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Epidemiologic Notes and Reports Update: Creutzfeldt-Jakob Disease in a Patient Receiving a Cadaveric Dura Mater Graft

CDC and the Food and Drug Administration (FDA) have investigated a case of Creutzfeldt-Jakob disease (CJD) in a 28-year-old woman who died 22 months after receiving a lyophilized, irradiated human cadaveric dura mater graft. They found that the most likely source of the disease was the graft, LYODURA (Lot 2105), produced by B. Braun Melsungen AG, Federal Republic of Germany (1). The CDC/FDA investigators were unable to obtain the identity of the donor of the implicated graft or to trace the disposition of other tissues from this donor. A representative of the producer of LYODURA reported that the company does not maintain records identifying donors and mixes dura from multiple donors during processing of a single lot. As a result of this investigation, FDA issued a Safety Alert on April 28, 1987, recommending disposal of all LYODURA from packages bearing a 4 digit lot number beginning with the digit "2" (the code for material packaged in 1982) as well as all unmarked LYODURA (2).

CDC conducted a telephone survey of 10 other known producers of dura mater used in the United States. All reported maintaining records that allow identification and tracing of each donor of a particular lot of product and of the recipient institution. In addition, it was found that these producers process dura from each donor individually so that there is no contact with or co-mingling of dura from different donors.

Reported by: Center for Devices and Radiological Health, Food and Drug Administration. Hospital Infections Program, Div of Viral Diseases, Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: Because of the differences between the processing of LYODURA and of other products, LYODURA may carry a higher risk of transmitting CJD than other dura mater products used in the United States. As indicated in the FDA Safety Alert, current procedures used to sterilize human dura mater are not adequate to inactivate the CJD agent, and even the most stringent donor screening cannot exclude asymptomatic prepatent carriers of CJD (2). Thus, the use of any human dura mater product carries some risk of transmission of CJD, and procedures that minimize the risk are important. Alternatives to these products, such as autologous fascia or synthetic materials, are available.

The potential for human tissue products to transmit infectious agents has been documented for several procedures other than this single case in a recipient of a dura mater graft. There have been reports of presumed transmission of rabies and CJD by corneal transplantation (3,4), of human immunodeficiency virus (HIV) by organ transplantation (5), and of hepatitis B and HIV by artificial insemination (6,7).

The methods of production and distribution of human tissue products are not routinely subjected to FDA inspection and approval. Health care providers are urged to use human tissue products that have been handled according to strict guidelines such as those established by the American Association of Tissue Banks (8). In addition, hospitals should maintain records so that infections associated with human tissue products can be linked with specific lot numbers of these products.

References

  1. CDC. Rapidly progressive dementia in a patient who received a cadaveric dura mater graft. MMWR 1987;36:49-50, 55.

  2. Food and Drug Administration. FDA safety alert: possibly contaminated dura mater transplant material. Rockville, Maryland: US Department of Health and Human Services, Public Health Service, April 28, 1987.

  3. CDC. Human-to-human transmission of rabies via a corneal transplant-France. MMWR 1980;29:25-6.

  4. Duffy P, Wolf J, Collins G, DeVoe AG, Streeten B, Cowan D. Possible person-to-parson transmission of Creutzfeldt-Jakob disease {Letter}. N Engl J Med 1974;290:692-3.

  5. CDC. Human immunodeficiency virus infection transmitted from an organ donor screened for HIV antibody-North Carolina. MMWR 1987:36:306-8.

  6. Borry WR, Gottesfeld RL, Alter HJ, Vierling JM. Transmission of hepatitis B virus by artificial insemination. JAMA 1987;257:1079-81.

  7. Stewart GJ, Cunningham AL, Dracoll GL, et al. Transmission of human T-cell lymphotropic virus type III (HTLV-III) by artificial insemination by donor. Lancet 1985;2:581-4.

  8. American Association of Tissue Banks. Standards for tissue banking. Arlington, Virginia: American Association of Tissue Banks, 1984.



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