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ART and the FDA

Posted Oct 21 2008 12:20am
You may be wondering what the Food and Drug Administration has to do with Assisted Reproduction Technology. In May of 2004 (actually there were some notations before this time as well) guidelines were drawn up for clinics in the United States of America to follow regarding testing of Egg Donors, Sperm Donors and Carriers. Some of this testing really threw off timing of the cycles for a while...certain tests needed certain results back before certain procedures could be completed....confusing as heck for a while. To top that off the FDA put together a team of professionals to audit files and procedures regarding the records of these guidelines, without any warning. They could enter a clinic and ask to see a senior staff member and get to work inspecting the files and interviewing the employees. By 2005 some of these guidelines were amended because it was near impossible to get the labs to complete most test results and have them back to the clinic in a timely manner. Below is a short example of what is expected:
Sec. 1271.75 How do I screen a donor?

(a) All donors . Except as provided under 1271.90, if you are the establishment that performs donor screening, you must screen a donor of cells or tissue by reviewing the donor's relevant medical records for:

(1) Risk factors for, and clinical evidence of, relevant communicable disease agents and diseases, including:

(i) Human immunodeficiency virus;

(ii) Hepatitis B virus;

(iii) Hepatitis C virus;

(iv) Human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease;

(v) Treponema pallidum ; and

(2) Communicable disease risks associated with xenotransplantation.

(b) Donors of viable, leukocyte-rich cells or tissue . In addition to the relevant communicable disease agents and diseases for which screening is required under paragraph (a) of this section, and except as provided under 1271.90, you must screen the donor of viable, leukocyte-rich cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of relevant cell-associated communicable disease agents and diseases, including Human T-lymphotropic virus.

(c) Donors of reproductive cells or tissue . In addition to the relevant communicable disease agents and diseases for which screening is required under paragraphs (a) and (b) of this section, as applicable, and except as provided under 1271.90, you must screen the donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of infection due to relevant communicable diseases of the genitourinary tract. Such screening must include screening for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section. However, if the reproductive cells or tissues are recovered by a method that ensures freedom from contamination of the cells or tissue by infectious disease organisms that may be present in the genitourinary tract, then screening for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section is not required. Communicable disease agents of the genitourinary tract for which you must screen include:

(1) Chlamydia trachomatis ; and

(2) Neisseria gonorrhea .

(d) Ineligible donors . You must determine ineligible a donor who is identified as having either of the following:

(1) A risk factor for or clinical evidence of any of the relevant communicable disease agents or diseases for which screening is required under paragraphs (a)(1), (b), or (c) of this section; or

(2) Any communicable disease risk associated with xenotransplantation.

(e) Abbreviated procedure for repeat donors . If you have performed a complete donor screening procedure on a living donor within the previous 6 months, you may use an abbreviated donor screening procedure on repeat donations. The abbreviated procedure must determine and document any changes in the donor's medical history since the previous donation that would make the donor ineligible, including relevant social behavior.

[66 FR 5466, Jan. 19, 2001, as amended at 71 FR 14798, Mar. 24, 2006]

As you can see this was amended in 2006....Could you understand all that? You can find more of the same onInfertility Answers, LLC - ART and the FDA. As dry as all this FDA stuff might be, it is a great idea to know what is expected of the clinic and ultimately of YOU as you enter the wonderful world of ART and IVF!

Sharon
www.InfertilityAnswers.net

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