Food and Drug Regulations

Version of section C.04.406 from 2006-12-14 to 2014-10-22:

  •  (1) At the beginning of each plasmapheresis session, a physician or physician substitute shall determine if the donor is suitable to participate in plasmapheresis.

  • (2) If the donor is determined to be temporarily not suitable to participate in plasmapheresis based on the criteria set out in Table 1 or any other medical reason justifying a determination of temporary non-suitability, the fabricator shall cancel the session, inform the donor of the reason why they are temporarily not suitable and indicate the date when the donor may continue to participate in plasmapheresis.

  • (3) If the donor is determined to be not suitable to participate in plasmapheresis for an indefinite period based on the exclusion criteria set out in Table 2 or any other medical reason justifying a determination of indefinite non-suitability, the fabricator shall cancel the session and inform the donor of the reason why they are not suitable to participate in plasmapheresis for an indefinite period.

    TABLE 1

    ItemCriteria
    1Weight of less than 50 kg
    2Temperature outside of normal limits
    3Blood pressure above 100 mmHg diastolic or 180 mmHg systolic
    4Haemoglobin level of less than 125 g/L of blood or haematocrit value of less than 0.38 L/L of blood
    5Total protein level of less than 60 g/L of blood
    6Substantial blood loss
    7Prior donation of plasma or other blood components
    8Pregnancy
    9History of medical or surgical procedures
    10History of convulsions requiring medical treatment
    11Ability to answer questions compromised by alcohol or drug use
    12Prior transfusion of blood, blood components or a blood product, or prior transplantation of a cell, tissue or organ other than dura mater
    13Skin infection at the site of the phlebotomy
    14Sign or symptom of infection
    15Risk of infection with HIV, hepatitis B virus or hepatitis C virus based on, but not limited to, a history of acupuncture, skin piercing, tattooing, accidental needle-stick injury or occasional sexual relations with a person at risk of having any of those infections
    16Current or past use of medication that poses a risk to a recipient of a product manufactured from source plasma
    17Receipt of a live attenuated vaccine
    18Animal bite requiring prophylaxis for rabies or for which the need for post-exposure prophylaxis has not been assessed

    TABLE 2

    ItemExclusion Criteria
    1Abnormal cardiovascular function or serious or chronic cardiovascular disease
    2Abnormal respiratory function or serious or chronic respiratory disease
    3Bleeding disorder that poses a risk to the donor in relation to plasmapheresis
    4Serious disease or medical condition of the liver, kidneys, another organ, a system or blood
    5Persistent abnormal plasma proteins including monoclonal or polyclonal gammopathy
    6Current or past use of medication that poses an ongoing risk to a recipient of a product manufactured from source plasma
    7History of recurrent fainting associated with the donation of blood or plasma
    8History, signs or symptoms of injectable drug abuse such as skin punctures, scars or sharing needles to inject drugs
    9History, signs or symptoms of AIDS or HIV infection
    10Risk of HIV infection based on sexual practices
    11History, signs or symptoms of a chronic or persistent infection or parasitic disease transmissible by blood
    12History, signs or symptoms of hepatitis, other than hepatitis A
    13Cancer, other than non-melanoma skin cancer or in-situ cervical cancer
    14Risk factor for Creutzfeldt-Jacob disease (CJD) or its variant (vCJD) based on, but not limited to, the receipt of dura mater transplant or a treatment using a human pituitary hormone
    15Positive test result for any transmissible disease agent
  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 3;
  • SOR/2006-353, s. 1.
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