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Plasma Exchange
A Clear Road to Results for MG and GBS Patients
Overview MG GBS How It Works Safety Resources References

Patient Safety

Plasma exchange is known to be safe and well tolerated, with the majority of reactions being mild, easily treated and of limited duration. (Winters, 2012)



Vascular Access

The type of vascular access chosen can impact the safety of the procedure. Plasma exchange on the Spectra Optia system can be performed via peripheral or central access, as well as on an outpatient or inpatient basis. Not all patients may be able to receive peripheral access, so a venous assessment should be performed by a qualified healthcare professional to determine optimal access for each patient.



Contraindications

There are no known contraindications for the system's use, except for those associated with all automated apheresis systems. The infusion of certain solutions and replacement fluids may be contraindicated in some patients.


Adverse Events (AEs) in Recent Literature

The World Apheresis Association registry data update of over 50,000 therapeutic apheresis procedures reported that 94.2 percent of patients did not experience any adverse event. Of the 5.8 percent of patients who did experience AEs, the type and severity of reactions is detailed below: (Mortzell Henriksson et al., 2016)

  • 2.4% Mild (tolerated without medication): access issues, device malfunctions, hypotension, tingling
  • 3.0% Moderate (needed medication due to AE): tingling, urticaria, hypotension, nausea
  • 0.4% Severe (interrupted due to AE): syncope/hypotension, urticaria, chills/fever, arrhythmia/asystole, nausea/vomiting

Use of Apheresis

Apheresis therapy is restricted to prescription use only. Operators must be familiar with the system's operating instructions, and qualified medical personnel must perform procedures. A supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus as long as he or she remains immediately available. (ASFA Guidelines, 2007)

For all other warnings and cautions associated with the Spectra Optia system, please refer to the safety information and the operator’s manual.


Safety Information

Contraindications

  • No known contraindications for the system's use, except for those associated with all automated apheresis systems
  • The infusion of certain solutions and replacement fluids may be contraindicated in some patients

Possible patient reactions

  • Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension and allergic reactions

Reactions to transfused blood products can include1

  • Fever, circulatory overload, shock, allergic reactions, alloimmunization, graft-versus-host disease and transmission of infection

Restricted to prescription use only

  • Operators must be familiar with the system's operating instructions
  • Procedures must be performed by qualified medical personnel
  • A supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus as long as he or she remains immediately available2

1AABB (ed.), et al., Circular of Information for the Use of Human Blood and Blood Components. 2006, tenth edition, Council of Europe Publishing, Seattle, WA.

2American Society for Apheresis. Guidelines for therapeutic apheresis clinical privileges. J Clin Apher. 2007;22(3):181-182.



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International Content. Approved labeling, indications and instructions may vary by country. Reference the Instructions for Use labeling for a complete listing of indications, warnings and precautions.

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