A guide to potential immunotoxic effects that might be associated with medical device materials.

Ref: http://www.fda.gov/cdrh/ost/ostggp/immunotox.html#T1

BODY CONTACT

CONTACT DURATION

IMMUNOTOXIC EFFECTS

1

2

3

4

5

Surface Devices -

Skin

A

pmbx

 

x

 

 

B

pmbx

x

x

x

x

C

pmbx

x

x

x

x

Mucosal Membranes

A

pmbx

 

x

 

 

B

pmbx

pmbx

mbx

x

x

C

pmbx

pmbx

mbx

mbx

mbx

Breached or Compromised Surface

A

pmbx

 

x

 

 

B

pmbx

pmbx

mbx

mbx

mbx

C

pmbx

pmbx

mbx

mbx

mbx

External Communicating Devices -

External devices that contact the circulating blood (e.g. dialyzers and immunoadsorbents); or the blood path indirectly at one point and serve as a conduit for entry into the vascular system (e.g. solution and blood administration sets); or tissue/bone/dentin (e.g. skin staples, laparoscopes, dental filling materials)

Blood Path,
Direct and Indirect

A

pmbx

 

x

 

 

B

pmbx

pmbx

mbx

pmbx

mbx

C

pmbx

pmbx

mbx

pmbx

mbx

Tissue/Bone/Dentin Communicating

A

pmbx

 

x

 

 

B

pmbx

cpmbx

mbx

pmbx

mbx

C

pmbx

cpmbx

mbx

pmbx

mbx

Implant Devices -

Tissue/Bone, Blood, and other Body Fluids

A

pmbx

 

x

 

 

B

pmbx

cpmbx

mbx

pmbx

mbx

C

pmbx

cpmbx

mbx

pmbx

mbx

 

A = Limited ( </= 24 hrs)
B = Prolonged (>24 hrs to 30 days)
C = Permanent (>30 days)

1 = Hypersensitivity
2 = Chronic Inflammation
3 = Immunosuppression
4 = Immunostimulation
5 = Autoimmunity

Effects Expected for Various Materials:
Plastics & Other Polymers = p
Metals = m
Ceramics, Glasses, Composites = c
Biological Materials = b
Other Materials (Specify) = x