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Food and Drug Regulations

Version of section C.04.409 from 2006-12-14 to 2014-10-22:

 A fabricator who conducts a plasmapheresis session shall

  • (a) use aseptic methods and a sterile collection system licensed under the Medical Devices Regulations;

  • (b) ensure that all surfaces intended to come into contact with blood or plasma are pyrogen free;

  • (c) ensure that the donor’s skin where the phlebotomy is to be made is

    • (i) determined to be free from lesion, rash or other source of infection, and

    • (ii) cleaned and disinfected; and

  • (d) ensure that emergency medical personnel are capable of attending to the medical needs of the donor within 10 minutes after being contacted by the fabricator.

  • SOR/78-545, s. 1
  • SOR/85-1022, s. 4
  • SOR/2006-353, s. 1

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