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The FDA News reported today that Timothy A. Ulatowski, Director of the Office of Compliance for the Center for Devices and Radiological Health, sent a warning letter to Dr. Richard J. Kagan, chief of staff at the Cincinnati Shriners Hospital, for violating FDA regulations.
Ulatowski's warning, found here, explains that the Cincinnati Shriners Hospital conducted a "Burn Wound Repair with Cultured Skin Substitutes" study to develop a cultured skin substitute (CSS) for burn wound repair. The hospital submitted a FDA application for premarket approval and the agency held an on-site inspection from March 16 to June 21, 2006 to verify that the Shriners Hospital's study data was scientifically valid and accurate, complied with federal regulations and was obtained while protecting human subjects from undue hazard or risk.
The Cincinnati district office conducted a three month investigation and found "objectionable conditions" as well as serious violations of FDA regulations regarding Investigational Device Exemptions (IDE) and Protection of Human Subjects.
Kagan and the Shriners Hospital were warned for failing to obtain informed consent, failing to report and accurately document unanticipated and anticipated adverse device events and failing to maintain accurate and complete case histories for each subject.
On September 6, 2000, the Institutional Review Board (IRB) approved the informed consent form (ICF) to be signed by the parents enrolling their burned children in the hospital's study. The study included data obtained from burned children enrolled from April 15, 1998 to July 17, 2000, though their parents had signed outdated and unapproved consent forms.
An audit of the study's investigational plans revealed that post operative data as well as engraftment assessments were found to be incomplete, performed on incorrect days or not completed at all.
Additionally, an audit of subjects' records found that no wound cultures were obtained at the required times, nor were the grafts taken or completed within the specified time frames.
Kagan and the Shriners Hospital were next warned for failing to report and accurately document unanticipated and anticipated adverse device events.
An audit of ten burned children's records found that none of their unanticipated adverse events or skin graft failures were listed in their case report forms (CRF) or reported to the IRB. Some of these adverse events included development of necrotic or dead tissue, pneumonia and elevated temperatures.
The FDA also questioned why the cultured skin substitute experiments were performed only in select situations in which grafting were needed.
Kagan and the Shriners Hospitals finally warned for failing to maintain accurate and complete case histories for each subject. Audited records found incomplete and inaccurate case report forms including missing Site Biopsy Logs and blank photography logs.
Kaplan and the Shriners Hospital were given a 15 day deadline to provide:
•proof that they have corrected these violations
•a plan to prevent future violations
•a complete list of all clinical trials for the past five years
The FDA News, provider of domestic and international regulatory, legislative and business news and information for executives in industries regulated by the U.S. Food and Drug Administration, reported that Kagan did not respond to requests for comment by press time.
The Shriners Hospitals is a 501c3 charity made up of 22 hospitals that provide free medical care to qualified burned or crippled children.
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