Biodfactor Product Insert

Enhancing Lif e Through Bi rth A wound covering derived from human amnion tissue
Allograft Tissue Information and Product Preparation Insert

evidence of infection due to relevant communicable disease agents and diseases and 2. The results of donor testing for the following relevant communicable disease agents are negative or non reactive: antibodies to the human immunodeficiency virus type 1and type 2 (anti-HIV-1 and anti-HIV-2) HIV-1/Hepatitis C by Transcription Mediated Amplification hepatitis B surface antigen (HBsAg) hepatitis B total core antibody antibodies to the hepatitis C virus (anti-HCV) antibodies to human T-lymphotropic virus type I and type II (anti-HTLV-I and anti-HTLV-II) syphilis using FDA-licensed tests. If the blood sample to be used for syphilis screening is determined and documented to be unacceptable for the screening assay (e.g. hemolysis, sample testing time restriction) then an FDA-licensed treponemal-specific confirmatory assay may be performed instead (e.g. FTA-Abs). All laboratories performing these tests are certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). At the time of recovery, cultures of the tissue are taken and grown out for evaluation. Additionally, a donors medical history and behavior risk assessment, incorporating U.S. Public Health Service guidelines, are obtained prior to donation. Discussions with physicians and/or the donor mother are conducted to identify circumstances that may lead to the exclusion of the donor or donated tissue. The blood sample test results, donor medical history, behavior risk assessment, physical assessment, and information from other sources or records, which may pertain to donor suitability, have been evaluated by a Medical Director. The Medical Director is a licensed physician who completes a comprehensive review of every donor record. The results are used to determine that the donor suitability criteria at the time of tissue recovery have been met, and that the tissue is acceptable for transplantation. The names and addresses of the testing laboratories, the interpretation of all required infectious disease tests, a listing of the documents reviewed as part of the relevant medical records and all pertinent donor medical information can be quickly retrieved upon request for any allograft tissue recovered on the behalf of BioDlogics, LLC.
CONTENTS / HOW SUPPLIED

This package contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. CAUTION: Federal (USA) law restricts this product to sale by or on the order of a licensed physician. The DONATED HUMAN TISSUE has been determined eligible for transplantation by a licensed Medical Director according to the criteria listed in the Donor Selection section below.
RECOVERY
Tissue recovery is aseptically performed by BioRecovery, LLC, an FDA-registered tissue bank,. At the time of recovery, medical records are collected and reviewed as part of donor eligibility.
PRODUCT DESCRIPTION
BioDfactor is a biological wound covering derived from the human placental organ and comes frozen in a vial. If the vial is open, do not use. Included in the packaging along with this insert are a Tracing Record and a set of patient labels. BioDfactor is intended for single patient, one time use only. Once opened, BioDfactor must be used immediately or discarded.
PROCESSING
BioDfactor is processed by BioDlogics, LLC., in a controlled environment using methods designed to prevent contamination and cross-contamination of the products. Technical quality assurance standards are rigorously maintained.
TISSUE DISTRIBUTION
BioDfactor is distributed by BioDlogics, LLC.
TISSUE STORAGE
It is the responsibility of the Tissue Dispensing Service and/or end user to maintain BioDfactor in its original packaging and at 65C or colder until ready for use.
INTRODUCTION
BioDlogics, LLC, is registered with the Food and Drug Administration (FDA) as a manufacturer and distributor of human cells, tissue, and cellular and tissue-based products (HCT/P). All donor recoveries are performed by BioRecovery, LLC, an affiliate of BioDlogics, LLC. BioRecovery, LLC is also registered with the FDA and adheres to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
HCT/P TRACKING
IMPORTANT notice to end-user: Recipient records must be maintained for the purpose of tracing tissue post-transplant per The Joint Commission and FDA requirements. The allograft ID number must be recorded in the operative record. The Tracing Record must be completed and returned to BioDlogics, LLC. Patient labels which include tissue numbers are contained in this package to aid in the tracking process.
DONOR SELECTION
The Medical Director of the registered recovery agency has determined that the donor of the tissue contained in this product is eligible to donate tissue for transplantation based on meeting the following criteria: 1. The results of donor screening indicated that the donor was free from risk factors for and clinical
GENERAL USAGE
BioDfactor is intended for use as a wound covering. This product is an allograft tissue intended for homologous use at the direction of a physician.
LITR-002 REV:H EFFECTIVE:
PRECAUTIONS
1. In order to reduce the risk of complications, BioDfactor should not be implanted in the presence of active infection. In addition, this product should not be used for intravenous or intrathecal applications. 2. Although donor tissue is evaluated and processed following the strict guidelines promulgated by the FDA, the donor screening methods are limited and may not detect all diseases. As with any grafting procedure, complications at the graft site may occur post operatively that are not readily apparent. These include, but are not limited to: transmission of diseases of unknown etiology, transmission of unknown infectious agents such as viruses, bacteria and fungi, immune rejection of or allergic reaction to implanted HCT/P. 3. In addition, in some pregnancies, a rare obstetric emergency referred to as amniotic fluid embolism has been reported in which amniotic fluid, fetal cells, hair or other debris enter the maternal circulatory system resulting in a severe adverse reaction possibly triggered by an anaphylactic reaction to fetal antigens. This condition usually
presents during labor and often results in maternal death.
3. Remove the frozen vial from packaging. DO NOT PLACE on the sterile field. 4. Open vial and aseptically add the following volume of sterile saline: BioDfactor Size 0.25ml BioDfactor 0.5ml BioDfactor 1.25ml BioDfactor Saline Added 0.25ml 0.5ml 0.75ml
ADVERSE REACTIONS
No adverse clinical reactions to this product or any similar human cellular or tissue-based product derived from amnion and processed by BioDlogics have been reported. Adverse reactions or outcomes that potentially involve the use of BioDfactor should be reported immediately to the BioDlogics, LLC Customer Service Department.
5. Replace the vial cap and allow to thaw completely. 6. Once thawed, use a sterile syringe to aseptically remove the complete contents of the vial for presentation onto the surgical field. 7. BioDfactor is ready to use.
RECOMMENDED INSTRUCTIONS FOR USE OF BIODFACTOR

These recommendations are designed only to serve as a general guideline. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care.
RETURN POLICY
BioDlogics, LLC accepts no returns of BioDfactor . NOTE: BioDlogics LLC makes no claims concerning the biological properties of allograft tissue. All tissue has been collected, processed, stored, and distributed in compliance with the FDA regulations governing HCT/Ps. Although every effort has been made to ensure the safety of allograft material, current technologies may not preclude the transmission of disease.
PREPARATION INSTRUCTIONS
1. Maintain BioDfactor at 65C or colder until immediately prior to use. 2. Remove product from cold storage and open the box.
WARNINGS
Do not sterilize. Discard all open and unused portions of the product. Do not use if the vial integrity has been violated, is opened or damaged, or if mishandling has caused possible damage or contamination. Store at -65C or colder. Once the expiration date on the label has been reached, the allograft must be discarded. Each allograft is intended for single patient use, on a single occasion only. Use is limited to specific health professionals (e.g. physicians).
AFTER USE, HANDLE AND DISPOSE OF ALL UNUSED PRODUCT AND PACKAGING IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS.
Donor Procurement and Eligibility Determined by: BioRecovery, LLC 7740A Trinity Road, Suite 107 Cordova, TN 38018 901-417-7868
LITR-002 REV:H EFFECTIVE:
Processed by: BioDlogics, LLC 7740A Trinity Road, Suite 107 Cordova, TN 38018 901-417-7868
7740A Trinity Road, Suite 107 Cordova, TN 38018 901-417-7868 (P) 901-417-7871 (F) www.biodlogics.com

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Biodfactor Product Insert

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Enhancing Lif e Through Bi rth A wound covering derived from human amnion tissue

Allograft Tissue Information and Product Preparation Insert

CONTENTS / HOW SUPPLIED

LITR-002 REV:H EFFECTIVE:

presents during labor and often results in maternal death.

RECOMMENDED INSTRUCTIONS FOR USE OF BIODFACTOR

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