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
Licence: Public Domain Mark
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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![slaw ANEVVEN LA sini DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION TASTRICT ADORESS AND PHONE MUSGER GATERS) OF EPESTION 03/25/2002 - 04/12/2602 60 Eighth Street NE Atlanta, GA 320309 (404) 253-1261 Fax: (404} 253-1202 Rae ANO TILE GF INDIVIDUAL TO WHOM REPORT ISSUED 10;: James C. Vander Wyk, VP of Quality Assurance/Regulatory Affairs PRM MAME STREET ACORESS Cryolife Inc 1655 Roberts Bivd Nw GTY, STATE, ZIP GOCE, COUNTRY “TYPE ESTABLIGHOAENT INSPECTED Kennesaw, GA 30144 Medical Device Manufacturer/HumanTissue Processor 2 3001451326 DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: 2) Review of complaint #01-5210090 revealed a specimen was received for testing on 10/5/01. This specimen was mishandled. A memo was written to the file dated 1/16/02, (approximately 3 months later) that attempted to explain the series of events. EQUIPMENT | H. Records/documentation review of the record for the Stomacher reveaied the following: 1) The firm failed to perform Installation Qualifications on the Stomachers (E0113F-purchased 10/16/00 and E01138-date unknown). 2) The firm does not have a maintenance program for the two Stomachers (E0113E and E0113F), Made] 80 used in the processing of humas tissue. The manufacturer's maintenance manual states in part: “ *** It is recommended that the following routine checks be carried out every 6 months unless local regulations or Code of Practice require more frequent service intervals. If the instrument is used very extensively, ¢.g., double shift werking in a laboratory, then the frequency should be increased to monthly intervals. *** The checks that the mammal recommends include but is not limited to the following: 1) Functional Check: 2) Electrical Check and 3) Mechanical Check. OBSERVATION 12 Records fail to be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particalar tissue involved. ~ Specifically, Records/documentation review revealed that the Standard Operating Procedures (SOPs- QS270, QS 2720, QS 2750/ were not followed. This review revealed the following: 1) Tissue allografts from Donor #{46305, 46308, 46310, 46313, 46315) were under processed for time periods ranging from 39-45 minutes. The firm SOPs states that the minimum time for antibiotic treatment is 22 hours (heart and orthopedic tissue allografts} and 8 hours for vascular tissue allografts. 2) SOP QA-0001 was not followed. The Material Review Board made a decision to approve the tissue allografts for use. *** Materal Review Board documentation should be complete and explicit enough to reflect the requirement, the departure from the requirement, the disposition, the rationale for the disposition and the root cause, as necessary, without any further documentation. 3) There were five products (P0206, PVO0O0(x2)}, AVO0, and MV10) from the four donors that were released and stipped for implantation OATE ISSVED SEE REVERSE OF THIS PAGE 04/12/2002 : Py RALS. SEE : FORMAIDA 453 (07/603 PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS. PAGE TOF 2 PAGES C- 00625](https://iiif.wellcomecollection.org/image/b32221514_0121.jp2/full/800%2C/0/default.jpg)
