Canal Diameter Catalogue Number (Refrigerated) Femur Medial Condyle Varies FO1 Femur Lateral Condyle Varies FO2 Tibia Medial Plateau Varies FO3 Tibia Lateral Plateau Varies FO4 Knee Whole Varies FO5 Talus Varies FO6 Os Calcaneus Varies FO7 Ankle Whole Varies FO8 Shoulder Whole Varies FO9 Elbow Whole Varies FO10 Grafts For Spinal (SG) Applications Items Height X Width X Length Catalogue Number Patella Wedge 15x13x33mm SGF1 SGL1 Ilium Strip Tri-Cortical 15-25x10x65mm SGF2 SGL2 Ilium Block Tri-Cortical 15-25x20x65mm SGF3 SGL3 Iliac Crest Wedge Small 9-14x9x18-25mm SGF4 SGL4 Fibula/Radius/Ulna Cortical Segment Large 15-25x10x25-30mm Small 40-65mm Large 66-99mm Femoral Ring 5-25mm Height SGF6 SGL6 SGF5 Catalogue Number (Lyophilized) SGL5 CANCELLOUS BONE (CB) GRAFTS Items Volume Catalogue Number Catalogue Number (Lyophilized) Cancellous Ground Bone 1-4mm Cancellous Ground Bone 4-10mm 5cc CBF1 CBL1 15cc CBF2 CBL2 20cc CBF3 CBL3 30cc CBF4 CBL4 40cc CBF5 CBL5 60cc CBF6 CBL6 90cc CBF7 CBL7 15cc CBF8 CBL8 20cc CBF9 CBL9 30cc CBF10 CBL10 40cc CBF11 CBL11 60cc CBF12 CBL12 90cc CBF13 CBL13 Products and Services Catalogue

8 Cortico-Cancellous (CC) Bone Grafts Items Volume Catalogue Number Cortico-Cancellous Ground Bone 1-4mm Cortico-Cancellous Ground Bone 4-10mm 15cc CCF1 CCL1 20cc CCF2 CCL2 30cc CCF3 CCL3 40cc CCF4 CCL4 60cc CCF5 CCL5 90cc CCF6 CCL6 15cc CCF7 CCL7 20cc CCF8 CCL8 30cc CCF9 CCL9 40cc CCF10 CCL10 60cc CCF11 CCL11 90cc CCF12 CCL12 Catalogue Number (Lyophilized) Flexible Grafts (FG) For Sports Medicine Applications Items Minimum Length Of Tendon Catalogue Number Achilles Tendon with Bone Block 160mm FG1 Patellar Tendon Whole with Bone Block 30mm (Width)X25mm(Length) FG2 Patellar Tendon Preshaped with Bone Block 15mm (Width)X25mm(Length) FG3 Patellar Tendon w/quad. Tendon 15mm (Width)X25mm(Length) FG4 with Bone Block & 100mm (Quad. Length) Anterior Tibialis Tendon with Bone Block 230mm FG5 Posterior Tibialis Tendon with Bone Block 230mm FG6 Gracilis Tendon 230mm FG7 Semi-Tendinosus Tendon 230mm FG8 Peroneus Longus Tendon with Bone Block 230mm FG9 Bundled Tendons (Gracilis & Semi-T.) 230mm each FG10 Meniscus Whole with Bone Block Varies FG11 Meniscus Medial with Bone Block Varies FG12 Meniscus Lateral with Bone Block Varies FG13 Fascia Lata 60mmx140mm FG Products and Services Catalogue

9 ORDER FORM Advancing Tissue Innovations Since University Ave., 6th floor, Room 209 Toronto, ON. M5G 1X5 Tel: (416) Fax: (416) Website: Name of Person Ordering Job/Title Telephone Number Fax Number Purchase Order Number# (if applicable) Surgeons Name or N/A if Stock Qty Catalogue # Product Description Additional Specifications Date of Surgery (MM/DD/YY) MSH USE ONLY Name of Person Confirming Allo-number(s) Date confirmed (MM/DD/YY) Total Product Cost Estimated Shipping Cost Expected Ship Date Page 1 of 2 Fax form to: (416)

10 Shipping & Billing Information Ship To: Bill To: (if different then ship to address) Facility Name Facility Name Street Name Street Name City Postal Code City Postal Code Location to Receive Tissue (i.e., Blood Bank 2 nd floor) Department Name Date and Time needed by (i.e., DD/MM/YY and 01:00am or pm) Contact Person Submitting, Confirmation & General Information Complete and fax all pages (2) to (416) Your order will be processed in 1 business day For emergency or same day orders please call (416) Confirmation of order will be faxed back to the number provided Upon implant of allograft(s) a completed recipient implant recorded shall be faxed back to (416) Account statements are sent on a monthly basis and are due within 30 days from date, unless stated otherwise. Payments can be made via corporate cheque. Make all cheques payable to: Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex 600 University Avenue, 6th floor, Room 209 Toronto, Ontario, Canada, M5G 1X5 Return Policy Lyophilized Tissues A return authorization number must be obtained from MSH within 4 business days of receipt of tissue. Upon receiving the authorization number the tissue must be shipped back to MSH in its original packaging and received by MSH within five (5) business days of the date and time indicated on the MSH shipping box, indicating the original shipment date and time from MSH. The original packaging must not be opened or compromised. In addition, the return authorization number must be documented on the top portion of the outside of the shipping container. Frozen Tissues A return authorization number must be obtained from MSH within 24hrs of receipt of tissue. Upon receiving the authorization number the tissue must be shipped back to MSH in its original shipping container and received by MSH within 48 hours of the date and time indicated on the MSH shipping container, indicating the original shipment date and time from MSH. The original shipping container must not be opened and the tamperproof seal must be intact. In addition, the return authorization number must be documented on the top portion of the outside of the shipping container Should a staff or surgeon question the quality or clinical effectiveness of a tissue, but the time frame has exceeded the limits listed above, authorization to return tissue to MSH will be considered on a case by case basis. A credit for the tissue will be granted only after the tissue has been properly returned to and inspected by MSH personnel. Thank you for your business! Page 2 of 2 Fax form to: (416)