Legal Issues Involving Tissue Grafting for Eye Surgery

Human amniotic membrane provides a valuable tissue for use in eye surgery. The medical and legal issues of tissue grafting with amniotic tissue often involve the proper use of this membrane for a variety of ocular surgical procedures.

Processing of amniotic tissue is an important consideration when evaluating proper use. Al tissue harvested must meet stringent criteria for donor screening and laboratory testing. This aspect is essential to reduce the risk of transmission of infectious diseases. The standards for obtaining and processing amniotic membranes for eye surgery are established by the American Association of Tissue Banks (AATB) and the United States Food and Drug Administration (FDA).

Full informed consent of mothers of newborn children is needed to obtain amniotic tissue for medical use. Donors must agree to an extensive medical history, family history, and social history. Donors who provide a history of certain medical problems, genetic familial diseases, or social activities that include high-risk sexual activity can be excluded as tissue donors. Potential donors are screened for a number of infectious diseases including human immunodeficiency virus, syphilis, cytomegalovirus, as well as Hepatitis B and C. Companies that offer amniotic tissue have the responsibility to meet public health guidelines to determine appropriate donor suitability.

Strict criteria are utilized used to process and sterilize amniotic tissue form ophthalmic use. Established quality-control methods are used to thoroughly clean and sterilize amniotic tissue. It is important that all residues be elimination and sterilization that does not lead to deleterious effects of the tissue be utilized. Antibiotics are often used to maintain sterilization of processed tissue.

The site of implantation in the eye needs to meet specific requirements. The presence of active infection is a contraindication to the use of amniotic tissue. Patients who have excessive dry eyes or other condition that may lead to a high-risk of post-operative complications or graft rejection are usually not ideal recipients for amniotic tissue graft.

Proper preparation and reconstitution of amniotic tissue graft is essential for successful implantation. Aseptic technique is vital to prevent contamination of the graft and the receptive field for tissue grafting. It is important to utilize sterile instruments and to avoid touching the inner packaging containing the graft from touching anything outside the sterile field. Proper placement of the amniotic tissue graft involves identification of the basement membrane of the graft by embossed lettering and position within the pouch. The FDA also requires proper recordkeeping for recipients who have had tissue grafting for eye surgery.

Return to Ocular Expert Home Page from Legal Issues Involving Tissue Grafting for Eye Surgery

This entry was published in Ocular Surgery. Bookmark the permalink.

Comments are closed.