Download Adverse Tissue Reaction Policy

Department(s): Infection Control
Effective Date:
Policy Title: Adverse Tissue Reaction
(Tissue Look Back Policy)
Review Dates:
Page 1 of 1
POLICY:
All suspected adverse tissue reactions or known incidents of tissue contamination or
infection will be investigated to prevent disease transmission.
PROCEDURE:
Adverse Event Reporting:
1. Adverse Patient Reactions Reporting to the Donor Source Facility/Manufacturer
A. All potential adverse events, including disease transmission or other
complication(s), suspected of being directly related to tissue use must be
reported to the manufacturer or source facility. Reporting will also be conducted
through the FDA’s Med Watch Program with Med Watch form 3500 utilized.
B. Identification criteria for suspected tissue adverse reactions will follow the
structure outlined in the Med Watch reporting form 3500. The infection control
practitioner will work with the source facility/manufacturer to identify criteria
specific to the tissue and location of implantation, however general symptoms
may include:
a. Increased temperature
b. Mental status changes
c. Increased white blood cell count
d. Pain and inflammation at or around implantation site
e. General malaise, fatigue
f. Hepatic function changes
2. Investigation of Potential Disease Transmission from the Donor Source
Facility/Manufacturer to the patient
A. Any tissue reported by the manufacturer or source facility as the cause of
possible infection or tissue involved in an event that may have contaminated
the product will be sequestered.
B. Patients receiving tissue from donors who have been identified as positive for
HIV, HTLV-I/II, viral hepatitis, or other infectious agents (including bacterial or
fungal) known to be transmissible by tissue shall be identified and informed of
infection risk.
C. Risk Management will be immediately notified of any suspected or identified
adverse tissue reaction or event. This includes, but is not limited to adverse
events involving possible serious injury, disease transmission or death
D. The source facility/manufacturer will be notified immediately (no less than one
business day) upon determination of an adverse event.
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