Description
Tutoplast Processed Sclera is a solvent dehydrated, gamma-irradiated
preserved human Sclera.
Recovery
All tissue recovered meets stringent specifications during
donor screening and laboratory testing to reduce the risk
of transmitting infectious disease.
Processing
The processing of all Tutoplast tissue consists of a strict,
quality-controlled procedure, which involves thorough cleaning,
processing, dehydration, and preservation.
The process leaves no deleterious residue and minimizes antigenic
potential. Additional assurance of sterility is achieved with
the use of a target of 25 kGy (2.5 Mrads) of gamma radiation.
Based on previous trials with gamma irradiation, the level
used in the Tutoplast process effectively significant adverse
effect on the biomechanical properties of the tissue.
Indications
Tutoplast Processed Sclera is indicated for implantation
with a specific spectrum of indications.
- Connective tissue graft replacement for a wide range of
ophthalmology surgical applications.
- The repair and/or replacement of the host scleral function.
Contraindications
- Implantation into areas with active or latent infection
or signs of tissue necrosis.
- Implantation into areas with a compromised circulation.
- Any disorder which would create an unacceptable risk of
post-operative complications.
Precautions
- Tutoplast Processed Sclera remains sterile and non-pyrogenic
as long as the package is not opened and/or damaged. The
graft must be used before the expiration date.
- Appropriate placement and fixation are critical factors
in the avoidance of potentially adverse effects on graft
service life.
- The adsorption process and reformation of endogenous tissue
begins one to two days after implantation and continues
for weeks, months, or years, depending on the size of the
graft and the responsiveness of the graft site.
Utilization/Implantation
- It is recommended that Tutoplast Processed Sclera be rehydrated
prior to use by soaking in 0.9% saline solution for 5 to
30 minutes, depending on the consistency desired, using
aseptic/sterile technique.
- Tutoplast Processed Sclera is packaged in various sizes
(length and width). The size of the section used should
correspond to the size of the respective defect.
- The surgeon should monitor the effect of rehydration by
visual inspection after completing the rehydration and while
cutting and shaping the allograft.
- Implantation should be preformed in such a way that the
free edges of the implant do not extend into areas where
the possibility of adhesion may present a problem.
- Absorbable or nonabsorbable suture material can be used
to fix Tutoplast Processed Sclera.
- For a Continuous suture, absorbable suture material and
round atraumatic needle are recommended.
- Suture gauge depends on the surgical indication.
- The suture should be located two to millimeters from the
edge of the graft.
- Better results are obtained by doubling the section at
suture sites that are under moderate to high stress.
Warnings
- Tutoplast Processed tissues have been used for over 25
years in more than 750,000 surgical transplant cases with
an outstanding safety record. As with all biological products,
it is not possible to give an absolute guarantee of freedom
of transmitting infectious diseases such as hepatitis and
CJD. Processed treatments shown to be capable of reducing
the risk of any transmission as well as strict donor screening
and laboratory testing are used to decrease the risk.
- The reaction of the body to any allograft is not completely
understood.
- Discard all damaged or mishandled grafts or when possible
contamination of the graft has occurred.
- Return all packages with flaws in the sterile barrier
to the supplier.
- Unused tissue should be properly discarded.
- DO NOT RE-STERILIZE.
- Single patient use only.
Adverse Effects
- As with any surgical procedure, the possibility of infection
exists.
- Although the Tutoplast process is designed to eliminate
antigenic properties of the graft, the possibility of rejection
is present in any allograft procedure.
- Reoperation could be necessary to correct adverse effects.
- Adverse reactions should be immediately reported to Tutogen
Medical, U.S., Inc.
Sterilization
- This graft has been sterilized by a target of 25 kGy (2.5
Mrads) of gamma radiation to provide sterility throughout
the unit.
- The Packaging of all sterile products should be inspected
for flaws in the sterile barrier before opening. In the
presence of such a flaw, the product must be assumed nonsterile.
- Care should be taken to prevent contamination of the graft.
In the event of such contamination, this product must be
discarded.
- If the package has been opened, but the product is not
used, the graft must not be resterilized and must therefore
be discarded.
Storage
This product should be stored in a clean, dry place at controlled
room temperature of 15*C to 30* C (59* to 86* F).
Caution: Federal Law (U.S.A.) restricts this device to sale
or use only by a licensed physician
IOP, Inc. distributes this tissue without any express or
warranties. All statements or descriptions are informational
only and not made or given as a warranty of the tissue in
any way. IOP, Inc. makes no guarantee whatsoever concerning
the biologic or biomechanical properties of the tissue. The
user shall be solely responsible for determining the adequacy
and appropriateness of the tissue for any and all uses to
which the user shall apply the tissue.
Blood from this donor was tested and found to be negative
or non-reactive for the following tests, among others: HIV-1&2,
Hepatitis B Surface Antigen, Hepatitis C Antibody, HTLV-1,
STS (syphilis).
The infectious disease test results, together with the consent
documents, donor medical history and behavior risk assessment
according to current public health service 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 by Tutogen Medical, U.S., Inc. and are
sufficient to indicate that the donor suitability criteria
current at the time of tissue recovery have been met. 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 establishing
determining the suitability of this human tissue are on file
at Tutogen Medical, U.S., Inc. and are available upon request.
This allograft has been determined to be suitable for Transplantation.
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