Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003.

  • United States. Congress. Senate. Committee on Governmental Affairs.
Date:
2003
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Credit: Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003. Source: Wellcome Collection.

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    Committee on Governmental Affairs Se CryoLife’ Inc. Biotechnalogies for Medicine™ May 15, 2002 Mr. Ballard H. Graham District Director, HFE-SEI60 Food and Drug Administration 60 Bigkth Street Atlanta, GA 30309 Re: Initial reply to Notice of Inspectiona! Observations (483) from Inspection of 3/23/02- 4N12N2 (FEL # 3001451326). Dear Mr. Graham: This submission is in reply to the inspectional observations in the Notice of Inspectional Observations (Notice) issued by investigators C. Brooks, K, Coleman, H. Bester, R. Jackson, and Microbiologist P. Bonneau as a result of the above-cited inspection of CryoLife, Inc., a registered tissue bank (Reg. # FEL 3001451326) and medical device manufacturer (Reg. # 1063481) located at 1655 Roberts Bivd, NW, Kennesaw, GA 30144. First, I would like to comment on the professional, interactive nature of the inspection. Tt is clear that the tissue processing industry faces challenges induced by certain sensationalizing of events in the national media. A‘ the outset of this inspection we were informed that the agency's purpose was to investigate two alleged heart valve endocarditis events associated with CryoLife- preserved allograft valves. Under the circumstances, the inspection might have devolved into confusion and acrimony. However, the investigators exhibited willingness and forbearance to discuss the observations, issues, and CryoLife positions openly and thoroughly throughout the inspection. While it is clear that there are some major differences in the positions stated by CryoLife and FDA, as representec by the investigators, CryoLife nonetheless appreciates the consideration extended by the investigators and local distcct. CryoLife cooperated fully with this inspection although we noted that these two claims by a single surgeon alleging that heart vaives supplied by CryoLife resulted in endocarditis infection in his two patients were isolated cases and there was no pattern of similar complaints and there was no historical basis for assuming a significant public health risk. The valves in question were implanted a significant period of time prior to the onset of symptoms claimed by the reporting surgeon (in the first case the implant was 5 months prior to symptoms and 8 months prior to the complaint; the second was implanted a year pricr to the symptoms and complaint). The second complaint had barely been received by CryoLife and we had not yet had the opportunity te initiate our own investigation. In both cases, the investigation conducted by CryoLife revealed, by pathology data submitted by the reporting surgeon's own hospital as well as other review, that the CryoLife-supplied heart valves were not infected. This supported CryoLife's initial hypothesis that the valves were not involved. . 1655 Roberts Boulevard, NW > Kennesaw, Georgia 30144 770-419-3255 + 1-800-438-8285 in tha USA and Conada * Fax: 770-426-003)