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

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
BODY CONTACT		CONTACT DURATION	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