Food and Drug Regulations

C.04.409 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.