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In November, 2001, three patients in Minnesota, including Brian Lykins, died shortly after having routine knee surgery. These deaths triggered an investigation by the Minnesota Department of Heath and the United States Centers For Disease Control and Prevention. The investigation exhaustively examined all of the circumstances of three deaths, looking at all personnel involved in the care of the patients, the medicines, equipment and supplies used, and the hospital buildings themselves. In Brian’s case, the investigation ultimately centered on a piece of tissue obtained from a cadaver (an allograft) which had been implanted in Brian’s left knee. Cultures obtained from Brian’s body revealed the presence of an anaerobic bacteria called Clostridium sordelli.

The source of the bacteria was traced by the CDC back to the allograft which had been manufactured and sold by Cryolife, Inc. The CDC discovered that the cadaver which had supplied the tissue had not been refrigerated for at least 19 hours after death. This was well outside the time allowed by the tissue industry standards for harvesting tissue from cadavers which had not been refrigerated. The harvesting of the tissue from the cadaver did not begin until at least 23½ hours after death. Cryolife still had 19 pieces of tissue in its inventory which were also intended to be sold and implanted into human patients. The CDC found that 2 of these tissues were also contaminated with the same Clostridium sordelli bacteria which had killed Brian Lykins. Clostridium bacteria was also found in the fluid in which some the tissues were bathed. The tissues became contaminated from bacteria in the cadaver’s gastrointestinal tract which had spread throughout the cadaver after death. The 19 hours that the cadaver was not refrigerated enhanced the likelihood of contamination.

The CDC then began a larger investigation of the problem of bacterial contamination of orthopedic allografts by soliciting reports of allograft associated infections from physicians around the country. The preliminary results of this investigation were published by the CDC on March 15, 2002. The CDC reported that in the United States in 1999, approximately 650,000 musculoskeletal allografts were distributed by all tissue processors. (Cryolife claimed in July, 2002 that since it was established in 1984 it has shipped a total of 12,000 orthopedic allografts). The CDC identified 26 cases of contaminated orthopedic allografts causing infections in the patients who received them. (The number of reported cases is now up 54 as of June 2002, half involving Cryolife). 13 of the 26 cases identified in the CDC preliminary report involved contamination by a species of Clostridium, either Clostridium sordelli or Clostridium septicum. Over half of the tissues found to be contaminated were manufactured and sold by Cryolife. Cryolife was additionally responsible for 85% of the cases of Clostridium contamination. The CDC attributed this to the fact that Cryolife failed to culture the cadaver tissue it bought for bacterial contaminants before immersing the tissue in antibiotics.

The CDC made a series of recommendations to Cryolife to reduce its rate of infection (a number of which were rejected by Cryolife). The recommendations were as follows:

A sporicidal method of bacterial decontamination should be used where possible. If not possible, appropriate warnings as to lack of sterility should be given to health care professionals regarding the risk for bacterial infection.
If sporicidal methods of bacterial decontamination are not available, steps to minimize the risk of bacterial contamination should be undertaken:

Cultures for bacterial contamination should taken before placement of tissue in antibiotic solutions (pre-processing culturing);
A positive pre-processing culture should result in the automatic destruction of all tissue from that donor which cannot be sterilized;
Validation of culture methods were required to ensure that residual antibiotics do not result in false negative culture results. Performing both destructive and swab cultures should be considered.
Recommended time limits for tissue harvesting should be followed.

A report of infection from the allograft should result in the quarantine of remaining tissue from that donor until it is verified that the tissue is not the source of the infection.
Immediately contact physicians who received allografts from the same donor where there is an allograft implicated infection.
Inventory samples prepared by the same processing method should be tested by an independent facility using validated methods when there is a contamination report.
Cryolife should conduct an audit of its inventory to determine the proportion of unreleased tissue which might be contaminated with microorganisms or spores.

You can go to the CDC website and review the full report by clicking here:

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5110a2.htm

You can also review at the CDC website an earlier investigation (1997) of a contaminated allograft sold by Cryolife by clicking here:

http://www.cdc.gov/mmwr/preview/mmwrhtml/00046991.htm

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Cryolife: The Smoking Guns

CDC Investigation Summary