THE AMNIOTIC MEMBRANE AS AN ALTERNATIVE DRESSING: NEW REGULATORY ADVANCES
Keywords:
Burn, Biological dressings, Amniotic membraneAbstract
Introduction: Brazil is the only country in South America that does not have regulations for the
distribution of amniotic membrane (AM) for clinical use. This tissue is widely accepted as an
alternative biological dressing in major burns and in other fields of medicine. Methods:
communication reports between the Skin Bank of Porto Alegre and the health authorities, technical
notes and the current regulations that involve the procedures for the clinical use of the amniotic
membrane were reviewed. Results: like all human tissue, the donation of MA is legally permitted, in
light of the Transplantation Law. Last year, according to opinion No 12/2021, the CFM stated
thatthere was scientific support for its clinical use, on a non-experimental basis. At the moment, the
liberation of AM use is awaiting approval by the SNT and CONITEC. Conclusion: regulation of the
amniotic membrane could provide an adequate, low-cost and highly available biological dressing.
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