Microsoft word - pi-49 rev 0

READ BEFORE USING
CAUTION: ALLOGRAFT IS FOR SINGLE USE ONLY.
ASEPTICALLY PROCESSED. PASSES USP <71> FOR STERILITY.
CAUTION: SPECIAL HANDLING INSTRUCTIONS
THIS ALLOGRAFT HAS BEEN CRYOPRESERVED AND SHIPPED IN THE VAPOR PHASE
OF LIQUID NITROGEN (-100C TO -196C). DO NOT STORE THE PACKAGE CONTAINING
THE VASCULAR ALLOGRAFT IN LIQUID NITROGEN; THE PACKAGE MUST BE
MAINTAINED IN THE VAPOR ENVIRONMENT UNTIL THAWING FOR
TRANSPLANTATION DURING SURGERY.
DO NOT USE THE ALLOGRAFT IF IT HAS BEEN IMMERSED IN LIQUID NITROGEN.
WARNING: INNER CONTENTS MUST NOT BE REMOVED FROM THE OUTER
FIBERBOARD BOX FOR STORAGE. HANDLE WITH CARE AS PACKAGING MATERIAL IS
FRAGILE AT STORAGE TEMPERATURES. CHECK PACKAGING INTEGRITY PRIOR TO
THIS HUMAN ALLOGRAFT IS RECOVERED FROM A DECEASED DONOR WHOSE LEGAL
NEXT-OF-KIN HAS GIVEN PERMISSION FOR THE DONATION. THIS RECOVERY WAS
PERFORMED USING ASEPTIC TECHNIQUES. PROCESSING AND PACKAGING WERE
PERFORMED UNDER ASEPTIC CONDITIONS. TERMINAL STERILIZATION AGENTS
WERE NOT USED IN THE PROCESS.
NO ADDITIONAL STERILIZATION STEP IS TO BE PERFORMED BY THE USER.
CAUTION: RESTRICTED TO USE BY A PHYSICIAN.
DESCRIPTION
This allograft is supplied in single-patient, single-use packaging consisting of two pouches, the innermostof which is filled with cryoprotectant and the allograft. The exterior of the outer pouch is not sterile andmust not be placed on a sterile field. The packaged allograft is stored inside a foam-lined fiberboard box.
This allograft has three dimensions: 1) length of the distended vein segment, 2) diameter of the proximallumen of the vein, and 3) diameter of the distal lumen of the vein. The proximal end of the venous segmentis identified by a prolene suture. This allograft has been cryopreserved and delivered in a liquid nitrogendry shipper.
This saphenous vein allograft was gently flushed with a plasmalyte solution that contains Heparin,Papaverine, and Sodium Bicarbonate to dislodge blood clots and relieve the vein’s smooth muscle spasm.
During processing the vein is continuously and gently flushed, inspected, the venous branches ligated and ifnecessary, superficial repairs made. The allograft was treated with the following antibiotics: Cefoxitin,Lincomycin, Vancomycin, and Polymyxin B. This tissue has been cooled at a controlled rate to the frozenstate and is provided in tissue culture medium with 10% DMSO (Dimethyl Sulfoxide) and 10% Fetal CalfSerum.
INDICATIONS FOR USE
Human cryopreserved vein allografts may be utilized in a number of vascular reconstructive applications.
CONTRAINDICATIONS
Tissues distributed by MTF are contraindicated in the following circumstances: Infection in or around the intended surgical site Previous adverse reactions/outcome to use of allograft vascular products Inability to cooperate with and/or comprehend post-operative instructions ADVERSE EFFECTS
Possible adverse effects of using human tissues include but are not limited to: Undesirable immune reaction to the allograft implant Failure of the allograft to perform as expected Adverse reaction to trace amounts of processing agents Within the United States: Adverse outcomes attributable to the tissue must be promptly reported to
MTF. Outside of the United States: Adverse outcomes attributable to the tissues must be promptly
reported to your local representative.
CAUTIONS
Trace amounts of Heparin, Papaverine, Polymyxin B Sulfate, Cefoxitin, Lincomycin, Vancomycin, DMSO,Sodium Bicarbonate, and Fetal Calf Serum may be present. Caution should be exercised if the recipient isallergic to any of these substances.
The specific antibiotics and reagents used in the dissection and disinfection steps during processing are: Extensive medical screening procedures have been used in the selection of all tissue donors for MTF.
Transmission of infectious diseases such as HIV or Hepatitis, as well as a theoretical risk of theCreutzfeldt-Jakob (CJD) agent, may occur in spite of careful donor selection and serological testing.
TISSUE INFORMATION
ALL ALLOGRAFTS ARE FOR SINGLE PATIENT USE ONLY.
The allografts are not terminally
sterilized. Each allograft is aseptically processed and the finished product passes USP <71> for sterility.
Do not subject allografts to additional sterilization procedures. Do not use portions of an allograft from
one container on multiple patients. If the allograft is not implanted, do not refreeze. Dispose of excess or
unused tissue in accordance with recognized procedures for discarding regulated medical waste materials.
ANY DAMAGED ALLOGRAFT PACKAGING (FIBERBOARD BOX, INNER AND OUTER
POUCHES)
INVOLVED
ALLOGRAFT
RETURNED
INSPECTION.
CONTACT MTF FOR INSTRUCTIONS ON HOW TO RETURN DAMAGED
PACKAGING OR UNUSED ALLOGRAFTS.
PREPARATION OF THE CRYOPRESERVED ALLOGRAFT FOR USE
Before use, the allograft must be thawed and the cryoprotectant must be diluted out of the tissue accordingto the Musculoskeletal Transplant Foundation’s Thawing and Diluting procedure.
completed prior to transplantation into the recipient. The allograft must not be refrozen after thawing.
RECOMMENDED SUPPLIES AND EQUIPMENT
One (1) sterile Kelly clamp, or equivalent One (1) pair sterile DeBakey forceps or equivalent 1000 ml cold (1C to 10C) (D5LR) Lactated Ringer’s with 5% dextrose & bag decanter INSTRUCTIONS FOR USE
The following procedure has been developed to assure the proper thawing rate and passive dilution ofcryoprotectant from the allograft. Maintenance of the saline bath in the range of 37C to 42C allows theallograft to approach physiologic temperatures in a controlled fashion. temperatures above this range may damage the tissue. The two-step dilution protocol reduces cryoprotectants from the allograft, from the original amount of 10%to minimal levels. These steps and final placement of the allograft into the recipient’s heparinized bloodwill help rehydrate the tissue toward an iso-osmotic state. The entire thawing/dilution process should take approximately 23 minutes.
During the thaw procedure, when the frozen cryoprotectant inside the pouch has turned to slushand the entire allograft is freely moveable within its pouch by visual examination, immediatelybegin the dilution phase of the process.
Once the allograft is ready for transplantation, it is recommended that it be immersed in the
recipient's own heparinized blood. In pediatric cases where patient blood volume is critical, the
allograft may be maintained on cold D5LR. Do not allow the allograft to dry out.
NOTE: The use of recipient's own heparinized blood as a final rinsing fluid serves two First, it allows the allograft to return to a more complete osmotic balance before transplantation. Second, it will also further reduce the amount ofresidual calf serum in the allograft added during cryopreservation; calf serum hasbeen suggested to be a heterologous antigen.
If either the inner or outer pouch shows evidence of failure, immediately contact MTF, or ifoutside of the United States, immediately contact your local representative. Do not use theallograft if both pouches show evidence of failure.
THAWING PROCEDURE
The thawing procedure is a non-sterile procedure performed on a back table by OR circulating staff. Priorto removing the allograft from its cryogenic storage location, assemble all needed equipment andcoordinate the timing of the allograft preparation for implantation with the surgeon.
Assemble the large 5000 ml basin, 4 liters of saline and a surgical towel on a non-sterile backtable.
While wearing insulated gloves, retrieve the allograft, in fiberboard box from VAPOR phaseLN2 storage and bring into the operating room. Open the fiberboard box and remove the pouch.
Carefully wipe the frost from the outer pouch with a towel to verify the allograft labelinformation and inspect the pouch for seal integrity. IF THE OUTER POUCH SHOWSEVIDENCE OF FAILURE, IMMEDIATELY CONTACT MTF.
Return the pouch to the open box and allow for initial warming at room temperature for six (6)minutes. Prepare the thawing bath.
Pour three (3) liters of warm saline into the large basin and maintain 37 to 42 C (98 to 108F) by referencing a suitable thermometer for the duration of the thawing procedure. Retain1000 ml of warm saline for later use.
Slowly immerse the pouch in the warm saline bath and continue to thaw the allograft forapproximately five (5) minutes, adding additional warm saline as necessary to maintain 37 to42 C. Gentle swirling of the bath will help to facilitate heat transfer from the graft and expeditethawing.
While the graft is thawing, set up the sterile field for the dilution step.
When the cryoprotectant media around the allograft appears SLUSHY (do not allow the media
to completely thaw), remove the allograft package from the warm saline and gently blot dry
with a towel. NOTE: Open the corner spot welds near the word PEEL and completely dry the
peel pouch at the initiation point.
The circulating nurse opens the outer peel pouch by separating and grasping both flaps betweenthumb and forefinger and peeling apart until the inner pouch is retrievable. Be careful not tocontaminate or damage the sterile inner pouch. NOTE: Make sure to initiate the peelingsequence at the location identified by the “ARROW” and “PEEL”. 10. Aseptically present the allograft to the scrub nurse who will retrieve the inner sterile pouch with the Kelly clamp NOTE: Do not puncture the inner pouch. Handle the pouch only at the outerseams of the package.
DILUTING PROCEDURE
Diluting is a procedure that must be performed using sterile technique.
Open the inner pouch with sterile scissors and carefully transfer the vein and media into the emptysterile 1000 ml basin.
Slowly add approximately 500 ml of the D5LR to the sterile 1000 ml basin containing theallograft and cryoprotectant media. Do not direct the solution onto the allograft. Add theremaining contents to the second sterile 1000 ml basin.
Allow the cryoprotectant to passively dilute from the allograft for 10 minutes, swirlingoccasionally. Secure a cannula to the distal end of the vein (distal end does not have the prolenesuture) with 3-0 silk ligature and then gently flush with D5LR.
Using the sterile DeBakey forceps, transfer the allograft to the second sterile basin containing 500ml of D5LR and periodically swirl basin for the final two (2) minutes of the dilution phase.
Gently and periodically flush with D5LR. The allograft may be maintained in this solution or in
the recipient’s own heparinized blood on cooling slush. Do not allow the allograft to dry out.
DONOR SCREENING & TESTING
Prior to donation, the donor’s medical/social history is screened for medical conditions or disease processesthat would contraindicate the donation of tissues in accordance with current policies and proceduresapproved by the MTF Medical Advisory Board.
Donor blood samples taken at the time of recovery were tested by a CLIA licensed facility for: In addition to the testing listed above, HIV Nucleic Acid Amplification Testing (NAT) was performed.
Furthermore, donors recovered on or after May 1, 2004 were tested for HCV utilizing the HCV NATtesting method.
The results of all serological testing were negative.
determined to be suitable for transplantation.
The infectious disease test results, consent, current donor medical history interview, physical assessment,available relevant medical records to include previous medical history, laboratory test results, autopsy andcoroner reports, if performed, and information obtained from any source or records which may pertain todonor suitability, have been evaluated by an MTF physician and are sufficient to indicate that donorsuitability criteria current at the time of procurement have been met.
transplantation. The donor suitability criteria used to screen this donor are in compliance with the FDAregulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation, asapplicable. All procedures for donor screening, serologic and microbiologic testing meet or exceed currentstandards established by the American Association of Tissue Banks.
PACKAGING AND LABELING
This allograft must not be used under any of the following conditions: If the container or seal is damaged, not intact or has any physical damage If the container label or identifying bar code is severely damaged, not readable or is missing If the inner or outer pouch is not intact If the expiration date shown on the container label has passed If the cryopreserved allograft has NOT been stored at -100°C or colder If either the inner or outer pouch shows evidence of damage, or the storage conditions or container
seals have been compromised, contact MTF or, if outside of the United States, immediately contact
your local representative. Any damaged allograft packaging (fiberboard box, inner and outer
pouches) and allograft must be returned to MTF for inspection.
WARNING: Use insulated gloves when handling the package.
Store this cryopreserved allograft in its fiberboard box at -100 C or colder. The cryopreserved allograft is
shipped and must remain stored in a liquid nitrogen “vapor phase” cryoenvironment (-100 C to -196 C),
but not immersed in liquid nitrogen. Do not store or use the cryopreserved allograft beyond the listed
expiration date. Handle with care as packaging material may become brittle at storage temperatures; do not
drop the frozen allograft. Check packaging integrity prior to use. It is the responsibility of the transplant
facility or clinician to maintain the tissue intended for transplantation in the appropriate recommended
storage conditions prior to transplant.
PATIENT RECORD
Tissue recipient records must be maintained by the consignee and transplant facility for the purpose oftracing tissue post-transplantation to facilitate the investigation of actual or suspected transmission of communicable disease and take appropriate and timely corrective action. A TissueTrace Tracking Formand peel-off labels have been included with each package of tissue. Record the patient name, the name andaddress of the transplant facility, allograft tissue information (using the peel-off labels) and commentsregarding the use of the tissue on the TissueTrace Tracking Form.
Within the United States: Once
completed, the bottom page of the form should be returned to MTF using the self-addressed, postage paidmailer.
Copies of this information should be retained by the transplant facility for future reference.
Outside of the United States: Once completed, the bottom page of the form should be returned to the local
allograft representative or provider. Copies of this information should be retained by the hospital for future
reference.
REFERENCES
Bodnar E, Olsen E, Florio R, Guerreiro D, and Ross D: Heterologous Antigenicity Induced in Human AorticHomografts During Preservation. European Journal of Cardiothoracic Surgery 2:43-47, 1988.
Hopkins, R.A. Cardiac Reconstruction with Allograft Valves. New York: Springer-Verlag, 1989.
Graft, D. and Gonzalez-Lavin, L. “The Homograft: A New Dimension for Cardiac Valve Replacement."AORN Journal 48, 5 (Nov. 1988): 911-917.
O'Brien MF: Panel Discussion II. Journal of Cardiac Surgery 2, No. 1 Supplement: 169, 1987.
Stelzer, P. and Elkins, R.C. "Homograft Valves and Conduits: Applications in Cardiac Surgery." CurrentProblems in Surgery (June 1989): 388-452.
Walsh J: Allograft Heart Valve Thaw and Dilution Protocol Validation, Organ Recovery Systems Inc., July31, 2001.
Current Standards for Tissue Banking, AATB, McLean, VA.
Current Policies and Procedures of MTF, Edison, NJ.
For orders and technical questions Outside of the United States: 1.714.708.1300 All recovery, processing and distribution costs were paid for by MTF, a non-profit organization.
CAUTION: Federal (US) law restricts this allograft to sale, distribution and use by or on the order of a physician
These tissue forms may be covered by one or more of the following US Patents: US 5, 284, 655; US 5,290,558; US 5,728,159; US 6,025,538; US 6,030,635; US 6,111,164; US 6,432,436; US 6,437,018; US 6,448,375; US 6,548,080; US 6,554,863; US 6,830,149; US 6,854,599; US 6,911,212; US 7,019,192; and US 7,045,141. Other Patents pending.
MTF® is a registered trademark of the Musculoskeletal Transplant Foundation.

Source: http://www.mtf.org/documents/PI-49_Rev_0.pdf