- 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.
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- http://www.fdanews.com/newsletter/article? issueId=10961&articleId=100706
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- Ulatowski's warning, found here,
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- http://www.fda.gov/foi/warning_letters/s6540c.htm
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- 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.
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- 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.
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- 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.
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- 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17, 2000, though their parents had signed outdated and unapproved consent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.
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- 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.
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- 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.
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- Kagan and the Shriners Hospital were next warned for
failing to report and accurately document unanticipated and anticipated
adverse device events.
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- 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.
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- The FDA also questioned why the cultured skin substitute
experiments were performed only in select situations in which grafting
were needed.
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- 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.
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- Kaplan and the Shriners Hospital were given a 15 day
deadline to provide:
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- ·proof that they have corrected these violations
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- ·a plan to prevent future violations
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- ·a complete list of all clinical trials for the
past five years
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- 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.
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- 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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- All copies of material reprinted or duplicated from by
Sandy Frost must include the following credit line:
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- From http://sandyfrost.newsvine.com Copyright ©
2007 by Sandy Frost. Used by permission.
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- Visit Sandy at:
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- http://sandyfrost.newsvine.com/
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- http://thecassandrafrostcollection.blogspot.com/
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