The MTF Quality Method. a P a

Transcription

1 The MTF Qulity Method P P

2 All llogrft tissue is the sme. Isn t it? Actully, you d be very surprised. There re ntionl stndrds for tissue bnks, set by the AATB nd FDA. But they set only miniml bseline for the industry. Beyond the bsics, most regultions re left to interprettion. As result, tissue qulity, consistency nd performnce cn chnge drsticlly from bnk to bnk. The rel question is, how do you get sfe llogrfts, without scrificing qulity? The simple nswer is MTF. MTF s process in its entirety is centered on bringing you the highest qulity tissue vilble in the industry. Our stndrds, set by medicl bord of trustees from the world s finest helthcre institutions, exceed those set by the AATB nd FDA. Creting nd meeting the industry s highest stndrds is not esy. It s n pproch, nd commitment, tht tkes plce in every step of the process from donor selection to delivery. You won t find more comprehensive, thorough, mediclly founded process thn ours. We invite you to see for yourself

3 The better pproch to qulity. Donor Selection Test Method MTF ccepts less thn 3% of potentil donors. Why? million Americns suffer from osteoporosis, which is responsible for more thn 2 million frctures per yer. 1 MTF is the only tissue bnk to use The VnGurd Method to customize finl tissue pthwy. By employing this stte-of-the-rt test method, MTF is ble to void hrsh processing nd steriliztion techniques. 2. Over lifetime, womn loses pproximtely 35% of her corticl bone nd 50% of her trbeculr bone People being treted for end-stge renl disese with hemodilysis re 17 times more susceptible to frcture Tendon nd ligment lxity occurs in 74% of ptients undergoing hemodilysis During the first yer of steroid tretment, bone loss mounts to The VnGurd Method fr exceeds the industry stndrd nd is defined by the following chrcteristics: Direct tissue testing Qulittive nd quntittive ssessment Close representtion of finl grft form Highly reproducible Highly ccurte 4% to 8%. 5 The decision to ccept or defer donor with these conditions is t the discretion of ech individul tissue bnk.

4 P 100% Aseptic Processing Depending on the results of the VnGurd Method TM, vlidted pthwy is selected to ensure sterility. Aseptic: Donor tissue with results tht comply with septic prmeters is sent down this pthwy. P Aseptic with tretment: Low dose gmm rdition is used on some tissues (bulk form) prior to processing. Not ll biologicl tissues re the sme nd neither re the processing methods they require. Soft Tissue: ACL Reconstruction MTF believes in miniml processing to mintin the biomechnicl integrity nd biochemistry of every grft. Recent clinicl dt Filure Rtes 5.6% 7 5% - 13% 9,10 Grft Source MTF Allogrft Autogrft suggests equivlence between MTF soft tissue llogrfts nd utogrfts for ACL reconstruction 6, nd demonstrtes no difference in outcome between younger nd older ptients. 7,8 Bone Tissue: At certin exposure times, hydrogen peroxide is known to impir the integrity of bone. 11 MTF uses vlidted process tht results in tissue with biologicl ctivity tht exceeds tissue from other bnks. 12 P P Osteoinductivity Score * 0* Pos.Control Neg.Control ATP Allowsh BioClense Vible Cell Tissues: MTF ensures optiml cell retention nd cell vibility by controlling vribles ffecting cell helth such s ge nd storge method. Deminerlized Bone: It is well documented tht certin processing nd steriliztion techniques cn impir the osteoinductivity of DBM. 13,14 MTF s vlidted process preserves the biologicl integrity of the tissue nd terminl rdition is never used. Derml Tissues: Hrsh chemicl processing nd vrious methods of steriliztion hve detrimentl effects on the mteril properties of derml tissues. 15,16 MTF derml tissues re processed using techniques tht yield grfts tht mimic ntive tissue nd meet sterility stndrds. P [peptide relesed per unit mss] [mg/ml/g] Osteoinductivity Score kGy 17.2kGy Enzyme Degrdtion nd Crosslinking DEGRADATION Unprocessed CROSS- HAD * AlloDerm Strttice Strttice Allomx LINKING Firm Plible * MTF Hydrted Acellulr Dermis

5 Qulity Verifiction Service All MTF tissues undergo series of review steps prior to relese. MTF offers brod tissue portfolio nd extensive inventory. Finl sterility results Three levels of tissue specifiction verifiction Finl donor chrt review Processing documenttion verifiction Processing suite environmentl verifiction Pckging/lbeling finl verifiction Services We Provide Locl Representtion Inventory Mngement Progrm Grft Mtching: Reconstructive Osteochondrl Meniscus Tissue for Reserch nd Chritble Outrech In-Services Professionl Eduction Services Frequent internl udits

6 References: 1. www. nof.org; About Osteoporosis, Bone Bsics, Why Bone Helth. 2. Vigorit, VJ. (2008). Metbolic Bone Disese: Prt I, Orthopedic Pthology, Second Edition. pp Phildelphi: Lippincott Willims nd Wilkins. 3. Coco M, Rush H. Incresed incidence of hip frctures in dilysis ptients with low serum prthyroid hormone. Am J Kidney Dis. 36: , Rillo, et l. Tendinous nd ligmentous hyperlxity in ptients receiving longterm hemodilysis. J of Rheumtology. 18:8, , Ln RF, et l. Low dose prednisone induces rpid reversible xil bone loss in ptients with rhuemtoid rthritis: A rndomized, controlled study. Ann Intern Med. 119: , Poehling et l. Anlysis of outcomes of nterior crucite ligment repir with 5-yer follow-up: llogrft vs utogrft. J Artho Rel Res 21(7): , Shh AA, et l. Filure rte of Achilles tendon llogrft in primry nterior crucite ligment reconstruction. J Arthroscopic nd Rel Surg. 26(5), , Brber et l. Anterior crucite ligment reconstruction using ptellr tendon llogrft: n ge-dependent outcome evlution. J Artho Rel Surg 26(4): , Shieb M, et l. A prospective rndomized comprison of ptellr tendon vs. semitendinosus nd grcilis tendon utogrfts for nterior crucite ligment reconstruction. Am J Sports Med. 2: , Slmon LJ, et l. Long term outcome of endoscopic nterior crucite ligment reconstruction with ptellr tendon utogrft: Minimum 13 yer review. Am J Sports Med. 34: , DePul et l. Effects of hydrogen peroxide clening procedures on bone grft osteoinductivity nd mechnicl properties. Cell nd Tissue Bnking. 6: , Dunn et l. Effect of llogrft bone processing on structurl corticl grfts: comprison of three proprietry processing methods. Proc of NASS 23rd Annul Meeting/The Spine Journl 8 138S: 78, Gertzmn et l. (2005) The effect of cold gmm rdition steriliztion on the properties of deminerlized bone mtrix. In Kennedy JF, Philips GO, Willims PA, editors. Steriliztion of tissues using ionizing rditions: CRC Press. pp l. 14. Hn et l. Effects of gmm irrdition on osteoinduction ssocited with deminerlized bone mtrix. JOR 26(1): 75-82, Freytes (2006) Steriliztion of Biologic Scffold Mterils. Encyclopedi of Medicl Devices nd Instrumenttion, Second Edition. pp Hung et l. Use of percetic cid to sterilize humn donor skin for production of cellulr derml mtrices for clinicl use. Wound Repir Regen. 12(3): , Anlysis of extrcellulr mtrix (ECM) chrcteristics vi enzyme degrdtion ssy. Dt on file, MTF. Feb 20, LE My Street n Edison, NJ n n mtf.org 2013 Musculoskeletl Trnsplnt Foundtion 0008-REV2 CI