CDC and Dura Mater Part 2

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The CDC sure was busy on Feb. 26, 1999 updated these stories...I wonder why?

June 05, 1987 / 36(21);324-325

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

CDC. Rapidly progressive dementia in a patient who received a cadaveric dura

mater graft. MMWR 1987;36:49-50, 55.

Food and Drug Administration. FDA safety alert: possibly contaminated dura

mater transplant material. Rockville, land: US Department of Health and

Human Services, Public Health Service, April 28, 1987.

CDC. Human-to-human transmission of rabies via a corneal transplant-France.

MMWR 1980;29:25-6.

Duffy P, Wolf J, 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.

CDC. Human immunodeficiency virus infection transmitted from an organ donor

screened for HIV antibody-North Carolina. MMWR 1987:36:306-8.

Borry WR, Gottesfeld RL, Alter HJ, Vierling JM. Transmission of hepatitis B

virus by artificial insemination. JAMA 1987;257:1079-81.

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.

American Association of Tissue Banks. Standards for tissue banking. Arlington,

Virginia: American Association of Tissue Banks, 1984.

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