EPIFIX® Dehydrated Human Amnion/Chorion Membrane (dHACM) Allograft is a placental-based tissue product that acts as a semi-permeable protective barrier that supports the healing cascade.
• Protects the wound bed to aid in the development of granulation tissue
• Provides a human biocompatible extracellular matrix
• Retains over 300 regulatory proteins
• Terminally sterilized for an additional level of safety
• Room temperature storage for up to five years shelf life
• Compatible with negative pressure wound therapy (NPWT) and hyperbaric oxygen therapy (HBO)
EPIFIX® is intended for homologous use in the treatment of acute and chronic wounds to provide a protective barrier and support the healing process.
EPIFIX® should not be used on (1) areas with active or latent infection and/or (2) a patient with a disorder that would create an unacceptable risk of post-operative complications.
EPIFIX® allografts remain suitable for transplantation in an unopened, undamaged package, under proper storage conditions.
Please inspect the integrity of the package upon receipt. If package and contents appear defective or damaged in any way, immediately contact the distributor.
This allograft is intended for single-patient use only. Discard all unused material.
The procedure should be performed by an authorized medical professional.
Strict donor screening and laboratory testing, along with dedicated processing and sterilization methods, are employed to reduce the risk of any disease transmission. However, as with all biological implants, an absolute guarantee of tissue safety is not possible. This allograft has the potential to transmit infectious disease to the recipient.
The reaction of the body to any biological implant is not completely understood.
Caution should be used when treating patients with a known sensitivity to aminoglycoside antibiotics.
Discard all damaged, mishandled or potentially contaminated tissue.
This product has not been tested in combination with other products.
Do not re-sterilize.
As with any procedure, the possibility of infection exists.
Proprietary processing and validated sterilization methods are employed to eliminate potential deleterious components of the allograft. However, as with all biological implants, the possibility of rejection exists.
Any adverse reactions, including the suspected transmission of disease attributable to this allograft, should be reported immediately to MIMEDX®.
EPIFIX® allografts should be stored in a clean, dry environment at room temperature.
EPIFIX® allografts have a five year shelf life. Check the label for the expiration date.
Moderate/Highly Exudating Wounds
Preparation, Reconstitution and Surgical Use: Prior to implantation, carefully follow the EPIFIX® allograft preparation steps below using aseptic technique: Wound Bed Preparation Ensure the wound is free from clinical sign of infection. Prepare wound bed as needed. Removing EPIFIX® from Packaging The outer peel pouch is not sterile. The inner pouch that contains EPIFIX® is sterile (unless the pouches are damaged or compromised). Carefully open the peelable corner of the outer pouch and extract the inner pouch using aseptic technique. Ensure the inner pouch does not come in contact with any portions of non-sterile surface of the outer pouch. Using aseptic technique, slowly peel a corner of the inner peel pouch and allow the authorized medical professional to grasp EPIFIX® with fingers or non-toothed, sterile forceps. Use EPIFIX® promptly after opening the inner, sterile pouch. Please take great care when removing EPIFIX® from the internal pouch. EPIFIX® is thin and extremely lightweight. EPIFIX® Preparation In a dry state, use sterile dry scissors to cut EPIFIX® to fit within the wound margins. It is acceptable to overlap the wound margins with EPIFIX® by 1mm. If needed, EPIFIX® can be fenestrated to accommodate wounds that produce copious amounts of exudate. EPIFIX® can be applied wet or dry. EPIFIX® can be hydrated while on the wound site with sterile saline solution. Simply apply several drops of sterile solution to EPIFIX®. During and following hydration, the embossment on EPIFIX® will begin to fade. EPIFIX® Orientation & Application EPIFIX® should be placed on the wound site, using the orientation of the embossment lettering as a guide. Proper orientation of EPIFIX® can be noted when the embossment nomenclature reads correctly from left to right. Absorbable, non-absorbable suture material and/or tissue adhesives can be used to fixate EPIFIX® to the site of application or itself if desired. Support Therapies EPIFIX® is compatible with offloading/compression/negative pressure therapies. EPIFIX® can be used in conjunction with hyperbaric oxygen therapy.
Primary Dressing EPIFIX® should be covered with a non-adherent contact layer. EPIFIX® should not be disturbed, if possible, for several days or before the next application, if needed. If an infection occurs at the graft site, treat infection per institution’s protocol. Secondary Dressing EPIFIX® requires a moist wound environment. Use appropriate moisture management dressings for the wound type and treatment ideology.
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