Description
Dehydrated Human Amniotic Membrane Allografts
AmbioDry Amniotic Membrane Allografts are dehydrated, decellularized, sterilized human
amniotic membrane tissue grafts.
Recovery & Quality Control
All tissue recovered meets stringent specifications during donor
screening and laboratory testing to reduce the risk of transmitting
infectious disease. AmbioDry amniotic membrane allografts are procured and processed
according to standards established by the American Association of
Tissue Banks (AATB) and the United States Food & Drug Administration
(FDA). All tissues are recovered under full informed consent of
the donors (represented by the mothers of the newborn children).
The donors have consented to transfer of the allografts to third
parties. A thorough medical and social history of the donor is also
obtained, including detailed family history. The donor is screened
for:
| Blood Type & Rh Factor |
|
|
| Antibody Screen |
HTLV-1 Antibody |
Hepatitis Core Antibody |
| HIV-1 Antibody |
HTLV-2 Antibody |
Hepatitis B Surface Antigen |
| HIV-2 Antibody |
Syphilis Screen |
Hepatitis C Virus Antibody |
| NAT HIV-1 & 2 |
Cytomegalovirus |
Alanine Amino Transferase |
Additionally, the following tests are performed on the blood from
the umbilical cord of the newborn:
| Blood Type & Rh Factor |
CBC with Differential |
Aerobic Bacterial Culture |
All tests results are reviewed prior to the release of the tissue.
Only tissue from donors that have a normal CBC, test
negative for serology and bacteriology and test negative
or non-reactive for infectious diseases and contamination
are released.
The infectious disease test results, together with the consent documents,
donor medical history and behavior risk assessment according to current
public health services guidelines, physical assessment, available
relevant medical records, as well as information from other sources
or records which may pertain to donor suitability, along with tissue
procurement test results, have been evaluated and are sufficient to
indicate that the donor suitability criteria current at this time
of tissue recovery have been met. This allograft has been
determined to be suitable for transplantation.
The names and addresses of the testing laboratories, the listing and
interpretation of all required infectious disease tests, a listing
of the documents reviewed as part of the relevant medical records,
and the name of the person or establishment determining the suitability
of this allograft are on file and available upon request.
AmbioDry Specifications
Human amniotic membrane is a unique, thin, collagenous membrane derived
from the placenta, the area in which the human fetus grows and develops
within the mother’s uterus. Human amniotic membrane consists
of collagen layers including: (1) basement membrane; (2) stromal matrix.
AmbioDry is a dehydrated, decellularized, substrate-free human
amniotic membrane allograft. Each allograft has been sterilized
and packaged in a double peel-pouch packaging configuration. In
its dry state, AmbioDry amniotic membrane allografts are thin, moderately translucent
and extremely lightweight.
Allograft Processing/Preservation/Sterilization
AmbioDry amniotic membrane allografts are processed and sterilized based upon strict,
quality-controlled protocols. Each allograft is thoroughly cleaned
using a process that leaves no deleterious residue and eliminates
antigenic potential. An additional assurance of safety is achieved
by terminally sterilizing each allograft. Based upon validations,
the sterilization level used effectively sterilizes the allograft
without causing adverse effects to the biomechanical properties
of the collagen.
Contraindications
AmbioDry should not be implanted into:
- areas with active or latent infection; and/or
- into a patient with a disorder that would create an unacceptable
risk of post-operative complications.
Preparation, Reconstitution and Surgical Use
Prior to surgery, carefully follow the AmbioDry™ allograft preparation
steps below:
- The outer peel pouch is NOT considered sterile. The inner pouch,
which contains the allograft, is considered sterile (unless the
pouches are damaged or compromised).
- Carefully open the peelable, corner of the outer pouch and present
the inner pouch onto the sterile field. Ensure that the inner
pouch does not come in contact with any portions of non-sterile
surface of the outer pouch.
- Take visual notice of the allograft within the contents of the
inner peel pouch. Note that each AmbioDry amniotic membrane allograft is packaged
with the stromal matrix side down to or in contact with the metallic
side of the pouch. The basement membrane side is packaged FACE
UP or away from the metallic side of the pouch.
- In the sterile field, SLOWLY peel a corner of the inner peel
pouch and allow the surgeon to grasp the allograft with fingers
or non-toothed forceps. PLEASE TAKE GREAT CARE WHEN REMOVING THE
ALLOGRAFT FROM THE INTERNAL POUCH. THE ALLOGRAFT IS THIN, TRANSLUCENT
AND EXTREMELY LIGHTWEIGHT.
- If side orientation of the allograft to the surgical site is
deemed significant by the surgeon, it is important that, while
handling the allograft and before applying to the surgical site,
the surgeon should track and maintain visual identification of
the stromal and basement side orientations. If side-orientation
is lost during manipulation, the surgeon can identify the STROMAL
membrane by noting, under magnification, the CONVEX, or “bumpy”,
grid pattern on the tissue. Conversely, the BASEMENT matrix can
be identified by noting the CONCAVE, or recessed, grid pattern
on the tissue.
- In its dry state and prior to hydration, the surgeon may cut
the allograft with sharp scissors to the appropriate and approximate
sized required.
- The allograft should then be place on the surgical site. If
applicable, the stromal side should be in contact with the surgical
site; the basement side should face away from the surgical site.
- The allograft can then be hydrated while on the surgical site
with sterile saline solution. Simply apply several drops of sterile
solution to the allograft at one to two minute intervals for a
period of 5 to 10 minutes. During and following hydration, the
grid pattern on the allograft will begin to fade. It may take
several minutes for the grid pattern to completely fade away.
- Following the recommended hydration period, the surgeon should
monitor the effect of hydration by visual inspection and while
manipulating the allograft. Some allografts may take slightly
longer to hydrate.
- Absorbable or non-absorbable suture material can be used to
fix AmbioDry amniotic membrane allografts.
Precautions/Warnings
- AmbioDry amniotic membrane allografts remain sterile and non-pyrogenic in an
unopened, undamaged package. Please inspect the integrity of the
package upon receipt. If sterile barrier appears defective or
damaged in any way, immediately contact the distributor.
- This allograft is intended for single-patient use only, performed
by physician or surgeon. Discard all unused material. DO NOT RE-STERILIZE.
- 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.
- Discard all damaged, mishandled or potentially contaminated
tissue.
Adverse Effects & Reporting
- As with any surgical procedure, the possibility of infection
exists.
- Dedicated processing and sterilization methods are employed
to eliminate antigenic properties 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 immediately
reported to OKTO Ophtho.
Recommended Storage
AmbioDry amniotic membrane allografts should be stored in a clean, dry environment
at controlled room temperature of 10º C to 29º C (50º
to 85º F).
Recipient Tracking
The F.D.A requires that recipient records be maintained for the
purpose of tracing the allograft following surgical transplantation.
The surgeon or operating staff member must complete the enclosed
Allograft Utilization Record, attach a peel-off, allograft-tracking
label provided, and mail to the distributor (postage-paid). Please
use the remaining peel-off, allograft-tracking labels for patient
and hospital records.
Caution: Federal law (U.S.A.) restricts this unit
to sale by or on the order of a physician.
OKTO Ophtho and its affiliates supply this
allograft without any express or implied warranties. All statements
or descriptions are informational only and not made or given as
a warranty of the allograft in any way. OKTO Ophtho and its affiliates
make no guarantee whatsoever concerning the biological or biomechanical
properties of the allograft. The user shall be solely responsible
for determining the adequacy and appropriateness of the allograft
for any and all uses to which the user shall apply the allograft.
AmbioDry is a trademark of OKTO Ophtho.
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