Department(s): Infection Control

/

Effective Date:

Policy Title: Adverse Tissue Reaction

(Tissue Look Back Policy) /

Review Dates:

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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
  1. All potential adverse events, including disease transmission or other complication(s), suspected ofbeing 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.
  2. Identification criteria for suspected tissue adverse reactionswill 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:
  3. Increased temperature
  4. Mental status changes
  5. Increased white blood cell count
  6. Pain and inflammation at or around implantation site
  7. General malaise, fatigue
  8. Hepatic function changes
  1. Investigation of Potential Disease Transmission from the Donor Source Facility/Manufacturer to the patient
  2. 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.
  3. 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.
  4. 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
  5. The source facility/manufacturer will be notified immediately (no less than one business day) upon determination of an adverse event.

200 Hoods Lane | P.O. Box 1168 | Marblehead, MA01945 |

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